跳至主要内容
临床试验/NCT05752500
NCT05752500
招募中
不适用

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

Butler Hospital3 个研究点 分布在 1 个国家目标入组 196 人2023年6月21日

概览

阶段
不适用
干预措施
Cognitive Behavioral Intervention for Physical Activity
疾病 / 适应症
Hiv
发起方
Butler Hospital
入组人数
196
试验地点
3
主要终点
Steps per day
状态
招募中
最后更新
上个月

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2023年6月21日
结束日期
2027年8月31日
最后更新
上个月
研究类型
Interventional
研究设计
Factorial
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

BASM + CB-PA + SS-PA

Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity

干预措施: Cognitive Behavioral Intervention for Physical Activity

BASM + PA Coaching

Brief Advice and Self-Monitoring Physical Activity Coaching

干预措施: Physical Activity Coaching

BASM + PA Coaching

Brief Advice and Self-Monitoring Physical Activity Coaching

干预措施: Brief Advice and Self-Monitoring

BASM + CB-PA

Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity

干预措施: Cognitive Behavioral Intervention for Physical Activity

BASM + CB-PA

Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity

干预措施: Brief Advice and Self-Monitoring

BASM + SS-PA

Brief Advice and Self-Monitoring Social support for Physical Activity

干预措施: Social Support for Physical Activity

BASM + SS-PA

Brief Advice and Self-Monitoring Social support for Physical Activity

干预措施: Brief Advice and Self-Monitoring

BASM + PA Coaching + CB-PA

Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity

干预措施: Cognitive Behavioral Intervention for Physical Activity

BASM + PA Coaching + CB-PA

Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity

干预措施: Physical Activity Coaching

BASM + PA Coaching + CB-PA

Brief Advice and Self-Monitoring Physical Activity Coaching Cognitive-Behavioral Intervention to Increase Physical Activity

干预措施: Brief Advice and Self-Monitoring

BASM + PA Coaching + SS-PA

Brief Advice and Self-Monitoring Physical Activity Coaching Social support for Physical Activity

干预措施: Social Support for Physical Activity

BASM + PA Coaching + SS-PA

Brief Advice and Self-Monitoring Physical Activity Coaching Social support for Physical Activity

干预措施: Physical Activity Coaching

BASM + PA Coaching + SS-PA

Brief Advice and Self-Monitoring Physical Activity Coaching Social support for Physical Activity

干预措施: Brief Advice and Self-Monitoring

BASM + CB-PA + SS-PA

Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity

干预措施: Social Support for Physical Activity

BASM + CB-PA + SS-PA

Brief Advice and Self-Monitoring Cognitive-Behavioral Intervention to Increase Physical Activity Social support for Physical Activity

干预措施: Brief Advice and Self-Monitoring

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

干预措施: Cognitive Behavioral Intervention for Physical Activity

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

干预措施: Social Support for Physical Activity

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

干预措施: Physical Activity Coaching

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

干预措施: Brief Advice and Self-Monitoring

BASM

Brief Advice and Self-Monitoring

干预措施: Brief Advice and Self-Monitoring

结局指标

主要结局

Steps per day

时间窗: Month 4

Assessed via Fitbit

次要结局

  • Minutes per week of moderate-vigorous activity, self-report(Month 4)
  • Physical performance(Month 4)
  • Minutes per week of moderate-vigorous activity(Month 4)
  • Physical functioning(Month 4)
  • Frailty Phenotype(Month 4)
  • CVD Risk(Month 4)
  • Emotional Well-being(Month 4)

研究点 (3)

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