Open Trial Investigation of the CHANGE (Changing Health in Autism Through Nutrition, Getting Fit and Expanding Variety) Obesity Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Willingness to Participate
研究概览
简要总结
The purpose of this study is to determine if a program can help children with autism who are overweight. Specifically, this study will look to see if changes in a child's eating habits and exercise can help with weight loss. Investigators also want to see how parents feel about the program and if they will complete the entire program.
Twenty children with autism spectrum disorder (ASD) who are also overweight will participate in this study at the Marcus Autism Center. All children who enroll will receive the The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) program. This involves 16 sessions over six months. After the six months, participants will come back every month for three months for a follow up visit. Therefore the study will last a total of nine months.
详细描述
The purpose of this study is to determine if a program can help children with autism who are overweight. Specifically, this study will look to see if changes in a child's eating habits and exercise can help with weight loss. Investigators also want to see how parents feel about the program and if they will complete the entire program.
This is a 24-week, open trial pilot of 20 children (ages 5 to 12 years old) with ASD and obesity. Subjects will be enrolled in the CHANGE program, a six-month long intervention consisting of 16 sessions. The first 10 sessions occur weekly while the remaining 6 sessions occur bi-weekly. Sessions last about 1 hour each. After 24 weeks, subjects will be asked to return for follow up assessments at 1, 2 and 3 months later.
The primary aims of this project are to 1) determine the feasibility of the intervention, 2) examine preliminary efficacy, and 3) obtain feedback from parents to improve the effectiveness of the intervention and fit for families.
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ASD using DSM-5 criteria, and clinically significant SCQ score.
- •Children with mild to moderate food selectivity, as reflected by a) a diet involving at least 6 food items, b) accepting at least one fruit or vegetable as measured by the Food Preference Inventory (FPI), and c) engaging in low mealtime behavior problems on Brief Autism Mealtime Behavior Inventory (BAMBI) Food Refusal subscale
- •Child with a clinic-confirmed body mass index (BMI) percentile in the obese range (i.e., > 95th percentile)
- •Parent (primary caregiver) who agrees to participate and attend treatment sessions
- •Participating parent able to speak, understand, read, and write in English (assessments, curriculum materials and instructions are in English)
排除标准
- •Children with severe feeding problems (e.g., < 5 preferred foods as measured by the FPI) or complex medical issues (e.g., gastrostomy-tube or formula dependent) who require a different treatment approach
- •Children on medication associated with weight gain in ASD (e.g., risperidone) that has not yet stabilized (stability criteria defined as 6 months or longer i.e. child has been on medication for less than 6 months).
- •Children with serious behavioral problems (i.e., aggression, tantrums, self-injury) or another psychiatric condition that requires a different treatment approach.
- •Children with unstable medical conditions or those with a known associated with weight problems will not be included in this study.
结局指标
主要结局
Willingness to Participate
时间窗: Baseline through Week 36 Follow Up
Willingness to participate is measured as \<30% refusal of study participation from eligible participants. Willingness to participate will be used to measure overall study feasibility.
Attendance Rate
时间窗: Baseline through Week 36 Follow Up
The number of participants who attend all study visits. The attendance rate will be used to measure overall study feasibility. A successful attendance rate will be measured as \>70% attendance.
Percent Homework Adherence
时间窗: Baseline through Week 36 Follow Up
The percentage of participants who complete all homework assignments. Percent homework adherence will be used to measure overall study feasibility. A successful adherence percentage will be measured as \>70%.
Attrition Rate
时间窗: Baseline through Week 36 Follow Up
The number of participants who do not complete all study visits. The attrition rate will be used to measure study feasibility. An acceptable attrition rate will be considered \<15%.
Percent Demonstration of Skills
时间窗: Baseline through Week 36 Follow Up
The percentage of participants who demonstrate skills learned through the CHANGE program. Percent demonstration of skills will be used to measure overall study feasibility. A successful percentage will be measured as \>80%.
Percent Satisfaction
时间窗: Baseline through Week 36 Follow Up
The percentage of participants who report being satisfied with the intervention. Percent satisfaction will be used to measure overall study feasibility. A successful percentage will be measured as \>90%.
Therapist Fidelity to the Treatment Manual
时间窗: Baseline through Week 36 Follow Up
The percentage of therapists who adhere to the treatment manual. Therapist fidelity will be used to measure overall study feasibility. A successful percentage rate is \>80%.
次要结局
- Difference in Body Mass Index (BMI) Percentile(Baseline through Week 36 Follow Up)
- Change in physical activity(Baseline through Week 36 Follow Up)
- Change in Food Preference Inventory (FPI) Score(Baseline through Week 36 Follow Up)
- Change in Parenting Stress Index- Short Form (PSI-SF) Score(Baseline through Week 36 Follow Up)
研究者
William Sharp, PhD
Associate Professor
Emory University