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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 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.
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
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00263536
The ClinicalTrials.gov registry entry for NCT00263536 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 147 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 1 intervention - of which Interpersonal Psychotherapy is the first listed.
NCT00263536 reports 0 study locations.
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.
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