Examining the Feasibility of a Brief Adjunctive Mindfulness Intervention for Adolescents With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Number of Sessions Attended by Participant
研究概览
简要总结
The goal of this study is to conduct a single arm open trial to examine the feasibility of a brief, adjunctive mindfulness intervention tailored to the needs of adolescents with severe obesity.
详细描述
The purpose of this study is to examine whether it is feasible to integrate a brief, adjunctive mindfulness intervention with the standard medical management of obesity in adolescents with severe obesity. Mindfulness refers to the experience of paying attention to the present moment in a nonjudgmental manner. Mindfulness training enhances one's ability to cope with negative emotions and one's awareness of decision-making processes and internal experiences.
The proposed study has two specific aims: 1) to conduct a single arm open trial to examine the feasibility and acceptability of the mindfulness intervention in a sample of 15 adolescents with severe obesity; and 2) to examine the preliminary efficacy of the mindfulness intervention on BMI, emotion regulation, eating and weight-related behaviors, impulsivity, waist circumference, and blood pressure in comparison to the standard of care.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the ages of 12 - 17 years
- •a current patient of our affiliated obesity clinic
- •have a body mass index (BMI) between 30 and 45 kg/m2.
排除标准
- •have a known genetic cause of obesity
- •have been diagnosed with a severe intellectual or learning disability
- •have been diagnosed with an autism spectrum disorder or current psychosis
- •are taking a medication intended to reduce body weight
结局指标
主要结局
Number of Sessions Attended by Participant
时间窗: 6 weeks post study start date
Retention will be tracked via attendance; research staff will take attendance during each assessment period and intervention session to determine the feasibility of retaining participants.
Participant Satisfaction: Satisfaction Survey
时间窗: 6 weeks post study start date
We will assess participants' satisfaction with the intervention by having them complete a satisfaction survey at the end of the program to assess perceived helpfulness of the intervention and to elicit feedback on the various components. Participants respond to 6 questions (e.g., "I enjoyed being a part of this program") on a scale of 1 (strongly disagree) to 5 (strongly agree). An average across scores will be calculated with higher scores reflecting greater satisfaction. Possible scores range from 1 to 5.
次要结局
- Mindful Attention Awareness Scale-Adolescent (MAAS-A)(Change from Baseline to 6 weeks)
- Body Mass Index (BMI)(Change from Baseline to 6 weeks)
- "Go" Reaction Time - Measure of Inhibitory Control(Change from Baseline to 6 weeks)
- Go No Go False Alarm Rate - Measure of Inhibitory Control(Change from Baseline to 6 weeks)
- Overeating - Eating Disorders Examination-Questionnaire (EDEQ).(Change from Baseline to 6 weeks)
- Binge Eating - Eating Disorders Examination-Questionnaire (EDEQ).(Change from Baseline to 6 weeks)
研究者
Elizabeth Cotter
Assistant Professor
American University