Preventing Excessive Weight Gain in Adolescent Girls at High-Risk for Adult Obesity
|ClinicalTrials.gov Identifier: NCT00680979|
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : October 6, 2017
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:
- Height and weight measurements.
- Interview and questionnaires about the child s general health, social and psychological functioning and eating patterns and behaviors.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Overweight Binge Eating||Behavioral: Interpersonal Psychotherapy Behavioral: Health Education||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preventing Excessive Weight Gain in Adolescent Girls at High-Risk for Adult Obesity|
|Study Start Date :||May 15, 2008|
|Actual Primary Completion Date :||April 16, 2015|
|Actual Study Completion Date :||April 16, 2015|
- Girls with LOC eating will be randomly assigned to IPT-WG or HE to examine their expected BMI change based upon CDC BMI growth chart data versus their actual in BMI over the course of two years. [ Time Frame: 1 year ]
- Efficacy of IPT-WG in improving socia [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680979
|United States, Maryland|
|United States Uniformed Health Service|
|Bethesda, Maryland, United States, 20889|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Jack A Yanovski, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|