Acceptance-based Care for Child Eating and Physical Activity Treatment

Pediatric Obesity Clinical Trial

— ACCEPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03368716
• Other study ID #: 5K12HS023009-04
• Secondary ID: 5P30DK079626-12i
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Executive Function
• Obesity
• Pediatric Obesity
• Self-Regulation

Intervention

Behavioral:
• Acceptance-based Behavioral Treatment (ABBT)
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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (5)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Alabama at Birmingham Diabetes Research Center, University of Alabama at Birmingham Patient Centered Outcomes Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Child and caregiver characteristics such as age, sex, race/ethnicity, educational level, family income, and marital status will be assessed via caregiver report at baseline only.	Baseline
Other	Participant satisfaction - interviews	Semi-structured group interviews will assess caregiver and child experiences with the program.	9 weeks, 18 weeks
Other	Participant satisfaction - surveys	Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.	9 weeks, 18 weeks
Other	Program feasibility - interviews	Semi-structured group interviews will assess caregiver and child experiences with the program.	9 weeks, 18 weeks
Other	Program feasibility - surveys	Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.	9 weeks, 18 weeks
Other	Adherence - attendance	The number of sessions attended will be the primary indicator of adherence.	9 weeks, 18 weeks
Other	Adherence - self-monitoring	As a secondary measure, we will use the number of days that self-monitoring records were completed. A completed self-monitoring record should have at least 2 meals and the total number of exercise minutes recorded per day.	9 weeks, 18 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cortisol	ug/dl	Baseline to 4.5 months
Primary	Blood pressure	Systolic over diastolic	Baseline to 4.5 months
Primary	Fasting glucose	mg/dl	Baseline to 4.5 months
Primary	Low-density lipoprotein (LDL-C) cholesterol	mg/dl	Baseline to 4.5 months
Primary	High-density lipoprotein (HDL-C) cholesterol	mg/dl	Baseline to 4.5 months
Primary	Triglyceride	mg/dl	Baseline to 4.5 months
Primary	Insulin	uU/ml	Baseline to 4.5 months
Primary	Hemoglobin A1C	Percentage	Baseline to 4.5 months
Primary	Leptin	ng/mL	Baseline to 4.5 months
Primary	Tumor necrosis factor (TNF-a)	pg/ml	Baseline to 4.5 months
Primary	Interleukin (IL-6)	pg/ml	Baseline to 4.5 months
Primary	High-sensitivity reactive protein (hsCRP)	mg/L	Baseline to 4.5 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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