NCT04994938

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
2 years until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2025

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

July 27, 2021

Results QC Date

December 19, 2025

Last Update Submit

January 28, 2026

Conditions

Keywords

Diet QualityPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • Change in 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

  • Change in Diet Quality as Measured by the HEI Score

    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 Outcomes (1)

  • Change in Mobility as Measured by the 30 Second Chair Stand Test

    12-weeks

Study Arms (1)

Peer led diet and exercise intervention

EXPERIMENTAL

participation in two-times per week diet and exercise peer led interventions.

Other: Diet InterventionOther: Exercise Intervention

Interventions

Participants will engage in discussions about healthy eating one time per week led by a trained peer leader for 12-weeks.

Peer led diet and exercise intervention

Participants will participate in a group exercise session led by a trained peer leader 2-times per week for 12-weeks.

Peer led diet and exercise intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Robbins RN, Serra MC, Kilpela LS, Parker EA, Jiwani R, Addison O. Intervention in Older Urban-Dwelling Veterans With Dysmobility: Protocol for a Pilot Feasibility Clinical Trial. JMIR Res Protoc. 2022 Jul 13;11(7):e39192. doi: 10.2196/39192.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Odessa Addison
Organization
Baltimore VAMC

Study Officials

  • Odessa R. Addison, PhD DPT

    Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 6, 2021

Study Start

August 1, 2023

Primary Completion

July 1, 2024

Study Completion

January 2, 2025

Last Updated

February 17, 2026

Results First Posted

February 17, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations