UC San Diego Center for Healthy Eating and Activity Research (CHEAR)
La Jolla, California, 92037, United States
NCT Number: NCT05741840
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).
This study is active but is not currently recruiting participants.
Notify Me6 year–12 year
All sexes
Interventional
Not applicable
La Jolla, California, 92037, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: parent based treatment, family based behavioral treatment
The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress.
Time frame: Change from baseline to month 3, 6, 12, and 18
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
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 6, 12, and 18
Block Fat/Sugar/Fruit/Vegetable Screener for adults
Time frame: Change from baseline to month 6, 12, and 18
BLOCK kids food screener completed by parent
Time frame: Change from baseline to month 6, 12, and 18
The International Physical Activity Questionnaire (IPAQ)
Time frame: Change from baseline to month 6, 12, and 18
The Children's Physical Activity Questionnaire (C-PAQ) parent proxy
Time frame: Change from baseline to month 6, 12, and 18
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
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 mid-treatment, months: 3, 6, 12, and 18
kg/m^2
Time frame: Change from baseline to month 6, 12, and 18
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.
University of California, San Diego
Other
Telehealth Parent-only Treatment for Youth With Autism Spectrum Disorder and Overweight/Obesity
Acronym: FRESH-A
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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