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Completed

NCT Number: NCT04087343

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.

    Time frame: baseline

    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.

  2. 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 12, 2019
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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