NCT04484831已完成不适用
An Acceptance-based Therapy Intervention vs. an Enhanced Care Condition for Weight Loss Among Adolescent Girls With Overweight/Obesity: A Randomized, Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- BMI Change, 95th BMI Percentile (%)
研究概览
简要总结
The purpose of this study is to investigate the effects of an acceptance-based therapy weight loss intervention compared with enhanced care for adolescents.
详细描述
Participants will complete baseline assessments and adolescents will be randomized to either an ABT weight loss intervention or enhanced care.
The intervention will include 15 sessions over 6 months. Enhanced care will include 15 healthy lifestyle handouts over 6 months.
Post-treatment assessments will occur.
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
- 14 Years 至 19 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adolescent between ages 14-19 with overweight or obesity at or above the 85th percentile for sex and age as determined by CDC growth charts
排除标准
- •Known pregnancy or plans to become pregnant in the next 2 years
- •Plans to move out of the area in the next year
- •Autism, any intellectual disability (e.g., down syndrome)
- •Any condition prohibiting physical activity
- •A diagnosis of cardiovascular disease or diabetes
- •Have active cancer or cancer requiring treatment in the past 2 years
- •Have active or chronic infections (e.g., HIV or TB)
- •Have active kidney disease or lung disease
- •An eating disorder or substance abuse disorder
- •Having recently begun a course of or changed the dosage of any medications known to affect appetite or body composition
- •Weight loss greater than or equal to 5% in the previous 6 months
- •If they do not follow the study plan
结局指标
主要结局
BMI Change, 95th BMI Percentile (%)
时间窗: Baseline; Month 6
Changes in weight relative to the BMI at the 95th percentile based on sex-and-age (as a difference in percentage units and/or a difference in BMI units) will be evaluated.
次要结局
- Change in Quality of Life(Baseline; Month 6)
- Change in Depression Using the Valid Beck Depression Inventory-II(Baseline; Month 6)
- Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment(Baseline; Month 6)
研究者
研究点 (2)
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