Wellness and Weight Family Group Project

Pediatric Obesity Clinical Trial

Official title:

Wellness and Weight Family Group Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677792
• Other study ID #: #2015-0155
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2022

Study information

• Verified date: February 2023
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Obesity

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Child Self-Efficacy for Total Healthy Lifestyle Behaviors	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)
Other	Change in Child-Reported Total Health-Related Quality of Life	Child-report; total score from Pediatric Quality of Life Inventory	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Other	Change in Parent-Reported Total Health-Related Quality of Life	Parent-report; total score from Pediatric Quality of Life Inventory	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Other	Change in Child Psychological Functioning (Total Problems Subscale from CBCL)	parent-report; Child Behavior Checklist (CBCL) Total Problems Scale	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Other	Change in Home Food Inventory Obesiogenic Food Availability Score	Parent-reported	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Other	Change in Total Parenting Competence	Parent-report; Total score from Parenting Sense of Competency (PSOC) Scale	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Primary	Change in Child Weight Status (BMIz)	BMIz calculated from measured child height and weight	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Secondary	Change in Total Child Physical Activity kcals from Block Kids Physical Activity Screener	Child-report questionnaire	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Secondary	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	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Secondary	Change in Child A1C Values	From child medical chart - testing completed as part of standard medical care	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Secondary	Change in Child Glucose Values	From child medical chart - testing completed as part of standard medical care	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Secondary	Change in Parent Weight	Measured parent weight	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Secondary	Change in Total Parent Physical Activity kcals from Block Physical Activity Screener Adults	Parent-report questionnaire	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)
Secondary	Change in Parent Dietary Intake Total kcals from 24-hour dietary recall	Parent-report 24-hour dietary recall assessed via ASA24-2014	Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)