An interventional study of Acceptance-based Behavioral Treatment (ABBT) in Pediatric Obesity, Executive Function and Self-Regulation, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-31.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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.
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.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's enrollment of 184 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
Change in child body mass index
Child height and weight measurements will be converted to zBMI using CDC age and sex specific scales.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 4.5 months
Cortisol
ug/dl
Time frame: Baseline to 4.5 months
Blood pressure
Systolic over diastolic
Time frame: Baseline to 4.5 months
Fasting glucose
mg/dl
Time frame: Baseline to 4.5 months
Low-density lipoprotein (LDL-C) cholesterol
mg/dl
Time frame: Baseline to 4.5 months
High-density lipoprotein (HDL-C) cholesterol
mg/dl
Time frame: Baseline to 4.5 months
Triglyceride
mg/dl
Time frame: Baseline to 4.5 months
Insulin
uU/ml
Time frame: Baseline to 4.5 months
Hemoglobin A1C
Percentage
Time frame: Baseline to 4.5 months
Leptin
ng/mL
Time frame: Baseline to 4.5 months
Tumor necrosis factor (TNF-a)
pg/ml
Time frame: Baseline to 4.5 months
Interleukin (IL-6)
pg/ml
Time frame: Baseline to 4.5 months
High-sensitivity reactive protein (hsCRP)
mg/L
Time frame: Baseline to 4.5 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 4.5 months
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.
Time frame: Baseline
Participant satisfaction - interviews
Semi-structured group interviews will assess caregiver and child experiences with the program.
Time frame: 9 weeks, 18 weeks
Participant satisfaction - surveys
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Time frame: 9 weeks, 18 weeks
Program feasibility - interviews
Semi-structured group interviews will assess caregiver and child experiences with the program.
Time frame: 9 weeks, 18 weeks
Program feasibility - surveys
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
Time frame: 9 weeks, 18 weeks
Adherence - attendance
The number of sessions attended will be the primary indicator of adherence.
Time frame: 9 weeks, 18 weeks
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.
Time frame: 9 weeks, 18 weeks
Plan to share: No — 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.
No publications or documents are linked to this record.
Ran from Feb 2019 to primary completion in Jan 2022, 35 months.
Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 35 months is above that.
Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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