Testing a Behavioral Weight Loss Intervention for Emerging Adults Implemented Within College Health Service Centers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
This pilot randomized controlled trial will examine a behavioral weight loss intervention that uses a "small change" approach fro emerging adult college students with overweight/obesity. The primary aim is to assess student acceptability and clinically-meaningful weight changes.
详细描述
Forty percent of emerging adults (age 18-25) have overweight or obesity, which is unlikely to remit and has significant health consequences. However, emerging adults are underrepresented in traditional weight loss programs, drop-out at high rates, and have blunted weight loss outcomes. One potential way to improve participation is to offer BWLIs in college health service centers to reduce barriers to participation. Approximately 40% of emerging adults are enrolled in a postsecondary institution and college health centers are used widely by students. Moreover, delivering an intervention with design features that are responsive to emerging adult preferences and lifestyles may also improve intervention effectiveness and attractiveness. The "small change" (SC) approach to weight loss addresses emerging adult barriers to engagement by focusing on reducing calories through a few self-selected, specific changes to current obesogenic behaviors, requiring less time and effort than traditional behavioral weight loss interventions (BWLI) and promoting autonomy and self-efficacy. The SC approach has been used effectively for weight loss in other populations. This randomized controlled pilot study is part of a larger study that aims to develop and refine a novel and effective BWLI based on a SC approach that is designed for emerging adults and for implementation in college health centers, an accessible care setting. The primary aim of this substudy is to assess acceptability and feasibility of the intervention and to get a preliminary understanding of potential clinical benefit for participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI of 25 or greater
- •Enrolled at college/university where study will take place
- •English-speaking
排除标准
- •History or current diagnosis of anorexia nervosa, bulimia nervosa, or alcohol use disorder (current symptoms also assessed at screening using validated screening questionnaires)
- •Participation in another formal weight loss program or current utilization of obesity medications
- •Current or recent pregnancy
- •Psychiatric hospitalization in the past 12 months
- •Recent weight loss of 5% body weight or more
- •History of bariatric surgery
- •Severe food or physical activity restrictions that would interfere with treatment recommendations
研究组 & 干预措施
BWLI-College
BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered synchronous sessions. As presently designed, the intervention will last 10 weeks.
干预措施: BWLI-College (Behavioral)
Control
The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention.
干预措施: Control (Behavioral)
结局指标
主要结局
Adherence
时间窗: 10 weeks
Average attendance of 75% or more (benchmark)
Weight Loss
时间窗: 10 weeks
Average weight loss of at least 3%
Acceptability
时间窗: 10 weeks
Refers to the satisfactory nature of a treatment and will be assessed via the 4-item Acceptability of Intervention Measure. Benchmarks are to reach mean scores of at least 4 out of 5.
Retention
时间窗: 10 weeks
Rate of retention of 70% or more (benchmark)
次要结局
未报告次要终点
