- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03368716
Acceptance-based Care for Child Eating and Physical Activity Treatment (ACCEPT)
Addressing Healthcare Disparities in Pediatric Obesity Treatment: Development of a Novel, Patient-centered Intervention Targeting Executive Function
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35209
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Acceptance-based Behavioral Treatment
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in child body mass index
Time Frame: Baseline to 4.5 months
|
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
Time Frame: Baseline to 4.5 months
|
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
Time Frame: Baseline to 4.5 months
|
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
Time Frame: Baseline to 4.5 months
|
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
Time Frame: Baseline to 4.5 months
|
ug/dl
|
Baseline to 4.5 months
|
Blood pressure
Time Frame: Baseline to 4.5 months
|
Systolic over diastolic
|
Baseline to 4.5 months
|
Fasting glucose
Time Frame: Baseline to 4.5 months
|
mg/dl
|
Baseline to 4.5 months
|
Low-density lipoprotein (LDL-C) cholesterol
Time Frame: Baseline to 4.5 months
|
mg/dl
|
Baseline to 4.5 months
|
High-density lipoprotein (HDL-C) cholesterol
Time Frame: Baseline to 4.5 months
|
mg/dl
|
Baseline to 4.5 months
|
Triglyceride
Time Frame: Baseline to 4.5 months
|
mg/dl
|
Baseline to 4.5 months
|
Insulin
Time Frame: Baseline to 4.5 months
|
uU/ml
|
Baseline to 4.5 months
|
Hemoglobin A1C
Time Frame: Baseline to 4.5 months
|
Percentage
|
Baseline to 4.5 months
|
Leptin
Time Frame: Baseline to 4.5 months
|
ng/mL
|
Baseline to 4.5 months
|
Tumor necrosis factor (TNF-a)
Time Frame: Baseline to 4.5 months
|
pg/ml
|
Baseline to 4.5 months
|
Interleukin (IL-6)
Time Frame: Baseline to 4.5 months
|
pg/ml
|
Baseline to 4.5 months
|
High-sensitivity reactive protein (hsCRP)
Time Frame: Baseline to 4.5 months
|
mg/L
|
Baseline to 4.5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child body fat percent
Time Frame: Baseline to 4.5 months
|
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
Time Frame: Baseline to 4.5 months
|
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
Time Frame: Baseline to 4.5 months
|
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
Time Frame: Baseline to 4.5 months
|
Child and parent dietary habits will be assessed via self-report throughout the intervention using the online USDA SuperTracker software.
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Baseline to 4.5 months
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Physical activity behavior
Time Frame: Baseline to 4.5 months
|
Child and parent physical activity habits will be assessed via self-report throughout the intervention using the online USDA SuperTracker software.
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Baseline to 4.5 months
|
Mindfulness
Time Frame: Baseline to 4.5 months
|
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.
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Baseline to 4.5 months
|
Psychological flexibility
Time Frame: Baseline to 4.5 months
|
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.
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Baseline to 4.5 months
|
Impact of the food environment
Time Frame: Baseline to 4.5 months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographics
Time Frame: Baseline
|
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
|
Participant satisfaction - interviews
Time Frame: 9 weeks, 18 weeks
|
Semi-structured group interviews will assess caregiver and child experiences with the program.
|
9 weeks, 18 weeks
|
Participant satisfaction - surveys
Time Frame: 9 weeks, 18 weeks
|
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
|
9 weeks, 18 weeks
|
Program feasibility - interviews
Time Frame: 9 weeks, 18 weeks
|
Semi-structured group interviews will assess caregiver and child experiences with the program.
|
9 weeks, 18 weeks
|
Program feasibility - surveys
Time Frame: 9 weeks, 18 weeks
|
Surveys will assess the utility of intervention content, intervention burden and satisfaction, participation barriers, and suggestions for change.
|
9 weeks, 18 weeks
|
Adherence - attendance
Time Frame: 9 weeks, 18 weeks
|
The number of sessions attended will be the primary indicator of adherence.
|
9 weeks, 18 weeks
|
Adherence - self-monitoring
Time Frame: 9 weeks, 18 weeks
|
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
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5K12HS023009-04 (AHRQ)
- in progress (Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation)
- 5P30DK079626-12 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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