NCT01102530

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

April 12, 2010

Last Update Submit

June 27, 2011

Conditions

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of type 2 diabetes
  • Non-English-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Nicklas JM, Zera CA, Seely EW, Abdul-Rahim ZS, Rudloff ND, Levkoff SE. Identifying postpartum intervention approaches to prevent type 2 diabetes in women with a history of gestational diabetes. BMC Pregnancy Childbirth. 2011 Mar 24;11:23. doi: 10.1186/1471-2393-11-23.

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sue E Levkoff, ScD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 13, 2010

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

June 28, 2011

Record last verified: 2011-06

Locations