Mental Health IssueNCT06415370
Food and Friends: Healthy Meals Delivered to You
A study testing Home Delivered Healthy Meals, In-person "friendly visits" and Student Companion calls in people with Mental Health Issue and Food Insecurity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if home delivered healthy meals (HDHM) with or without (intervention vs. control) social interaction can impact mental health and food security in adults aged 65 and older who live alone and have trouble accessing food. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mental Health Issue, Food Insecurity
- What is being tested?
- Home Delivered Healthy Meals, In-person "friendly visits" and Student Companion calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 and older
- Live alone
- Screen positive for food insecurity or have a medical professional concerned about their food security
- Diagnosed with at least 1 diet-related chronic illness
- Be a Medicaid/Medicare dual beneficiary
- Speak English
- Have a microwave
Who cannot join
- Diagnosis of dementia/Alzheimer's
- Presence of illness or allergies that would preclude consuming HDHM
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 275499
About this study
Official title: Examining the Relationship Between Home-Delivered Healthy Meals to Seniors and Social Connectedness: A Mixed Methods Study
The goal of this clinical trial is to learn if home delivered healthy meals (HDHM) with or without (intervention vs. control) social interaction can impact mental health and food security in adults aged 65 and older who live alone and have trouble accessing food.
The main questions it aims to answer are:
Read more
Does HDHM with or without social interaction change the quality of participant food intake? Does HDHM with or without social interaction change the loneliness that participants may experience? Does HDHM with or without social interaction change the depression that participants may experience?
Researchers will compare a group that receives HDHM only to a group that receives HDHM and social interaction to see if there is a difference between the two groups in their experienced loneliness and depression, and the quality of food that they eat.
Participants will receive 12 weeks' worth of HDHM delivered to their home. Half of the participants will receive weekly phone calls from volunteer student "companions) Participants will also be asked to complete questionnaires over the phone at three timepoints (baseline, 6 weeks, and 12 weeks) during the study. Some participants may also be asked to give their opinions on the program via a telephone conversation.
Read the detailed description
This study is a randomized control trial (RCT) to measure the impact of a combined social interaction and culturally tailored home delivered healthy meals (HDHM) intervention on participants' mental health and food insecurity compared to those in the control group receiving HDHM alone. In addition, the study aims to test the feasibility of including structured, consistent social interactions as part of HDHM.
This study will include a sample size of 60 participants. Participants in the study will be randomized to a HDHM only group (control), or HDHM with social interactions group (intervention). All participants will receive HDHM (a frozen meal product based on the Mediterranean Diet adapted for United States Southeastern taste preferences) for 12 weeks.
The study team will collect data from participants at baseline, 6 weeks, and 12 weeks via a telephone-administered survey.
A subgroup of 10 participants (5 from the intervention, 5 from the control group) will participate in informant interviews to assess feasibility.
- Conditions
- Mental Health Issue, Food Insecurity
- Being tested
- Home Delivered Healthy Meals, In-person "friendly visits", Student Companion calls
- Keywords
- Food Insecurity, Mental Health, Seniors
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Delivered Healthy MealsBehavioural
In-person delivery of HDHM at least one time weekly for 12 weeks.
In-person "friendly visits"Behavioural
"Friendly visits" last approximately 5-10 minutes and include brief "wellness check" questions such as, "How are you doing today?" "Did you try [HDHM recipe] yesterday- how did it taste? Any suggestions for future flavors?" "What are some of the things you plan to do in the next few days?" "Is there anything else you want to share with me?"
