Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online) (CARE2)
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (CARE2)
This study will compare a psychological treatment (cognitive-behavioral therapy; CBT-BED) and a lifestyle beahvioral obesity intervention (LBOI) for adolescents who experience binge eating and have overweight or obesity. These treatments will be compared to each other and to a control condition that involves self-monitoring eating and mood using an "app". Participants can be located in most states in the United States. All participation occurs remotely by telehealth. The goal is to learn which approach works best for reducing binge eating and excess weight in this age group.
研究概览
地位
详细说明
Binge eating is the most prevalent eating disorder but has the lowest rate (<4%) of receiving eating disorder treatment. Binge eating often begins in adolescence and is related to obesity, physical and mental health problems, and psychological distress. Yet, there are virtually no established treatments, and no clear standard of care, for adolescents with binge eating. Evidence-based treatments exist for adults, including psychological treatments (e.g., CBT-BED) and lifestyle behavioral obesity intervention (LBOI), but how well these treatments work for adolescents remains largely unknown. LBOI is an effective treatment for adolescent obesity, but has only been tested as additional outcomes (not the initial goal) for binge eating. There is an urgent need for research to establish the efficacy of interventions for adolescents with binge eating to improve adolescents' health and quality of life. This study will conduct a randomized controlled trial (RCT) in which adolescents are randomized to Psychological Treatment (cognitive behavioral therapy for binge eating, or CBT-BED), Behavioral Treatment (lifestyle health behavioral treatment for obesity, or LBOI), or Active Control. In this study, we will compare both CBT-BED and LBOI to each other and to an Active Control. Active Control is daily self-monitoring (emotions, eating, exercise) on an "app", mimicking real-world self-help, followed by choice of CBT-BED or LBOI.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University School of Medicine
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接触：
- Janet Lydecker, PhD
- 电话号码：317-963-7288
- 邮箱：jalydeck@iu.edu
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Be in the age range ≥12 years old and ≤17 years old;
- Have a BMI that places them above the 85th percentile based on their age and sex;
- Report 4 episodes of binge eating (feeling a loss of control while eating) per month for the past 3 months;
- Be available for participation in the study for 18 months.
Exclusion Criteria:
- Have a medical or psychiatric condition that would require a higher level of care, such as hospitalization or intensive outpatient care (e.g., neurological disorder, psychotic disorders, suicidality);
- Have a medical or psychiatric condition that would prohibit them from engaging in behavioral treatment or moderate physical activity (e.g., cardiovascular problems);
- Have uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
- Be pregnant or breastfeeding;
- Be taking medication(s) or participating in treatment(s) that could influence weight or appetite;
- Have begun taking hormonal contraceptives less than 3 months prior, as this can be related to weight changes;
- Have a developmental or cognitive disorder that would interfere with engaging in cognitive treatment;
- Have a concurrent feeding/eating disorder (e.g., bulimia nervosa); or
- Be participating in another clinical research study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cognitive-Behavioral Therapy
Cognitive-behavioral therapy for binge-eating disorder (CBT-BED) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. |
Cognitive-behavioral therapy for binge-eating disorder (CBT-BED) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. Sessions target cognitive and emotional drivers of binge eating through coping skills, problem-solving triggers, cognitive restructuring, and executive-function skill training; parent sessions focus on communication and support.
其他名称：
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实验性的：Lifestyle Behavioral Obesity Intervention
Lifestyle behavioral obesity intervention (LBOI) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. |
Lifestyle behavioral obesity intervention (LBOI) for adolescents with binge eating and overweight or obesity, delivered remotely by telehealth. Sessions provide nutrition and physical-activity prescriptions to create a modest calorie deficit and sustainable lifestyle habits and problem-solve nonadherence; parent sessions focus on the home food environment.
其他名称：
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有源比较器：Active Control
Active control: daily self-monitoring of eating, emotions, and physical activity via an "app," similar to real-world digital self-help. At the end of the initial period, individuals are presented with descriptions of CBT-BED and LBOI, choose their preferred treatment, and receive it. |
Self-monitoring eating, emotions, and exercise daily in a digital "app" that is similar to real-world self-help.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Binge Eating Episode Frequency
大体时间：End of treatment (6 months)
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Eating episodes will be assessed by the Eating Disorder Examination |
End of treatment (6 months)
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Weight (e.g., Percent Loss)
大体时间：End of treatment (6 months)
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Percent body mass index change |
End of treatment (6 months)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Eating Disorder Severity
大体时间：End of treatment (6 months)
|
Global eating-disorder psychopathology will be assessed by the Eating Disorder Examination (scores range from 0 through 6; higher scores indicate more severe psychopathology). |
End of treatment (6 months)
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Weight-related Quality of Life score
大体时间：End of treatment (6 months)
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Weight-related quality of life will be assessed by questionnaire. |
End of treatment (6 months)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 32948
- R01DK146817 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
de-identified data will be shared with qualified researchers with ethics board approval and a data use agreement.
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