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临床试验/NCT01888406
NCT01888406Unknown不适用

Targeting Binge Eating to Prevent Weight Gain in College Students

Francine Rosselli4 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
130
试验地点
4
主要终点
BMI

研究概览

简要总结

BEST4US compares the effectiveness of two forms of self-help interventions that target college students, ages 18 years to 22 years, who report binge eating. The overall question is whether one or the other format will prevent excess weight gain and lead to differences in eating behaviors. The two formats are (1) "pure self-help" (receipt of a self-help program via book form or online texts) and (2) a combination of the self-help program and guidance provided by a trained peer coach over the course of 8 weekly sessions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 22 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • binge eating episodes at least once per week in the past 28 days
  • 18 to 22 years old
  • full-time student at Wesleyan University (Middletown, CT, USA) or Manchester Community College (Manchester, CT, USA)

排除标准

  • purging more than once per week in the past three months
  • BMI less than 18 or greater than/equal to 40
  • currently pregnant
  • severe depressive symptoms or suicidality

结局指标

主要结局

BMI

时间窗: Baseline, post-intervention (8-week), and 6-month follow-up

The primary outcome measure is change in BMI from randomization. Height and weight will be measured by study staff at the baseline visit using a stadiometer (collecting height measures twice and reporting the average) and a calibrated scale (light clothing, street shoes removed). BMI will be calculated as weight in kilograms divided by height in squared centimeters. Weight will be re-measured at 8 week- and 6 month assessments. BMI change is a primary-, and incidence of obesity (i.e., obesity onset since baseline, BMI \> 30) is a secondary outcome variable. While we assess weight at the post-treatment assessment, the key question of our study is whether the intervention will reduce excess weight gain at 6-month follow-up.

次要结局

  • Cessation of Binge Eating(Baseline, post-intervention (8-week), and 6-month follow-up)

研究者

发起方
Francine Rosselli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Francine Rosselli

Visting Scholar, Dept of Psychology; Co-Investigator, BEST4US

Wesleyan University

研究点 (4)

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