Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults
Primary Purpose
Frailty
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meals plus exercise
Meals only
Sponsored by
About this trial
This is an interventional supportive care trial for Frailty focused on measuring homebound patients, exercise, nutrition
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Meals plus exercise
Meals only
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Levels of Plasma Vitamin C
Levels of Plasma Vitamin C
Levels of Serum Folate
Levels of Serum Folate
Levels of Vitamin B12
Levels of Vitamin B12
Levels of Vitamin 25-OHD
Levels of Vitamin 25-OHD
Levels of Methylmalonic Acid (MMA)
Levels of Methylmalonic Acid (MMA)
Levels of Homocysteine (HCy)
Levels of Homocysteine (HCy)
Full Information
NCT ID
NCT04087343
First Posted
September 10, 2019
Last Updated
January 9, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT04087343
Brief Title
Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults
Official Title
Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
January 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
homebound patients, exercise, nutrition
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meals plus exercise
Arm Type
Experimental
Arm Title
Meals only
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Meals plus exercise
Intervention Description
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
Intervention Name(s)
Meals only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
Description
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.
Time Frame
baseline
Title
Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
Description
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.
Time Frame
12 weeks after study initiation
Secondary Outcome Measure Information:
Title
Levels of Plasma Vitamin C
Time Frame
baseline
Title
Levels of Plasma Vitamin C
Time Frame
12 weeks from baseline
Title
Levels of Serum Folate
Time Frame
Baseline
Title
Levels of Serum Folate
Time Frame
12 weeks from baseline
Title
Levels of Vitamin B12
Time Frame
Baseline
Title
Levels of Vitamin B12
Time Frame
12 weeks from baseline
Title
Levels of Vitamin 25-OHD
Time Frame
Baseline
Title
Levels of Vitamin 25-OHD
Time Frame
12 weeks from baseline
Title
Levels of Methylmalonic Acid (MMA)
Time Frame
Baseline
Title
Levels of Methylmalonic Acid (MMA)
Time Frame
12 weeks from baseline
Title
Levels of Homocysteine (HCy)
Time Frame
Baseline
Title
Levels of Homocysteine (HCy)
Time Frame
12 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Lee, MD,MS
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults
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