CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
FBT-PO +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00807560
NCT00807560Phase 2Completed
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Parent-Based Treatment for Pediatric Overweight

Icahn School of Medicine at Mount Sinai·interventional·Posted Dec 12, 2008·Updated Jan 8, 2016

In Brief

A Phase 2 clinical trial evaluating FBT-PO and NEC for Overweight and Obesity. Completed, enrolled 77 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obesity
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 12, 2008
Enrollment StartSep 1, 2008
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 17.6 years ago

Interventions

FBT-PObehavioral

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.

NECbehavioral

Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks.