Meal Delivery and Exercise

December 4, 2024 updated by: Jessica Lee, The University of Texas Health Science Center, Houston

A Meal Delivery and Exercise Intervention to Increase Resilience in Homebound Older Adults

The purpose of this study is to evaluate the effects of a home-based exercise program administered through Meals on wheels (MOW) on gait speed and frailty status and to assess the association between novel serum biomarkers (70 kilodalton heat shock proteins (HSP70),Macrophage Inflammatory Proteins(MIP1b), soluble IL-6 receptor alpha-chain (sIL-6R)) and established but non-specific frailty biomarkers (Interleukin 6 (IL-6), C-reactive protein (CRP), Tumor necrosis factor (TNF-α)) in frail and prefrail homebound older adults before and after the exercise intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • homebound (normally unable to leave the home unassisted)
  • frail or prefrail by The Fried Frailty Phenotype (FFP)
  • medically stable

Exclusion Criteria:

  • robust by FFP
  • have Mini-Cog score <3 and/or are unable to follow instructions
  • have a pre-diagnosed terminal illness
  • unable to ambulate
  • unable to use their upper extremities, and/or are already participating in physician-prescribed physical therapy or occupational therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Meals plus exercise
Behavioral: Meals plus exercise
Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. Participants will also will receive an exercise kit from the MOW driver with their first meal delivery which will contain 2 tennis balls, 2 1-pound hand weights, and one towel. Every week, the driver will give the participants a handout containing 3 exercises from the NIA Go4Life Workout-to-Go book that are designed to help with strength/endurance, balance, and flexibility20. The participants will be asked to do the 3 exercises every day, if possible, on their own. Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers.
Experimental: Meals only
Behavioral: Meals only
Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. they will be asked to continue their usual level of activity.Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in gait speed
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
this is the time one takes to walk a specified distance on level surfaces over a short distance and is measured in meters/second
4 weeks,8 weeks,12 weeks from baseline
Change in total FFP score as assessed by the Fried Frailty Phenotype (FFP) screening test
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
Score from 0(not frail),1-2(pre frail) and 3-5(frail)
4 weeks,8 weeks,12 weeks from baseline
Change in measure of HSP70 (ng/mL) expression
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
Change in Measure of MIP-1β (pg/mL) expression
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
Change in Measure of sIL-6R (pg/mL) expression
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in overall frailty status as assessed by the Fried Frailty Phenotype (FFP) screening test
Time Frame: 4 weeks,8 weeks,12 weeks from 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.
4 weeks,8 weeks,12 weeks from baseline
Change in grip strength
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles .This is measured by using a dynamometer which will be squeezed by the participant 3 times in each hand.The force is measured in kilograms.
4 weeks,8 weeks,12 weeks from baseline
Change in daily average steps from the activity tracker
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
Number of patients that required emergency room visits
Time Frame: 6 months post baseline visit
6 months post baseline visit
Number of patients that required hospitalization
Time Frame: 6 months post baseline visit
6 months post baseline visit
Change in activities of daily living as measured by the Katz Index of Independence in Activities of Daily Living
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
This consists of 6 questions and each is scored form 0(patient is very dependent)-6(patient is independent)
4 weeks,8 weeks,12 weeks from baseline
Change in instrumental activities of daily living as measured by the LAWTON - BRODY INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (I.A.D.L.)
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
This consists of 8 questions and each has a summary score range from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
4 weeks,8 weeks,12 weeks from baseline
Change in loneliness as assessed by the UCLA Loneliness Scale (ULS)
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
This questionnaire consists of 20 questions and each is answered from 1(never)-4(always) for a total score ranging form 20-80
4 weeks,8 weeks,12 weeks from baseline
Social network as assessed by the LUBBEN SOCIAL NETWORK SCALE - 18 (LSNS-18)
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
LSNS-R total score is an equally weighted sum of twelve items. Scores range from 0 to 90, a higher number indicating a better outcome
4 weeks,8 weeks,12 weeks from baseline
change in measure of IL-6 (pg/mL) expression
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
Change in measures of CRP (ng/mL) expression
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
Change in measures of TNF-α (pg/mL) expression
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
Change in measures of microbiome (fecal sample) expression
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
change in IL-6 (pg/mL) as measured by the frailty status
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
change in CRP (ng/mL) as measured by the frailty status
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
change in TNF-α (pg/mL) as measured by the frailty status
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
change in HSP70 (ng/mL) as measured by the frailty status
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
change in MIP-1β (pg/mL) as measured by the frailty status
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
change in sIL-6R (pg/mL) as measured by the frailty status
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline
change in microbiome (fecal sample) as measured by the frailty status
Time Frame: 4 weeks,8 weeks,12 weeks from baseline
4 weeks,8 weeks,12 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessica Lee, MD,MS, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-21-0125
  • 1K23AG072042-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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