Parenting Intervention for Pediatric Obesity

Sponsor

Nemours Children's Health System (Other)

Overall Status

Completed

CT.gov ID

NCT03796221

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

120

Enrollment

Location

Arms

30.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Obesity Parenting	Behavioral: Parenting videos Behavioral: Standard pediatric obesity treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Integrating Parenting Interventions Into Pediatric Obesity Care

Actual Study Start Date :

Mar 11, 2019

Actual Primary Completion Date :

Feb 19, 2021

Actual Study Completion Date :

Sep 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group Will receive standard pediatric obesity treatment	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.
Experimental: Intervention Group Will receive standard pediatric obesity treatment and parenting videos	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.

Arm

Intervention/Treatment

Active Comparator: Control Group

Will receive standard pediatric obesity treatment

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.

Experimental: Intervention Group

Will receive standard pediatric obesity treatment and parenting videos

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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