Obesity and Physical Activity: Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- the feasibility of implementing the PAS intervention (e.g., recruitment rate, eligibility rate) for adults with obesity recruited from a local weight management center in the USA.
研究概览
简要总结
The Physical Activity Self-efficacy (PAS) intervention is a web-based behavioral intervention newly developed to promote physical activity in adults with obesity. The conceptual framework for the PAS intervention is based on self-efficacy theory. The objective of this study is to investigate the feasibility and acceptability of implementing the PAS online intervention for adults with obesity recruited from a local weight management center in the United States of America (USA). The study design is a prospective, double-blind, parallel group randomized pilot trial. Thirty participants will be randomly assigned to the PAS group or usual care group to achieve a 1:1 group assignment. Recruitment of participants is scheduled to begin in January 2024 or earlier at a local weight management center within a private healthcare system in the USA. There are five eligibility criteria for participation in this study (e.g., a body mass index ≥ 25.00 kg/m2). Eligibility verification and data collection will be conducted online. Three waves of data collection will take up to 14 weeks depending on participants' progress in the study. Instruments designed to measure demographic information, anthropometric characteristics, self-efficacy, and acceptability will be included in the survey battery. A research-grade accelerometer will be used to measure free-living physical activity objectively. Data will be analyzed using descriptive statistics and inferential statistical models under an intention-to-treat approach. This study will be sponsored by the Transdisciplinary Areas of Excellence Seed Grant Program from Binghamton University.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
the feasibility of implementing the PAS intervention (e.g., recruitment rate, eligibility rate) for adults with obesity recruited from a local weight management center in the USA.
时间窗: By Week 7
The feasibility of implementing the PAS online intervention for adults with obesity recruited from a local weight management center in the USA will be assessed with descriptive statistics. Descriptive statistics will include (a) recruitment rate, (b) eligibility rate, (c) consent rate, (d) participation rates, and (e) retention rates.
the acceptability of implementing the PAS intervention (e.g., engagement, accelerometer-based assessment of physical activity) for adults with obesity recruited from a local weight management center in the USA.
时间窗: By Week 7
The acceptability of implementing the PAS online intervention for adults with obesity recruited from a local weight management center in the USA will be assessed with descriptive statistics. Descriptive statistics will include acceptability of the PAS intervention (e.g., engagement behavior, subjective experience) and acceptability of accelerometer-based assessment of physical activity.
a preliminary effect size estimate for each direct effect depicted in the conceptual model for the PAS online intervention.
时间窗: By Week 14
Within 7 days after the W1 and W3 survey battery, participants will be asked to enter a code into the PAS intervention website in order to start wearing a physical activity monitor for the next consecutive 7 days. They will be instructed to wear a research-grade accelerometer, ActiGraph wGT3X-BT, on their waist. The primary measure of physical activity in this study will be the average minutes per day of Moderate to Vigorous Physical Activity (MVPA) based on both widely accepted recommendations for health-enhancing physical activity. Instruments designed to measure the acceptability of accelerometer-based assessment of physical activity and self-reported physical activity will also be included in the W1 and W3 physical activity monitoring.
次要结局
- Self-efficacy to engage(By Week 7)
- Physical activity self-efficacy(By Week 3, By Week 7, By Week 14)
- Self-efficacy to regulate physical activity(By Week 3, By Week 7, By Week 14)
研究者
Seungmin Lee
Assistant Professor
Binghamton University