Telehealth program for parents of children with autism and obesity
Telehealth Parent-only Treatment for Youth With Autism Spectrum Disorder and Overweight/Obesity
This study is testing a telehealth program for parents to see if it helps children with autism and obesity manage their weight better than a regular health education program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT05741840 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a telehealth parent-based behavioral program (PBT-A) compared to a health education program (HE) for managing weight in children with autism who are overweight or obese. Over a period of 18 months, parents will participate in a group program designed to support their child's weight management, with assessments conducted at multiple time points. The study will gather data on child and parent anthropometry, autism characteristics, eating behaviors, and parenting relationships to inform tailored interventions. The goal is to enhance standard practices for addressing obesity in children with autism through easily disseminated programs.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-12 years with a diagnosis of autism and overweight or obesity, along with their parents who are willing to participate.
Not a fit: Patients who do not have a diagnosis of autism or who are not overweight or obese may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide effective strategies for managing obesity in children with autism, improving their overall health and well-being.
How similar studies have performed: Other studies have shown promise in using telehealth interventions for behavioral support in managing obesity, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. A child with OW/OB (\>=85% BMI for age) aged 6-12 years 2. Documented (1) community diagnosis or provisional diagnosis of ASD or (2) educational diagnosis of ASD 3. The child meets cut-off criteria for autism on the Autism Diagnostic Interview-Revised (ADI-R), as well as overall DSM 5 criteria based on the clinical judgement of an experienced clinician 4. The parent who is responsible for food preparation is willing to participate 5. The family is willing to commit to attending all treatment and assessment sessions 6. Child on a stable medication regimen (minimum of 3 months) 7. Child does not have any medical conditions that limit ability to participate in physical activity for the duration of the study. Parent can participate in physical activity or at least facilitate support of child's completion of recommended physical activity. 8. Child and/or parent are not participating in another organized weight control program 9. Family owns a device that can facilitate zoom meetings Exclusion Criteria: 1. Child diagnoses of a serious chronic physical disease (e.g., cystic fibrosis, type 1 diabetes) for which physician supervision of diet and/or exercise is needed 2. Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report 3. Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, moderate or severe alcohol or substance use disorder) that could interfere with treatment. 4. Parent is not currently pregnant, lactating or planning to get pregnant during the study duration 5. Parent has had bariatric surgery less than 6 months ago and/or is not yet eating solid food or is planning to have bariatric surgery over the study duration 6. Child is taking medication for the purpose of weight loss
Where this trial is running
La Jolla, California
- UC San Diego Center for Healthy Eating and Activity Research (CHEAR) — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Kerri Boutelle, PhD — University of California, San Diego
- Study coordinator: Recruitment Coordinator
- Email: chear@health.ucsd.edu
- Phone: 8558273498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.