Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults Living With HIV
HiActivity
1 other identifier
interventional
196
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Jun 2023
Longer than P75 for not_applicable hiv
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedStudy Start
First participant enrolled
June 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
March 17, 2026
July 1, 2025
4 years
February 22, 2023
March 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Steps per day
Assessed via Fitbit
Month 4
Secondary Outcomes (7)
Minutes per week of moderate-vigorous activity
Month 4
Minutes per week of moderate-vigorous activity, self-report
Month 4
Frailty Phenotype
Month 4
CVD Risk
Month 4
Physical performance
Month 4
- +2 more secondary outcomes
Study Arms (8)
BASM + PA Coaching
EXPERIMENTALBrief Advice and Self-Monitoring Physical Activity Coaching
BASM + CB-PA
EXPERIMENTALBrief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity
BASM + SS-PA
EXPERIMENTALBrief Advice and Self-Monitoring Social support for Physical Activity
BASM + PA Coaching + CB-PA
EXPERIMENTALBrief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity
BASM + PA Coaching + SS-PA
EXPERIMENTALBrief Advice and Self-Monitoring Physical Activity Coaching Social support for Physical Activity
BASM + CB-PA + SS-PA
EXPERIMENTALBrief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity
BASM + PA Coaching + CB-PA + SS-PA
EXPERIMENTALBrief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity
BASM
OTHERBrief Advice and Self-Monitoring
Interventions
Participants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit.
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.
This component will leverage the social functionality of the Fitbit app, promoting social support and friendly competition via a moderated Facebook group.
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.
Eligibility Criteria
You may qualify if:
- HIV positive: defined by HIV antibody, detectable HIV RNA in plasma, or a note from the participant's HIV care provider.
- Must be on continuous antiretroviral therapy (ART) for \> 3 months, as assessed via self-report.
- 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.
- 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.
- Age 50 years or older.
- 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).
- Capacity to consent, documented by acceptable answers in a consent "teach-back" process.
- Score of greater than 16 on the MOCA
- Able to ambulate without assistive devices
- Ability to use the FitBit application, as demonstrated to study staff.
You may not qualify if:
- Medical conditions or physical or neurocognitive limitations that interfere with PA or study participation.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Butler Hospitallead
Study Sites (2)
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 54415, United States
Brown University Health
Providence, Rhode Island, 02904, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Uebelacker, PhD
Butler Hospital
- PRINCIPAL INVESTIGATOR
Jason Baker, MD
Hennepin Healthcare
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Data analyst will be masked to intervention component assignment labels.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2023
First Posted
March 2, 2023
Study Start
June 21, 2023
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
March 17, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share