Status:
COMPLETED
Acceptance-based Care for Child Eating and Physical Activity Treatment
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Pediatric Obesity
Executive Function
Eligibility:
All Genders
8-12 years
Phase:
NA
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 specifi...
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 (u...
Eligibility Criteria
Inclusion
- \- 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
- \- 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.
Key Trial Info
Start Date :
February 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT03368716
Start Date
February 4 2019
End Date
January 31 2022
Last Update
August 31 2022
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35209