Parenting Intervention for Pediatric Obesity
March 22, 2022 updated by: Thao-Ly Phan, Nemours Children's Health System
Integrating Parenting Interventions Into Pediatric Obesity Care
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
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
-
-
Delaware
-
Wilmington, Delaware, United States, 19803
- Nemours Alfred I. Dupont Hospital for Children
-
-
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
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Will receive 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.
|
|
Experimental: Intervention Group
Will receive standard pediatric obesity treatment and parenting videos
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in child weight status
Time Frame: 6 months
|
Change in child BMI-z score
|
6 months
|
|
Change in child weight status
Time Frame: 6 months
|
Change in child BMI percentile (referenced to the 95th percentile)
|
6 months
|
|
Change in caregiver confidence managing child lifestyle behaviors
Time Frame: 6 months
|
Change in Lifestyle Behavior Checklist Confidence score
|
6 months
|
|
Change in child lifestyle behaviors
Time Frame: 6 months
|
Change in Lifestyle Behavior Checklist Problem score
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 month, 2 months, 3 months, 6 months
|
|
Change in child weight status
Time Frame: 3 months
|
Change in child BMI-z score
|
3 months
|
|
Change in child weight status
Time Frame: 3 months
|
Change in child BMI percentile (referenced to the 95th percentile)
|
3 months
|
|
Change in caregiver confidence managing child lifestyle behaviors
Time Frame: 3 months
|
Change in Lifestyle Behavior Checklist Confidence score
|
3 months
|
|
Change in child lifestyle behaviors
Time Frame: 3 months
|
Change in Lifestyle Behavior Checklist Problem score
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thao-Ly T Phan, MD MPH, Nemours Children's Health System
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 (Actual)
March 11, 2019
Primary Completion (Actual)
February 19, 2021
Study Completion (Actual)
September 12, 2021
Study Registration Dates
First Submitted
January 4, 2019
First Submitted That Met QC Criteria
January 4, 2019
First Posted (Actual)
January 8, 2019
Study Record Updates
Last Update Posted (Actual)
March 23, 2022
Last Update Submitted That Met QC Criteria
March 22, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23HD083439 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.