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Funding withdrawn before any participants enrolled in treatment.
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| Name | Class |
|---|---|
| Rady Children's Hospital, San Diego | OTHER |
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The pilot study will be a one group open-label treatment program and will be used to refine a parent-based behavioral treatment enhanced with executive-function training (PBT-EF) for children with comorbid overweight or obesity and Attention-Deficit Hyperactivity Disorder (ADHD).
The currently recommended treatment for children with overweight or obesity (OW/OB), family-based behavioral treatment (FBT), results in sustained weight loss for only 1/3 of children. Attention-Deficit Hyperactivity Disorder (ADHD) is one of the most common neurobehavioral disorders in children and is characterized by difficulties in Executive Function (EF). Substantial research suggests higher rates of OW/OB in children with ADHD; thus, children with OW/OB and ADHD are likely to have greater difficulties with EF and achieving success in FBT. The proposed study aims to develop a parent-based behavioral treatment enhanced with EF training (PBT-EF) to improve treatment outcomes for children with comorbid OW/OB and ADHD. The treatment will be administered to parents in 18 group sessions over 5 months. Parents and children will be assessed at baseline, post-treatment, and 3-month follow-up. Assessments will include body mass index (BMI), assessments of executive function, and behavioral questionnaires. This study could provide a novel model to treat OW/OB in children with ADHD, and could inform clinical decision making regarding obesity treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Executive Function-Enhanced Parent-Based Behavioral Treatment (PBT-EF) | Experimental | PBT-EF will integrate executive function training with family-based behavioral treatment (FBT) for obesity, the gold-standard behavioral treatment for childhood obesity. PBT-EF will include self-monitoring, calorie reduction, and dietary and physical activity recommendations in addition to planning, organization, and problem-solving skills. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBT-EF | Behavioral | PBT-EF will be delivered to parents only. Parents will be taught general behavioral weight loss skills to apply to their child and themselves including decreasing caloric intake and increasing physical activity, self-monitoring, and goal setting. Additionally, parents will learn compensatory strategies surrounding organization, habit learning, planning, and problem-solving to generalize FBT skills to real-world behaviors (e.g., self-monitoring of food intake). Each session will include interactive exercises to help train an aspect of EF. Skills taught will be presented to be practiced with real-world applications. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as measured by number of treatment sessions attended | Attendance at Treatment Sessions | Over the course of 5 months of treatment |
| Acceptability | Ratings of usefulness of treatment | At 5 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Child body mass index (BMI) | As measured by height and weight (kg/m^2) | Change from baseline at an average of 5 months and 8 months |
| Child executive function | Change in executive function measured by Behavior Rating in Executive Functioning - 2 (BRIEF-2). The Global Executive Composite score reflects a standardized t-score with higher scores reflecting greater difficulties in executive function. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn M Eichen, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Center for Healthy Eating and Activity Research (CHEAR) | San Diego | California | 92037 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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This is an open-label one-arm pilot study.
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| Change from baseline at an average of 5 months and 8 months |
| Parent executive function | Change in executive function measured by Behavior Rating in Executive Functioning - Adult (BRIEF-A). The Global Executive Composite score reflects a standardized t-score with higher scores reflecting greater difficulties in executive function. | Change from baseline at an average of 5 months and 8 months |
| Child behavioral symptoms - Child Behavior Checklist (CBCL) | Change in child behavioral symptoms rated by parents as measured by CBCL. The CBCL is a widely used parent-report questionnaire designed to assess behavioral problems and social competencies of children ages 4-18. It yields standardized T scores and age adjusted scores on internalizing, externalizing, and total behavior difficulties. Higher scores reflect greater behavioral difficulties. | Change from baseline at an average of 5 months and 8 months |
| Child behavioral symptoms - Vanderbilt ADHD [Attention Deficit Hyperactivity Disorder] Parent Rating Scale | Change in child behavioral symptoms rated by parents as measured by Vanderbilt ADHD Parent Rating Scale. This scale is a parent-report questionnaire. The parent rates the frequency of 47 behaviors that may indicate behavioral issues. There are also 8 performance questions. Change in total symptoms of the 18 ADHD criteria will be reported. Higher scores reflect greater ADHD symptomatology. | Change from baseline at an average of 5 months and 8 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001836 | Body Weight Changes |