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临床试验/NCT05895461
NCT05895461已完成不适用

Developing a Behavioral Weight Loss Intervention for Emerging Adults Implemented Within College Health Service Centers

The Miriam Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年5月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Weight Loss

研究概览

简要总结

This Proof-of-Concept study consists of a series of uncontrolled pilot studies to refine a behavioral weight loss trial using a "small change" approach for emerging adult college students with overweight/obesity. The primary aim of this study is maximize student acceptability of the intervention and weight loss outcomes.

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 proof-of-concept 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 proof-of-concept study is to iteratively test and refine the intervention to maximize student acceptability and weight loss outcomes.

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
None

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
  • •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

Experimental

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 asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement.

干预措施: BWLI-College (Behavioral)

Control

Active Comparator

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

Weight Loss

时间窗: 10 weeks

Average weight loss of at least 3% (benchmark)

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 80% or more (benchmark)

Adherence

时间窗: 10 weeks

Average attendance and completion of sessions of 75% or more (benchmark)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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