- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02677792
Wellness and Weight Family Group Project
February 22, 2023 updated by: Crystal Stack Lim, University of Mississippi Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral Family Intervention (BFI)
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
|
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
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Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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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
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Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
|
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
|
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
|
Change in Parent Weight
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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Measured parent weight
|
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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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)
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Parent-report questionnaire
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Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
|
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
|
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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Change in Child-Reported Total Health-Related Quality of Life
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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Child-report; total score from Pediatric Quality of Life Inventory
|
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
|
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
|
Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
|
Change in Child Psychological Functioning (Total Problems Subscale from CBCL)
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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parent-report; Child Behavior Checklist (CBCL) Total Problems Scale
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Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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Change in Home Food Inventory Obesiogenic Food Availability Score
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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Parent-reported
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Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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Change in Total Parenting Competence
Time Frame: Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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Parent-report; Total score from Parenting Sense of Competency (PSOC) Scale
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Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
February 2, 2016
First Submitted That Met QC Criteria
February 4, 2016
First Posted (Estimate)
February 9, 2016
Study Record Updates
Last Update Posted (Estimate)
February 23, 2023
Last Update Submitted That Met QC Criteria
February 22, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #2015-0155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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