Development of a Manual-based, Interdisciplinary Intervention for Youth With ASD and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in body mass index percentile/ratio
研究概览
简要总结
The purpose of the proposed study is to develop and pilot test a manual-based, interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder (ASD) and overweight called the Changing Health in Autism through Nutrition, Getting fit, and Expanding variety (CHANGE) obesity program.
详细描述
The purpose of the study is to develop and test the feasibility of a structured, innovative approach to treat obesity in 16 children (age 3 to 10 years) with autism spectrum disorder (ASD). This 16-week program integrates behavioral psychology and nutrition science to meet the challenges of obesity in children with autism spectrum disorder (ASD). The PI will apply an evidence-based behavioral intervention to increase food variety,15 use applied behavior analytic strategies to teach physical activities in a developmentally-appropriate manner, employ biometrics to assess progress, utilize dietetic interventions to improve nutritional balance, and train caregivers to use behavior management strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of ASD confirmed by a clinical psychologist using a "gold standard" diagnostic tools
- •Overweight status, as evidenced by a BMI percentile > 85% to 94%, and 4) mild to no food selectivity, as evidenced by either history of consuming some fruits and vegetable, tolerating new foods near their plate, and/or trying new foods
排除标准
- •Children being treated with atypical antipsychotics (e.g., olanzapine, aripiprazole, risperidone) or other medications known to cause weight gain will be excluded from the study due to the weight gain associated with these medications
- •Children with unstable medical conditions will be excluded for safety concerns
- •Children presenting with severe aggression, self injury, or other disruptive behaviors that require intensive behavioral intervention will be excluded and referred to other services as needed
研究组 & 干预措施
Manual-based Behavioral Treatment
up to 16 weekly behavioral therapy sessions (intervention) following the CHANGE obesity manual, lasting approximately 45 minutes and nutritional therapy sessions, lasting approximately 30 to 60 minutes.
干预措施: Manual-based Behavioral Treatment (Behavioral)
Parent Education Program
up to 16 weekly behavioral therapy sessions following the parent education program
干预措施: Parent Education Program (Behavioral)
结局指标
主要结局
Change in body mass index percentile/ratio
时间窗: baseline, post treatment (up to 16 weeks)
Body Mass Index (BMI) is a number calculated from a person's weight divided by height.
次要结局
- Change in intake of healthy food(baseline, post treatment (up to 16 weeks))
- Change in physical activity(baseline, post treatment (up to 16 weeks))
研究者
Kristen K. Criado
Kristen Criado, Ph.D.
Emory University