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Trial record 14 of 703 for:    eating disorders OR anorexia OR appetite disorder OR binge eating disorder OR bulimia OR coprophagia OR hyperphagia OR pica disease OR purge OR orthorexia OR feeding behaviors OR nutrition disorders OR obesity OR thinness OR women's health | Recruiting, Not yet recruiting, Available Studies | NIH

Parenting Intervention for Pediatric Obesity

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ClinicalTrials.gov Identifier: NCT03796221
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Thao-Ly Phan, Nemours Children's Health System

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 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 : March 11, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in child weight status [ Time Frame: 6 months ]
    Change in child BMI-z score

  2. Change in child weight status [ Time Frame: 6 months ]
    Change in child BMI percentile (referenced to the 95th percentile)

  3. Change in caregiver confidence managing child lifestyle behaviors [ Time Frame: 6 months ]
    Change in Lifestyle Behavior Checklist Confidence score

  4. Change in child lifestyle behaviors [ Time Frame: 6 months ]
    Change in Lifestyle Behavior Checklist Problem score


Secondary Outcome Measures :
  1. 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

  2. Change in child weight status [ Time Frame: 3 months ]
    Change in child BMI-z score

  3. Change in child weight status [ Time Frame: 3 months ]
    Change in child BMI percentile (referenced to the 95th percentile)

  4. Change in caregiver confidence managing child lifestyle behaviors [ Time Frame: 3 months ]
    Change in Lifestyle Behavior Checklist Confidence score

  5. Change in child lifestyle behaviors [ Time Frame: 3 months ]
    Change in Lifestyle Behavior Checklist Problem score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796221


Contacts
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Contact: Thao-Ly T Phan, MD, MPH 302-651-4730 tphan@nemours.org

Locations
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United States, Delaware
Nemours Alfred I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Thao-Ly Phan-Vo         
Sponsors and Collaborators
Nemours Children's Health System
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Thao-Ly T Phan, MD MPH Nemours Children's Health System

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Responsible Party: Thao-Ly Phan, Associate Professor of Pediatrics, Nemours Children's Health System
ClinicalTrials.gov Identifier: NCT03796221     History of Changes
Other Study ID Numbers: K23HD083439 ( U.S. NIH Grant/Contract )
K23HD083439 ( U.S. NIH Grant/Contract )
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thao-Ly Phan, Nemours Children's Health System:
Childhood obesity
Parenting intervention
Video intervention
Healthcare delivery
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms