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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD106991 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PBT-A | Experimental | PBT-A includes the elements of family based behavioral treatment for children with obesity, delivered exclusively to a parent via telehealth. |
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| Health Education | Active Comparator | This program provides information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress delivered exclusively to a parent via telehealth. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBT-A | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Change from baseline to month 3, 6, 12, and 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Dietary Intake | Block Fat/Sugar/Fruit/Vegetable Screener for adults | Change from baseline to month 6, 12, and 18 |
| Child Dietary Intake | BLOCK kids food screener completed by parent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerri Boutelle, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Center for Healthy Eating and Activity Research (CHEAR) | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42061554 | Derived | Boutelle KN, Eichen DM, Martinez K, Pinson CK, Strong DR, Reed KL, Akshoomoff N, Rhee KE, Brookman-Frazee L. 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 Jul;166:108330. doi: 10.1016/j.cct.2026.108330. Epub 2026 Apr 28. |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D063766 | Pediatric Obesity |
| D001321 | Autistic Disorder |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D050177 | Overweight |
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| Health Education (HE) | Behavioral | The HE arm will provide information about nutrition, physical activity, sedentary behavior, sleep, emotions, and stress. |
|
| Change from baseline to month 6, 12, and 18 |
| Parent Physical Activity | The International Physical Activity Questionnaire (IPAQ) | Change from baseline to month 6, 12, and 18 |
| Child Physical Activity | The Children's Physical Activity Questionnaire (C-PAQ) parent proxy | 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 | 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. | Change from baseline to month 6, 12, and 18 |
| Parent body mass index (BMI) | kg/m^2 | 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. | Change from baseline to month 6, 12, and 18 |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |