Mobile Health Intervention for Children With Autism

Browse trials for

• Autism Spectrum Disorder 1,726
• Obesity 6,296
• Autistic Disorder 1,344

Keywords

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

Autism Spectrum Disorder

1,726 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.

This study's enrollment of 276 is above the median of 52 across 1,370 interventional studies indexed under Autism Spectrum Disorder.

Lead sponsor

Hunan Normal University is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Study arms

• 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

• 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

• 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

Interventions

• BehavioralStandard 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.

• BehavioralWeChat-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.

• BehavioralCoach-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.

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.

   Time frame: Baseline (pre-intervention), the 16-week intervention (primary endpoint), 6-month, 12-month, and 24-month post-intervention follow-up visits.

Secondary outcomes

1. 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.

   Time frame: At the 6-month, 12-month, and 24-month post-intervention follow-up visits.

2. 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.

   Time frame: The 16-week intervention.

Other outcomes

1. 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.

   Time frame: Baseline (pre-intervention),the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.

2. 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.

   Time frame: Baseline (pre-intervention), the 16-week intervention, 6-month, 12-month, and 24-month post-intervention follow-up visits.

3. 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.

   Time frame: Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.

4. 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.

   Time frame: Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.

5. 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.

   Time frame: Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.

6. 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.

   Time frame: Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.

7. 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.

   Time frame: Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.

8. 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.

   Time frame: Baseline (pre-intervention), the 16-week intervention,the 6-month, 12-month, and 24-month post-intervention follow-up visits.

9. 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.

   Time frame: Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.

10. 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.

    Time frame: Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.

11. 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.

    Time frame: Baseline (pre-intervention),the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.

12. 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.

    Time frame: Baseline (pre-intervention), the 16-week intervention, the 6-month, 12-month, and 24-month post-intervention follow-up visits.

13. 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.

    Time frame: Baseline (pre-intervention), the 16-week intervention, the 12-month and 24-month post-intervention follow-up visits.

14. 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.

    Time frame: Baseline (pre-intervention), the 16-week intervention, the 12-month and 24-month post-intervention follow-up visits.

15. 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.

    Time frame: Baseline (pre-intervention), the 16-week intervention, the 12-month and 24-month post-intervention follow-up visits.

16. 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.

    Time frame: Baseline (pre-intervention), the 16-week intervention, the 12-month and 24-month post-intervention follow-up visits.

17. 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.

    Time frame: Baseline (pre-intervention), the 16-week intervention,the 12-month and 24-month post-intervention follow-up visits.

18. 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.

    Time frame: Continuously monitored from enrollment through the end of the 24-month follow-up period.

Individual participant data

Plan to share: 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.