Diet, Food and NutritionNCT06586970
Occupational Therapy and Registered Dietitian Services to Reduce Fall Risk Among Home Delivered Meal Clients
A study testing Meals + RD services, Meals + OT services and Meals + RD + OT services in people with Diet, Food and Nutrition and Accidental Falls, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to determine which of the following four service models is most effective for reducing fall risk among home-delivered meal clients: (1) meals alone, (2) meals + registered dietitian services, (3) meals + occupational therapy services, (4) meals + registered dietitian + occupational therapy… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diet, Food and Nutrition, Accidental Falls, Cardiovascular Diseases
- What is being tested?
- Meals + RD services, Meals + OT services and Meals + RD + OT services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2024to 31 Jul 2027
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible to receive meals according to LifeCare Alliance's standard in-take criteria (Over the age of 60; unable to safely and independently leave the home; does not have access to a caregiver who can prepare meals)
- Has a working freezer to store between 7-14 frozen meals/week
- Has a working microwave or oven to reheat meals
- Lives within LifeCare Alliance's 5-county service area
Who cannot join
- Individuals already receiving home-delivered meals from LifeCare Alliance or other meal agency (within the past 40 days)
- Individuals residing in residential care or a skilled nursing facility
- Individuals whose dietary restrictions prohibit them from eating meals from LifeCare Alliance's frozen meal selection
- Individuals at home on hospice care
- Unable to independently answer LifeCare Alliance's in-take questions
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, 1 recruiting
- Recruiting
LifeCare Alliance
Columbus, Ohio, 43223
Andrea Devier, (614) 437-2858, adevier@lifecarealliance.org
About this study
Official title: Tailored Occupational Therapy and Registered Dietitian Services for Home-Delivered Meal Clients: A Randomized Controlled Trial
The purpose of this study is to determine which of the following four service models is most effective for reducing fall risk among home-delivered meal clients: (1) meals alone, (2) meals + registered dietitian services, (3) meals + occupational therapy services, (4) meals + registered dietitian + occupational therapy services.
Read the detailed description
Home delivered meal programs provide essential health and nutritional support to community-dwelling older adults in the United States. Without this support, nearly three million older adults would be at even greater risk for malnourishment and subsequent health decline, leading to potential hospitalizations and nursing home placements. Despite the reported value of home delivered meals, the increasingly complex health needs of the older adult population warrant new, innovative approaches that enhance home-delivered meal services. In our prior work, we identified that the majority of home delivered meal clients are at high risk for malnutrition, increasing clients' risk of falling and warranting the need for registered dietitian services to attenuate health decline. Additionally, our other work has identified that 80% of home delivered meal clients are at elevated risk for falling,6 and over 40% have experienced a fall in the past year. The high prevalence of fall risk factors among home delivered clients suggests that additional services - such as occupational therapy - are also needed to optimize clients' ability to safely remain living in their own homes and communities. In response to home delivered meal clients' need for more enhanced and specialized services, the present study will test four different service models to determine which model is most effective for reducing fall-related outcomes.
- Conditions
- Diet, Food and Nutrition, Accidental Falls, Cardiovascular Diseases, Diabetes, Debility, Frailty
- Being tested
- Meals + RD services, Meals + OT services, Meals + RD + OT services
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meals + RD servicesBehavioural
Registered dietitians (RD) will provide tailored dietitian counseling and nutrition education
Meals + OT servicesBehavioural
Occupational therapists (OT) will provide tailored home safety recommendations and fall prevention education/strategies
Meals + RD + OT servicesBehavioural
A combination of tailored registered dietitian and occupational therapy services will be provided
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Meals only | No intervention | ARM 1: Meals only. Participants randomized to receive "meals only" will receive 7-14 frozen meals, delivered 1x/week, for 3-months. Participants will be provided with a menu of 42 meal options and instructions for how to select their meals and change weekly meal selections (if desired). Participants in this arm will also receive nutrition education and fall prevention handouts. Nutrition education handouts will indicate which of LifeCare Alliance's meals are considered to be "heart healthy" as well as "diabetic-friendly." Participants will have the autonomy to select their own meals according to their preferences and their ability to self-manage their own health conditions (e.g., diabetes, cardiovascular disease). Fall prevention education handouts will provide guidance on how to reduce fall risk at home and modify the home environment to eliminate fall hazards. |
| Arm 2: Meals + RD services | Active comparator | ARM 2: Meals + registered dietitian services. Participants randomized to receive "meals + RD only" will receive 7-14 frozen meals, delivered 1x/week, for 3-months. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will have a telephone-based nutrition assessment completed by one of LifeCare Alliance's registered dietitians who will assign participants a nutrition diagnosis (e.g., overconsumption of carbohydrates) within 60 days of study enrollment. Receives: Behavioral: Meals + RD services |
| Meals + OT services | Active comparator | ARM 3: Meals + occupational therapy services. Participants randomized to this arm will receive 7-14 frozen meals, delivered 1x/week, for 3-months and be able to make weekly meal selections from LifeCare Alliance's full list of 40 meals. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will be contacted (within 30 days of study enrollment) by one of Lifecare Alliance's occupational therapists to complete a phone screen to determine each participant's occupational therapy needs (e.g., home safety/fall risk hazards, need for durable medical equipment). Receives: Behavioral: Meals + OT services |
| Arm 4: Meals + RD + OT services | Active comparator | ARM 4: Meals + registered dietitian services + occupational therapy services. Participants in this arm will receive 7-14 frozen meals, delivered 1x/week, for 3-months as well as the same nutrition education and fall prevention handouts as provided in Arms 1-3. Additionally, participants will receive the combination of dietitian and OT services as provided in Arms 2 and 3 and have the same autonomy to make their own weekly meal selections from a curated list provided by the dietitian. Receives: Behavioral: Meals + RD + OT services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls Efficacy Scale
Questionnaire to assess concerns with falling during routine activities of daily living; scores range from 7-28 points with lower scores indicating a lower concern with falling
Measured: Baseline; 3-months; 6-months
Secondary outcomes (3)
Mini Nutritional Assessment-Short Form
Questionnaire to assess risk of malnutrition; scores range from 0-14 points with lower scores indicating a lower risk of malnutrition
Measured: Baseline; 3-months; 6-months
Dietary intake
Four items drawn from the Summary of Diabetes Self-Care Activities questionnaire to assess quality of foods consumed; scores range from 0-28 with higher scores indicating consumption of higher quality foods
Measured: Baseline; 3-months; 6-months
EQ-5D-5L
Five domain measure to assess quality of life in the areas of mobility, self-care, usual activities, pain/discomfort and anxiety/depression; scores range from 5 to 25 points with lower scores indicating better quality of life
Measured: Baseline; 3-months; 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Aug 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, Food and NutritionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- LifeCare Alliance
- Responsible party
- Principal investigator, Lisa Juckett, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586970
- Sponsor's protocol ID
- 90INNU0044-01-00
- Other IDs
- 90INNU0044-01-00
- Status last verified
- Apr 2026
- First submitted
- 4 Sep 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not required by our funder and is not of interest to our partner agency who is leading the provision of the interventions being tested
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Occupational Therapy and Registered Dietitian Services for Home-Delivered Meal Clients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06586970
- Acronym / sponsor ID
- 90INNU0044-01-00
- Conditions
- Diet, Food and Nutrition, Accidental Falls, Cardiovascular Diseases, Diabetes, Debility, Frailty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- LifeCare Alliance
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Sep 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 purpose of this study is to determine which of the following four service models is most effective for reducing fall risk among home-delivered meal clients: (1) meals alone, (2) meals + registered dietitian services, (3) meals + occupational therapy services, (4) meals + registered dietitian + occupational therapy services.
