Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults Living With HIV

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Butler Hospital
Study ID
NCT05752500
Status
Recruiting
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Conditions

  • Aging
  • Hiv
  • Physical Inactivity

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive Behavioral Intervention for Physical Activity — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    Participants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit.

Study Details

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.

Key Dates

Start date
Jun 21, 2023
Status verified
Jul 2025
Primary completion
Jul 1, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
196 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Steps per day [ Time Frame: Month 4 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hennepin Healthcare Research InstituteMinneapolisMinnesota54415
Nwando Ikeogu
612-449-5974
Jason Baker, MD (PRINCIPAL_INVESTIGATOR)
Brown University HealthProvidenceRhode Island02904
Lizzie Cepeda, BA
401-793-8870
Megan Pinkston-Camp, PhD (PRINCIPAL_INVESTIGATOR)

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