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Completed

NCT Number: NCT02677792

Wellness and Weight Family Group Project

The purpose of the current study is examine the feasibility and efficacy of providing a behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending a multidisciplinary pediatric obesity clinic and their parents. Participating families will complete assessments consisting of weight status, dietary intake, physical activity, health-related quality of life, psychological functioning, home-food environment, parenting skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month post-treatment follow-up (Month 5). Family attendance data will be collected during the behavioral family intervention and children and parents will complete a treatment satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C, glucose) routinely assessed through standard medical care in the multidisciplinary pediatric obesity clinic will be obtained from child medical charts.

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Key information

Conditions

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

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • child 10 to 17 years of age attending an outpatient pediatric obesity clinic visit
  • child or adolescent is obese (equal to or above the 95th percentile for BMI based on Centers for Disease Control and Prevention (CDC) norms for age and gender)
  • child or adolescent is accompanied by a parent or legal guardian
  • participating child and parent speak and read English
  • family agrees to attend group meetings at a medical clinic over a 3 month period

Exclusion criteria

  • participating child or parent, according to parent report, has dietary restriction or medical condition contraindicating mild energy restriction or moderate physical activity (e.g., musculoskeletal, heart, or respiratory condition, uncontrolled blood pressure or exercise induced asthma)
  • child diagnosed according to parent report with pervasive developmental delay (e.g., autistic disorder)
  • child or parent, according to parent report, in commercial weight loss program
  • child or parent currently prescribed medications to impact appetite or weight loss/gain, according to parent report
  • parent and child do not speak and read English

Treatment and study plan

Behavioral Family Intervention (BFI)

Behavioral

Participating families will receive standard medical care through the Wellness and Weight Clinic, as well as the BFI. The BFI is based on family systems (Minuchin et al., 1975) and social-cognitive (Bandura, 1998) theories. Each dyad will participate in simultaneous, but separate, 75-minute parent and child groups over a 3 month period. The groups will start off meeting every week for 8 weeks and then bi-weekly for 1 month. Thus, dyads will attend a total of 10 group meetings over the 3 month period (12.5 hours of total treatment contact).

Primary outcomes

  1. Change in Child Weight Status (BMIz)

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    BMIz calculated from measured child height and weight

Secondary outcomes

  1. Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    Child-report questionnaire

  2. Change in Child Dietary Intake Total kcals from 24-hour dietary recall

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    Child-report 24-hour dietary recall assessed via Automated Self-administered 24-hour recall (ASA24) System; Children will complete the ASA-2014-Kids

  3. Change in Child A1C Values

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    From child medical chart - testing completed as part of standard medical care

  4. Change in Child Glucose Values

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    From child medical chart - testing completed as part of standard medical care

  5. Change in Parent Weight

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    Measured parent weight

  6. Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    Parent-report questionnaire

  7. Change in Parent Dietary Intake Total kcals from 24-hour dietary recall

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    Parent-report 24-hour dietary recall assessed via ASA24-2014

Other outcomes

  1. Change in Child Self-Efficacy for Total Healthy Lifestyle Behaviors

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    Child-report questionnaire; sum of scores from Child Dietary Self-Efficacy Scale and Self-Efficacy for Physical Activity Scale

  2. Change in Child-Reported Total Health-Related Quality of Life

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    Child-report; total score from Pediatric Quality of Life Inventory

  3. Change in Parent-Reported Total Health-Related Quality of Life

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    Parent-report; total score from Pediatric Quality of Life Inventory

  4. Change in Child Psychological Functioning (Total Problems Subscale from CBCL)

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    parent-report; Child Behavior Checklist (CBCL) Total Problems Scale

  5. Change in Home Food Inventory Obesiogenic Food Availability Score

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    Parent-reported

  6. Change in Total Parenting Competence

    Time frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

    Parent-report; Total score from Parenting Sense of Competency (PSOC) Scale

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Feb 9, 2016
Registry last updated
Feb 23, 2023

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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