Back to resultsAcceptance-based Care for Child Eating and Physical Activity Treatment (ACCEPT)
Primary Purpose
Pediatric Obesity, Executive Function, Self-Regulation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance-based Behavioral Treatment (ABBT)
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring Pediatric Obesity, Executive Function, Behavioral Intervention, Self-Regulation, Acceptance-Based
Eligibility Criteria
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.
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acceptance-based Behavioral Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in child body mass index
Child height and weight measurements will be converted to zBMI using CDC age and sex specific scales.
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.
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.
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.
Cortisol
ug/dl
Blood pressure
Systolic over diastolic
Fasting glucose
mg/dl
Low-density lipoprotein (LDL-C) cholesterol
mg/dl
High-density lipoprotein (HDL-C) cholesterol
mg/dl
Triglyceride
mg/dl
Insulin
uU/ml
Hemoglobin A1C
Percentage
Leptin
ng/mL
Tumor necrosis factor (TNF-a)
pg/ml
Interleukin (IL-6)
pg/ml
High-sensitivity reactive protein (hsCRP)
mg/L
Secondary Outcome Measures
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.
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.
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.
Dietary behavior
Child and parent dietary habits will be assessed via self-report throughout the intervention using the online USDA SuperTracker software.
Physical activity behavior
Child and parent physical activity habits will be assessed via self-report throughout the intervention using the online USDA SuperTracker software.
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.
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.
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.
Full Information
NCT ID
NCT03368716
First Posted
November 29, 2017
Last Updated
August 30, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
University of Alabama at Birmingham Patient Centered Outcomes Research Program, University of Alabama at Birmingham Diabetes Research Center, Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03368716
Brief Title
Acceptance-based Care for Child Eating and Physical Activity Treatment
Acronym
ACCEPT
Official Title
Addressing Healthcare Disparities in Pediatric Obesity Treatment: Development of a Novel, Patient-centered Intervention Targeting Executive Function
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 4, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
University of Alabama at Birmingham Patient Centered Outcomes Research Program, University of Alabama at Birmingham Diabetes Research Center, Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Executive Function, Self-Regulation
Keywords
Pediatric Obesity, Executive Function, Behavioral Intervention, Self-Regulation, Acceptance-Based
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acceptance-based Behavioral Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance-based Behavioral Treatment (ABBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in child body mass index
Description
Child height and weight measurements will be converted to zBMI using CDC age and sex specific scales.
Time Frame
Baseline to 4.5 months
Title
Change in child objective executive function
Description
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.
Time Frame
Baseline to 4.5 months
Title
Change in child subjective executive function
Description
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.
Time Frame
Baseline to 4.5 months
Title
Change in Health-Related Quality of Life
Description
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.
Time Frame
Baseline to 4.5 months
Title
Cortisol
Description
ug/dl
Time Frame
Baseline to 4.5 months
Title
Blood pressure
Description
Systolic over diastolic
Time Frame
Baseline to 4.5 months
Title
Fasting glucose
Description
mg/dl
Time Frame
Baseline to 4.5 months
Title
Low-density lipoprotein (LDL-C) cholesterol
Description
mg/dl
Time Frame
Baseline to 4.5 months
Title
High-density lipoprotein (HDL-C) cholesterol
Description
mg/dl
Time Frame
Baseline to 4.5 months
Title
Triglyceride
Description
mg/dl
Time Frame
Baseline to 4.5 months
Title
Insulin
Description
uU/ml
Time Frame
Baseline to 4.5 months
Title
Hemoglobin A1C
Description
Percentage
Time Frame
Baseline to 4.5 months
Title
Leptin
Description
ng/mL
Time Frame
Baseline to 4.5 months
Title
Tumor necrosis factor (TNF-a)
Description
pg/ml
Time Frame
Baseline to 4.5 months
Title
Interleukin (IL-6)
Description
pg/ml
Time Frame
Baseline to 4.5 months
Title
High-sensitivity reactive protein (hsCRP)
Description
mg/L
Time Frame
Baseline to 4.5 months
Secondary Outcome Measure Information:
Title
Child body fat percent
Description
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.
Time Frame
Baseline to 4.5 months
Title
Waist circumference
Description
The Gulick II anthropometric tape will be utilized to measure children's waist circumference, which will be converted to national published standardized (z) scores.
Time Frame
Baseline to 4.5 months
Title
Child eating behavior
Description
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.
Time Frame
Baseline to 4.5 months
Title
Dietary behavior
Description
Child and parent dietary habits will be assessed via self-report throughout the intervention using the online USDA SuperTracker software.
Time Frame
Baseline to 4.5 months
Title
Physical activity behavior
Description
Child and parent physical activity habits will be assessed via self-report throughout the intervention using the online USDA SuperTracker software.
Time Frame
Baseline to 4.5 months
Title
Mindfulness
Description
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.
Time Frame
Baseline to 4.5 months
Title
Psychological flexibility
Description
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.
Time Frame
Baseline to 4.5 months
Title
Impact of the food environment
Description
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.
Time Frame
Baseline to 4.5 months
Other Pre-specified Outcome Measures:
Title
Demographics
Description
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.
Time Frame
Baseline
Title
Participant satisfaction - interviews
Description
Semi-structured group interviews will assess caregiver and child experiences with the program.
Time Frame
9 weeks, 18 weeks
Title
Participant satisfaction - surveys
Description
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Time Frame
9 weeks, 18 weeks
Title
Program feasibility - interviews
Description
Semi-structured group interviews will assess caregiver and child experiences with the program.
Time Frame
9 weeks, 18 weeks
Title
Program feasibility - surveys
Description
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Time Frame
9 weeks, 18 weeks
Title
Adherence - attendance
Description
The number of sessions attended will be the primary indicator of adherence.
Time Frame
9 weeks, 18 weeks
Title
Adherence - self-monitoring
Description
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.
Time Frame
9 weeks, 18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marissa A Gowey, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Given the small number of participants involved in various aspects of the pilot study, we currently do not plan to widely share individual participant data to maximize confidentiality. Individual requests will be considered.
Links:
URL
https://www.uab.edu/medicine/peds/research/division-research/gi-research/reach-lab
Description
Dr. Marissa Gowey's Research of Eating and Activity for Child Health (REACH) Lab focuses on identifying modifiable factors that are associated with response to treatment for obesity.
Learn more about this trial
Acceptance-based Care for Child Eating and Physical Activity Treatment
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