NCT03796221

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2021

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

1.9 years

First QC Date

January 4, 2019

Last Update Submit

March 22, 2022

Conditions

Childhood ObesityParenting

Keywords

Childhood obesityParenting interventionVideo interventionHealthcare delivery

Outcome Measures

Primary Outcomes (4)

  • Change in child weight status

    Change in child BMI-z score

    6 months

  • Change in child weight status

    Change in child BMI percentile (referenced to the 95th percentile)

    6 months

  • Change in caregiver confidence managing child lifestyle behaviors

    Change in Lifestyle Behavior Checklist Confidence score

    6 months

  • Change in child lifestyle behaviors

    Change in Lifestyle Behavior Checklist Problem score

    6 months

Secondary Outcomes (5)

  • Discussion of parenting topics during visits to the pediatric obesity clinic

    1 month, 2 months, 3 months, 6 months

  • Change in child weight status

    3 months

  • Change in child weight status

    3 months

  • Change in caregiver confidence managing child lifestyle behaviors

    3 months

  • Change in child lifestyle behaviors

    3 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Will receive standard pediatric obesity treatment

Behavioral: Standard pediatric obesity treatment

Intervention Group

EXPERIMENTAL

Will receive standard pediatric obesity treatment and parenting videos

Behavioral: Parenting videosBehavioral: Standard pediatric obesity treatment

Interventions

Parenting videosBEHAVIORAL

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.

Intervention Group
Standard pediatric obesity treatmentBEHAVIORAL

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.

Control GroupIntervention Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nemours Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thao-Ly T Phan, MD MPH

    Nemours Children's Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 8, 2019

Study Start

March 11, 2019

Primary Completion

February 19, 2021

Study Completion

September 12, 2021

Last Updated

March 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)