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NCT01910805 · ClinicalTrials.gov registry record · NA
Recent GDM Lifestyle Intervention
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT01910805: Completed NA study, sponsored by Brigham and Women's Hospital.
NCT01910805 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01910805, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
Women with a history of gestational diabetes (GDM) have a substantially increased risk of developing type 2 diabetes. In fact, 50-70% of these women will go on to develop type 2 diabetes within the 20 years following their GDM-complicated pregnancy. Perceived risk of developing type 2 diabetes among women with a history of GDM may be particularly important to altering behavior changes associated with reducing risk. Certain populations have lower perceived risk of developing type 2 diabetes, despite having a higher prevalence of the disease. Specifically, African-Americans have a lower perceived risk of developing type 2 diabetes compared to whites, despite their more than doubled risk of developing the disease. Improvement in awareness of diabetes risk among African-American women at high-risk of developing type 2 diabetes, such as those with a history of GDM, could reduce future risk of this disease among this group. As such, we will conduct a two-armed, pilot randomized controlled trial to evaluate whether a postpartum diabetes education intervention, incorporating nutrition, exercise, and diabetes risk assessment can improve diabetes risk awareness, diet, and physical activity levels at 1-year post-pregnancy among African-American women with a recent history of gestational diabetes. We hypothesize that attendance at a 3-month and 9-month postpartum diabetes education class will: 1. Improve diabetes awareness as measured using the Risk Perception for Developing Diabetes among women in the intervention group compared to women in the control group when measuring at 3-months postpartum compared to 12-months postpartum 2. Improve dietary habits and physical activity levels in the intervention group compared to the control group when measuring at 3-months postpartum compared to 12-months postpartum
Primary Outcome
Using an adapted version of the Risk Perception Survey for Developing Diabetes for women with a history of gestational diabetes, women will be asked to respond on web-based or paper questionnaires regarding their individual and group risk of getting diabetes. The primary outcome will measure the change in their awareness of diabetes based on their diabetes risk perception score at baseline (3 months postpartum) compared to 12 months postpartum.
Interventions
- BEHAVIORAL Lifestyle and Risk Assessment class
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-07 |
| Phase | NA |
What the finished NCT01910805 record still lists
NCT01910805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Lifestyle and Risk Assessment class is the first listed.
NCT01910805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01910805 about?
NCT01910805 is a clinical study titled "Recent GDM Lifestyle Intervention". Women with a history of gestational diabetes (GDM) have a substantially increased risk of developing type 2 diabetes. In fact, 50-70% of these women will go on to develop type 2 diabetes within the 20 years following their GDM-complicated pregnancy. Perceived risk of developing type 2 diabetes among...
What is the current status of trial NCT01910805?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2014-08. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01910805?
The interventions under investigation include: Lifestyle and Risk Assessment class (BEHAVIORAL).
Who is sponsoring clinical trial NCT01910805?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01910805's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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