W8Loss2Go: Behavioral Weight Loss Intervention Utilizing Mobile Health Technology in Pediatric Patients Referred to a Tertiary Care Center Weight Management Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Body Mass Index (BMI) z -Score
研究概览
简要总结
The investigators will test a recent mobile technology based (mHealth) behavioral weight loss intervention (W8Loss2Go), which is designed for children and adolescents, and uses an addiction model to promote withdrawal from problem foods, snacking, and excessive amounts at meals. The investigators will test whether this intervention will reduce body mass index (BMI), help subjects identify and withdraw from "problem foods", eliminate snacking, and reduce the amounts of foods consumed at home meals.
详细描述
Background and Rationale: About one in five 12-18 year-olds in the U.S. are obese. It has been theorized that overeating in some individuals may have addictive qualities, and that specific foods may have addictive potential for these people. But few weight management interventions have tested therapeutic techniques founded in addiction medicine principles to date. Since mHealth interventions have been successful in the treatment of other addictions, the investigators hypothesize that mHealth technologies which are rooted in behavioral theory could be effective to promote weight loss in some individuals.
Dr. Robert Pretlow, together with E-Health International, created a weight loss intervention via an iPhone application (W8Loss2Go), based on the addiction treatment approach of staged, incremental withdrawal from problem foods, snacking/grazing, and excessive amounts of foods at meals. The W8Loss2Go application helps participants address their dependence on specific problem foods prior to addressing the amount of food consumed. A secondary focus of the application is to increase the amount of health provider-patient interaction outside of clinic based face-to-face-sessions in a cost-effective manner. Initial pilot studies in obese adolescents in a community setting showed success in improving these problem behaviors and improving BMI.
Intervention: The investigators will test a recent mobile technology based (mHealth) behavioral weight loss intervention, W8Loss2Go, which is designed for children and adolescents, and uses an addiction model to promote a staged withdrawal from problem foods, snacking, and excessive amounts at meals.
Hypothesis: The investigators hypothesize that participants who display addictive behaviors will respond well the mHealth intervention and will be able to withdraw from problem foods and eliminate snacking and excessive amounts eaten at meals, and will therefore show significant decrease in BMI z score from first to last visit.
Specific Aim 1: Determine if participants utilizing the app can stop eating certain self-identified problem foods.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-18 years
- •Patients referred to EMPOWER
- •Positive screen on the Yale Food Addiction Scale for Children
- •Participant will not be leaving the country during the study duration.
排除标准
- •Obesity comorbidities including impaired glucose tolerance, impaired fasting glucose, diabetes, fatty liver with ALT>40, BP > 99th percentile for age, gender, and height
- •Psychiatric illness including depression and anxiety disorder
- •Known developmental delay
结局指标
主要结局
Body Mass Index (BMI) z -Score
时间窗: Baseline and 6 months
The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A negative change value reflects a decrease in BMI or a better outcome and a positive change value reflects an increase in BMI or a worsening in the outcome.
次要结局
- Number of Participants Able to Reduce Daily Meal Portion Size Utilizing Wireless Food Scale.(1 month)
- Number of Participants With Success in Withdrawing From Problem Foods(6 months)
- Number of Participants Able to Eliminated Day Time Snacking(3 months)
研究者
Alaina Vidmar, MD
Pediatric Endocrinology Fellow Children's Hospital of Los Angeles
Children's Hospital Los Angeles