Acceptance-based Care for Child Eating and Physical Activity Treatment

NCT03368716 | Completed

• 3 other identifiers: 5K12HS023009-045P30DK079626-12in progress
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity; Executive Function; Self-Regulation

Keywords

Pediatric Obesity; Executive Function; Behavioral Intervention; Self-Regulation; Acceptance-Based

Outcome Measures

Primary Outcomes (16)

• Change in child body mass index

  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

  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

  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

  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

  ug/dl

  Baseline to 4.5 months

• Blood pressure

  Systolic over diastolic

  Baseline to 4.5 months

• Fasting glucose

  mg/dl

  Baseline to 4.5 months

• Low-density lipoprotein (LDL-C) cholesterol

  mg/dl

  Baseline to 4.5 months

• High-density lipoprotein (HDL-C) cholesterol

  mg/dl

  Baseline to 4.5 months

• Triglyceride

  mg/dl

  Baseline to 4.5 months

• Insulin

  uU/ml

  Baseline to 4.5 months

• Hemoglobin A1C

  Percentage

  Baseline to 4.5 months

• Leptin

  ng/mL

  Baseline to 4.5 months

• Tumor necrosis factor (TNF-a)

  pg/ml

  Baseline to 4.5 months

• Interleukin (IL-6)

  pg/ml

  Baseline to 4.5 months

• High-sensitivity reactive protein (hsCRP)

  mg/L

  Baseline to 4.5 months

Secondary Outcomes (8)

• Child body fat percent

  Baseline to 4.5 months

• Waist circumference

  Baseline to 4.5 months

• Child eating behavior

  Baseline to 4.5 months

• Dietary behavior

  Baseline to 4.5 months

• Physical activity behavior

  Baseline to 4.5 months

Other Outcomes (7)

• Demographics

  Baseline

• Participant satisfaction - interviews

  9 weeks, 18 weeks

• Participant satisfaction - surveys

  9 weeks, 18 weeks

Study Arms (1)

Acceptance-based Behavioral Treatment

EXPERIMENTAL

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)

Interventions

Acceptance-based Behavioral Treatment (ABBT) BEHAVIORAL

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.

Acceptance-based Behavioral Treatment

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35209, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Self-Control

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Marissa A Gowey, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 11, 2017
• Study Start: February 4, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)