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NCT00680979 · ClinicalTrials.gov registry record · Phase 2
Preventing Excessive Weight Gain in Adolescent Girls at High-Risk for Adult Obesity
A Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 166
- Enrollment target
NCT00680979 is a Phase 2 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 166 participants.
The verdict
NCT00680979, a Phase 2 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 166 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Health Education
- BEHAVIORAL Interpersonal Psychotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2008-05-15 |
| Est. Completion | 2015-04-16 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00680979
The ClinicalTrials.gov registry entry for NCT00680979 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Health Education is the first listed.
NCT00680979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00680979 about?
NCT00680979 is a clinical study titled "Preventing Excessive Weight Gain in Adolescent Girls at High-Risk for Adult Obesity". 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 b...
What is the current status of trial NCT00680979?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2008-05-15. Estimated completion is 2015-04-16.
What interventions are being tested in trial NCT00680979?
The interventions under investigation include: Health Education (BEHAVIORAL), Interpersonal Psychotherapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT00680979?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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