Optimization of a Behavioral Intervention to Increase Physical Activity in Older Adults Living With HIV (HiActivity)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Lisa Uebelacker, PhD
- Phone Number: 401-455-6381
- Email: luebelacker@butler.org
Study Contact Backup
- Name: Bailey O'Keeffe, MS
- Phone Number: 401-455-6219
- Email: bokeeffe@butler.org
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 54415
- Recruiting
- Hennepin Healthcare Research Institute
-
Principal Investigator:
- Jason Baker, MD
-
Contact:
- Nwando Ikeogu
- Phone Number: 612-449-5974
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02904
- Recruiting
- Brown University Health
-
Principal Investigator:
- Megan Pinkston-Camp, PhD
-
Contact:
- Lizzie Cepeda, BA
- Phone Number: 401-793-8870
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: BASM + PA Coaching
Brief Advice and Self-Monitoring 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.
Other Names:
Participants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit.
Other Names:
|
|
Experimental: BASM + CB-PA
Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity
|
Participants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit.
Other Names:
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.
Other Names:
|
|
Experimental: BASM + SS-PA
Brief Advice and Self-Monitoring 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.
Other Names:
Participants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit.
Other Names:
|
|
Experimental: BASM + PA Coaching + CB-PA
Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity
|
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.
Other Names:
Participants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit.
Other Names:
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.
Other Names:
|
|
Experimental: BASM + PA Coaching + SS-PA
Brief Advice and Self-Monitoring Physical Activity Coaching Social support for Physical Activity
|
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.
Other Names:
This component will leverage the social functionality of the Fitbit app, promoting social support and friendly competition via a moderated Facebook group.
Other Names:
Participants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit.
Other Names:
|
|
Experimental: BASM + CB-PA + SS-PA
Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity 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.
Other Names:
Participants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit.
Other Names:
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.
Other Names:
|
|
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
|
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.
Other Names:
This component will leverage the social functionality of the Fitbit app, promoting social support and friendly competition via a moderated Facebook group.
Other Names:
Participants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit.
Other Names:
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.
Other Names:
|
|
Other: BASM
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Steps per day
Time Frame: Month 4
|
Assessed via Fitbit
|
Month 4
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Minutes per week of moderate-vigorous activity
Time Frame: Month 4
|
Assessed via FitBit
|
Month 4
|
|
Minutes per week of moderate-vigorous activity, self-report
Time Frame: Month 4
|
Assessed via the International Physical Activity Questionnaire
|
Month 4
|
|
Frailty Phenotype
Time Frame: Month 4
|
Assessed via the Fried Criteria
|
Month 4
|
|
CVD Risk
Time Frame: Month 4
|
Assessed using Life's Simple 7 Scale
|
Month 4
|
|
Physical performance
Time Frame: Month 4
|
Assessed via the Short Physical Performance Battery
|
Month 4
|
|
Emotional Well-being
Time Frame: Month 4
|
Assessed via PROMIS-29 v2.1 profile - Mental Health summary score
|
Month 4
|
|
Physical functioning
Time Frame: Month 4
|
Assessed via PROMIS-29 v2.1 profile - Physical Health summary score
|
Month 4
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Jason Baker, MD, Hennepin Healthcare
- Principal Investigator: Lisa Uebelacker, PhD, Butler Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Slow Virus Diseases
- HIV Infections
- Behavior
- Acquired Immunodeficiency Syndrome
- Sedentary Behavior
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Psychotherapy
- Behavioral Disciplines and Activities
- Exercise
- Crisis Intervention
Other Study ID Numbers
Other Study ID Numbers
- 2208-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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