Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Stress Physiology
研究概览
简要总结
Adverse childhood experiences (ACEs), referring to traumatic experiences occurring before 18 years of age (e.g., abuse/neglect), are associated with a 30-70% increased risk of developing adolescent and adult obesity and obesity-related cardiometabolic comorbidities, which may be due to dysregulation in stress-related physiology and engagement in stress-related behaviors. While adolescents with ACEs have a 2.25 times increased risk of obesity, standard-of-care lifestyle (e.g., nutrition/physical activity) interventions do not typically incorporate trauma-informed care, including assessment and therapeutic attention to effects of ACEs. Heart rate variability (HRV) biofeedback is an evidence-based, relatively brief, mind-body intervention targeting the stress physiology that can be dysregulated in adolescents with ACEs. The objective of this proposal is to adapt and test a 4-session HRV biofeedback protocol for 12-17-year-olds with BMI>85th percentile and ACEs. First (Phase 1), we will iteratively adapt a 4-session HRV biofeedback facilitator protocol with n=3-5 adolescents with overweight/obesity and ACEs, using adolescent quantitative and qualitative feedback to hone and optimize HRV biofeedback for this population (Aim 1). Next (Phase 2), we will conduct a randomized waitlist-controlled pilot study of n=30 adolescents with overweight/obesity and ACEs to assess acceptability and feasibility (Aim 2) and to describe changes in theorized targets of biofeedback (Aim 3).
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Four or more ACEs
- •BMI at or above the 85th percentile;
排除标准
- •Major renal, hepatic, endocrinologic, rheumatologic, cardiac, or pulmonary medical problem likely to affect mood or weight
- •Medications affecting mood or weight (e.g. anti-anxiety/depressants/psychotics, stimulants, mood stabilizers, insulin sensitizers, weight loss)
结局指标
主要结局
Stress Physiology
时间窗: Year 2
Inflammatory Biomarkers
时间窗: Year 2
Facilitator Protocol
时间窗: Year 1
4-session biofeedback facilitator protocol
Stress Eating
时间窗: Year 2
Insulin Sensitivity
时间窗: Year 2
Feasibility/Acceptability
时间窗: Year 1
Protocol implementation will be feasible in terms of recruitment (≥60% eligible enroll), intervention adherence (≥80% will receive \>80% dosage), baseline/post-treatment assessment adherence (\<20% missing data), and post-treatment retention (≥80%). Biofeedback will be acceptable based on session likeability ratings (80% \>4:5) and qualitative themes assessed by interview indicative of likeability/benefit.
次要结局
未报告次要终点