Dialectal Behaviour Therapy to Enhance Health Behaviour Change for Adolescents Living With Obesity (DIRECTION Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Adherence to the intervention
研究概览
简要总结
This research is being conducted to evaluate emotion-focused therapy that incorporates elements of mindfulness, distress tolerance, and relationship support. The investigators want to learn if this therapy, called Dialectical Behavioral Therapy (DBT) will help improve quality of life and weight management in youth at risk for type 2 diabetes. Individuals will be randomly assigned to weekly group based session in one of 3 intervention arms; lifestyle + DBT, lifestyle alone, or a control arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •14-17 years old
- •BMI z-score >1.4
- •signs of mild-moderate depression (PHQ-9 score 5-19)
- •willing and able to comply with study procedures
排除标准
- •more than one health co-morbidity
- •being treated with medication for obesity
- •taking steroids
- •currently being treated for atypical antipsychotics
- •have an orthopedic injury or chronic illness that would prevent them from performing the intervention
- •experienced weight loss or enrolled in weight loss program in the six months prior to the study
- •they are currently and/or in the past 12 months have been prescribed any weight loss medication(s) including Ozempic
- •self reported history of alcoholism or drug abuse
- •history of self-harm or suicide attempts in the past 12 months
- •currently enrolled in psychotherapy or DBT
- •parents do not approve of you participating
- •unable to read, speak and understand English as translation will not be provided
- •unable/unwilling to give assent/consent
结局指标
主要结局
Adherence to the intervention
时间窗: 16 weeks
defined as the percentage of prescribed sessions that adolescents/families attend during the trial
Enrollment rates
时间窗: 16 weeks
defined as the number of adolescents/families who consent to participate and are randomized to one of the arms of the study
Adherence to the intervention
时间窗: 16 weeks
defined as the percentage of prescribed sessions that adolescents/families attend during the trial
Retention for follow up measurements
时间窗: Measured at week 16 and week 32
defined as the number of adolescents who complete follow up measurements at 16 weeks and 32 weeks
次要结局
- Quality of Life measure using the PedsQL questionnaire(Measured at baseline, 16 weeks and 32 weeks)
- Body composition measured by dual-x-ray absorptiometry (DXA)(Measured at baseline, 16 weeks and 32 weeks)
- Readiness for Lifestyle Behavior Change(Measured at baseline, 16 weeks and 32 weeks)
- Quality of Life measure using the PedsQL questionnaire(Measured at baseline, 16 weeks and 32 weeks)
- Body Mass Index (BMI) z-score(Measured at baseline, 16 weeks and 32 weeks)
- Body composition measured by dual-x-ray absorptiometry (DXA)(Measured at baseline, 16 weeks and 32 weeks)
- Emotional regulation(Measured at baseline, 16 weeks and 32 weeks)
- Emotional reactive eating(Measured at baseline, 16 weeks and 32 weeks)
- Depressive symptoms(Measured at baseline, 16 weeks and 32 weeks)
- Psychological distress(Measured at baseline, 16 weeks and 32 weeks)
- Anxiety symptoms(Measured at baseline, 16 weeks and 32 weeks)
- Readiness for Lifestyle Behavior Change(Measured at baseline, 16 weeks and 32 weeks)
- Sleep habits(Measured at baseline, 16 weeks and 32 weeks)
- Objective physical activity and sleep patterns(Measured at baseline, 16 weeks and 32 weeks)
- Behavior regulation in exercise(Measured at baseline, 16 weeks and 32 weeks)
- Self-reported healthy lifestyle behaviors - physical activity and screen time(Measured at baseline, 16 weeks and 32 weeks)
研究者
Jon McGavock
Principal Investigator
University of Manitoba