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NCT01425905 · ClinicalTrials.gov registry record · Phase 2
Mood and Insulin Resistance in Adolescents At-Risk for Diabetes
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
- 174
- Enrollment target
NCT01425905: Completed Phase 2 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT01425905 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 174 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01425905, 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
- 174 participants
- Enrollment target
Study Summary
Background: Type 2 diabetes is a chronic disease that puts individuals at risk for serious health problems like heart disease, kidney failure, vision problems, and stroke. A major way that type 2 diabetes occurs is through insulin resistance. Insulin resistance means that insulin (an important hormone in the body to keep blood sugar normal) isn t working as well as it should, which can lead to problems with high blood sugar. Insulin resistance has been linked to mood problems, stress, and depression, especially in women. To determine if group programs can help reduce the risk for type 2 diabetes, researchers want to look at teenage girls who are at risk for developing the disease. Objectives: To test whether a group program designed to improve mood also can help improve insulin resistance in teenage girls who are at risk for developing type 2 diabetes, or whether a group program that teaches healthy living skills is just as helpful. Eligibility: Teenage girls between 12 and 17 years of age who are at risk for developing type 2 diabetes. Design: * Participants will have two screening visits to find out if they are eligible to take part in the study. The first visit takes about 3 hours and will involve a physical exam, medical history, questionnaires and an interview about mood problems and possible depression. The second visit takes about 6 hours and will involve a full body scan to measure muscle and fat, blood draws and a glucose test to determine insulin resistance, questionnaires about general well-being and eating habits, eating meals and snacks, and an exercise test. * Participants will join one of two group programs at the National Institutes of Health. One group focuses on learning skills to help with bad moods and stress. The other group covers topics that are important for teens to lead a healthy life. The groups will meet for 1 hour once a week for 6 weeks during after-school hours. * At the end of the groups, participants will have three follow-up
Interventions
- OTHER The Blues Program
- OTHER Hey Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2011-08-23 |
| Est. Completion | 2015-08-10 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT01425905 record still lists
NCT01425905 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% higher).
The record links to 0 conditions, and to 2 interventions - of which The Blues Program is the first listed.
NCT01425905 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01425905 about?
NCT01425905 is a clinical study titled "Mood and Insulin Resistance in Adolescents At-Risk for Diabetes". Background: Type 2 diabetes is a chronic disease that puts individuals at risk for serious health problems like heart disease, kidney failure, vision problems, and stroke. A major way that type 2 diabetes occurs is through insulin resistance. Insulin resistance means that insulin (an important horm...
What is the current status of trial NCT01425905?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 174 participants. The study started on 2011-08-23. Estimated completion is 2015-08-10.
What interventions are being tested in trial NCT01425905?
The interventions under investigation include: The Blues Program (OTHER), Hey Durham (OTHER).
Who is sponsoring clinical trial NCT01425905?
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 NCT01425905's enrollment target sits among peer trials
174 396th of 2000 higher than 1,604 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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