Student Companion callsBehavioural
Student Companions call participants at least one time weekly to provide telephone reassurance- i.e., checking on the participant's well-being. These calls may also include referrals to appropriate resources such as NCCARE 360 (statewide network that connects individuals with complex health and social needs, to community resources and service)
| Study group | Role | What they receive |
|---|---|---|
| HDHM and Social Interaction (Intervention) | Experimental | Home delivered healthy meals are delivered in-person, including a "friendly visit" with the participant if the participant desires. Student companions will also contact participants at least one time weekly for telephone reassurance and to provide resource referrals. Receives: Behavioral: Home Delivered Healthy Meals; Behavioral: In-person "friendly visits"; Behavioral: Student Companion calls |
| HDHM Only (Control) | Experimental | Home delivered healthy meals are delivered directly to the participant or dropped off at the participant's home in a cooler at their front door if they are not available. Any interaction will be limited. Receives: Behavioral: Home Delivered Healthy Meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Adult Food Security Score
Food security status will be assessed using the United States Adult Food Security Survey Module- a 10-item measure that assesses a person's ability to access food. Questions include topics such as having enough food in the house, running out of food due to lack of money, skipping meals, and reducing portion sizes. Scoring range is from 0-10. A higher score represents a lower food security status. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change of Adult Food Security Score
Food security status will be assessed using the United States Adult Food Security Survey Module- a 10-item measure that assesses a person's ability to access food. Questions include topics such as having enough food in the house, running out of food due to lack of money, skipping meals, and reducing portion sizes. Scoring range is from 0-10. A higher score represents a lower food security status. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Fruit Eaten Per Day
Total cups of fruit eaten per day will be assessed using question 1 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("On average, how many total cups (use your fist as a measure of a cup) of fruit do you eat each day? Count all that you eat whether in a combination dish or by itself"). Scoring range is categorical, with the following answer choices: 0; ½; 1; 1 ½ ; 2; 2 ½; 3; 3 ½; 4 or more. A higher score represents a greater amount of fruit consumed. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Fruit Eaten Per Day
Total cups of fruit eaten per day will be assessed using question 1 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("On average, how many total cups (use your fist as a measure of a cup) of fruit do you eat each day? Count all that you eat whether in a combination dish or by itself"). Scoring range is categorical, with the following answer choices: 0; ½; 1; 1 ½ ; 2; 2 ½; 3; 3 ½; 4 or more. A higher score represents a greater amount of fruit consumed. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Vegetables Eaten Per Day
Total cups of vegetables eaten per day will be assessed using question 2 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("On average, how many total cups (use your fist as a measure of a cup) of vegetables do you eat each day? Count all that you eat whether in a combination dish or by itself"). Scoring range is categorical, with the following answer choices: 0; ½; 1; 1 ½ ; 2; 2 ½; 3; 3 ½; 4 or more. A higher score represents a greater amount of vegetables consumed. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Vegetables Eaten Per Day
Total cups of vegetables eaten per day will be assessed using question 2 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("On average, how many total cups (use your fist as a measure of a cup) of vegetables do you eat each day? Count all that you eat whether in a combination dish or by itself"). Scoring range is categorical, with the following answer choices: 0; ½; 1; 1 ½ ; 2; 2 ½; 3; 3 ½; 4 or more. A higher score represents a greater amount of vegetables consumed. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Water Consumed Per Day
Frequency of water consumed per day will be assessed using question 3 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you drink water (count tap, bottled, or sparkling water)?"). Scoring range is from 0-4. A higher score represents a greater frequency of water consumption. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Water Consumed Per Day
Frequency of water consumed per day will be assessed using question 3 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you drink water (count tap, bottled, or sparkling water)?"). Scoring range is from 0-4. A higher score represents a greater frequency of water consumption. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Soda Consumed Per Day
Frequency of soda consumed per day will be assessed using question 4 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you drink regular (not diet) soda?"). Scoring range is from 0-4. A higher score represents a greater frequency of soda consumption. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Soda Consumed Per Day
Frequency of soda consumed per day will be assessed using question 4 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you drink regular (not diet) soda?"). Scoring range is from 0-4. A higher score represents a greater frequency of soda consumption. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Usage of 1% Milk, Skim Milk, and/or Low-fat Yogurt Per Day
Usage of 1% milk, skim milk, and/or low-fat yogurt per day will be assessed using question 5 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you use 1% milk, skim milk, and/or low-fat yogurt?"). Scoring range is from 0-4. A higher score represents a greater usage of 1% milk, skim milk, and/or low-fat yogurt. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Usage of 1% Milk, Skim Milk, and/or Low-fat Yogurt Per Day
Usage of 1% milk, skim milk, and/or low-fat yogurt per day will be assessed using question 5 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you use 1% milk, skim milk, and/or low-fat yogurt?"). Scoring range is from 0-4. A higher score represents a greater usage of 1% milk, skim milk, and/or low-fat yogurt. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Fruit Per Day
Frequency of consumption of greater than 1 kind of fruit per day will be assessed using question 6 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you eat more than one kind of fruit each day (apple, peach, berries, etc.)"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming more than one fruit per day. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Fruit Per Day
Frequency of consumption of greater than 1 kind of fruit per day will be assessed using question 6 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you eat more than one kind of fruit each day (apple, peach, berries, etc.)"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming more than one fruit per day. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Vegetable Per Day
