Virtual Health Focused Acceptance-Based Program for Parents and Youth

Study Overview
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Brief Summary
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The main purpose of vHAPPY is to pilot test a new type of virtual family-based healthy lifestyle program for children aged 8-14 with obesity and their caregivers. vHAPPY aims to (1) Transition a previously developed acceptance-based behavioral treatment to web-based platform, utilizing qualitative and quantitative program evaluation data from past participants. (2) Determine the feasibility, acceptability, and preliminary outcomes of the adapted web-based treatment. (3) Evaluate whether the adapted web-based treatment (self-guided treatment + brief coaching) is similar to the traditional treatment (interventionist-guided treatment) in terms of feasibility, acceptability, and preliminary outcomes utilizing a non-randomized sequential arm design.

Detailed Description
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Caregiver and child pairs will complete a 14 week virtual, self-guided healthy lifestyle program including education on health and wellness topics such as food groups, physical activity and stress management. Special skill builders for managing the thoughts, feelings and emotions associated with changing health behaviors will also be included. Pairs will have biweekly 15 minute coaching sessions to check in on progress in the past week, set goals and problem solve. Optional group sessions will be offered for peer support. In order to assess progress, pairs will also complete assessment visits before and after the program. These visits include one virtual assessment via Zoom and one in-person assessment at the University of Alabama at Birmingham. Caregivers and children will complete questionnaires and measures such has height, weight, blood pressure and a finger prick.

Official Title
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Targeting Self-Regulation in Family-Based Behavioral Treatment for Obesity and Cardiovascular Disease Prevention

Conditions
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Pediatric Obesity, Executive Function

Intervention / Treatment
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* Behavioral: Web Based Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children who: have a BMI ≥ 85th percentile; are 8 and 14 years old at the beginning of treatment; can read, write, and speak English, along with their caregiver; plan to stay living in the local area during the study period; have a consenting caregiver who can commit to all study procedures. Exclusion Criteria: Children who: have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight, physical activity level or executive function; are currently participating in a formal weight management program beyond usual medical care or have a caregiver participating in a formal weight management program.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-Based Treatment<br>A web-based treatment for pediatric overweight or obesity will be piloted with 10 caregiver and child pairs. Assessments will take place pre (0 months), post intervention (3.5 months) and at six months post-intervention (9.5 months) to evaluate patient outcomes, acceptability and feasibility. | Behavioral: Web Based Treatment<br>* The literature regarding the efficacy of web-based platforms for behavioral weight management interventions in pediatric populations continues to grow. Considering the continued increase in technology and internet use among youth, web-based interventions have the potential to serve as a more cost-effective and personalized approach to pediatric behavioral weight management. Extant research supports this consideration. More research that compares web-based vs. traditional delivery of acceptance-based pediatric behavioral weight management interventions is necessary to understand the utility of this platform as well as which aspects are most effective.<br>* Other names: Acceptance-Based Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability - Interviews | Semi-structured group interviews will assess caregiver and child experiences with the program. | 3.5 months | 
| Acceptability - Surveys | Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change. | 3.5 months | 
| Feasibility - Interviews | Semi-structured group interviews will assess caregiver and child experiences with the program. | 3.5 months | 
| Feasibility - Surveys | Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change. | 3.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Body Mass Index Z-Score | Measure child's height and weight. Enter into the Children's Hospital Of Philadelphia Body Mass Index calculator. | Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks) | 
| Parent Body Mass Index | Measure parent's height and weight. Enter into the Centers for Disease Control adult Body Mass Index calculator. | Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks) | 
| Parent Subjective Executive Function | Behavior Rating Inventory of Executive Function (BRIEF) - Adult. Subjective EF will be measured using the Behavioral Rating Inventory of Executive Function. The Global Severity Index will be used which is interpreted using T-scores. Higher t-scores indicate better function. | Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks) | 
| Child Subjective Executive Function | Behavior Rating Inventory of Executive Function (BRIEF) screener and BRIEF 2 (parent-report). Subjective EF will be measured using the Behavioral Rating Inventory of Executive Function. The Global Severity Index will be used which is interpreted using T-scores. Higher t-scores indicate better function. | Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks) | 
| Parent Behavioral Functioning - Anxiety | Generalized Anxiety Disorder 7. Self-report questionnaire that will be used to measure parent anxiety symptoms over the past 2 weeks. Responses are coded 0-3. 0 = Not at all and 3 = Nearly every day. Total scores range from 0-21 and are ranked from minimal anxiety to severe anxiety. | Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks) | 
| Parent Behavioral Functioning - Depression | Patient Health Questionnaire 8. Self-report questionnaire that will be used to measure parent depressive symptoms over the past 2 weeks. Eight items, each of which is scored 0-3, providing a 0-24 severity score. | Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks) | 
| Child Behavioral Functioning - Overall | Pediatric Symptom Checklist -17. A parent-proxy report screener of child risk for internalizing (depression), externalizing (oppositional defiant disorder), and attention problems (ADHD). Each item is rated as never, sometimes or often present and scored 0,1 and 2 respectively. Total score is calculated by adding together the score for each item. Three subscale scores (attention, externalizing and internalizing) are calculated by adding the score for appropriately categorized items. | Baseline (0 weeks), post intervention (14 weeks) and six months post intervention (38 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Obesity, Executive Function, Behavioral Intervention, Acceptance Based