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

Gestational Diabetes Clinical Trial

Official title:

Diabetes Prevention in Women With a Recent History of Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102530
• Other study ID #: 2009p000042
• Secondary ID: MM-1094-09/09
• Status: Completed
• Phase: N/A
• First received: April 12, 2010
• Last updated: June 27, 2011
• Start date: January 2009
• Est. completion date: March 2010

Study information

• Verified date: June 2011
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States,