Frequency of consumption of greater than 1 kind of vegetable per day will be assessed using question 7 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you eat more than one kind of vegetable each day (carrots, corn, green beans, etc.)"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming more than one vegetable per day. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Vegetable Per Day (Baseline to Week 6)
Frequency of consumption of greater than 1 kind of vegetable per day will be assessed using question 7 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you eat more than one kind of vegetable each day (carrots, corn, green beans, etc.)"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming more than one vegetable per day. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Healthy Food Option Consideration
How often someone considers healthy food choices when deciding what to eat will be assessed using question 8 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("When deciding what to eat, how often do you think about healthy food choices?"). Scoring range is from 0-4. A higher score represents a greater frequency considering healthy food choices when deciding what to eat. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Healthy Food Option Consideration
How often someone considers healthy food choices when deciding what to eat will be assessed using question 8 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("When deciding what to eat, how often do you think about healthy food choices?"). Scoring range is from 0-4. A higher score represents a greater frequency considering healthy food choices when deciding what to eat. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Usage of "Nutrition Facts" Label
How often someone uses a "Nutrition Facts" label to when making food choices will be assessed using question 9 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you use the "Nutrition Facts" on the food label to make food choices?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the "Nutrition Facts" when making food choices. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Usage of "Nutrition Facts" Label
How often someone uses a "Nutrition Facts" label to when making food choices will be assessed using question 9 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you use the "Nutrition Facts" on the food label to make food choices?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the "Nutrition Facts" when making food choices. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Consideration of Food Label (Salt/Sodium)
How often someone uses a food label to select food with less salt or sodium will be assessed using question 10 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less salt or sodium?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less salt or sodium. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Consideration of Food Label (Salt/Sodium)
How often someone uses a food label to select food with less salt or sodium will be assessed using question 10 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less salt or sodium?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less salt or sodium. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Consideration of Food Label (Sugar)
How often someone uses a food label to select food with less or no added sugar will be assessed using question 11 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less or no added sugar?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less or no added sugar. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Consideration of Food Label (Sugar)
How often someone uses a food label to select food with less or no added sugar will be assessed using question 11 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less or no added sugar?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less or no added sugar. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Consideration of Food Label (Fat)
How often someone uses a food label to select food with less saturated fat will be assessed using question 12 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less saturated fat?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less saturated fat. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Consideration of Food Label (Fat)
How often someone uses a food label to select food with less saturated fat will be assessed using question 12 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less saturated fat?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less saturated fat. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Whole Grain Consumption
How often someone consumes whole grain instead of white or enriched flour ones will be assessed using question 13 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you eat whole grains (whole wheat bread, whole wheat tortillas, brown rice, oatmeal, etc.) in place of white or enriched flour ones?"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming whole grains instead of white or enriched flour ones. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Whole Grain Consumption
How often someone consumes whole grain instead of white or enriched flour ones will be assessed using question 13 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you eat whole grains (whole wheat bread, whole wheat tortillas, brown rice, oatmeal, etc.) in place of white or enriched flour ones?"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming whole grains instead of white or enriched flour ones. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Meal Preparation
How often someone prepares meals at home will be assessed using question 14 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you prepare meals at home?"). Scoring range is from 0-4. A higher score represents a greater frequency of preparing meals at home. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Meal Preparation
How often someone prepares meals at home will be assessed using question 14 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you prepare meals at home?"). Scoring range is from 0-4. A higher score represents a greater frequency of preparing meals at home. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Strength Training
How often someone includes strength training when they exercise will be assessed using question 19 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you include strength training when you exercise?"). Scoring range is from 0-4. A higher score represents a greater frequency of strength training. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Strength Training
How often someone includes strength training when they exercise will be assessed using question 19 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you include strength training when you exercise?"). Scoring range is from 0-4. A higher score represents a greater frequency of strength training. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Food Frequency Assessment- Physical Activity
