An interventional study of Cognitive Behavioral Intervention for Physical Activity and Social Support for Physical Activity in Hiv, Physical Inactivity and Aging, sponsored by Butler Hospital. Recruiting at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Butler Hospital · Not applicable, Interventional, and Treatment
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.
Increasing numbers of persons living with HIV (PLWH) are living to older ages. Older PLWH are at increased risk for a wide spectrum of co-morbid conditions such as cardiovascular disease, frailty phenotype, and mental health disorders. Practical primary care-based interventions are needed for older PLWH that target lifestyle factors to reduce complications of aging and improve healthspan. Most PLWH engage in less physical activity (PA) than is recommended by public health guidelines. Thus, increasing PA can lead to numerous mental and physical health benefits among PLWH. Current studies in PLWH typically focus on the impact of supervised exercise. However, there are many barriers to this type of PA. Lifestyle physical activity (LPA) programs that focus on integrating PA, especially walking, into everyday life, may be more successful in producing a sustained increase in PA. The long-term goal of this research is to develop an effective and efficient primary care intervention that increases LPA among older PLWH. We leverage the Multiphase Optimization STrategy (MOST) as a framework for developing, optimizing, and evaluating a multicomponent behavioral intervention. MOST is comprised of three phases. First, in the preparation phase, an empirical and theory-driven conceptual model is developed that identifies differentiable intervention components and specifies optimization criteria (i.e., goal of intervention development). We have completed this phase. Second, in the optimization phase, the impact of each intervention component on the desired outcome is empirically examined. The goal is to determine which components to include in a final intervention package that is optimized for efficacy and efficiency. The proposed study reflects the second phase, or an optimization trial. Finally, in the evaluation phase, the optimized intervention package is evaluated for efficacy in a traditional RCT; this will be the next step in this line of research following the currently proposed project. In this project, we will test the impact of three separable intervention components on steps per day after 4 months of intervention. We will recruit 196 PLWH of age ≥50 year classified as low-active. All participants receive component '0': brief advice to exercise and a Fitbit activity tracker. We then test 3 additional components in a factorial design: 1) PA Coaching-focused on goal-setting and self-monitoring; 2) Cognitive-Behavioral intervention for PA (CB-PA)-focused on identifying values and addressing internal barriers to PA such as pain, depression, or fatigue; 3) Social Support for PA (SS-PA)-a component which leverages the social functionality of the Fitbit app, promoting social support and friendly competition. The primary outcome will be steps per day during Month 4. The observed main and interaction effects for the 3 candidate components will guide selection of components to be included in an optimized intervention that will be tested in a future RCT. We will also examine potential mediators for each intervention component, as well as secondary outcomes including perceived physical health, mental health, cardiovascular disease risk, and the frailty phenotype.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 196 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →Butler Hospital is the lead sponsor of 119 studies on the registry; 14 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Compared within Sedentary Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Acquired Immunodeficiency Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brief Advice and Self-Monitoring Physical Activity Coaching
Behavioral: Physical Activity Coaching · Behavioral: Brief Advice and Self-Monitoring
Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity
Behavioral: Cognitive Behavioral Intervention for Physical Activity · Behavioral: Brief Advice and Self-Monitoring
Brief Advice and Self-Monitoring Social support for Physical Activity
Behavioral: Social Support for Physical Activity · Behavioral: Brief Advice and Self-Monitoring
Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity
Behavioral: Cognitive Behavioral Intervention for Physical Activity · Behavioral: Physical Activity Coaching · Behavioral: Brief Advice and Self-Monitoring
Brief Advice and Self-Monitoring Physical Activity Coaching Social support for Physical Activity
Behavioral: Social Support for Physical Activity · Behavioral: Physical Activity Coaching · Behavioral: Brief Advice and Self-Monitoring
Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity
Behavioral: Cognitive Behavioral Intervention for Physical Activity · Behavioral: Social Support for Physical Activity · Behavioral: Brief Advice and Self-Monitoring
Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity
Behavioral: Cognitive Behavioral Intervention for Physical Activity · Behavioral: Social Support for Physical Activity · Behavioral: Physical Activity Coaching · Behavioral: Brief Advice and Self-Monitoring
Brief Advice and Self-Monitoring
Behavioral: Brief Advice and Self-Monitoring
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.
Also known as: CB- PA
This component will leverage the social functionality of the Fitbit app, promoting social support and friendly competition via a moderated Facebook group.
Also known as: SS-PA
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.
Also known as: PA Coaching
Participants will receive a single session with brief advice about increasing physical activity, and instructions on how to use their study-provided FitBit.
Also known as: BASM
Steps per day
Assessed via Fitbit
Time frame: Month 4
Minutes per week of moderate-vigorous activity
Assessed via FitBit
Time frame: Month 4
Minutes per week of moderate-vigorous activity, self-report
Assessed via the International Physical Activity Questionnaire
Time frame: Month 4
Frailty Phenotype
Assessed via the Fried Criteria
Time frame: Month 4
CVD Risk
Assessed using Life's Simple 7 Scale
Time frame: Month 4
Physical performance
Assessed via the Short Physical Performance Battery
Time frame: Month 4
Emotional Well-being
Assessed via PROMIS-29 v2.1 profile - Mental Health summary score
Time frame: Month 4
Physical functioning
Assessed via PROMIS-29 v2.1 profile - Physical Health summary score
Time frame: Month 4
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Aug 2027, 49 months after the start.
Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 49 months is above that.
Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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