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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05752500
Acronym
HiActivity
Enrollment
196
Registered
2023-03-02
Start date
2023-06-21
Completion date
2027-08-31
Last updated
2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Hiv, Physical Inactivity

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.

Detailed description

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.

Interventions

BEHAVIORALCognitive Behavioral Intervention for Physical Activity

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.

BEHAVIORALSocial 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.

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.

BEHAVIORALBrief 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.

Sponsors

Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

Data analyst will be masked to intervention component assignment labels.

Intervention model description

2x2x2 factorial design

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. HIV positive: defined by HIV antibody, detectable HIV RNA in plasma, or a note from the participant's HIV care provider. 2. Must be on continuous antiretroviral therapy (ART) for \> 3 months, as assessed via self-report. 3. 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. 4. 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. 5. Age 50 years or older. 6. 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). 7. Capacity to consent, documented by acceptable answers in a consent "teach-back" process. 8. Score of greater than 16 on the MOCA 9. Able to ambulate without assistive devices 10. Ability to use the FitBit application, as demonstrated to study staff.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Steps per dayMonth 4Assessed via Fitbit

Secondary

MeasureTime frameDescription
Minutes per week of moderate-vigorous activityMonth 4Assessed via FitBit
Minutes per week of moderate-vigorous activity, self-reportMonth 4Assessed via the International Physical Activity Questionnaire
Frailty PhenotypeMonth 4Assessed via the Fried Criteria
CVD RiskMonth 4Assessed using Life's Simple 7 Scale
Physical performanceMonth 4Assessed via the Short Physical Performance Battery
Emotional Well-beingMonth 4Assessed via PROMIS-29 v2.1 profile - Mental Health summary score
Physical functioningMonth 4Assessed via PROMIS-29 v2.1 profile - Physical Health summary score

Countries

United States

Contacts

CONTACTBailey O'Keeffe, MS
bokeeffe@butler.org401-455-6219
CONTACTLisa Uebelacker, PhD
luebelacker@butler.org401-455-6381
PRINCIPAL_INVESTIGATORLisa Uebelacker, PhD

Butler Hospital

PRINCIPAL_INVESTIGATORJason Baker, MD

Hennepin Healthcare

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026