Wellness Achieved Through Changing Habits (The WATCH Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Decide to Participate in the Intervention
研究概览
简要总结
The purpose of this pilot, feasibility study is to investigate the acceptability of an acceptance-based therapy healthy lifestyle intervention in adolescent girls with overweight/obesity.
详细描述
Participants will attend 2 baseline clinic visits and adolescents will participate in an ABT healthy lifestyle intervention.
The intervention will include 15 sessions over 6 months.
A post-treatment visit will occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 girls between ages 14-19 with overweight or obesity 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
- •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 begun a course of or changed the dosage of any medications known to affect appetite or body composition within the previous 3 months
- •Weight loss greater than or equal to 5% in the previous 6 months
- •If they do not follow the study plan
研究组 & 干预措施
ABT Weight Loss Intervention
Adolescent girls will attend healthy lifestyle sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.
干预措施: ABT Weight Loss Intervention (Behavioral)
结局指标
主要结局
Percentage of Participants Who Decide to Participate in the Intervention
时间窗: Baseline; Week 1
Of the participants who completed baseline visits, this percentage details what percentage of enrollees decided to participate in the intervention. The study will be deemed "acceptable" if at least 80% of enrolled participants decide to participate in the intervention.
Number of Participants Recruited
时间窗: Baseline; Week 8
Number of teens who enrolled and completed both initial baseline visits. The recruitment strategy will be deemed 'feasible' if 15 participants are recruited within the 8 weeks.
Percentage of Participants Who Did Not Complete the Intervention.
时间窗: Baseline; Month 6
The attrition strategy will be deemed "feasible" if there is less than 50% attrition at the end of the 6-month intervention. This percentage details attrition, or the percentage of participants who did not complete the intervention.
Percentage of Participants Who Attend All Intervention Sessions.
时间窗: Week 1; Week 24
This percentage details the percentage of those who attended all 15 intervention sessions among intervention completers (n=11). The study will be deemed 'acceptable' if at least 70% of intervention completers attend all sessions.
次要结局
- Change in BMI Z-score(Baseline; Month 6)