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Sponsors and Collaborators: |
Mount Sinai School of Medicine Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00807560 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Parent-Based Treatment for Pediatric Overweight |
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.
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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.
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2: Active Comparator
Nutritional Educational Control Condition (NEC).
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Behavioral: NEC
Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.
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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.
Ages Eligible for Study: | 13 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Terri L Bacow, Ph.D. | (917) 710-0846 | Terri.Bacow@mssm.edu |
Contact: Kali Ludwig |
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 |
Principal Investigator: | Katherine L Loeb, PH.D. | Mount Sinai School of Medicine |
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 |
Overweight Obesity Adolescents Family Therapy |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |