Diabete Type 2NOURISHNCT07713836
Nutrition Intervention Optimization to Better Utilize Resources and Support Health
A study testing Meal kits, No-prep meals and Culinary nutrition classes in people with Diabete Type 2 and Obesity & Overweight, run by Tufts University at 1 site in United States.
Trial summary
Not having enough food for each person in a household, also called food insecurity, makes it hard to eat a nutritious diet, maintain a healthy weight, and manage diabetes risk. Food banks and pantries provide direct food assistance that can mitigate food insecurity among people with lower income, however, people that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Type 2, Obesity & Overweight, Nutritional Intervention
- What is being tested?
- Meal kits, No-prep meals and Culinary nutrition classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18+,
- Body mass index (BMI)≥ 25;
- Access to a device with SMS and MMS (picture) text and Wi-Fi capabilities (e.g., phone, tablet, computer) and willingness to use the device regularly during the study;
- Willingness to complete four in-person data collection appointments;
- Willing and able to consent.
Who cannot join
- Presence of a condition or dietary restriction precluding eating study meals or weight loss (e.g., condition requiring liquid diet, pregnancy);
- Another member of the household participating;
- Planning to move within the next 12 months;
- Unwilling to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Crossroads Community Services
Dallas, Texas, 75236
NICHE Lab Team, (469) 240-9112, niche@tufts.edu
About this study
Official title: Optimizing Interventions to Improve Nutrition Security and Reduce Diabetes Risk Among Food Pantry Clients
Not having enough food for each person in a household, also called food insecurity, makes it hard to eat a nutritious diet, maintain a healthy weight, and manage diabetes risk. Food banks and pantries provide direct food assistance that can mitigate food insecurity among people with lower income, however, people that utilize these organizations face time, resource, and physical constraints that limit their ability to consistently select and cook healthier meals and the organizations face budget constraints that limit their bandwidth for implementing nutrition programs. This research will test four innovative nutrition programs (nutritious prepared meals, medically tailored groceries in the form of meal kits, culinary medicine, motivational text messages) to identify which are the most effective for supporting healthy eating and food security and the most cost effective for organizations to implement, as an effort to reduce diabetes risk, improve diabetes self-management, and diminish health disparities.
- Being tested
- Meal kits, No-prep meals, Culinary nutrition classes, Text messages
- Keywords
- Food is Medicine, Medically tailored meals, Medically tailored groceries, Type 2 Diabetes, Culinary medicine
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal kitsBehavioural
Also called medically tailored groceries, MTGs
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
No-prep mealsBehavioural
Also called ready-to-eat meals, no prep, ready to eat meals
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases. Each entree has at least one serving of proteins, whole grains, and two vegetables. Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Culinary nutrition classesBehavioural
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum.
Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Text messagesBehavioural
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research. Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
| Study group | Role | What they receive |
|---|---|---|
| Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS | Experimental | Pantry provisions, meal kits, no-prep meals, culinary nutrition classes, and text messages Receives: Behavioral: Meal kits; Behavioral: No-prep meals; Behavioral: Culinary nutrition classes; Behavioral: Text messages |
| Condition 2: Pantry, MTG, No-prep meals, and Culinary classes | Experimental | Pantry provisions, meal kits, no-prep meals, and culinary nutrition classes Receives: Behavioral: Meal kits; Behavioral: No-prep meals; Behavioral: Culinary nutrition classes |
| Condition 3: Pantry, MTG, No-prep meals, and SMS | Experimental | Pantry provisions, meal kits, no-prep meals, and text messages Receives: Behavioral: Meal kits; Behavioral: No-prep meals; Behavioral: Text messages |
| Condition 4: Pantry, MTG, and No-prep meals | Experimental | Pantry provisions, meal kits, and no-prep meals Receives: Behavioral: Meal kits; Behavioral: No-prep meals |
| Condition 5: Pantry, MTG, Culinary classes, and SMS | Experimental | Pantry provisions, meal kits, culinary nutrition classes, and text messages Receives: Behavioral: Meal kits; Behavioral: Culinary nutrition classes; Behavioral: Text messages |
| Condition 6: Pantry, MTG, and Culinary classes | Experimental | Pantry provisions, meal kits, and culinary nutrition classes Receives: Behavioral: Meal kits; Behavioral: Culinary nutrition classes |
| Condition 7: Pantry, MTG, and SMS | Experimental | Pantry provisions, meal kits, and text messages Receives: Behavioral: Meal kits; Behavioral: Text messages |
| Condition 8: Pantry and MTG | Experimental | Pantry provisions and meal kits Receives: Behavioral: Meal kits |
| Condition 9: Pantry, No-prep meals, Culinary classes, and SMS | Experimental | Pantry provisions, no-prep meals, culinary nutrition classes and text messages Receives: Behavioral: No-prep meals; Behavioral: Culinary nutrition classes; Behavioral: Text messages |
| Condition 10: Pantry, No-prep meals, and Culinary classes | Experimental | Pantry provisions, no-prep meals, and culinary nutrition classes Receives: Behavioral: No-prep meals; Behavioral: Culinary nutrition classes |
| Condition 11: Pantry, No-prep meals, and SMS | Experimental | Pantry provisions, no-prep meals, and text messages Receives: Behavioral: No-prep meals; Behavioral: Text messages |
| Condition 12: Pantry and No-prep meals | Experimental | Pantry provisions and no-prep meals Receives: Behavioral: No-prep meals |
| Condition 13: Pantry, Culinary classes, and SMS | Experimental | Pantry provisions, culinary nutrition classes, and text messages Receives: Behavioral: Culinary nutrition classes; Behavioral: Text messages |
| Condition 14: Pantry and Culinary classes | Experimental | Pantry provisions and culinary nutrition classes Receives: Behavioral: Culinary nutrition classes |
| Condition 15: Pantry and SMS | Experimental | Pantry provisions and text messages Receives: Behavioral: Text messages |
| Condition 16: Pantry only | No intervention | Pantry provisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet
24-hour recall based on recommendations from the National Cancer Institute and prior evidence suggesting feasibility and validity of the measure with Spanish speakers. Diet will be assessed using 24-hour recall administered via the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) in English and Spanish. Will be used to calculate a Healthy Eating Index (HEI) score. The HEI is a scale from 0 to 100.
Measured: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
Secondary outcomes (3)
Household food security
Measured using the USDA 6-item household food security survey and will be treated as a continuous variable if normally distributed or a categorical variable if data is non-normal. Categorical scoring will be based on USDA recommendations (0-1 affirmative responses = high or marginal food security, 2-4 = low food security, 5-6 = very low food security).
Measured: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
Percent body weight change
Will be calculated as (Baseline weight minus follow-up weight) / (Baseline weight) x 100. Height and weight will be measured using an externally validated and calibrated Tanita DC-240MA scale.
Measured: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
Hemoglobin A1C (HbA1c)
Will be measured using the externally validated point-of-care instrument, DCA VantageAnalyzer (1μl finger stick, nonfasting). This method has been implemented in food pantries and is less invasive and more cost effective than a venous blood draw.
Measured: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Kelseanna Hollis-Hansen, PhD, MPH, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713836
- Sponsor's protocol ID
- STUDY00006929
- Other IDs
- 1R01DK145891-01
- Acronym
- NOURISH
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Interventions to Improve Nutrition Security and Reduce Diabetes Risk Among Food Pantry Clients
- ClinicalTrials.gov ID
- NCT07713836
- Acronym / sponsor ID
- NOURISH / STUDY00006929
- Keywords
- Food is Medicine, Medically tailored meals, Medically tailored groceries, Type 2 Diabetes, Culinary medicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 20 Jul 2026 (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.
Not having enough food for each person in a household, also called food insecurity, makes it hard to eat a nutritious diet, maintain a healthy weight, and manage diabetes risk. Food banks and pantries provide direct food assistance that can mitigate food insecurity among people with lower income, however, people that utilize these organizations face time, resource, and physical constraints that limit their ability to consistently select and cook healthier meals and the organizations face budget constraints that limit their bandwidth for implementing nutrition programs. This research will test four innovative nutrition programs (nutritious prepared meals, medically tailored groceries in the form of meal kits, culinary medicine, motivational text messages) to identify which are the most effective for supporting healthy eating and food security and the most cost effective for organizations to implement, as an effort to reduce diabetes risk, improve diabetes self-management, and diminish health disparities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS | Experimental | Behavioral: Meal kits, Behavioral: No-prep meals, Behavioral: Culinary nutrition classes, Behavioral: Text messagesPantry provisions, meal kits, no-prep meals, culinary nutrition classes, and text messages |
| Condition 2: Pantry, MTG, No-prep meals, and Culinary classes | Experimental | Behavioral: Meal kits, Behavioral: No-prep meals, Behavioral: Culinary nutrition classesPantry provisions, meal kits, no-prep meals, and culinary nutrition classes |
| Condition 3: Pantry, MTG, No-prep meals, and SMS | Experimental | Behavioral: Meal kits, Behavioral: No-prep meals, Behavioral: Text messagesPantry provisions, meal kits, no-prep meals, and text messages |
| Condition 4: Pantry, MTG, and No-prep meals | Experimental | Behavioral: Meal kits, Behavioral: No-prep mealsPantry provisions, meal kits, and no-prep meals |
| Condition 5: Pantry, MTG, Culinary classes, and SMS | Experimental | Behavioral: Meal kits, Behavioral: Culinary nutrition classes, Behavioral: Text messagesPantry provisions, meal kits, culinary nutrition classes, and text messages |
| Condition 6: Pantry, MTG, and Culinary classes | Experimental | Behavioral: Meal kits, Behavioral: Culinary nutrition classesPantry provisions, meal kits, and culinary nutrition classes |
| Condition 7: Pantry, MTG, and SMS | Experimental | Behavioral: Meal kits, Behavioral: Text messagesPantry provisions, meal kits, and text messages |
| Condition 8: Pantry and MTG | Experimental | Behavioral: Meal kitsPantry provisions and meal kits |
| Condition 9: Pantry, No-prep meals, Culinary classes, and SMS | Experimental | Behavioral: No-prep meals, Behavioral: Culinary nutrition classes, Behavioral: Text messagesPantry provisions, no-prep meals, culinary nutrition classes and text messages |
| Condition 10: Pantry, No-prep meals, and Culinary classes | Experimental | Behavioral: No-prep meals, Behavioral: Culinary nutrition classesPantry provisions, no-prep meals, and culinary nutrition classes |
| Condition 11: Pantry, No-prep meals, and SMS | Experimental | Behavioral: No-prep meals, Behavioral: Text messagesPantry provisions, no-prep meals, and text messages |