Participants' amount of physical activity will be assessed using question 20 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How much physical activity (exercise) do you do in a day?"). Scoring is categorical, with the following answer choices: 0-20 minutes; 21-30 minutes; 31-40 minutes; 41-60 minutes; more than 60 minutes. A higher score represents a greater amount of physical activity. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Food Frequency Assessment- Physical Activity
Participants' amount of physical activity will be assessed using question 20 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How much physical activity (exercise) do you do in a day?"). Scoring is categorical, with the following answer choices: 0-20 minutes; 21-30 minutes; 31-40 minutes; 41-60 minutes; more than 60 minutes. A higher score represents a greater amount of physical activity. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change of PRAPARE Score
Distinct social determinant of health risks will be assessed using the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experience (PRAPARE) assessment- a 21-item measure that assesses a participant's various social determinant of health risk responses. Questions include topics such as housing status, work situations, level of education, and others. Scoring range is from 0-22, with a higher score representing a higher amount of risks present. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change of PRAPARE Score
Distinct social determinant of health risks will be assessed using the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experience (PRAPARE) assessment- a 21-item measure that assesses a participant's various social determinant of health risk responses. Questions include topics such as housing status, work situations, level of education, and others. Scoring range is from 0-22, with a higher score representing a higher amount of risks present. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in Patient Health Questionaire-8
Depressive symptoms will be assessed using the Patient Health Questionnaire-8, an 8-item measure that assesses the number of days a person has experienced various symptoms of depression over the past two weeks. Questions include assessing how often a participant has had little to no interest in doing things, how often they feel down, depressed, irritable, or hopeless, etc. Scoring range is from 0-24. A higher score means greater depressive symptoms. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in Patient Health Questionaire-8
Depressive symptoms will be assessed using the Patient Health Questionnaire-8, an 8-item measure that assesses the number of days a person has experienced various symptoms of depression over the past two weeks. Questions include assessing how often a participant has had little to no interest in doing things, how often they feel down, depressed, irritable, or hopeless, etc. Scoring range is from 0-24. A higher score means greater depressive symptoms. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Mean Change in sum of University of California- Los Angeles Loneliness Scale Short form
Loneliness will be assessed using the University of California- Los Angeles Loneliness Scale Short Form, a 6 item measure that assesses how often participants feel left out or not connected to other people. Scoring range is from 3-9. A higher score means greater loneliness. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Median Change in sum of University of California- Los Angeles Loneliness Scale Short form
Loneliness will be assessed using the University of California- Los Angeles Loneliness Scale Short Form, a 6 item measure that assesses how often participants feel left out or not connected to other people. Scoring range is from 3-9. A higher score means greater loneliness. Assessed at baseline, week 6, and week 12.
Measured: Baseline up to week 12
Number of successful HDHM Deliveries made to participants in control group
Program feasibility will be assessed using the number of successful HDHM deliveries made to participants during the study. This is defined as the delivery driver being able to deliver the HDHM to the participant's residence. A higher number of successful deliveries indicate greater feasibility.
Measured: Baseline up to week 12
Number of successful HDHM Deliveries and Social Interactions made to participants in intervention group
Program feasibility will be assessed using the number of successful HDHM deliveries including "friendly visits" made to intervention participant's homes during the study. This is defined as the delivery driver being able to deliver the HDHM to the participant's residence and complete a brief social interaction. A higher number of successful deliveries indicates greater feasibility of the program.
Measured: Baseline up to week 12
Number of HDHM meals consumed by participants weekly
Program feasibility will be assessed using the number of meals consumed by participants per week. A higher number of meals consumed indicates greater feasibility of the program.
Measured: Baseline up to week 12
Duration of Student Companion Calls
Program feasibility will be assessed using the duration of Student Companion calls that take place during the study for participants in the intervention group. Duration will be assessed in minutes per week. A higher number of minutes indicates greater feasibility of the program.
Measured: Baseline up to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start14 Aug 2024
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Humana Foundation
- Responsible party
- Sponsor
- Investigators
- Lindsey Haynes-Maslow, PhD, MHA, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415370
- Sponsor's protocol ID
- 24-0190
- Status last verified
- Feb 2025
- First submitted
- 10 May 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Relationship Between Home-Delivered Healthy Meals to Seniors and Social Connectedness: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT06415370
- Acronym / sponsor ID
- 24-0190
- Conditions
- Mental Health Issue, Food Insecurity
- Keywords
- Food Insecurity, Mental Health, Seniors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Humana Foundation
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if home delivered healthy meals (HDHM) with or without (intervention vs. control) social interaction can impact mental health and food security in adults aged 65 and older who live alone and have trouble accessing food.
The main questions it aims to answer are:
Does HDHM with or without social interaction change the quality of participant food intake? Does HDHM with or without social interaction change the loneliness that participants may experience? Does HDHM with or without social interaction change the depression that participants may experience?
Researchers will compare a group that receives HDHM only to a group that receives HDHM and social interaction to see if there is a difference between the two groups in their experienced loneliness and depression, and the quality of food that they eat.
Participants will receive 12 weeks' worth of HDHM delivered to their home. Half of the participants will receive weekly phone calls from volunteer student "companions) Participants will also be asked to complete questionnaires over the phone at three timepoints (baseline, 6 weeks, and 12 weeks) during the study. Some participants may also be asked to give their opinions on the program via a telephone conversation.
Detailed description
This study is a randomized control trial (RCT) to measure the impact of a combined social interaction and culturally tailored home delivered healthy meals (HDHM) intervention on participants' mental health and food insecurity compared to those in the control group receiving HDHM alone. In addition, the study aims to test the feasibility of including structured, consistent social interactions as part of HDHM.
This study will include a sample size of 60 participants. Participants in the study will be randomized to a HDHM only group (control), or HDHM with social interactions group (intervention). All participants will receive HDHM (a frozen meal product based on the Mediterranean Diet adapted for United States Southeastern taste preferences) for 12 weeks.
The study team will collect data from participants at baseline, 6 weeks, and 12 weeks via a telephone-administered survey.
A subgroup of 10 participants (5 from the intervention, 5 from the control group) will participate in informant interviews to assess feasibility.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HDHM and Social Interaction (Intervention) | Experimental | Behavioral: Home Delivered Healthy Meals, Behavioral: In-person "friendly visits", Behavioral: Student Companion callsHome delivered healthy meals are delivered in-person, including a "friendly visit" with the participant if the participant desires. Student companions will also contact participants at least one time weekly for telephone reassurance and to provide resource referrals. |
| HDHM Only (Control) | Experimental | Behavioral: Home Delivered Healthy MealsHome delivered healthy meals are delivered directly to the participant or dropped off at the participant's home in a cooler at their front door if they are not available. Any interaction will be limited. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 65 and older
- Live alone
- Screen positive for food insecurity or have a medical professional concerned about their food security
- Diagnosed with at least 1 diet-related chronic illness
- Be a Medicaid/Medicare dual beneficiary
Key exclusion criteria (2 listed)
- Diagnosis of dementia/Alzheimer's
- Presence of illness or allergies that would preclude consuming HDHM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Delivered Healthy MealsIn-person delivery of HDHM at least one time weekly for 12 weeks. | Behavioural | HDHM Only (Control), HDHM and Social Interaction (Intervention) |
| In-person "friendly visits""Friendly visits" last approximately 5-10 minutes and include brief "wellness check" questions such as, "How are you doing today?" "Did you try [HDHM recipe] yesterday- how did it taste? Any suggestions for future flavors?" "What are some of the things you plan to do in the next few days?" "Is there anything else you want to share with me?" | Behavioural | HDHM and Social Interaction (Intervention) |
| Student Companion callsStudent Companions call participants at least one time weekly to provide telephone reassurance- i.e., checking on the participant's well-being. These calls may also include referrals to appropriate resources such as NCCARE 360 (statewide network that connects individuals with complex health and social needs, to community resources and service) | Behavioural | HDHM and Social Interaction (Intervention) |
Primary outcome
Mean Change in Adult Food Security Score
Time frame: Baseline up to week 12
Food security status will be assessed using the United States Adult Food Security Survey Module- a 10-item measure that assesses a person's ability to access food. Questions include topics such as having enough food in the house, running out of food due to lack of money, skipping meals, and reducing portion sizes. Scoring range is from 0-10. A higher score represents a lower food security status. Assessed at baseline, week 6, and week 12.
