An interventional study of Meals + RD services and Meals + OT services in Diet, Food and Nutrition, Accidental Falls and Cardiovascular Diseases, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 750 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 + 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.
Behavioral: Meals + RD services
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).
Behavioral: Meals + OT services
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.
Behavioral: Meals + RD + OT services
Registered dietitians (RD) will provide tailored dietitian counseling and nutrition education
Occupational therapists (OT) will provide tailored home safety recommendations and fall prevention education/strategies
A combination of tailored registered dietitian and occupational therapy services will be provided
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
Time frame: Baseline; 3-months; 6-months
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
Time frame: 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
Time frame: 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
Time frame: Baseline; 3-months; 6-months
Plan to share: 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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