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Completed

NCT Number: NCT03368716

Acceptance-based Care for Child Eating and Physical Activity Treatment

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.

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Key information

Conditions

Pediatric Obesity Behavior Body Weight Executive Function Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Self-Control Self-regulation Signs and Symptoms Social Behavior

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Cortisol

    Time frame: Baseline to 4.5 months

    ug/dl

  6. Blood pressure

    Time frame: Baseline to 4.5 months

    Systolic over diastolic

  7. Fasting glucose

    Time frame: Baseline to 4.5 months

    mg/dl

  8. Low-density lipoprotein (LDL-C) cholesterol

    Time frame: Baseline to 4.5 months

    mg/dl

  9. High-density lipoprotein (HDL-C) cholesterol

    Time frame: Baseline to 4.5 months

    mg/dl

  10. Triglyceride

    Time frame: Baseline to 4.5 months

    mg/dl

  11. Insulin

    Time frame: Baseline to 4.5 months

    uU/ml

  12. Hemoglobin A1C

    Time frame: Baseline to 4.5 months

    Percentage

  13. Leptin

    Time frame: Baseline to 4.5 months

    ng/mL

  14. Tumor necrosis factor (TNF-a)

    Time frame: Baseline to 4.5 months

    pg/ml

  15. Interleukin (IL-6)

    Time frame: Baseline to 4.5 months

    pg/ml

  16. High-sensitivity reactive protein (hsCRP)

    Time frame: Baseline to 4.5 months

    mg/L

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Other outcomes

  1. 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.

  2. Participant satisfaction - interviews

    Time frame: 9 weeks, 18 weeks

    Semi-structured group interviews will assess caregiver and child experiences with the program.

  3. 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.

  4. Program feasibility - interviews

    Time frame: 9 weeks, 18 weeks

    Semi-structured group interviews will assess caregiver and child experiences with the program.

  5. 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.

  6. Adherence - attendance

    Time frame: 9 weeks, 18 weeks

    The number of sessions attended will be the primary indicator of adherence.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Addressing Healthcare Disparities in Pediatric Obesity Treatment: Development of a Novel, Patient-centered Intervention Targeting Executive Function

Acronym: ACCEPT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 11, 2017
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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