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

NCT ID: NCT04087343

Last Updated: 2023-02-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-18

Study Completion Date

2020-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Frailty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Meals plus exercise

Group Type EXPERIMENTAL

Meals plus exercise

Intervention Type 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 only

Group Type ACTIVE_COMPARATOR

Meals only

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jessica Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jessica Lee, MD,MS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KL2TR003168

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-19-0191

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Home Exercise And Resiliency Training (Heart) Club
NCT05543733 ACTIVE_NOT_RECRUITING NA