An Addiction Model Based Mobile Health Weight Loss Intervention With Coaching in Adolescents With Overweight and Obesity: Multi-Site Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- %BMIp95
研究概览
简要总结
The proposed multi-site randomized control trial (RCT) will test the effectiveness of an addiction-based weight loss intervention, embodied first as a smartphone app with telephone coaching and second as an identical approach phone-coaching alone intervention compared to age matched controls participating in an in-clinic weight management interventions in a larger sample of economically, racially and ethnically diverse adolescents (ages 14-18). One hundred and eighty adolescents will be recruited from pediatric interdisciplinary weight management clinics operating out of five different hospital systems in Southern California and through targeted mailing to 40 ethnically, racially and economically diverse neighborhoods in Los Angeles County. The adolescents will be randomized 1:1 via stratified block randomization to either receive 1) interactive addiction model based mobile health (mHealth) weight-loss intervention with personalized phone-coaching (AppCoach), 2) interactive addiction model based mHealth weight-loss intervention alone (App) or 3) Multidisciplinary in-clinic weight management program (Clinic). Assessment of the intervention's effect on zBMI and percent over the 95th percentile (%BMIp95), fasting metabolic parameters, addictive eating habits, executive function, and motivation for change will be obtained at enrollment, 3, 6, 12 and 18 months (1 year post intervention follow up).
详细描述
Aim 1 (Primary Outcomes): To test the effectiveness of an addiction-based weight loss intervention, embodied first as a smartphone app with telephone coaching (AppCoach) compared to (1) addiction model based weight-loss app alone (App) and (2) multi-disciplinary in-clinic weight loss intervention (Clinic) on weight outcomes of overweight and obese adolescents at 3, 6, 12 and 18 months post enrollment.
Hypothesis 1a: Participants who complete the six month AppCoach will have a greater decrease in their zBMI and %BMIp95 compared to baseline at completion of the 6 months intervention, than those receiving App or Clinic.
Hypothesis 1b: Participants who completed the six month AppCoach will have greater decrease in their zBMI and %BMIp95 compared to baseline at 6 and 12 months post intervention completion compared to App and Clinic.
Aim 2 (Secondary Outcomes): To compare the effects of AppCoach on addictive eating behaviors, motivation and self-regulatory behaviors at completion of the intervention and 6 and 12 months post intervention.
Hypothesis 2: Compared to App or Clinic, AppCoach will result in lower YFAS-c scores, higher motivation and improved self- regulatory behaviors scores when evaluated at completion of the intervention and 6 and 12 months post intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blocked randomization will be utilized, to ensure the groups are balanced in terms of number of subjects and the distribution of potential confounding variables. Blocked randomization will be used to ensure the number of eligible subjects assigned to each group is equally distributed. Block size will be blinded from the primary investigator performing the study.
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14-18 years
- •Body mass index [BMI] ≥85th percentile for age and gender
排除标准
- •Concurrent participation in an alternative weight loss intervention
- •Blood pressure > 99th percentile for age, gender, and height
- •Known poorly controlled psychiatric illness and/or developmental delay
- •Participants Inability to read English
结局指标
主要结局
%BMIp95
时间窗: 6 months
Mean change in excess BMI percent over the 95th percentile (%BMIp95) over the study period compared at 6 months to baseline. value at 6 months minus value at baseline
次要结局
- Cost Analysis(6 months)
- Yale Food Addiction Scale(6 months)
研究者
Alaina P. Vidmar, MD
Assistant Professor Department of Pediatric Endocrinology
Children's Hospital Los Angeles