Mobile Health Intervention for Children With Autism (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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Autism Spectrum Disorder; Pediatric Overweight
• Intervention / Treatment: Behavioral: Standard Lifestyle Recommendations; Behavioral: WeChat-Based Mobile Health Intervention; Behavioral: Coach-Facilitated Tele-Group Sessions

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200438
      • Shanghai University of Sport

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Incident Obesity	This metric is the key secondary endpoint for evaluating the long-term obesity prevention effect of the intervention, defined as the cumulative proportion of new-onset obesity among participants without obesity at baseline. Obesity is diagnosed strictly in accordance with the criteria of the Working Group on Obesity in China (WGOC), i.e., BMI at or above the age- and sex-specific 95th percentile for Chinese children and adolescents, using the same standardized measurement protocol as the primary outcome.	At the 6-month, 12-month, and 24-month post-intervention follow-up visits.
BMI z-score Responder Status	This is a binary supportive secondary outcome, defined as the proportion of participants who achieve a reduction in BMI z-score of ≥0.20 from baseline to the end of the 16-week intervention, used to assess the clinical significance of the intervention effect. The BMI z-score is calculated using the exact same standardized protocol as the primary outcome. This outcome is reported as the responder rate (range: 0% to 100%), with a higher responder rate indicating a greater clinical benefit of the intervention on weight-related outcomes.	The 16-week intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events and Serious Adverse Events	This safety outcome assesses the incidence, nature, severity, seriousness, and study-relatedness of adverse events (AEs) and serious adverse events (SAEs) from enrollment to the end of follow-up. Data are collected via active multi-channel surveillance, including spontaneous caregiver reports, scheduled assessment contacts, and dedicated safety prompts embedded in the intervention platform. SAEs are defined in full compliance with Good Clinical Practice (GCP) standards. Intervention-specific AEs (including exercise-related injuries, medically unsafe weight loss, restrictive eating behaviors, and caregiver/child distress related to intervention participation) are prioritized for monitoring to comprehensively evaluate the safety of the intervention.	Continuously monitored from enrollment through the end of the 24-month follow-up period.
Change in Waist Circumference	This metric reflects the change in waist circumference from baseline to each follow-up time point, an objective indicator of abdominal fat accumulation and central obesity risk in children. It is measured with a study-specified nonelastic medical tape at standardized anatomical landmarks (midpoint between the lowest rib and the iliac crest at the end of normal expiration), guided by blinded assessors via video calls, with the mean of repeated measurements used for analysis. A decrease in waist circumference indicates the intervention reduces abdominal adiposity and related metabolic risk in children.	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	This metric reflects the change in body fat percentage from baseline to each follow-up time point, a direct and sensitive indicator of changes in children's body composition. It is assessed with a study-designated bioelectrical impedance analysis (BIA) device under standardized premeasurement conditions (including morning measurement after voiding, light clothing, and avoidance of vigorous activity prior to testing), with invalid measurements recorded as missing rather than imputed. A decrease in body fat percentage indicates the intervention reduces excess adiposity and improves body composition in children.	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)	This metric reflects the change in daily moderate-to-vigorous physical activity duration (minutes per day) from baseline to each follow-up time point, a core indicator of children's health-enhancing physical activity levels. It is objectively measured via a research-grade triaxial accelerometer worn continuously for 7 consecutive days (including at least 2 weekend days) on the non-dominant wrist, with a protocol adapted for children with autism (including sensory-friendly adjustable fabric bands and desensitization guidance). Data are processed using the pediatric-validated Evenson algorithm. Increased duration indicates the intervention improves children's physical activity status.	Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.
Change in Objective Light Physical Activity Time	This metric reflects the change in daily light-intensity physical activity duration (minutes per day) from baseline to each follow-up time point, a key component of children's daily energy expenditure. It is collected via the same 7-day triaxial accelerometer wearing protocol as MVPA, and classified using the same prespecified pediatric-validated algorithm to distinguish activity intensity. Increased duration indicates the intervention effectively reduces sedentary behavior in children.	Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.
Change in Objective Sedentary Time	This metric reflects the change in daily sedentary behavior duration (minutes per day) from baseline to each follow-up time point, an independent risk factor for childhood obesity and metabolic disorders. It is measured via the same 7-day triaxial accelerometer wearing protocol as other activity outcomes, with a prespecified algorithm used to distinguish waking sedentary behavior from different intensity activities. Decreased duration indicates the intervention improves children's daily activity patterns.	Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.
Change in Objective Daily Total Step Count	This metric reflects the change in average daily total step count from baseline to each follow-up time point, an intuitive and objective indicator of children's overall daily physical activity volume. It is continuously recorded via the same 7-day triaxial accelerometer wearing protocol as other activity outcomes, with the average daily value from valid wear periods used for statistical analysis. Increased step count indicates the intervention improves children's overall physical activity levels.	Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.
