Health TrialsbyHealthPanel

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

ConditionsHivPhysical InactivityAging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorButler Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Exclusion Criteria

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).

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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.

Treatment groups

196 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: BASM + PA CoachingExperimental treatment 2 interventions
Group B: BASM + CB-PAExperimental treatment 2 interventions
Group C: BASM + SS-PAExperimental treatment 2 interventions
Group D: BASM + PA Coaching + CB-PAExperimental treatment 3 interventions
Group E: BASM + PA Coaching + SS-PAExperimental treatment 3 interventions
Group F: BASM + CB-PA + SS-PAExperimental treatment 3 interventions
Group G: BASM + PA Coaching + CB-PA + SS-PAExperimental treatment 4 interventions
Group H: BASMOther 1 intervention

Trial outcomes

Primary outcomes

1

Steps per day

Assessed via Fitbit

Time frame
Month 4

Secondary outcomes

1

Minutes per week of moderate-vigorous activity

Assessed via FitBit

Time frame
Month 4
2

Minutes per week of moderate-vigorous activity, self-report

Assessed via the International Physical Activity Questionnaire

Time frame
Month 4
3

Frailty Phenotype

Assessed via the Fried Criteria

Time frame
Month 4
4

CVD Risk

Assessed using Life's Simple 7 Scale

Time frame
Month 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Butler Hospital

Lead sponsor

Source ClinicalTrials.gov
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