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Wellness and Weight Family Group Project

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Family Intervention (BFI)
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral Family Intervention (BFI)

Arm Description

Outcomes

Primary Outcome Measures

Change in Child Weight Status (BMIz)
BMIz calculated from measured child height and weight

Secondary Outcome Measures

Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener
Child-report questionnaire
Change in Child Dietary Intake Total kcals from 24-hour dietary recall
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 Child A1C Values
From child medical chart - testing completed as part of standard medical care
Change in Child Glucose Values
From child medical chart - testing completed as part of standard medical care
Change in Parent Weight
Measured parent weight
Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults
Parent-report questionnaire
Change in Parent Dietary Intake Total kcals from 24-hour dietary recall
Parent-report 24-hour dietary recall assessed via ASA24-2014

Full Information

First Posted
February 2, 2016
Last Updated
February 22, 2023
Sponsor
University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02677792
Brief Title
Wellness and Weight Family Group Project
Official Title
Wellness and Weight Family Group Project
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Family Intervention (BFI)
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Family Intervention (BFI)
Intervention Description
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 Outcome Measure Information:
Title
Change in Child Weight Status (BMIz)
Description
BMIz calculated from measured child height and weight
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Secondary Outcome Measure Information:
Title
Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener
Description
Child-report questionnaire
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Title
Change in Child Dietary Intake Total kcals from 24-hour dietary recall
Description
Child-report 24-hour dietary recall assessed via Automated Self-administered 24-hour recall (ASA24) System; Children will complete the ASA-2014-Kids
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Title
Change in Child A1C Values
Description
From child medical chart - testing completed as part of standard medical care
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Title
Change in Child Glucose Values
Description
From child medical chart - testing completed as part of standard medical care
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Title
Change in Parent Weight
Description
Measured parent weight
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Title
Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults
Description
Parent-report questionnaire
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Title
Change in Parent Dietary Intake Total kcals from 24-hour dietary recall
Description
Parent-report 24-hour dietary recall assessed via ASA24-2014
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Other Pre-specified Outcome Measures:
Title
Change in Child Self-Efficacy for Total Healthy Lifestyle Behaviors
Description
Child-report questionnaire; sum of scores from Child Dietary Self-Efficacy Scale and Self-Efficacy for Physical Activity Scale
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Title
Change in Child-Reported Total Health-Related Quality of Life
Description
Child-report; total score from Pediatric Quality of Life Inventory
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Title
Change in Parent-Reported Total Health-Related Quality of Life
Description
Parent-report; total score from Pediatric Quality of Life Inventory
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Title
Change in Child Psychological Functioning (Total Problems Subscale from CBCL)
Description
parent-report; Child Behavior Checklist (CBCL) Total Problems Scale
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Title
Change in Home Food Inventory Obesiogenic Food Availability Score
Description
Parent-reported
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Title
Change in Total Parenting Competence
Description
Parent-report; Total score from Parenting Sense of Competency (PSOC) Scale
Time Frame
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crystal S. Lim, Ph.D.
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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