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

NCT04087343 | Completed Results DMC

• 2 other identifiers: HSC-MS-19-0191KL2TR003168
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frailty

Keywords

homebound patients; exercise; nutrition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• 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

Study Arms (2)

Meals plus exercise

EXPERIMENTAL

Behavioral: Meals plus exercise

Meals only

ACTIVE COMPARATOR

Behavioral: Meals only

Interventions

Meals plus exercise BEHAVIORAL

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.

Meals plus exercise

Meals only BEHAVIORAL

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.

Meals only

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• enrolled in UT-Health Harris Health House Call Program (HCP)
• Frail or pre frail by FFP
• medically stable

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Frailty; Motor Activity

Interventions

Meals; Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Jessica Lee, MD, MS, Assistant Professor
• Organization: The University of Texas Health Science Center at Houston

Jessica.Lee@uth.tmc.edu

713-500-5457

Study Officials

• Jessica Lee, MD,MS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: September 18, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: February 8, 2023
• Results First Posted: July 1, 2021

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)