Randomized Controlled Pilot Trial Targeting Weight and Shape Concern Among Women Enrolled in Behavioral Weight Management
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Weight and shape concern
研究概览
简要总结
This study is a randomized controlled trial to evaluate the effect of an adapted version of the Body Project program among adult women of higher body weight who want to lose weight. The study will evaluate treatment effects on weight and shape concern and explore the impact of intervention on weight loss outcomes.
详细描述
The objective of this study is to conduct a randomized controlled pilot trial to test the effects of a 28-week treatment protocol that combines a modified body image intervention (The Body Project: weeks 1-4) with a 6-month standard behavioral weight management treatment (weeks 5-28). The combined protocol will be evaluated in comparison to a control group that receives an education only program during weeks 1-4 followed by the same 6-month weight management treatment. It will be tested among women with high body weight who report High Weight and Shape Concern and would like to lose weight.
The goals of the study are:
- To evaluate effects of a manualized intervention on Weight and Shape Concern prior to starting weight management.
- To evaluate the effects of the modified Body Project intervention on momentary weight/shape-related thoughts and overeating episodes during behavioral weight management.
- To conduct exploratory analyses comparing effects of the two treatment conditions on weight loss and other weight-related behaviors (e.g., exercise, adherence to self-monitoring).
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index between 25-40
- •Eating Disorder Examination-Questionnaire weight concern subscale greater than or equal to 4
- •Eating Disorder Examination-Questionnaire shape concern subscale greater than or equal to 4.25
- •Personal use of cell phone
- •Able to engage in moderate intensity activity
- •Desire for weight loss
排除标准
- •No eating disorder history
- •Not pregnant
- •Not breastfeeding
- •No childbirth/delivery within 9 months
- •No substance use disorder
- •No weight loss medication or history of bariatric surgery
- •No other weight loss program participation
结局指标
主要结局
Weight and shape concern
时间窗: week 4
Assessed using the weight concern and shape concern subscales of the Eating Disorder Examination-Questionnaire. Subscale scores range from 0-6.
次要结局
- Momentary Weight and Shape Concern(week 16, week 28)
- Overeating(week 16, week 28)