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NCT00460018 · ClinicalTrials.gov registry record · Phase 2
Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial)
A Phase 2 study of Gestational Diabetes Mellitus, sponsored by Kaiser Permanente.
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 5
- Study locations
NCT00460018 is a Phase 2 study of Gestational Diabetes Mellitus that has completed, run by Kaiser Permanente. The registered enrollment target is 180 participants, below the 408-participant average among 16 other Gestational Diabetes Mellitus trials with a reported enrollment target (56% lower). The trial reports 5 study locations across 1 state.
The verdict
NCT00460018, a Phase 2 study of Gestational Diabetes Mellitus, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 5
- Study locations
Study Summary
The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GDM). Secondary outcomes are postpartum levels of plasma insulin, markers of insulin resistance, adiponectin, dietary fat, physical activity, and breastfeeding duration.
Conditions Studied
Interventions
- BEHAVIORAL Diet, Exercise, and Breastfeeding Intervention
Study Locations (5)
California
- Kaiser Permanente Oakland - Oakland
- Kaiser Permanente Division of Research - Oakland
- Kaiser Permanente San Francisco - San Francisco
- Kaiser Permanente Santa Clara/Santa Teresa - Santa Clara
- Kaiser Permanente Walnut Creek - Walnut Creek
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2005-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00460018
The ClinicalTrials.gov registry entry for NCT00460018 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 408-participant average among 16 other Gestational Diabetes Mellitus trials with a reported enrollment target (56% lower). The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gestational Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Diet, Exercise, and Breastfeeding Intervention is the first listed.
NCT00460018 reports 5 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00460018 about?
NCT00460018 is a clinical study titled "Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial)". The primary aim of this study is to evaluate whether a lifestyle intervention of diet, exercise, and breastfeeding is associated with decreased postpartum weight retention and reduced plasma glucose levels, measured at 6-weeks and 1-year postpartum, among women with gestational diabetes mellitus (GD...
What is the current status of trial NCT00460018?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2005-09.
What conditions does trial NCT00460018 study?
This clinical trial studies the following conditions: Gestational Diabetes Mellitus.
What interventions are being tested in trial NCT00460018?
The interventions under investigation include: Diet, Exercise, and Breastfeeding Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT00460018?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00460018 being conducted?
This trial has 5 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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