Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04087343
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jessica Lee, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Frailty Behavioral: Meals plus exercise Behavioral: Meals only Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults
Estimated Study Start Date : September 9, 2019
Estimated Primary Completion Date : September 9, 2020
Estimated Study Completion Date : September 9, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Overall frailty status as assessed by the Fried Frailty Phenotype (FFP) screening test. [ Time Frame: 12 weeks after study initiation ]
    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 :
  1. Levels of plasma Vitamin C [ Time Frame: baseline ]
  2. Levels of plasma Vitamin C [ Time Frame: 12 weeks from baseline ]
  3. Levels of serum folate [ Time Frame: Baseline ]
  4. Levels of serum folate [ Time Frame: 12 weeks from baseline ]
  5. Levels of vitamin B12 [ Time Frame: Baseline ]
  6. Levels of vitamin B12 [ Time Frame: 12 weeks from baseline ]
  7. Levels of vitamin 25-OHD [ Time Frame: Baseline ]
  8. Levels of vitamin 25-OHD [ Time Frame: 12 weeks from baseline ]
  9. Levels of methylmalonic acid (MMA) [ Time Frame: Baseline ]
  10. Levels of methylmalonic acid (MMA) [ Time Frame: 12 weeks from baseline ]
  11. Levels of homocysteine (HCy) [ Time Frame: Baseline ]
  12. Levels of homocysteine (HCy) [ Time Frame: 12 weeks from baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087343


Contacts
Layout table for location contacts
Contact: Jessica lee, MD,MS 7135006634 Jessica.Lee@uth.tmc.edu
Contact: Arlene White-Brisco 7135006634 Arlene.WhiteBrisco@uth.tmc.edu

Locations
Layout table for location information
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Jessica Lee, MD,MS    713-500-6634    Jessica.Lee@uth.tmc.edu   
Contact: Arlene White-Brisco    7135006634    Arlene.WhiteBrisco@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Jessica Lee, MD,MS The University of Texas Health Science Center, Houston

Layout table for additonal information
Responsible Party: Jessica Lee, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04087343     History of Changes
Other Study ID Numbers: HSC-MS-19-0191
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica Lee, The University of Texas Health Science Center, Houston:
homebound patients
exercise
nutrition
Additional relevant MeSH terms:
Layout table for MeSH terms
Frailty
Pathologic Processes