Wellness and Weight Family Group Project

Not Applicable

Completed

• Conditions: Pediatric Obesity
• Interventions: Behavioral: Behavioral Family Intervention (BFI)

• Registration Number: NCT02677792
• Lead Sponsor: University of Mississippi Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-04
• Study First Posted: 2016-02-09
• Primary Completion: 2020-12
• Study Completion: 2022-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. child 10 to 17 years of age attending an outpatient pediatric obesity clinic visit
2. 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)
3. child or adolescent is accompanied by a parent or legal guardian
4. participating child and parent speak and read English
5. family agrees to attend group meetings at a medical clinic over a 3 month period

Exclusion Criteria

1. 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)
2. child diagnosed according to parent report with pervasive developmental delay (e.g., autistic disorder)
3. child or parent, according to parent report, in commercial weight loss program
4. child or parent currently prescribed medications to impact appetite or weight loss/gain, according to parent report
5. parent and child do not speak and read English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral Family Intervention (BFI)	Behavioral Family Intervention (BFI)	-

Primary Outcome Measures

Name	Time	Method
Change in Child Weight Status (BMIz)	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)	BMIz calculated from measured child height and weight

Secondary Outcome Measures

Name	Time	Method
Change in Child A1C Values	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)	From child medical chart - testing completed as part of standard medical care
Change in Child Glucose Values	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)	From child medical chart - testing completed as part of standard medical care
Change in Child Dietary Intake Total kcals from 24-hour dietary recall	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
Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)	Parent-report questionnaire
Change in Parent Dietary Intake Total kcals from 24-hour dietary recall	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)	Parent-report 24-hour dietary recall assessed via ASA24-2014
Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)	Child-report questionnaire
Change in Parent Weight	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)	Measured parent weight

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States