Recruiting

Behavioral Intervention

Sponsor:

Butler Hospital

Code:

NCT05752500

Conditions

Hiv

Physical Inactivity

Aging

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Intervention for Physical Activity

Social Support for Physical Activity

Physical Activity Coaching

Brief Advice and Self-Monitoring

Study Details

Brief summary:

The goal of this clinical trial is to examine 3 interventions designed to increase physical activity in older adults with HIV. We will examine 3 potential components of an intervention package: physical activity coaching, cognitive behavioral therapy targeted toward common barriers to physical activity such as low motivation or chronic pain, and a Fitbit-based social support intervention. Our primary outcome will be physical activity, defined as steps per day. Results will guide choice of intervention components to be used in an optimized behavioral intervention.

Conditions

Hiv

Physical Inactivity

Aging

Study ID

NCT05752500

Start date

Jun 21, 2023

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. HIV positive: defined by HIV antibody, detectable HIV RNA in plasma, or a note from the participant's HIV care provider.
2. Must be on continuous antiretroviral therapy (ART) for > 3 months, as assessed via self-report.
3. Low PA: defined as self-report of < 90 minutes of moderate-vigorous PA (MVPA) per week in the previous 3 months AND less than 14 hours per week of sustained walking in the previous 4 weeks.
4. Medically cleared for moderate PA. If participants report a) a history of cardiovascular disease including known coronary artery disease, peripheral vascular disease, heart failure, or stroke; or b) chest pain, shortness of breath, or dizziness or syncope either at rest or during activity in the past 3 months, then they must have medical clearance by a physician or primary care provider.
5. Age 50 years or older.
6. Proficiency in English: sufficient to engage in informed consent, understand assessments and materials provided, and engage and use Fitbit application (all materials provided in English).
7. Capacity to consent, documented by acceptable answers in a consent "teach-back" process.
8. Score of greater than 16 on the MOCA
9. Able to ambulate without assistive devices
10. Ability to use the FitBit application, as demonstrated to study staff.

Exclusion Criteria:

  • Exclusion Criteria

1. Medical conditions or physical or neurocognitive limitations that interfere with PA or study participation.
2. Hazardous substance use, assessed via a score ≥15 on the Alcohol Use Disorders Identification Test (AUDIT) or ≥6 on the Drug Abuse Screening Test (DAST).

Study Design

Enrollment

196 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BASM + PA Coaching

Brief Advice and Self-Monitoring Physical Activity Coaching

experimental: BASM + CB-PA

Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity

experimental: BASM + SS-PA

Brief Advice and Self-Monitoring Social support for Physical Activity

experimental: BASM + PA Coaching + CB-PA

Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity

experimental: BASM + PA Coaching + SS-PA

Brief Advice and Self-Monitoring Physical Activity Coaching Social support for Physical Activity

experimental: BASM + CB-PA + SS-PA

Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity

experimental: BASM + PA Coaching + CB-PA + SS-PA

Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity

other: BASM

Brief Advice and Self-Monitoring

Interventions

Cognitive Behavioral Intervention for Physical Activity

Interventionist will use cognitive and behavioral techniques to help the participant increase facilitators and decrease barriers to physical activity, particularly barriers such as lack of motivation, depression, and chronic pain. Meetings will occur every other week for 4 months.

Social Support for Physical Activity

This component will leverage the social functionality of the Fitbit app, promoting social support and friendly competition via a moderated Facebook group.

Physical Activity Coaching

The PA coach will meet with the participant to set goals for physical activity (steps) and encourage self-monitoring. Meetings will occur every other week for 4 months.

Brief Advice and Self-Monitoring

Participants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit.

Primary outcome measure

  • Steps per day [ Time Frame: Month 4 ]

Central Contacts and Locations

Central contacts

Locations

Hennepin Healthcare Research Institute

Recruiting

Minneapolis, Minnesota, United States, 54415

Contacts

Nwando Ikeogu

612-449-5974

Principal Investigator:

Jason Baker, MD

Brown University Health

Recruiting

Providence, Rhode Island, United States, 02904

Contacts

Lizzie Cepeda, BA

401-793-8870

Principal Investigator:

Megan Pinkston-Camp, PhD

More Information

Sponsor

Butler Hospital

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Butler Hospital on 2026-08-07.