Clinical trial NCT03368716: Acceptance-based Care for Child Eating and Physical Activity Treatment
Official title: Addressing Healthcare Disparities in Pediatric Obesity Treatment: Development of a Novel, Patient-centered Intervention Targeting Executive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Executive Function
Self-Regulation
Keywords: Pediatric Obesity
Executive Function
Behavioral Intervention
Self-Regulation
Acceptance-Based
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-12-11
Enrollment: 184
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in child body mass index
timeFrame: Baseline to 4.5 months
measure: Change in child objective executive function
timeFrame: Baseline to 4.5 months
measure: Change in child subjective executive function
timeFrame: Baseline to 4.5 months
measure: Change in Health-Related Quality of Life
timeFrame: Baseline to 4.5 months
measure: Cortisol
timeFrame: Baseline to 4.5 months
measure: Blood pressure
timeFrame: Baseline to 4.5 months
measure: Fasting glucose
timeFrame: Baseline to 4.5 months
measure: Low-density lipoprotein (LDL-C) cholesterol
timeFrame: Baseline to 4.5 months
measure: High-density lipoprotein (HDL-C) cholesterol
timeFrame: Baseline to 4.5 months
measure: Triglyceride
timeFrame: Baseline to 4.5 months
measure: Insulin
timeFrame: Baseline to 4.5 months
measure: Hemoglobin A1C
timeFrame: Baseline to 4.5 months
measure: Leptin
timeFrame: Baseline to 4.5 months
measure: Tumor necrosis factor (TNF-a)
timeFrame: Baseline to 4.5 months
measure: Interleukin (IL-6)
timeFrame: Baseline to 4.5 months
measure: High-sensitivity reactive protein (hsCRP)
timeFrame: Baseline to 4.5 months
Secondary outcomes:
measure: Child body fat percent
timeFrame: Baseline to 4.5 months
measure: Waist circumference
timeFrame: Baseline to 4.5 months
measure: Child eating behavior
timeFrame: Baseline to 4.5 months
measure: Dietary behavior
timeFrame: Baseline to 4.5 months
measure: Physical activity behavior
timeFrame: Baseline to 4.5 months
measure: Mindfulness
timeFrame: Baseline to 4.5 months
measure: Psychological flexibility
timeFrame: Baseline to 4.5 months
measure: Impact of the food environment
timeFrame: Baseline to 4.5 months
Other outcomes:
measure: Demographics
timeFrame: Baseline
measure: Participant satisfaction - interviews
timeFrame: 9 weeks, 18 weeks
measure: Participant satisfaction - surveys
timeFrame: 9 weeks, 18 weeks
measure: Program feasibility - interviews
timeFrame: 9 weeks, 18 weeks
measure: Program feasibility - surveys
timeFrame: 9 weeks, 18 weeks
measure: Adherence - attendance
timeFrame: 9 weeks, 18 weeks
measure: Adherence - self-monitoring
timeFrame: 9 weeks, 18 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Marissa A Gowey, PhD
role: PRINCIPAL_INVESTIGATOR
References: