Mobile Health Intervention for Children With Autism

NCT07514910 | Completed

• 1 other identifier: Sus2024
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Autism; Mobile Health; WeChat; Lifestyle Intervention; BMI z-score; Obesity Prevention; Randomized Controlled Trial; China

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• 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.

Other Outcomes (18)

• 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.

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Standard Lifestyle Recommendations

WeChat-Based Mobile Health Intervention

EXPERIMENTAL

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.

Behavioral: WeChat-Based Mobile Health Intervention

WeChat-Based Intervention Plus Enhanced Human Support

EXPERIMENTAL

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.

Behavioral: Coach-Facilitated Tele-Group Sessions

Interventions

Standard Lifestyle Recommendations BEHAVIORAL

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.

Usual Care

WeChat-Based Mobile Health Intervention BEHAVIORAL

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.

WeChat-Based Mobile Health Intervention

Coach-Facilitated Tele-Group Sessions BEHAVIORAL

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.

WeChat-Based Intervention Plus Enhanced Human Support

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunan Normal University: lead

Study Sites (1)

Shanghai University of Sport

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Obesity; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a 3-arm parallel randomized controlled trial. Eligible participants are randomly assigned in a 1:1:1 ratio to 3 groups: usual care, WeChat-based mobile health intervention, or the same intervention plus enhanced human support. Randomization uses randomly permuted blocks of varying sizes, stratified by age group, sex, and baseline weight risk. Allocation is concealed via a secure centralized electronic system.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: January 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)