Diabetes Prevention in Women With a Recent History of Gestational Diabetes (Focus Groups)

This study has been completed.
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01102530
First received: April 12, 2010
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

The objective of this research is to conduct focus groups in order to adapt the Diabetes Prevention Program (DPP) so that it may successfully target women diagnosed with gestational diabetes (GDM) who are at high risk for developing Type 2 diabetes in the post-partum period. As this research seeks to gather formative data for a future intervention, the focus groups will: 1) provide information to maximize participation in the future intervention and 2) inform the location, content and format of the intervention.

We will be conducting focus groups and informant interviews to determine the DPP modifications necessary for adapting to the post-partum lifestyles of women with a recent history of GDM. Subjects will attend a 1 hour focus group or phone interview where they will be encouraged to respond to the facilitators' questions and to each other's comments on topics such as: gestational diabetes, healthy eating, exercise, and other type 2 diabetes prevention related activities. Working with a variety of health care providers, including endocrinologists, obstetricians and nurse-practitioners, we will identify and enroll up to 60 women total who are either current GDM patients at BWH or have a recent history of GDM who have delivered at Brigham and Women's Hospital in the last 5 years.


Condition
Gestational Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Diabetes Prevention in Women With a Recent History of Gestational Diabetes

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Enrollment: 29
Study Start Date: January 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy women with a diagnosis of gestational diabetes during a pregnancy within the past 5 years

Criteria

Inclusion Criteria:

  • Healthy women ages 18-45
  • Diagnosis of gestational diabetes within the past 5 years (Carpenter-Coustan criteria)
  • English-speaking
  • Currently not diagnosed with type 2 diabetes

Exclusion Criteria:

  • Diagnosis of type 2 diabetes
  • Non-English-speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102530

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Sue E Levkoff, ScD Brigham and Women's Hospital
  More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sue E. Levkoff, ScD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01102530     History of Changes
Other Study ID Numbers: 2009p000042, MM-1094-09/09
Study First Received: April 12, 2010
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on October 23, 2014