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Parent-Based Treatment for Pediatric Overweight (PO)
This study is currently recruiting participants.
Verified by Mount Sinai School of Medicine, January 2009
First Received: December 11, 2008   Last Updated: January 26, 2009   History of Changes
Sponsors and Collaborators: Mount Sinai School of Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00807560
  Purpose

The purpose of this study is to determine whether a parent/guardian intervention for adolescent overweight/obesity more effective than a nutritional counseling education curriculum for reducing body mass index z-score (BMI Z-score) and related outcomes.


Condition Intervention Phase
Overweight
Obesity
Behavioral: FBT-PO
Behavioral: NEC
Phase I
Phase II

MedlinePlus related topics: Obesity Obesity in Children
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Parent-Based Treatment for Pediatric Overweight

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Height and weight(converted into BMI Z-score) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Youth and Parent/Guardian Eating Questionnaire Y-EDE Q [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • Child Depression Inventory (CDI) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • PEDS QL [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • Moderate to Vigorous Physical Activity Measure (MVPA) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • Sedentary Activity Checklist(SAC) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • PACE +Fruit Vegetable Screening Measure (FVS) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • PACE+ Dietary Fat Screening Measure (DFS) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • Parent 24 Hour Dietary Recall [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]
  • Parent Overweight Status Height and weight (converted into BMI z-score) [ Time Frame: Baseline, Post, 6-month, 12-month ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Family Based Therapy for Pediatric Overweight.
Behavioral: FBT-PO
The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases.
2: Active Comparator
Nutritional Educational Control Condition (NEC).
Behavioral: NEC
Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.

Detailed Description:

Rates of pediatric overweight (PO) among Americans are increasing and associated with significant psychological, social, quality of life, and health related outcomes. Because of the broad mental and physical health implications of PO and the difficulty in sustaining weight loss as an adult, it is of interest to find successful methods of weight loss and/or prevention of weight gain for obese children and adolescents. The family unit is a logical and empirically supported point of intervention for PO. Interventions on this level have shown good long term efficacy in young children, but there is very little research on adolescent family intervention. Within the eating disorder literature, there is growing support for the efficacy of family-based interventions (FBI) for adolescents. Given its trans-developmental applicability, focus on family as the unit of intervention, and utility in creating a healthy eating environment, FBI is a logical candidate for adaptation to intervention for PO and intervention for at-risk for overweight youth (FBI-PO).

The core of the current project is to test the feasibility and efficacy of an adapted FBI manual for adolescent overweight and at-risk for overweight in an outpatient eating and weight disorders clinic and compare this modality to a minimal nutritional educational control (NEC) condition.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 13-17
  • Male and female
  • Living with at least one parent or guardian who is willing to participate in treatment
  • A BMI percentile >85% for gender and age (e.g., overweight or at risk for overweight)

Exclusion Criteria:

  • Current psychotic illness
  • Current alcohol/drug dependence
  • Active suicidality
  • Eating disorders (e.g., binge eating disorder)
  • History of bariatric surgery
  • Medication associated with significant weight changes (e.g., antipsychotics)
  • Serious medical or physical conditions resulting in significant weight changes (e.g., pregnancy, genetic disorders).
  • Complications of obesity that contraindicate moderate physical activity (e.g. orthopedic disorders)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807560

Contacts
Contact: Terri L Bacow, Ph.D. (917) 710-0846 Terri.Bacow@mssm.edu
Contact: Kali Ludwig

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Daniel le Grange, Ph.D.     773-702-9277     legrange@uchicago.edu    
Contact: Kali Ludwig, BA     (773) 702-0789     kludwig@bsd.uchicago.edu    
Principal Investigator: Daniel le Grange, Ph.D.            
Sub-Investigator: Angela Celio Doyle, Ph.D.            
United States, New York
Mount Sinai School of Medicine Recruiting
NY, New York, United States, 10029
Contact: Katherine L Loeb, Ph.D.     212-659-8724     Katharine.Loeb@mssm.edu    
Contact: Teri L Bacow, Ph.D.     (917) 710-0846     Terri.Bacow@mssm.edu    
Principal Investigator: Katherine L Loeb, Ph.D.            
Sub-Investigator: Thomas Hildebrandt, Psy.D.            
Sub-Investigator: Danielle Laraque, MD            
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Katherine L Loeb, PH.D. Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Mount Sinai School of Medicine ( Dr. Katharine Loeb )
Study ID Numbers: GCO# 07-0216, 1R21-HD057394-01
Study First Received: December 11, 2008
Last Updated: January 26, 2009
ClinicalTrials.gov Identifier: NCT00807560     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Overweight
Obesity
Adolescents
Family Therapy

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overnutrition
Overweight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on May 06, 2009