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

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.

Study Overview

• Status: Completed
• Conditions: Frailty
• Intervention / Treatment: Behavioral: Meals plus exercise; Behavioral: Meals only

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Meals plus exercise	Behavioral: Meals plus exercise; 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.
ACTIVE_COMPARATOR: Meals only	Behavioral: Meals only; 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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Center for Advancing Translational Sciences (NCATS)

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2019
• Primary Completion (ACTUAL): January 10, 2020
• Study Completion (ACTUAL): January 10, 2020

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (ACTUAL): September 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: exercise; nutrition; homebound patients
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: HSC-MS-19-0191; KL2TR003168 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No