- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04994938
Peer-Led Diet and Exercise Intervention
The Development and Implementation of a Peer-Led Diet and Exercise Intervention in Older Urban Dwelling Veterans With Dysmobility
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Over the next ten years the share of Veterans age 65+ years will increase to over 50% of the total Veteran population. The ability to safely maintain mobility with aging is critical. Older Veterans with multiple chronic health conditions are more likely to experience mobility decline and report reduced physical activity levels and poor dietary quality. While a multitude of interventions have attempted to address poor diet and physical inactivity in older adults; most have utilized resource-intensive professionally led diet OR exercise interventions, and few have focused on the unique needs of older Veterans. Peer support offers a potentially low-cost, easily scalable approach to encourage long-term dietary and physical activity change.
In this proposal the investigators seek to develop and pilot a 12-week peer-led lifestyle intervention that targets older Veterans with multiple chronic health conditions and dysmobility, in two diverse urban areas with a high percentage of underrepresented minority Veteran populations (Baltimore, MD and San Antonio, TX). The investigators will develop a theory-driven, peer-led nutrition and exercise intervention tailored for older Veterans with dysmobility. The investigators will also determine the feasibility and acceptability of the peer-led intervention as well as the estimated magnitude and potential impact on selected outcomes (i.e diet quality and mobility) in older Veterans with dysmobility and multiple chronic health conditions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
-
-
Texas
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San Antonio, Texas, United States, 78229
- South Texas Health Care System, San Antonio, TX
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Self-reported difficulty in at least one of the following activities: Walking quickly across the street, walking one mile, ascending one flight of stairs, rising from a chair without using arms
- Self-reports at least two chronic medical conditions such as hypertension, diabetes, hyperlipidemia, or coronary artery disease
- Speaks English
Exclusion Criteria:
- high cardiovascular risk
- using home oxygen
- contraindications to an exercise intervention
- dementia
- regular exercise participation
- current participation in a weight loss intervention
- acute psychosis, major depression, or behavior that preventions group interaction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer led diet and exercise intervention
participation in two-times per week diet and exercise peer led interventions.
|
Participants will engage in discussions about healthy eating one time per week led by a trained peer leader for 12-weeks.
Participants will participate in a group exercise session led by a trained peer leader 2-times per week for 12-weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cardiovascular Endurance
Time Frame: 12-weeks
|
Cardiovascular endurance will be assessed with the distance covered during a six-minute walk test.
The distance covered from baseline will be compared to post 12-week intervention.
|
12-weeks
|
|
Change in Diet Quality as Measured by the HEI Score
Time Frame: 12-weeks
|
Food records will be gathered and analyzed using the automated self-administered recall system (ASA24) to evaluate diet quality.
Results from baseline will be compared to those after 12 weeks of intervention.
The Healthy Eating Index (HEI) is a summary score describing dietary quality on a 0-100 scale; higher scores indicate better diet quality.
|
12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mobility as Measured by the 30 Second Chair Stand Test
Time Frame: 12-weeks
|
The number of time and individuals can rise from a chair-without using their arms during a 30-second time period will be recorded and used as a measure of mobility.
Results from baseline will be compared to those after 12-weeks of intervention.
|
12-weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Odessa R. Addison, PhD DPT, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E3739-P
- RX003739-01A1 (Other Grant/Funding Number: Veteran Affairs Rehabilitation R&D Service)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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