Parenting Intervention for Pediatric Obesity
Primary Purpose
Childhood Obesity, Parenting
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parenting videos
Standard pediatric obesity treatment
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring Childhood obesity, Parenting intervention, Video intervention, Healthcare delivery
Eligibility Criteria
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
Sites / Locations
- Nemours Alfred I. duPont Hospital for Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Intervention Group
Arm Description
Will receive standard pediatric obesity treatment
Will receive standard pediatric obesity treatment and parenting videos
Outcomes
Primary Outcome Measures
Change in child weight status
Change in child BMI-z score
Change in child weight status
Change in child BMI percentile (referenced to the 95th percentile)
Change in caregiver confidence managing child lifestyle behaviors
Change in Lifestyle Behavior Checklist Confidence score
Change in child lifestyle behaviors
Change in Lifestyle Behavior Checklist Problem score
Secondary Outcome Measures
Discussion of parenting topics during visits to the pediatric obesity clinic
Discussion helpfulness ratings at each visit
Change in child weight status
Change in child BMI-z score
Change in child weight status
Change in child BMI percentile (referenced to the 95th percentile)
Change in caregiver confidence managing child lifestyle behaviors
Change in Lifestyle Behavior Checklist Confidence score
Change in child lifestyle behaviors
Change in Lifestyle Behavior Checklist Problem score
Full Information
NCT ID
NCT03796221
First Posted
January 4, 2019
Last Updated
March 22, 2022
Sponsor
Nemours Children's Health System
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03796221
Brief Title
Parenting Intervention for Pediatric Obesity
Official Title
Integrating Parenting Interventions Into Pediatric Obesity Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
September 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Health System
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Parenting
Keywords
Childhood obesity, Parenting intervention, Video intervention, Healthcare delivery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Will receive standard pediatric obesity treatment
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Will receive standard pediatric obesity treatment and parenting videos
Intervention Type
Behavioral
Intervention Name(s)
Parenting videos
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Standard pediatric obesity treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in child weight status
Description
Change in child BMI-z score
Time Frame
6 months
Title
Change in child weight status
Description
Change in child BMI percentile (referenced to the 95th percentile)
Time Frame
6 months
Title
Change in caregiver confidence managing child lifestyle behaviors
Description
Change in Lifestyle Behavior Checklist Confidence score
Time Frame
6 months
Title
Change in child lifestyle behaviors
Description
Change in Lifestyle Behavior Checklist Problem score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Discussion of parenting topics during visits to the pediatric obesity clinic
Description
Discussion helpfulness ratings at each visit
Time Frame
1 month, 2 months, 3 months, 6 months
Title
Change in child weight status
Description
Change in child BMI-z score
Time Frame
3 months
Title
Change in child weight status
Description
Change in child BMI percentile (referenced to the 95th percentile)
Time Frame
3 months
Title
Change in caregiver confidence managing child lifestyle behaviors
Description
Change in Lifestyle Behavior Checklist Confidence score
Time Frame
3 months
Title
Change in child lifestyle behaviors
Description
Change in Lifestyle Behavior Checklist Problem score
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thao-Ly T Phan, MD MPH
Organizational Affiliation
Nemours Children's Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Parenting Intervention for Pediatric Obesity
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