Summary

Eligibility
for people ages 6-12 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at La Jolla, California
Dates
study started
completion around
Principal Investigator
by Kerri Boutelle, PhD

Description

Summary

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).

Official Title

Telehealth Parent-only Treatment for Youth With Autism Spectrum Disorder and Overweight/Obesity

Details

The study will compare the efficacy of PBT-A and health education program delivered via telehealth to parents on child weight management. Investigators will provide 6 months of a group program (PBT-A or HE) and will follow participants for 12-months post-treatment (total time = 18 months). Investigators will recruit parents of children diagnosed with autism and overweight or obesity. Assessments will occur at 5 timepoints: baseline, mid-treatment, post-treatment, 6-month and 12-month follow-up. Assessments will include anthropometry for both parent and child. Parent will also provide information regarding autism diagnosis and characteristics, eating behaviors, and parenting relationship measures. This program of research has the potential to advance the standard of practice for children with autism and overweight or obesity by developing tailored interventions which can be easily disseminated.

Keywords

Autism Spectrum Disorder, Obesity, Childhood, Autism, obesity, treatment, intervention, behavioral treatment, parent based treatment, children, Pediatric Obesity, Autistic Disorder, PBT-A, Health Education (HE)

Eligibility

You can join if…

Open to people ages 6-12

  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 and parent are 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 and a device that can facilitate video recording

You CAN'T join if...

  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

Location

  • UC San Diego Center for Healthy Eating and Activity Research (CHEAR) accepting new patients
    La Jolla California 92037 United States

Lead Scientist at UCSD

  • Kerri Boutelle, PhD
    Professor, Pediatrics, Vc-health Sciences-schools. Authored (or co-authored) 141 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05741840
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated