Autism Spectrum DisorderWeChat-AutismNCT07514910
Mobile Health Intervention for Children With Autism
A study testing Standard Lifestyle Recommendations, WeChat-Based Mobile Health Intervention and Coach-Facilitated Tele-Group Sessions in people with Autism Spectrum Disorder and Obesity, run by Hunan Normal University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder, Obesity, Pediatric Overweight
- What is being tested?
- Standard Lifestyle Recommendations, WeChat-Based Mobile Health Intervention and Coach-Facilitated Tele-Group Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai University of Sport
Shanghai, Shanghai Municipality, 200438
About this study
Official title: 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.
Read more
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
- Being tested
- Standard Lifestyle Recommendations, WeChat-Based Mobile Health Intervention, Coach-Facilitated Tele-Group Sessions
- Keywords
- Autism, Mobile Health, WeChat, Lifestyle Intervention, BMI z-score, Obesity Prevention, Randomized Controlled Trial, China
- Medical subject headings
- Autism Spectrum Disorder, Obesity, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Lifestyle RecommendationsBehavioural
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.
WeChat-Based Mobile Health InterventionBehavioural
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.
Coach-Facilitated Tele-Group SessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Coach-Facilitated Tele-Group Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: The 16-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jan 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Xin, Shanghai University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514910
- Sponsor's protocol ID
- Sus2024
- Acronym
- WeChat-Autism
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07514910
- Acronym / sponsor ID
- WeChat-Autism / Sus2024
- Conditions
- Autism Spectrum Disorder, Obesity, Pediatric Overweight
- Keywords
- Autism, Mobile Health, WeChat, Lifestyle Intervention, BMI z-score, Obesity Prevention, Randomized Controlled Trial, China
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Hunan Normal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Standard Lifestyle RecommendationsParticipants 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. |
| WeChat-Based Mobile Health Intervention | Experimental | Behavioral: WeChat-Based Mobile Health InterventionParticipants 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. |
| WeChat-Based Intervention Plus Enhanced Human Support | Experimental | Behavioral: Coach-Facilitated Tele-Group SessionsParticipants 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Lifestyle RecommendationsParticipants 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. | Behavioural | Usual Care |
| WeChat-Based Mobile Health InterventionA 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. | Behavioural | WeChat-Based Mobile Health Intervention |
| Coach-Facilitated Tele-Group SessionsWeekly 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. | Behavioural | WeChat-Based Intervention Plus Enhanced Human Support |
Primary outcome
Change in Body Mass Index (BMI) z-score
Time frame: 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.
2 secondary outcomes
Cumulative Incident Obesity
Time frame: At the 6-month, 12-month, and 24-month post-intervention follow-up visits.
BMI z-score Responder Status
Time frame: The 16-week intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Lifestyle Recommendations, WeChat-Based Mobile Health Intervention and Coach-Facilitated Tele-Group Sessions in people with Autism Spectrum Disorder and Obesity, run by Hunan Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) z-score (time frame: Baseline (pre-intervention), the 16-week intervention (primary endpoint), 6-month, 12-month, and 24-month post-intervention follow-up visits.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.