NCT05741840Active, not recruiting
Family, Responsibility, Education, Support, and Health for Families With a Child With Autism
Telehealth Parent-only Treatment for Youth With Autism Spectrum Disorder and Overweight/Obesity
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 13 Feb 2023
- Start date
- 18 Aug 2023
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- University of California, San Diego
- NCT number
- NCT05741840
What you commit to
- Study type: Interventional
- Participants enrolled: 140
- From 18 Aug 2023 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Child is taking medication for the purpose of weight loss
Other illness
- 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
- Acute parent psychiatric disorder (e.g., acute suicidality; recent hospitalization; psychosis, moderate or severe alcohol or substance use disorder) that could interfere with treatment.
Other
- Child or first degree relative with diagnosis of anorexia or bulimia nervosa based on parent report
- Parent is not currently pregnant, lactating or planning to get pregnant during the study duration
Who the study is looking for
- A child with OW/OB (\>=85% BMI for age) aged 6-12 years
- Documented (1) community diagnosis or provisional diagnosis of ASD or (2) educational diagnosis of ASD
- 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
- The parent who is responsible for food preparation is willing to participate
- The family is willing to commit to attending all treatment and assessment sessions
- Child on a stable regimen of prescription medications which affect appetite or weight (minimum of 3 months)
- 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.
- Child and/or parent are not participating in another organized weight control program
- Family owns a device that can facilitate zoom meetings
Age in the registry: 6 years to 12 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UC San Diego Center for Healthy Eating and Activity Research (CHEAR) Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
Related publications
- Design of the FRESH-A study: A randomized controlled trial evaluating telehealth parent-only treatment for autistic youth with overweight/obesity.Contemp Clin Trials · 2026 · PMID 42061554
This page is information, not medical advice. Discuss any trial with your doctor.