Median Change of Adult Food Security Score
Time frame: Baseline up to week 12
Food security status will be assessed using the United States Adult Food Security Survey Module- a 10-item measure that assesses a person's ability to access food. Questions include topics such as having enough food in the house, running out of food due to lack of money, skipping meals, and reducing portion sizes. Scoring range is from 0-10. A higher score represents a lower food security status. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Fruit Eaten Per Day
Time frame: Baseline up to week 12
Total cups of fruit eaten per day will be assessed using question 1 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("On average, how many total cups (use your fist as a measure of a cup) of fruit do you eat each day? Count all that you eat whether in a combination dish or by itself"). Scoring range is categorical, with the following answer choices: 0; ½; 1; 1 ½ ; 2; 2 ½; 3; 3 ½; 4 or more. A higher score represents a greater amount of fruit consumed. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Fruit Eaten Per Day
Time frame: Baseline up to week 12
Total cups of fruit eaten per day will be assessed using question 1 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("On average, how many total cups (use your fist as a measure of a cup) of fruit do you eat each day? Count all that you eat whether in a combination dish or by itself"). Scoring range is categorical, with the following answer choices: 0; ½; 1; 1 ½ ; 2; 2 ½; 3; 3 ½; 4 or more. A higher score represents a greater amount of fruit consumed. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Vegetables Eaten Per Day
Time frame: Baseline up to week 12
Total cups of vegetables eaten per day will be assessed using question 2 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("On average, how many total cups (use your fist as a measure of a cup) of vegetables do you eat each day? Count all that you eat whether in a combination dish or by itself"). Scoring range is categorical, with the following answer choices: 0; ½; 1; 1 ½ ; 2; 2 ½; 3; 3 ½; 4 or more. A higher score represents a greater amount of vegetables consumed. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Vegetables Eaten Per Day
Time frame: Baseline up to week 12
Total cups of vegetables eaten per day will be assessed using question 2 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("On average, how many total cups (use your fist as a measure of a cup) of vegetables do you eat each day? Count all that you eat whether in a combination dish or by itself"). Scoring range is categorical, with the following answer choices: 0; ½; 1; 1 ½ ; 2; 2 ½; 3; 3 ½; 4 or more. A higher score represents a greater amount of vegetables consumed. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Water Consumed Per Day
Time frame: Baseline up to week 12
Frequency of water consumed per day will be assessed using question 3 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you drink water (count tap, bottled, or sparkling water)?"). Scoring range is from 0-4. A higher score represents a greater frequency of water consumption. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Water Consumed Per Day
Time frame: Baseline up to week 12
Frequency of water consumed per day will be assessed using question 3 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you drink water (count tap, bottled, or sparkling water)?"). Scoring range is from 0-4. A higher score represents a greater frequency of water consumption. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Soda Consumed Per Day
Time frame: Baseline up to week 12
Frequency of soda consumed per day will be assessed using question 4 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you drink regular (not diet) soda?"). Scoring range is from 0-4. A higher score represents a greater frequency of soda consumption. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Soda Consumed Per Day
Time frame: Baseline up to week 12
Frequency of soda consumed per day will be assessed using question 4 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you drink regular (not diet) soda?"). Scoring range is from 0-4. A higher score represents a greater frequency of soda consumption. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Usage of 1% Milk, Skim Milk, and/or Low-fat Yogurt Per Day
Time frame: Baseline up to week 12
Usage of 1% milk, skim milk, and/or low-fat yogurt per day will be assessed using question 5 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you use 1% milk, skim milk, and/or low-fat yogurt?"). Scoring range is from 0-4. A higher score represents a greater usage of 1% milk, skim milk, and/or low-fat yogurt. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Usage of 1% Milk, Skim Milk, and/or Low-fat Yogurt Per Day
Time frame: Baseline up to week 12
Usage of 1% milk, skim milk, and/or low-fat yogurt per day will be assessed using question 5 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you use 1% milk, skim milk, and/or low-fat yogurt?"). Scoring range is from 0-4. A higher score represents a greater usage of 1% milk, skim milk, and/or low-fat yogurt. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Fruit Per Day
Time frame: Baseline up to week 12
Frequency of consumption of greater than 1 kind of fruit per day will be assessed using question 6 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you eat more than one kind of fruit each day (apple, peach, berries, etc.)"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming more than one fruit per day. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Fruit Per Day
Time frame: Baseline up to week 12
Frequency of consumption of greater than 1 kind of fruit per day will be assessed using question 6 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you eat more than one kind of fruit each day (apple, peach, berries, etc.)"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming more than one fruit per day. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Vegetable Per Day
Time frame: Baseline up to week 12
Frequency of consumption of greater than 1 kind of vegetable per day will be assessed using question 7 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you eat more than one kind of vegetable each day (carrots, corn, green beans, etc.)"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming more than one vegetable per day. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Vegetable Per Day (Baseline to Week 6)
Time frame: Baseline up to week 12
Frequency of consumption of greater than 1 kind of vegetable per day will be assessed using question 7 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you eat more than one kind of vegetable each day (carrots, corn, green beans, etc.)"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming more than one vegetable per day. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Healthy Food Option Consideration
Time frame: Baseline up to week 12
