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NCT00263536 · ClinicalTrials.gov registry record · Phase 1
Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain
A Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 1
- Development phase
- 147
- Enrollment target
NCT00263536: Completed Phase 1 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00263536 is a Phase 1 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 147 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (145% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00263536, a Phase 1 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 147 participants
- Enrollment target
Study Summary
This study will examine whether family-based interpersonal psychotherapy (FB-IPT) is an effective tool for helping pre-adolescent girls and boys at risk for become obese to reduce weight gain. IPT is a time-limited group therapy for preventing and treating depression in children. It is also effective for treating binge eating disorder in adults and has resulted in weight maintenance or modest weight loss in obese adults. IPT focuses on improving how people relate to one another by relating symptoms to personal problem areas and then developing strategies for dealing with these problems. Girls and boys between the ages of 8-13 years of age who are in good general health with the exception of being overweight and whose body mass index (BMI) is above the 85th percentile for their age and sex may be eligible for this study. Candidates are screened with a physical examination, measurement of their height and weight, blood and urine tests, a DEXA scan (x-ray scan that measures body fat, muscle and bone mineral content), and questionnaires and an interview to obtain information about the child's general health, social and psychological function, and eating patterns. Parents are also screened for their health and are asked to give blood samples for genetic studies and participate in a few questionnaires and interviews. Participants are randomly assigned to participate in FB-IPT or a health education program. Both programs involve 12 weekly visits. At the end of the study, the body weight and mood of the girls and boys in both groups are compared. Participants (a parent and their child) meet individually with the therapist for 12 sessions (each approximately an 45 minutes ). Girls and boys offered FB-IPT have meetings in which they develop strategies for dealing with the problems girls struggle with that may lead to increased eating. Girls and boys in the health education group have meetings that focus on teaching teens children to live healthier lives and review topics re
Interventions
- PROCEDURE Interpersonal Psychotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2005-12-05 |
| Est. Completion | 2016-08-16 |
| Phase | Phase 1 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00263536 record still lists
NCT00263536 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (145% higher).
The record links to 0 conditions, and to 1 intervention - of which Interpersonal Psychotherapy is the first listed.
NCT00263536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00263536 about?
NCT00263536 is a clinical study titled "Pilot Program for Targeted Prevention of Child or Adolescent Weight Gain". This study will examine whether family-based interpersonal psychotherapy (FB-IPT) is an effective tool for helping pre-adolescent girls and boys at risk for become obese to reduce weight gain. IPT is a time-limited group therapy for preventing and treating depression in children. It is also effectiv...
What is the current status of trial NCT00263536?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 147 participants. The study started on 2005-12-05. Estimated completion is 2016-08-16.
What interventions are being tested in trial NCT00263536?
The interventions under investigation include: Interpersonal Psychotherapy (PROCEDURE).
Who is sponsoring clinical trial NCT00263536?
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00263536's enrollment target sits among peer trials
147 387th of 2000 higher than 1,610 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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