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NCT01344278 · ClinicalTrials.gov registry record · NA
Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)
A NA study of Obesity and Gestational Diabetes, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 2,480
- Enrollment target
- 1
- Study location
NCT01344278: Completed NA study of Obesity and Gestational Diabetes, sponsored by Kaiser Permanente.
NCT01344278 is a NA study of Obesity and Gestational Diabetes that has completed, run by Kaiser Permanente. The registered enrollment target is 2,480 participants, above the 817-participant average among 1,053 other Obesity trials with a reported enrollment target (204% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01344278, a NA study of Obesity and Gestational Diabetes, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,480 participants
- Enrollment target
- 1
- Study location
Study Summary
The main goal of this study is to examine the comparative effectiveness of diabetes prevention strategies in women with Gestational Diabetes Mellitus (GDM) on the control of the following conditions: obesity, hyperglycemia, hypertension and depression. This randomized lifestyle intervention study will be conducted at Kaiser Permanente Northern California. Women in the intervention will receive a letter on gestational weight gain during pregnancy and in the postpartum period, a curriculum of individualized lifestyle counseling via telephone, augmented with e-mail and an interactive Web site. Patients randomized to the usual care arm will receive the standard-care telephone calls from the Perinatal Center during pregnancy and the Center's printed educational materials postpartum. Outcomes will be assessed through the electronic medical record and patient surveys conducted during pregnancy and at 6-weeks, 6- months and 1-year postpartum.
Primary Outcome
Will be the proportion of women who reach their postpartum weight goal (based on their pre-pregnancy weight) and the total amount of weight change (in kilograms). Weight goals: a) reaching pre-pregnancy weight if women had a normal pre-pregnancy weight; or b) achieving a 5% reduction from pre-pregnancy weight if overweight or obese prior to pregnancy.
Conditions Studied
Interventions
- BEHAVIORAL Lifestyle Counseling
Study Locations (1)
California
- Division of Research Northern California - Oakland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,480 participants |
| Start Date | 2011-04 |
| Est. Completion | 2015-09 |
| Phase | NA |
What the finished NCT01344278 record still lists
NCT01344278 is an interventional study that assigns participants to a tested intervention. Its 2,480 participants enrollment target places it among the larger protocols in the corpus, above the 817-participant average among 1,053 other Obesity trials with a reported enrollment target (204% higher).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Lifestyle Counseling is the first listed.
NCT01344278 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01344278 about?
NCT01344278 is a clinical study titled "Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)". The main goal of this study is to examine the comparative effectiveness of diabetes prevention strategies in women with Gestational Diabetes Mellitus (GDM) on the control of the following conditions: obesity, hyperglycemia, hypertension and depression. This randomized lifestyle intervention study wi...
What is the current status of trial NCT01344278?
This trial is currently completed. It is a NA study. The enrollment target is 2,480 participants. The study started on 2011-04. Estimated completion is 2015-09.
What conditions does trial NCT01344278 study?
This clinical trial studies the following conditions: Obesity, Gestational Diabetes.
What interventions are being tested in trial NCT01344278?
The interventions under investigation include: Lifestyle Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT01344278?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01344278 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01344278's enrollment target sits among peer trials
2,480 39th of 1053 higher than 1,015 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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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