| Condition 12: Pantry and No-prep meals | Experimental | Behavioral: No-prep mealsPantry provisions and no-prep meals |
| Condition 13: Pantry, Culinary classes, and SMS | Experimental | Behavioral: Culinary nutrition classes, Behavioral: Text messagesPantry provisions, culinary nutrition classes, and text messages |
| Condition 14: Pantry and Culinary classes | Experimental | Behavioral: Culinary nutrition classesPantry provisions and culinary nutrition classes |
| Condition 15: Pantry and SMS | Experimental | Behavioral: Text messagesPantry provisions and text messages |
| Condition 16: Pantry only | No intervention | –Pantry provisions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18+,
- Body mass index (BMI)≥ 25;
- Access to a device with SMS and MMS (picture) text and Wi-Fi capabilities (e.g., phone, tablet, computer) and willingness to use the device regularly during the study;
- Willingness to complete four in-person data collection appointments;
- Willing and able to consent.
Key exclusion criteria (4 listed)
- Presence of a condition or dietary restriction precluding eating study meals or weight loss (e.g., condition requiring liquid diet, pregnancy);
- Another member of the household participating;
- Planning to move within the next 12 months;
- Unwilling to participate.
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 |
|---|---|---|
| Meal kitsAlso: medically tailored groceries, MTGsMeal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes). | Behavioural | Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS, Condition 2: Pantry, MTG, No-prep meals, and Culinary classes, Condition 3: Pantry, MTG, No-prep meals, and SMS, Condition 4: Pantry, MTG, and No-prep meals, Condition 5: Pantry, MTG, Culinary classes, and SMS, Condition 6: Pantry, MTG, and Culinary classes, Condition 7: Pantry, MTG, and SMS, Condition 8: Pantry and MTG |
| No-prep mealsAlso: ready-to-eat meals, no prep, ready to eat mealsThe meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases. Each entree has at least one serving of proteins, whole grains, and two vegetables. Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes. | Behavioural | Condition 10: Pantry, No-prep meals, and Culinary classes, Condition 11: Pantry, No-prep meals, and SMS, Condition 12: Pantry and No-prep meals, Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS, Condition 2: Pantry, MTG, No-prep meals, and Culinary classes, Condition 3: Pantry, MTG, No-prep meals, and SMS, Condition 4: Pantry, MTG, and No-prep meals, Condition 9: Pantry, No-prep meals, Culinary classes, and SMS |
| Culinary nutrition classesParticipants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. | Behavioural | Condition 10: Pantry, No-prep meals, and Culinary classes, Condition 13: Pantry, Culinary classes, and SMS, Condition 14: Pantry and Culinary classes, Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS, Condition 2: Pantry, MTG, No-prep meals, and Culinary classes, Condition 5: Pantry, MTG, Culinary classes, and SMS, Condition 6: Pantry, MTG, and Culinary classes, Condition 9: Pantry, No-prep meals, Culinary classes, and SMS |
| Text messagesParticipants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research. Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM). | Behavioural | Condition 11: Pantry, No-prep meals, and SMS, Condition 13: Pantry, Culinary classes, and SMS, Condition 15: Pantry and SMS, Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS, Condition 3: Pantry, MTG, No-prep meals, and SMS, Condition 5: Pantry, MTG, Culinary classes, and SMS, Condition 7: Pantry, MTG, and SMS, Condition 9: Pantry, No-prep meals, Culinary classes, and SMS |
Primary outcome
Diet
Time frame: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
24-hour recall based on recommendations from the National Cancer Institute and prior evidence suggesting feasibility and validity of the measure with Spanish speakers. Diet will be assessed using 24-hour recall administered via the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) in English and Spanish. Will be used to calculate a Healthy Eating Index (HEI) score. The HEI is a scale from 0 to 100.
3 secondary outcomes
Household food security
Time frame: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
Percent body weight change
Time frame: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
Hemoglobin A1C (HbA1c)
Time frame: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
Kelseanna Hollis-Hansen, PhD, MPH principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal kits, No-prep meals and Culinary nutrition classes in people with Diabete Type 2 and Obesity & Overweight, run by Tufts University 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NICHE Lab Team ((469) 240-9112, niche@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet (time frame: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).). 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 19 Oct 2026.