Wellness and Weight Family Group Project

NCT02677792 | Completed

• 1 other identifier: #2015-0155
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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 Child Dietary Intake Total kcals from 24-hour dietary recall

  Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

• 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 Parent Weight

  Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

Other Outcomes (6)

• Change in Child Self-Efficacy for Total Healthy Lifestyle Behaviors

  Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

• Change in Child-Reported Total Health-Related Quality of Life

  Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

• Change in Parent-Reported Total Health-Related Quality of Life

  Baseline, Post-Treatment (Month 3), and Follow-up (Month 5)

Study Arms (1)

Behavioral Family Intervention (BFI)

EXPERIMENTAL

Behavioral: Behavioral Family Intervention (BFI)

Interventions

Behavioral Family Intervention (BFI) BEHAVIORAL

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).

Behavioral Family Intervention (BFI)

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Crystal S. Lim, Ph.D.

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 9, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)