Purpose

The overarching aims of this project are to develop and pilot test a novel, patient-centered, family model for weight management [Acceptance-based Behavioral Treatment (ABBT)] in children aged 8-12 with obesity and their caregivers. Our aims are (1) to determine the treatment needs of children aged 8-12 with obesity and their families with a focus on executive functioning and (2) to evaluate the feasibility and acceptability of family ABBT.

Conditions

Eligibility

Eligible Ages
Between 8 Years and 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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) have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight; (2) are currently participating in a formal weight management program beyond usual medical care or have a caregiver participating in a formal weight management program; (3) had a caregiver participate in focus groups.

Study Design

Phase
N/A
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Caroline Keller, MPH
205-638-6543
ckeller@peds.uab.edu

More Details

NCT ID
NCT03368716
Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Caroline Keller, MPH
205-638-6543
ckeller@peds.uab.edu

Detailed Description

Pilot Treatment Group. Children and caregivers who meet preliminary eligibility via phone screening will be scheduled for a baseline visit within one month of the first treatment session. During this visit, eligibility will be confirmed including height/weight measurements to determine BMI and informed consent/assent procedures will be conducted. Pairs providing informed consent/assent will complete questionnaires, measurements, and cognitive testing. Pre- and post-evaluations are estimated to take less than 70 minutes to complete. The assessments will be identical with the exception of online food/activity monitoring training at pre-treatment only and program evaluation surveys at post-evaluation only. Each treatment group will include a total of 8 child-caregiver pairs (total of 16 child-caregiver dyads with groups combined). A total of 18 weekly treatment sessions will be held over 4.5 months for the ABBT protocol at a rate of 1 session per week. Semi-structured group interviews will be incorporated into an extended treatment session at week 9 and week 18 to assess caregiver and child experiences with the program.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.