How often someone considers healthy food choices when deciding what to eat will be assessed using question 8 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("When deciding what to eat, how often do you think about healthy food choices?"). Scoring range is from 0-4. A higher score represents a greater frequency considering healthy food choices when deciding what to eat. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Healthy Food Option Consideration
Time frame: Baseline up to week 12
How often someone considers healthy food choices when deciding what to eat will be assessed using question 8 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("When deciding what to eat, how often do you think about healthy food choices?"). Scoring range is from 0-4. A higher score represents a greater frequency considering healthy food choices when deciding what to eat. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Usage of "Nutrition Facts" Label
Time frame: Baseline up to week 12
How often someone uses a "Nutrition Facts" label to when making food choices will be assessed using question 9 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you use the "Nutrition Facts" on the food label to make food choices?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the "Nutrition Facts" when making food choices. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Usage of "Nutrition Facts" Label
Time frame: Baseline up to week 12
How often someone uses a "Nutrition Facts" label to when making food choices will be assessed using question 9 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you use the "Nutrition Facts" on the food label to make food choices?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the "Nutrition Facts" when making food choices. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Consideration of Food Label (Salt/Sodium)
Time frame: Baseline up to week 12
How often someone uses a food label to select food with less salt or sodium will be assessed using question 10 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less salt or sodium?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less salt or sodium. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Consideration of Food Label (Salt/Sodium)
Time frame: Baseline up to week 12
How often someone uses a food label to select food with less salt or sodium will be assessed using question 10 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less salt or sodium?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less salt or sodium. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Consideration of Food Label (Sugar)
Time frame: Baseline up to week 12
How often someone uses a food label to select food with less or no added sugar will be assessed using question 11 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less or no added sugar?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less or no added sugar. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Consideration of Food Label (Sugar)
Time frame: Baseline up to week 12
How often someone uses a food label to select food with less or no added sugar will be assessed using question 11 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less or no added sugar?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less or no added sugar. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Consideration of Food Label (Fat)
Time frame: Baseline up to week 12
How often someone uses a food label to select food with less saturated fat will be assessed using question 12 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less saturated fat?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less saturated fat. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Consideration of Food Label (Fat)
Time frame: Baseline up to week 12
How often someone uses a food label to select food with less saturated fat will be assessed using question 12 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you read food labels to select foods with less saturated fat?"). Scoring range is from 0-4. A higher score represents a greater frequency of using the food label when making food choices with less saturated fat. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Whole Grain Consumption
Time frame: Baseline up to week 12
How often someone consumes whole grain instead of white or enriched flour ones will be assessed using question 13 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you eat whole grains (whole wheat bread, whole wheat tortillas, brown rice, oatmeal, etc.) in place of white or enriched flour ones?"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming whole grains instead of white or enriched flour ones. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Whole Grain Consumption
Time frame: Baseline up to week 12
How often someone consumes whole grain instead of white or enriched flour ones will be assessed using question 13 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How often do you eat whole grains (whole wheat bread, whole wheat tortillas, brown rice, oatmeal, etc.) in place of white or enriched flour ones?"). Scoring range is from 0-4. A higher score represents a greater frequency of consuming whole grains instead of white or enriched flour ones. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Meal Preparation
Time frame: Baseline up to week 12
How often someone prepares meals at home will be assessed using question 14 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you prepare meals at home?"). Scoring range is from 0-4. A higher score represents a greater frequency of preparing meals at home. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Meal Preparation
Time frame: Baseline up to week 12
How often someone prepares meals at home will be assessed using question 14 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you prepare meals at home?"). Scoring range is from 0-4. A higher score represents a greater frequency of preparing meals at home. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Strength Training
Time frame: Baseline up to week 12
How often someone includes strength training when they exercise will be assessed using question 19 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you include strength training when you exercise?"). Scoring range is from 0-4. A higher score represents a greater frequency of strength training. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Strength Training
Time frame: Baseline up to week 12
How often someone includes strength training when they exercise will be assessed using question 19 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("Do you include strength training when you exercise?"). Scoring range is from 0-4. A higher score represents a greater frequency of strength training. Assessed at baseline, week 6, and week 12.
Mean Change in Food Frequency Assessment- Physical Activity
Time frame: Baseline up to week 12
Participants' amount of physical activity will be assessed using question 20 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How much physical activity (exercise) do you do in a day?"). Scoring is categorical, with the following answer choices: 0-20 minutes; 21-30 minutes; 31-40 minutes; 41-60 minutes; more than 60 minutes. A higher score represents a greater amount of physical activity. Assessed at baseline, week 6, and week 12.
Median Change in Food Frequency Assessment- Physical Activity
Time frame: Baseline up to week 12
Participants' amount of physical activity will be assessed using question 20 of a food frequency assessment adapted from the 17-item National Cancer Institute fruit and vegetable screener and the National Health and Nutrition Examination Survey (NHANES) Dietary Screener ("How much physical activity (exercise) do you do in a day?"). Scoring is categorical, with the following answer choices: 0-20 minutes; 21-30 minutes; 31-40 minutes; 41-60 minutes; more than 60 minutes. A higher score represents a greater amount of physical activity. Assessed at baseline, week 6, and week 12.
Mean Change of PRAPARE Score
Time frame: Baseline up to week 12
Distinct social determinant of health risks will be assessed using the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experience (PRAPARE) assessment- a 21-item measure that assesses a participant's various social determinant of health risk responses. Questions include topics such as housing status, work situations, level of education, and others. Scoring range is from 0-22, with a higher score representing a higher amount of risks present. Assessed at baseline, week 6, and week 12.
Median Change of PRAPARE Score
Time frame: Baseline up to week 12
Distinct social determinant of health risks will be assessed using the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experience (PRAPARE) assessment- a 21-item measure that assesses a participant's various social determinant of health risk responses. Questions include topics such as housing status, work situations, level of education, and others. Scoring range is from 0-22, with a higher score representing a higher amount of risks present. Assessed at baseline, week 6, and week 12.
Mean Change in Patient Health Questionaire-8
Time frame: Baseline up to week 12
Depressive symptoms will be assessed using the Patient Health Questionnaire-8, an 8-item measure that assesses the number of days a person has experienced various symptoms of depression over the past two weeks. Questions include assessing how often a participant has had little to no interest in doing things, how often they feel down, depressed, irritable, or hopeless, etc. Scoring range is from 0-24. A higher score means greater depressive symptoms. Assessed at baseline, week 6, and week 12.
Median Change in Patient Health Questionaire-8
Time frame: Baseline up to week 12
Depressive symptoms will be assessed using the Patient Health Questionnaire-8, an 8-item measure that assesses the number of days a person has experienced various symptoms of depression over the past two weeks. Questions include assessing how often a participant has had little to no interest in doing things, how often they feel down, depressed, irritable, or hopeless, etc. Scoring range is from 0-24. A higher score means greater depressive symptoms. Assessed at baseline, week 6, and week 12.
Mean Change in sum of University of California- Los Angeles Loneliness Scale Short form
Time frame: Baseline up to week 12
Loneliness will be assessed using the University of California- Los Angeles Loneliness Scale Short Form, a 6 item measure that assesses how often participants feel left out or not connected to other people. Scoring range is from 3-9. A higher score means greater loneliness. Assessed at baseline, week 6, and week 12.
Median Change in sum of University of California- Los Angeles Loneliness Scale Short form
Time frame: Baseline up to week 12
Loneliness will be assessed using the University of California- Los Angeles Loneliness Scale Short Form, a 6 item measure that assesses how often participants feel left out or not connected to other people. Scoring range is from 3-9. A higher score means greater loneliness. Assessed at baseline, week 6, and week 12.
Number of successful HDHM Deliveries made to participants in control group
Time frame: Baseline up to week 12
Program feasibility will be assessed using the number of successful HDHM deliveries made to participants during the study. This is defined as the delivery driver being able to deliver the HDHM to the participant's residence. A higher number of successful deliveries indicate greater feasibility.
Number of successful HDHM Deliveries and Social Interactions made to participants in intervention group
Time frame: Baseline up to week 12
Program feasibility will be assessed using the number of successful HDHM deliveries including "friendly visits" made to intervention participant's homes during the study. This is defined as the delivery driver being able to deliver the HDHM to the participant's residence and complete a brief social interaction. A higher number of successful deliveries indicates greater feasibility of the program.
Number of HDHM meals consumed by participants weekly
Time frame: Baseline up to week 12
Program feasibility will be assessed using the number of meals consumed by participants per week. A higher number of meals consumed indicates greater feasibility of the program.
Duration of Student Companion Calls
Time frame: Baseline up to week 12
Program feasibility will be assessed using the duration of Student Companion calls that take place during the study for participants in the intervention group. Duration will be assessed in minutes per week. A higher number of minutes indicates greater feasibility of the program.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey Haynes-Maslow, PhD, MHA principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Delivered Healthy Meals, In-person "friendly visits" and Student Companion calls in people with Mental Health Issue and Food Insecurity, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Adult Food Security Score (time frame: Baseline up to week 12). The study lists 44 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.