Acceptance-based Care for Child Eating and Physical Activity Treatment

Study Overview
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Brief Summary
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The purpose of this study is to develop and pilot test a new type of patient-centered, family-based treatment for children aged 8-12 with obesity and their caregivers. The treatment will focus specifically on improving children's self-regulation (SR) skills to help them better manage their feelings, behaviors, and thoughts to help them live a healthier lifestyle.

Detailed Description
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We aim to: (1) To determine the treatment needs of children ages 8-12 with obesity and their families with a focus on understanding cognitive function challenges that are related to self-regulation (using focus groups i.e. FG and feedback sessions i.e. FB). (2) To evaluate the feasibility and acceptability of this novel family-based treatment. (3) Explore potential associations between pediatric cardiovascular (CVD) risk factors and self-regulation in children with and without overweight or obesity. (4) To refine the F-ABT protocol and to maximize participant feasibility, acceptability, safety, and tolerability of F-ABT. (5) To provide pilot, proof-of-concept, and preliminary efficacy data of beneficial effects of F-ABT on SR and BMI in children with SR deficits and their caregivers.

Official Title
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Addressing Healthcare Disparities in Pediatric Obesity Treatment: Development of a Novel, Patient-centered Intervention Targeting Executive Function

Conditions
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Pediatric Obesity, Executive Function, Self-Regulation

Intervention / Treatment
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* Behavioral: Acceptance-based Behavioral Treatment (ABBT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Children who: (1) have a BMI ≥ 85th percentile; (2) are ≥8 and ≤12 years old at the beginning of treatment; (3) can read, write, and speak English, along with their caregiver; (4) plan to stay living in the local area during the study period; (5) have a consenting caregiver who can commit to all study procedures and provide reliable travel. Exclusion Criteria: - Children who:(1) comorbid developmental/intellectual disability/traumatic brain injury/other identified condition known to substantially impact EF and/or weight management; (2) taking medication that is known to affect weight or appetite, (3) recent infection that may cause confounds of acute inflammation, (4) have an uncorrected visual or hearing impairment that would prohibit completion of cognitive testing, and (5) are unable to use an iPad with appropriate training for cognitive testing. The children without obesity (n=32) will have normal-range BMI scores (5th ≤BMI percentile< 85th) but otherwise follow the same inclusion/exclusion criteria.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Acceptance-based Behavioral Treatment<br>Family acceptance-based behavioral treatment (ABBT) will be piloted with 16 child-caregiver pairs. At weeks 0 (pre-treatment), 9 (mid-treatment), and 18 (post-treatment), feedback regarding the feasibility and acceptability will be collected from participants through surveys and semi-structured group interviews to refine the family ABBT protocol. | Behavioral: Acceptance-based Behavioral Treatment (ABBT)<br>* ABBT is rooted in behavioral therapy but also cultivates self-regulation skills including experiential acceptance of potentially uncomfortable internal experiences (e.g., emotions, cravings), mindful awareness of decision making (e.g., mindful eating), and values clarification and behavioral commitment (e.g., practicing daily physical activity to be a contributing member on a sports team). ABBT has been used effectively to help youth and adults manage various medical and psychological problems. Moreover, components of ABBT have been shown to improve child and adult EF including inhibitory control and cognitive flexibility. Recently, ABBT has been integrated with components of standard behavioral treatment of obesity and applied with robust efficacy to weight management in adults.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child body mass index | Child height and weight measurements will be converted to zBMI using CDC age and sex specific scales. | Baseline to 4.5 months | 
| Change in child objective executive function | Performance-based EF will be tested using the NIH Toolbox Cognitive Battery which measures executive function (inhibitory control and cognitive flexibility), attention, episodic memory, language, processing speed, and working memory. T-scores will be used for each domain. Higher t-scores indicate better function. | Baseline to 4.5 months | 
| Change in child subjective executive function | 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 to 4.5 months | 
| Change in Health-Related Quality of Life | Sizing Me Up© & Sizing Them Up© are validated obesity-specific self-report and parent-report measures, respectively, of health-related quality of life for children 5-13 years old that measure functioning in a variety of areas (e.g., emotional, physical, teasing/marginalization). The Total Score will be used as the outcome, which is a scaled score ranging from 0-100 with higher scores representing better quality of life. | Baseline to 4.5 months | 
| Cortisol | ug/dl | Baseline to 4.5 months | 
| Blood pressure | Systolic over diastolic | Baseline to 4.5 months | 
| Fasting glucose | mg/dl | Baseline to 4.5 months | 
| Low-density lipoprotein (LDL-C) cholesterol | mg/dl | Baseline to 4.5 months | 
| High-density lipoprotein (HDL-C) cholesterol | mg/dl | Baseline to 4.5 months | 
| Triglyceride | mg/dl | Baseline to 4.5 months | 
| Insulin | uU/ml | Baseline to 4.5 months | 
| Hemoglobin A1C | Percentage | Baseline to 4.5 months | 
| Leptin | ng/mL | Baseline to 4.5 months | 
| Tumor necrosis factor (TNF-a) | pg/ml | Baseline to 4.5 months | 
| Interleukin (IL-6) | pg/ml | Baseline to 4.5 months | 
| High-sensitivity reactive protein (hsCRP) | mg/L | Baseline to 4.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child body fat percent | The Tanita SC-240 BIA device has been validated for use with children to assess total body fat to the nearest 0.1%. Total body fat percent will be standardized using age and sex specific CDC conversions. | Baseline to 4.5 months | 
| Waist circumference | The Gulick II anthropometric tape will be utilized to measure children's waist circumference, which will be converted to national published standardized (z) scores. | Baseline to 4.5 months | 
| Child eating behavior | The Children's Eating Behaviour Questionnaire is a 35-item parent proxy-report measure of eating behavior producing 8 subscales: responsiveness to food, enjoyment of food, satiety responsiveness, slowness in eating, fussiness, emotional overeating, emotional undereating, desire for drinks. Items are scored on a 5-point Likert scale and the mean score of each subscale is used. Higher scores indicate more eating behaviors in a certain domain. | Baseline to 4.5 months | 
| Dietary behavior | Child and parent dietary habits will be assessed via self-report throughout the intervention using the online USDA SuperTracker software. | Baseline to 4.5 months | 
| Physical activity behavior | Child and parent physical activity habits will be assessed via self-report throughout the intervention using the online USDA SuperTracker software. | Baseline to 4.5 months | 
| Mindfulness | The Child Acceptance and Mindfulness Measure (CAMM) is a 10-item measure of children's awareness and acceptance of their own private events or internal experiences. Items are reverse scored on a 5-point Likert scale. Higher scores correspond to higher levels of mindfulness. | Baseline to 4.5 months | 
| Psychological flexibility | The Avoidance and Fusion Questionnaire for Youth (AFQ-Y) is a 17-item self-report measure for to assess psychological inflexibility in children. Items are scored on a 5-point Likert scale and summed for a total score ranging between 0-68. Higher scores are indicative of greater psychological inflexibility. The Parental Acceptance and Action Questionnaire (PAAQ) is a 15-item measure that evaluates parents' experiential acceptance and action tendencies in the context of their relationship with their children. The Total score is used which is a sum of all items which are rated on a 7-point Likert scale. Higher scores represent a greater degree of parental experiential avoidance. | Baseline to 4.5 months | 
| Impact of the food environment | The Children's Power of Food Scale is a 15-item self-report assessment of the psychological impact of living in food-abundant environments. Items are rated on a 5-point Likert scale and summed to create a total score. Higher scores reflect greater responsiveness to the food environment. | Baseline to 4.5 months | 

 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, Self-Regulation, Acceptance-Based