A 3-Group, Parallel-Group Randomized Clinical Trial Comparing Usual Care, a WeChat-Delivered Mobile Health Intervention, and the Same Intervention Plus Enhanced Human Support for Children With Autism in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index (BMI) z-score
研究概览
简要总结
This study is a randomized clinical trial conducted in China from January 2023 to July 2025. It aims to test whether a mobile health program delivered via WeChat, with or without additional human support, can help improve body weight outcomes in children with autism.
Children aged 8 to 16 years with autism were randomly assigned to one of three groups: (1) usual care, (2) a 16-week WeChat-based lifestyle intervention, or (3) the same WeChat intervention plus weekly tele-group sessions led by a coach.
The main outcome is the change in body mass index (BMI) z-score after 16 weeks. Secondary outcomes include the development of obesity over 6, 12, and 24 months, as well as changes in physical activity, screen time, eating habits, and other health behaviors.
A total of 276 families participated. The results will help understand whether digital health programs can be an effective and scalable option for supporting healthy lifestyles in children with autism.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were blinded to group assignment for the entire study duration. Due to the nature of the behavioral lifestyle interventions, participants, their caregivers, and intervention delivery staff were not blinded to treatment assignment. Participants and their parents/legal guardians were instructed not to disclose group assignment during all outcome assessments.
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 8 to 12 years at the time of enrollment
- •Confirmed diagnosis of autism via prior clinical documentation, verified by the Childhood Autism Rating Scale, Second Edition (CARS-2)
- •Parent or legal guardian is able and willing to provide written informed consent for the child's study participation
- •The family has consistent smartphone access to receive and engage with the WeChat-based intervention
- •No baseline obesity, as defined by age- and sex-specific BMI cutoffs for Chinese children and adolescents
排除标准
- •Meets the definition of baseline obesity per age- and sex-specific BMI cutoffs for Chinese children and adolescents
- •Has any medical or developmental condition that precludes safe participation in the remotely delivered lifestyle intervention
- •Unable to comply with the study intervention and assessment procedures
- •Parent or legal guardian refuses to provide written informed consent for the child's study participation
研究组 & 干预措施
Usual Care
Participants assigned to this group continue to receive routine clinical care for autism, and receive a one-time written standard recommendation on healthy eating and physical activity for children. No digital support, individualized feedback, or scheduled coaching is provided.
干预措施: Standard Lifestyle Recommendations (Behavioral)
WeChat-Based Mobile Health Intervention
Participants assigned to this group receive a 16-week culturally adapted, family-based behavioral lifestyle intervention delivered via WeChat. Content is delivered through 3 prescheduled weekly WeChat messages in multimedia formats (short texts, infographics, videos), targeting healthy eating, physical activity, sedentary behavior reduction, and parent-mediated behavior change strategies. Automated prompts for weekly tasks and standardized reminders are provided; asynchronous technical assistance is available, with no scheduled counseling.
干预措施: WeChat-Based Mobile Health Intervention (Behavioral)
WeChat-Based Intervention Plus Enhanced Human Support
Participants assigned to this group receive the full 16-week WeChat-based mobile health intervention (identical to the WeChat-only intervention group), plus weekly coach-facilitated tele-group sessions delivered via Tencent Meeting. Each 20-30 minute session includes 6-8 families, delivered by trained master's level research assistants, focusing on reinforcing intervention messages, progress review, barrier problem-solving, peer exchange, and weekly family goal setting.
干预措施: Coach-Facilitated Tele-Group Sessions (Behavioral)
结局指标
主要结局
Change in Body Mass Index (BMI) z-score
时间窗: Baseline (pre-intervention), the 16-week intervention (primary endpoint), 6-month, 12-month, and 24-month post-intervention follow-up visits.
This metric is the primary continuous endpoint for obesity prevention in children with autism spectrum disorder. BMI is measured with calibrated medical-grade devices, guided by blinded assessors via real-time video calls. Longitudinal changes at 6-, 12-, and 24-month post-intervention follow-ups are secondary analyses.Age- and Sex-Standardized Body Mass Index (BMI) Z-Score. The z-score uses the updated national growth reference for Chinese school-aged children, aligned with WGOC criteria for epidemiological validity.As a standardized statistical measure of population mean deviations, this metric has no fixed theoretical minimum or maximum values.Higher scores mean worse outcomes (greater obesity relative to the reference population), while a z-score decrease indicates better outcomes, reflecting a clinically meaningful weight control benefit.
次要结局
- Cumulative Incident Obesity(At the 6-month, 12-month, and 24-month post-intervention follow-up visits.)
- BMI z-score Responder Status(The 16-week intervention.)
研究者
Shen Xin
Principal Investigator
Shanghai University of Sport