An interventional study of PBT-A and Health Education (HE) in Autism Spectrum Disorder, Obesity, Childhood and Autism, sponsored by University of California, San Diego. Active, not recruiting at 1 site in United States. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
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).
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.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 140 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Exclusion Criteria:
PBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth.
Behavioral: PBT-A
This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth.
Behavioral: Health Education (HE)
PBT-A provides all the elements of family based treatment for children with obesity, including nutrition and physical activity education, behavior therapy skills, and parenting skills.
Also known as: parent based treatment, family based behavioral treatment
The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
Child BMIz age and sex adjusted BMI (kg/m^2)
age and sex adjusted body mass index (BMI) z-score based on the CDC norms
Time frame: Change from baseline to month 3, 6, 12, and 18
Child %BMIp95
Age and Sex specific percentage of the 95th percentile BMI for age and sex that is more sensitive to change in children with higher weights
Time frame: Change from baseline to month 3, 6, 12, and 18
Parent Dietary Intake
Block Fat/Sugar/Fruit/Vegetable Screener for adults
Time frame: Change from baseline to month 6, 12, and 18
Child Dietary Intake
BLOCK kids food screener completed by parent
Time frame: Change from baseline to month 6, 12, and 18
Parent Physical Activity
The International Physical Activity Questionnaire (IPAQ)
Time frame: Change from baseline to month 6, 12, and 18
Child Physical Activity
The Children's Physical Activity Questionnaire (C-PAQ) parent proxy
Time frame: Change from baseline to month 6, 12, and 18
Child Mealtime Behaviors
The Brief Autism Mealtime Behavior Inventory (BAMBI) with scores ranging from 18 to 90 with higher scores indicating greater mealtime problem behaviors
Time frame: Change from baseline to month 6, 12, and 18
Parent self-efficacy
The Parenting Sense of Competence Scale (PSOC) - Scores range from 17-102 with higher scores representing higher parenting sense of competence.
Time frame: Change from baseline to month 6, 12, and 18
Parent body mass index (BMI)
kg/m\^2
Time frame: Change from baseline to mid-treatment, months: 3, 6, 12, and 18
Parenting as measured by the Alabama Parenting Questionnaire (APQ)
Parents will self-report parenting behaviors via the APQ across 5 domains: 1) positive involvement with children, 2) supervision and monitoring, 3) use of positive discipline techniques, 4) consistency in the use of such discipline, and 5) use of corporal punishment. Higher scores indicate greater frequency of engagement with that particular parenting domain. Scores range from 1-5.
Time frame: Change from baseline to month 6, 12, and 18
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of California, San Diego