WeChat-Autism
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
Sponsor study identifier
interventional
276
1 country
1
Study Start
January 1, 2023
Actual (reported)Primary Completion
July 1, 2025
Actual (reported)Study Completion
July 1, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2023
Actual (reported)July 1, 2025
Actual (reported)July 1, 2025
Actual (reported)March 31, 2026
Actual (reported)April 7, 2026
Actual (reported)Change in Body Mass Index (BMI) z-score
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.
Baseline (pre-intervention), the 16-week intervention (primary endpoint), 6-month, 12-month, and 24-month post-intervention follow-up visits.
Cumulative Incident Obesity
At the 6-month, 12-month, and 24-month post-intervention follow-up visits.
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.
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.
Participants continue to receive routine clinical care and receive 1-time written standard recommendations on healthy eating and physical activity for children. No digital support, individualized feedback, or scheduled coaching is provided.
A culturally adapted, family-based behavioral lifestyle intervention delivered via WeChat for 16 weeks. Content is delivered through 3 prescheduled WeChat messages per week in health literacy-informed multimedia formats (e.g., short texts, infographics, and videos). The intervention targets healthy eating, physical activity, reduction of sedentary behavior, and parent-mediated behavior change strategies. It incorporates behavior change techniques including goal setting, self-monitoring, and positive reinforcement. Families receive automated prompts to complete weekly behavior-change tasks and standardized reminders.
Shanghai University of Sport
Shanghai, Shanghai Municipality, 200438, China
276 participants (actual enrollment reported by the registry).
First Submitted
March 31, 2026
Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial
BMI z-score Responder Status
The 16-week intervention.
Change in Waist Circumference
Baseline (pre-intervention),the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.
Change in Body Fat Percentage
Baseline (pre-intervention), the 16-week intervention, 6-month, 12-month, and 24-month post-intervention follow-up visits.
Change in Objective Moderate-to-Vigorous Physical Activity (MVPA)
Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.
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.
Weekly coach-facilitated tele-group sessions delivered remotely via Tencent Meeting. Sessions last approximately 20 to 30 minutes and typically include 6 to 8 families. The sessions are delivered according to a structured manual by trained research assistants with master's degrees in psychology or related fields. Session content focuses on reinforcing key intervention messages, reviewing progress, problem-solving barriers, facilitating peer exchange, and setting weekly family goals.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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First Posted
April 7, 2026
Study Start
January 1, 2023
Actual (reported)Primary Completion
July 1, 2025
Actual (reported)Study Completion
July 1, 2025
Actual (reported)Last Updated
April 13, 2026
Record last verified: 2026-04
This study involves minor participants (children aged 8-16 years with autism spectrum disorder), a vulnerable population. Individual participant data (IPD) contains sensitive clinical, behavioral, and family-related personal information, and the protection of participants' privacy and data security is the primary principle. The study's informed consent form and approved ethical review protocol did not pre-notify participants and their guardians that individual-level data would be shared with third parties. In addition, the data are subject to relevant laws and regulations on personal information protection in China, which restrict the sharing of individual sensitive personal data of minors. Aggregate-level study results will be published in peer-reviewed journals, and relevant statistical analysis code will be available from the corresponding author upon reasonable request to ensure the reproducibility of the results, while fully protecting the privacy of participants.
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Source: ClinicalTrials.gov.
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