NCT07514910

Mobile Health Intervention for Children With 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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Hunan Normal University · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Autism Spectrum Disorder
• Obesity
• Pediatric Overweight

Interventions

Type	Name	Description
BEHAVIORAL	Standard Lifestyle Recommendations	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.
BEHAVIORAL	WeChat-Based Mobile Health Intervention	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.
BEHAVIORAL	Coach-Facilitated Tele-Group Sessions	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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2026-04-07
• Last updated: 2026-04-13

Locations

1 site across 1 country: China