Change in Weekday Recreational Screen Exposure Time	This metric reflects the change in average daily weekday recreational screen exposure duration (hours per day) from baseline to each follow-up time point, a core behavioral endpoint linked to sedentary behavior and obesity risk. It is assessed via a validated standardized electronic questionnaire completed by the primary caregiver, distinguishing recreational use from screen time required for school or therapy. Decreased duration indicates the intervention reduces sedentary behavior in children.	Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.
Change in Objective Sleep Metrics	This set of metrics reflects changes in objective sleep characteristics from baseline to each follow-up time point, including total sleep time, sleep efficiency, sleep latency, and wake after sleep onset, which are closely linked to childhood obesity risk and overall health. They are derived from the same 7-day accelerometer monitoring period used for physical activity assessment, processed via a pediatric-validated sleep algorithm, with invalid data recorded as missing. Improved metrics indicate the intervention optimizes children's sleep quality.	Baseline (pre-intervention), the 16-week intervention,the 6-month, 12-month, and 24-month post-intervention follow-up visits.
Change in Resting Systolic and Diastolic Blood Pressure	This metric reflects the change in resting systolic and diastolic blood pressure from baseline to each follow-up time point, a core indicator of children's cardiometabolic risk. It is measured with a study-specified medical-grade automated electronic sphygmomanometer with an age-appropriate cuff following a standardized protocol (after 5 minutes of quiet rest, 3 sequential readings at 1-minute intervals), with the mean of the second and third readings used as the final value. Reduced blood pressure indicates the intervention improves children's cardiometabolic health.	Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.
Change in Sugar-Sweetened Beverage (SSB) Intake Frequency	This metric reflects the change in weekly frequency of sugar-sweetened beverage intake from baseline to each follow-up time point, a key dietary risk factor for childhood obesity. It is assessed via a validated semi-quantitative food frequency questionnaire completed by the primary caregiver. Decreased frequency indicates the intervention improves children's dietary patterns.	Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.
Change in Family Meal Frequency	This metric reflects the change in the number of days per week with shared family meals from baseline to each follow-up time point, a core family routine indicator associated with reduced childhood obesity risk. It is assessed via a validated standardized electronic questionnaire completed by the primary caregiver. Increased frequency indicates the intervention establishes healthier family dietary routines.	Baseline (pre-intervention),the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.
Change in Breakfast Frequency	This metric reflects the change in the number of days per week with regular breakfast consumption from baseline to each follow-up time point, a dietary behavior closely linked to weight regulation and metabolic health in children. It is assessed via a validated standardized electronic questionnaire completed by the primary caregiver. Increased frequency indicates the intervention improves children's daily dietary routines.	Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.
Brief Autism Mealtime Behavior Inventory (BAMBI) Total Score	This metric assesses autism-specific mealtime behavioral problems, including food selectivity, eating stereotypies, and mealtime disruptive behaviors in children with autism, which are key factors influencing intervention adherence and dietary outcomes. It uses the validated Chinese version of the Brief Autism Mealtime Behavior Inventory (BAMBI). The total score of this scale ranges from a minimum of 18 to a maximum of 90, with higher total scores indicating more severe autism-specific mealtime behavioral challenges and worse clinical outcomes.	Baseline (pre-intervention), the 16-week intervention, the 12-month and 24-month post-intervention follow-up visits.
Caregiver Pittsburgh Sleep Quality Index (PSQI) Total Score	This self-reported metric assesses the primary caregiver's sleep quality and sleep disturbances over the past month, a key indicator of caregiver well-being and the family psychosocial environment. It uses the validated Chinese version of the PSQI, with total scores ranging from 0 to 21; higher scores indicate worse sleep quality and more severe sleep disturbances. This is a caregiver-specific outcome, not a child-level outcome.	Baseline (pre-intervention), the 16-week intervention, the 12-month and 24-month post-intervention follow-up visits.
Caregiver Hospital Anxiety and Depression Scale (HADS) Total Score	This self-reported metric evaluates the primary caregiver's anxiety and depression symptoms over the past week, a core indicator of caregiver mental health status. It uses the validated Chinese version of the HADS, with total scores ranging from 0 to 42; higher scores indicate more severe anxiety and depression symptoms. This is a caregiver-specific outcome, not a child-level outcome.	Baseline (pre-intervention), the 16-week intervention, the 12-month and 24-month post-intervention follow-up visits.
Caregiver Parenting Sense of Competence Scale (PSOC) Total Score	This self-reported metric assesses the primary caregiver's parenting competence and self-efficacy, a key factor influencing intervention adherence and family implementation of behavior change strategies. It uses the validated Chinese version of the PSOC, with total scores ranging from 17 to 102; higher scores indicate better parenting competence and self-efficacy. This is a caregiver-specific outcome, not a child-level outcome.	Baseline (pre-intervention), the 16-week intervention, the 12-month and 24-month post-intervention follow-up visits.
Caregiver World Health Organization Quality of Life-BREF (WHOQOL-BREF) Physical and Psychological Domain Scores	This self-reported metric evaluates the primary caregiver's quality of life in the physical and psychological domains, reflecting the caregiver's overall health and well-being. It uses the validated Chinese version of the WHOQOL-BREF, with higher domain scores indicating better quality of life in the corresponding domain. This is a caregiver-specific outcome, not a child-level outcome.	Baseline (pre-intervention), the 16-week intervention,the 12-month and 24-month post-intervention follow-up visits.

Collaborators and Investigators

• Sponsor: Hunan Normal University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: China; Mobile Health; Randomized Controlled Trial; Autism; Lifestyle Intervention; Obesity Prevention; WeChat; BMI z-score
• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Autism Spectrum Disorder; Obesity; Autistic Disorder
• Other Study ID Numbers: Sus2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No