Detailed description
Home delivered meal programs provide essential health and nutritional support to community-dwelling older adults in the United States. Without this support, nearly three million older adults would be at even greater risk for malnourishment and subsequent health decline, leading to potential hospitalizations and nursing home placements. Despite the reported value of home delivered meals, the increasingly complex health needs of the older adult population warrant new, innovative approaches that enhance home-delivered meal services. In our prior work, we identified that the majority of home delivered meal clients are at high risk for malnutrition, increasing clients' risk of falling and warranting the need for registered dietitian services to attenuate health decline. Additionally, our other work has identified that 80% of home delivered meal clients are at elevated risk for falling,6 and over 40% have experienced a fall in the past year. The high prevalence of fall risk factors among home delivered clients suggests that additional services - such as occupational therapy - are also needed to optimize clients' ability to safely remain living in their own homes and communities. In response to home delivered meal clients' need for more enhanced and specialized services, the present study will test four different service models to determine which model is most effective for reducing fall-related outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Meals only | No intervention | –ARM 1: Meals only. Participants randomized to receive "meals only" will receive 7-14 frozen meals, delivered 1x/week, for 3-months. Participants will be provided with a menu of 42 meal options and instructions for how to select their meals and change weekly meal selections (if desired). Participants in this arm will also receive nutrition education and fall prevention handouts. Nutrition education handouts will indicate which of LifeCare Alliance's meals are considered to be "heart healthy" as well as "diabetic-friendly." Participants will have the autonomy to select their own meals according to their preferences and their ability to self-manage their own health conditions (e.g., diabetes, cardiovascular disease). Fall prevention education handouts will provide guidance on how to reduce fall risk at home and modify the home environment to eliminate fall hazards. |
| Arm 2: Meals + RD services | Active comparator | Behavioral: Meals + RD servicesARM 2: Meals + registered dietitian services. Participants randomized to receive "meals + RD only" will receive 7-14 frozen meals, delivered 1x/week, for 3-months. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will have a telephone-based nutrition assessment completed by one of LifeCare Alliance's registered dietitians who will assign participants a nutrition diagnosis (e.g., overconsumption of carbohydrates) within 60 days of study enrollment. |
| Meals + OT services | Active comparator | Behavioral: Meals + OT servicesARM 3: Meals + occupational therapy services. Participants randomized to this arm will receive 7-14 frozen meals, delivered 1x/week, for 3-months and be able to make weekly meal selections from LifeCare Alliance's full list of 40 meals. In addition to receiving nutrition education and fall prevention handouts, participants in this arm will be contacted (within 30 days of study enrollment) by one of Lifecare Alliance's occupational therapists to complete a phone screen to determine each participant's occupational therapy needs (e.g., home safety/fall risk hazards, need for durable medical equipment). |
| Arm 4: Meals + RD + OT services | Active comparator | Behavioral: Meals + RD + OT servicesARM 4: Meals + registered dietitian services + occupational therapy services. Participants in this arm will receive 7-14 frozen meals, delivered 1x/week, for 3-months as well as the same nutrition education and fall prevention handouts as provided in Arms 1-3. Additionally, participants will receive the combination of dietitian and OT services as provided in Arms 2 and 3 and have the same autonomy to make their own weekly meal selections from a curated list provided by the dietitian. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible to receive meals according to LifeCare Alliance's standard in-take criteria (Over the age of 60; unable to safely and independently leave the home; does not have access to a caregiver who can prepare meals)
- Has a working freezer to store between 7-14 frozen meals/week
- Has a working microwave or oven to reheat meals
- Lives within LifeCare Alliance's 5-county service area
Key exclusion criteria (5 listed)
- Individuals already receiving home-delivered meals from LifeCare Alliance or other meal agency (within the past 40 days)
- Individuals residing in residential care or a skilled nursing facility
- Individuals whose dietary restrictions prohibit them from eating meals from LifeCare Alliance's frozen meal selection
- Individuals at home on hospice care
- Unable to independently answer LifeCare Alliance's in-take questions
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 |
|---|---|---|
| Meals + RD servicesRegistered dietitians (RD) will provide tailored dietitian counseling and nutrition education | Behavioural | Arm 2: Meals + RD services |
| Meals + OT servicesOccupational therapists (OT) will provide tailored home safety recommendations and fall prevention education/strategies | Behavioural | Meals + OT services |
| Meals + RD + OT servicesA combination of tailored registered dietitian and occupational therapy services will be provided | Behavioural | Arm 4: Meals + RD + OT services |
Primary outcome
Falls Efficacy Scale
Time frame: Baseline; 3-months; 6-months
Questionnaire to assess concerns with falling during routine activities of daily living; scores range from 7-28 points with lower scores indicating a lower concern with falling
3 secondary outcomes
Mini Nutritional Assessment-Short Form
Time frame: Baseline; 3-months; 6-months
Dietary intake
Time frame: Baseline; 3-months; 6-months
EQ-5D-5L
Time frame: Baseline; 3-months; 6-months
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 13 Apr 2026.
- Individual participant dataSharing planned: No. This is not required by our funder and is not of interest to our partner agency who is leading the provision of the interventions being tested
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meals + RD services, Meals + OT services and Meals + RD + OT services in people with Diet, Food and Nutrition and Accidental Falls, run by Ohio State 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Apr 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 Lisa A Juckett, PhD, OTR/L (614-366-7543, lisa.juckett@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls Efficacy Scale (time frame: Baseline; 3-months; 6-months). 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 13 Apr 2026.