Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults

Study Overview
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Brief Summary
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The purpose of this study is to implement a home-based exercise program, administered through Interfaith Ministries of Greater Houston Meals on Wheels (MOWGH), and evaluate its effects on frailty status and nutritional markers in homebound older adults.

Official Title
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Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults

Conditions
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Frailty

Intervention / Treatment
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* Behavioral: Meals plus exercise
* Behavioral: Meals only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: enrolled in UT-Health Harris Health House Call Program (HCP) Frail or pre frail by FFP medically stable Exclusion Criteria: robust by FFP Mini-Cog score <3 and/or are unable to follow instructions pre-diagnosed terminal illness unable to ambulate,and/or are unable to use their upper extremities

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meals plus exercise<br> | Behavioral: Meals plus exercise<br>* Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.<br>|
| Active Comparator: Meals only<br> | Behavioral: Meals only<br>* Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | The FFP defines frailty as having 3 or more characteristics of unintentional weight loss, fatigue, decreased physical activity, weakness, and slowness.Those who have 1 or 2 characteristics are considered pre frail, while those who have no characteristics are robust. | baseline | 
| Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test. | The FFP defines frailty as having 3 or more characteristics of unintentional weight loss, fatigue, decreased physical activity, weakness, and slowness.Those who have 1 or 2 characteristics are considered pre frail, while those who have no characteristics are robust. | 12 weeks after study initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of Plasma Vitamin C |  | baseline | 
| Levels of Plasma Vitamin C |  | 12 weeks from baseline | 
| Levels of Serum Folate |  | Baseline | 
| Levels of Serum Folate |  | 12 weeks from baseline | 
| Levels of Vitamin B12 |  | Baseline | 
| Levels of Vitamin B12 |  | 12 weeks from baseline | 
| Levels of Vitamin 25-OHD |  | Baseline | 
| Levels of Vitamin 25-OHD |  | 12 weeks from baseline | 
| Levels of Methylmalonic Acid (MMA) |  | Baseline | 
| Levels of Methylmalonic Acid (MMA) |  | 12 weeks from baseline | 
| Levels of Homocysteine (HCy) |  | Baseline | 
| Levels of Homocysteine (HCy) |  | 12 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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homebound patients, exercise, nutrition