Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
77 participants
INTERVENTIONAL
2008-09-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FBT-PO
Family Based Therapy for Pediatric Overweight.
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.
NEC-control
Nutritional Educational Control Condition (NEC).
NEC
Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.
Interventions
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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.
NEC
Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
13 Years
17 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Principal Investigators
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Katherine L Loeb, PH.D.
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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The University of Chicago
Chicago, Illinois, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Other Identifiers
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GCO 07-0216
Identifier Type: -
Identifier Source: org_study_id
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