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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 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 15 participants.

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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

Interventions

  • BEHAVIORAL Lifestyle and Risk Assessment class

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2014-08
Est. Completion 2015-07
Phase NA

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT01910805

The ClinicalTrials.gov registry entry for NCT01910805 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Lifestyle and Risk Assessment class is the first listed.

NCT01910805 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.