Peer-Led Diet and Exercise Intervention

Physical Activity Clinical Trial

Official title:

The Development and Implementation of a Peer-Led Diet and Exercise Intervention in Older Urban Dwelling Veterans With Dysmobility

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994938
• Other study ID #: E3739-P
• Secondary ID: RX003739-01A1
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: January 2, 2026

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Jeffrey P Beans, BS
• Phone: (410) 605-7000
• Email: jeffrey.beans[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The majority of older Veterans do not meet the minimum healthy diet or physical activity recommendations, despite known benefits. Identifying novel ways to increase adherence to rehabilitation programs that improve dietary quality and physical activity may reduce the risk of disability in older Veterans. Peer-based interventions may be one method to facilitate lasting behavioral change since peers often share a common culture and knowledge about the problems that their community experiences. The investigators propose to develop and evaluate a novel peer-led diet and exercise intervention that targets older Veterans with multiple chronic health conditions. Successful development and pilot of this intervention will provide the preliminary data for a larger multisite trial focused on the use of peer-led interventions to improve long-term compliance to lifestyle interventions in older Veterans.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diet Quality
• Physical Activity

Intervention

Other:
• Diet Intervention
Participants will engage in discussions about healthy eating one time per week led by a trained peer leader for 12-weeks.
• Exercise Intervention
Participants will participate in a group exercise session led by a trained peer leader 2-times per week for 12-weeks.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland
United States	South Texas Health Care System, San Antonio, TX	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Endurance	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
Primary	Diet Quality	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.	12-weeks
Secondary	Mobility	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