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Clinical Trials/NCT02677792
NCT02677792
Completed
Not Applicable

Wellness and Weight Family Group Project

University of Mississippi Medical Center1 site in 1 country34 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Obesity
Sponsor
University of Mississippi Medical Center
Enrollment
34
Locations
1
Primary Endpoint
Change in Child Weight Status (BMIz)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
December 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Crystal Stack Lim

Assistant Professor

University of Mississippi Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Change in Child A1C Values(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))
  • Change in Child Glucose Values(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))
  • Change in Child Dietary Intake Total kcals from 24-hour dietary recall(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))
  • Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))
  • Change in Parent Dietary Intake Total kcals from 24-hour dietary recall(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))
  • Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))
  • Change in Parent Weight(Baseline, Post-Treatment (Month 3), and Follow-up (Month 5))

Study Sites (1)

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