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| Name | Class |
|---|---|
| LifeCare Alliance | UNKNOWN |
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This is a single-blinded, four-arm randomized controlled trial that will compare health outcomes of home-delivered meal clients. The purpose of this pilot study is to explore which service model is most effective for improving nutritional status, disease management, fall risk, and adherence to meal recommendations. Participants will be randomized into one of four study arms: In Arm 1: clients will receive home-delivered meals and basic nutrition education and fall prevention education. In Arm 2: clients will receive home-delivered meals plus dietitian services. In Arm 3: clients will receive home-delivered meals plus occupational therapy services. In Arm 4: clients will receive home-delivered meals plus dietitian and occupational therapy services. Outcomes will be assessed at baseline and at 3-month follow-up.
Participants will be randomized into one of four study arms: ARM 1 - Meals only: Participants randomized to receive "meals only" will receive 14 frozen meals, delivered 1x/week, for 3-months. Participants will be provided with a menu of 40 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 education via standard 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 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. During the same phone call, the registered dietitian will also assist participants with their initial meal selections and encourage participants to contact the dietitian with follow-up questions or concerns via phone. Participants will be able to make weekly meal selections based on an approved menu of meals tailored (by a dietitian) to the health needs of the participant. Additionally, dietitians will initiate at least one follow-up phone call no later than 45 days after the nutrition assessment is completed. ARM 3 - Meals + occupational therapy services: Participants randomized to this arm will receive 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). Within 30 days after the phone screen, the occupational therapist will then complete an in-home assessment with the participant and provide any initial interventions, equipment, exercises, education as indicated. Within 45 days of the in-home assessment/treatment encounter, the OT will complete an in-home OR phone-based (at the OT's discretion) follow-up session to determine participants' adherence to fall prevention recommendations. All participants randomized to this arm will also be encouraged to call the occupational therapist with questions or concerns over the 3-month study period. ARM 4 - Meals + registered dietitian services + occupational therapy services: Participants in this arm will receive 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meals only | No Intervention | ARM 1: Meals only. Participants randomized to receive "meals only" will receive 14 frozen meals, delivered 1x/week, for 3-months. Participants will be provided with a menu of 40 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. | |
| Meals + registered dietitian services | Active Comparator | ARM 2: Meals + registered dietitian services. Participants randomized to receive "meals + RD only" will receive 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. |
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| Meals + occupational therapy services | Active Comparator | ARM 3: Meals + occupational therapy services. Participants randomized to this arm will receive 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meals + RD services only | Behavioral | Registered dietitians (RD) will provide tailored dietitian counseling and nutrition education |
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| Measure | Description | Time Frame |
|---|---|---|
| Mini Nutritional Assessment-Short Form | Determine level of malnutrition status | Baseline and 3-months |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Diabetes Self-Care Activities Measure | Assess management of diabetes as well as heart disease | Baseline and 3-months |
| Falls efficacy scale | Assess concerns with falling during daily activities |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LifeCare Alliance | Columbus | Ohio | 43223 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41992111 | Derived | Juckett LA, Joshi S, Hyer JM, Hariharan G, Thomas KS, Howard ML, Bunck LE, Rowe ML, Devier A, Parrett K; LifeCare Alliance SixtyPLUS Team. Study protocol for a randomized, parallel-group trial to compare the effectiveness of registered dietitian and occupational therapy services on fall risk among home-delivered meal recipients. BMC Geriatr. 2026 Apr 16;26(1):749. doi: 10.1186/s12877-026-07376-z. | |
| 40348980 |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D062407 | Meals |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Outcomes assessor will be blinded to participant group assignment
|
| Meals + registered dietitian + occupational therapy services | Experimental | ARM 4: Meals + registered dietitian services + occupational therapy services. Participants in this arm will receive 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. |
|
| Meals + OT services only | Behavioral | Occupational therapists (OT) will provide tailored home safety recommendations and fall prevention education/strategies |
|
| Meals + RD + OT services | Behavioral | A combination of tailored registered dietitian and occupational therapy services will be provided |
|
| Baseline and 3-months |
| Derived |
| Juckett LA, Joshi S, Hyer JM, Hariharan G, Thomas KS, Sathya TS, Howard ML, Bunck LE, Rowe ML, Devier A, Parrett K; LifeCare Alliance SixtyPLUS Team. Occupational therapy and registered dietitian services to reduce fall risk among home delivered meal clients: a randomized controlled feasibility trial. BMC Geriatr. 2025 May 10;25(1):325. doi: 10.1186/s12877-025-06008-2. |
| 40188322 | Derived | Juckett LA, Joshi S, Hyer JM, Hariharan G, Thomas KS, Sathya TS, Howard ML, Bunck LE, Rowe ML, Devier A, Parrett K; LifeCare Alliance SixtyPLUS Team. Tailoring registered dietitian and occupational therapy services for home-delivered meal recipients: feasibility study protocol for a randomized controlled trial. Pilot Feasibility Stud. 2025 Apr 5;11(1):41. doi: 10.1186/s40814-025-01623-7. |
| D002318 | Cardiovascular Diseases |