Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06059404 |
| Other study ID # |
2023H0248 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
September 20, 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Ohio State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
