CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 166 enrolled
Drug / intervention
Interpersonal Psychotherapy +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/NCT00680979
NCT00680979Phase 2Completed

Preventing Excessive Weight Gain in Adolescent Girls at High-Risk for Adult Obesity

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·interventional·Posted May 20, 2008·Updated Oct 1, 2019

In Brief

A Phase 2 clinical trial evaluating Interpersonal Psychotherapy and Health Education for Obesity and 2 related conditions. Completed, enrolled 166 participants across 2 sites.

Detailed Summary

This study will examine whether interpersonal psychotherapy (IPT) can help reduce excessive weight gain in adolescent girls. It will compare the effectiveness of IPT with a teen health education program in preventing weight gain. Adolescent girls between 12 and 17 years of age who are at risk for becoming overweight adults, by virtue of being above average weight and experiencing episodes of loss of control over eating, may be eligible for this study. Candidates are screened in two visits with the following procedures: Visit 1 * Height and weight measurements. * Interview and questionnaires about the child s general health, social and psychological functioning and eating patterns and behaviors. Visit 2 * Physical examination, blood and urine tests. * DXA scan to measure body fat, muscle and bone mineral content. * Laboratory test meal. The child fills out a rating scale about her level of hunger and is then given a food buffet from which she is instructed to eat as much as she wants. Immediately after eating, the child again completes the hunger rating forms. * Interview about the child s mood and psychological functioning. Participants are assigned at random to either the IPT or teen health education program. All participants have a 1- to 1 1/2-hour individual session with a therapist, followed by 12 weekly group sessions of 1 1/2 hours each in their assigned program. They are assessed at the end of the program with questionnaires and body measurements. They return to the clinic after 6 months for body measurements, blood test, DXA scan, questionnaires, interview and a test meal, and again at 1 year for body measurements, questionnaires and a DXA scan.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 20, 2008
Enrollment StartMay 15, 2008
Primary CompletionApr 16, 2015
TodayJul 1, 2026
Enrollment to primary: 6.9 yearsPosted 18.1 years ago

Interventions

Interpersonal Psychotherapybehavioral

Health Educationbehavioral