Parenting Intervention for Pediatric Obesity

Childhood Obesity Clinical Trial

Official title:

Integrating Parenting Interventions Into Pediatric Obesity Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796221
• Other study ID #: K23HD083439
• Secondary ID: K23HD083439
• Status: Completed
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: September 12, 2021

Study information

• Verified date: March 2022
• Source: Nemours Children's Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 12, 2021
• Est. primary completion date: February 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Parenting
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Nemours Alfred I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Health System	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

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