Parenting Intervention for Pediatric Obesity

Overview

The purpose of this study is to see if educational videos about how to help children develop healthy behaviors, paired with treatment in a pediatric obesity clinic, can increase caregiver confidence and improve child behaviors and weight. Caregivers of children between the ages of 4 and 11 years old who are new patients to a pediatric obesity clinic will be invited to take part in the study. All families will receive the standard treatment provided in the pediatric obesity clinic. Half of the caregivers will be assigned to also watch a few educational videos every month for 3 months in between clinic visits.

Full Title of Study: “Integrating Parenting Interventions Into Pediatric Obesity Care”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2021

Interventions

  • Behavioral: Parenting videos
    • Brief online videos, featuring families of children with obesity of diverse backgrounds, to provide education on parenting skills and motivate families to adopt healthy lifestyle behaviors as a family. Videos will be delivered monthly for three months in between pediatric obesity clinic visits.
  • Behavioral: Standard pediatric obesity treatment
    • Standard treatment in a hospital-based pediatric obesity clinic with a team of medical providers, dietitians, exercise specialists, and behavioral health specialists. Treatment includes management of obesity-related medical conditions, nutrition education, physical activity counseling, and discussion of behavioral strategies such as goal-setting and self-monitoring, with elements of motivational interviewing used to encourage behavior change and adoption of healthy lifestyle behaviors by the entire family.

Arms, Groups and Cohorts

  • Active Comparator: Control Group
    • Will receive standard pediatric obesity treatment
  • Experimental: Intervention Group
    • Will receive standard pediatric obesity treatment and parenting videos

Clinical Trial Outcome Measures

Primary Measures

  • Change in child weight status
    • Time Frame: 6 months
    • Change in child BMI-z score
  • Change in child weight status
    • Time Frame: 6 months
    • Change in child BMI percentile (referenced to the 95th percentile)
  • Change in caregiver confidence managing child lifestyle behaviors
    • Time Frame: 6 months
    • Change in Lifestyle Behavior Checklist Confidence score
  • Change in child lifestyle behaviors
    • Time Frame: 6 months
    • Change in Lifestyle Behavior Checklist Problem score

Secondary Measures

  • Discussion of parenting topics during visits to the pediatric obesity clinic
    • Time Frame: 1 month, 2 months, 3 months, 6 months
    • Discussion helpfulness ratings at each visit
  • Change in child weight status
    • Time Frame: 3 months
    • Change in child BMI-z score
  • Change in child weight status
    • Time Frame: 3 months
    • Change in child BMI percentile (referenced to the 95th percentile)
  • Change in caregiver confidence managing child lifestyle behaviors
    • Time Frame: 3 months
    • Change in Lifestyle Behavior Checklist Confidence score
  • Change in child lifestyle behaviors
    • Time Frame: 3 months
    • Change in Lifestyle Behavior Checklist Problem score

Participating in This Clinical Trial

Inclusion Criteria

  • Legal guardian of a new patient to the Nemours pediatric obesity clinic – Child with body mass index (BMI) greater than the 95th percentile for age and sex – Child 4-11 years of age Exclusion Criteria:

  • Not proficient in English or Spanish – Not able to access the internet on any type of device – Child has a genetic syndrome or primary endocrine disorder associated with obesity – Child is taking a medication known to impact weight

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Nemours Children’s Health System
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Thao-Ly Phan, Associate Professor of Pediatrics – Nemours Children’s Health System
  • Overall Official(s)
    • Thao-Ly T Phan, MD MPH, Principal Investigator, Nemours Children’s Health System
  • Overall Contact(s)
    • Thao-Ly T Phan, MD, MPH, 302-651-4730, tphan@nemours.org

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