Physical ActivityNCT04994938
Peer-Led Diet and Exercise Intervention
A study testing Diet Intervention and Exercise Intervention in people with Physical Activity and Peer Leaders, run by VA Office of Research and Development at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Physical Activity, Peer Leaders, Diet Quality
- What is being tested?
- Diet Intervention and Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2023to 2 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
About this study
Official title: The Development and Implementation of a Peer-Led Diet and Exercise Intervention in Older Urban Dwelling Veterans With Dysmobility
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.
Read the 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.
- Conditions
- Physical Activity, Peer Leaders, Diet Quality
- Being tested
- Diet Intervention, Exercise Intervention
- Keywords
- Diet Quality, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet InterventionOther
Participants will engage in discussions about healthy eating one time per week led by a trained peer leader for 12-weeks.
Exercise InterventionOther
Participants will participate in a group exercise session led by a trained peer leader 2-times per week for 12-weeks.
| Study group | Role | What they receive |
|---|---|---|
| Peer led diet and exercise intervention | Experimental | participation in two-times per week diet and exercise peer led interventions. Receives: Other: Diet Intervention; Other: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12-weeks
Secondary outcomes (1)
Change in Mobility as Measured by the 30 Second Chair Stand Test
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.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Aug 2023
- Primary completion1 Jul 2024
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Odessa R. Addison, PhD DPT, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994938
- Sponsor's protocol ID
- E3739-P
- Other IDs
- RX003739-01A1
- Status last verified
- Jan 2026
- First submitted
- 27 Jul 2021
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35830251
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Implementation of a Peer-Led Diet and Exercise Intervention in Older Urban Dwelling Veterans With Dysmobility
- ClinicalTrials.gov ID
- NCT04994938
- Acronym / sponsor ID
- E3739-P
- Conditions
- Physical Activity, Peer Leaders, Diet Quality
- Keywords
- Diet Quality, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer led diet and exercise intervention | Experimental | Other: Diet Intervention, Other: Exercise Interventionparticipation in two-times per week diet and exercise peer led interventions. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- high cardiovascular risk
- using home oxygen
- contraindications to an exercise intervention
- dementia
- regular exercise participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet InterventionParticipants will engage in discussions about healthy eating one time per week led by a trained peer leader for 12-weeks. | Other | Peer led diet and exercise intervention |
| Exercise InterventionParticipants will participate in a group exercise session led by a trained peer leader 2-times per week for 12-weeks. | Other | Peer led diet and exercise intervention |
Primary outcome
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.
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.
1 secondary outcome
Change in Mobility as Measured by the 30 Second Chair Stand Test
Time frame: 12-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35830251Robbins 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odessa R. Addison, PhD DPT principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet Intervention and Exercise Intervention in people with Physical Activity and Peer Leaders, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiovascular Endurance (time frame: 12-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04994938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.