Gestational DiabetesNCT01102530
Diabetes Prevention in Women With a Recent History of Gestational Diabetes (Focus Groups)
An observational study of Gestational Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy women with a diagnosis of gestational diabetes during a pregnancy within the past 5 years
Who may be able to join
- 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
Who cannot join
- Diagnosis of type 2 diabetes
- Non-English-speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Diabetes Prevention in Women With a Recent History of Gestational Diabetes
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.
- Conditions
- Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sue E Levkoff, ScD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102530
- Sponsor's protocol ID
- 2009p000042
- Other IDs
- MM-1094-09/09
- Status last verified
- Jun 2011
- First submitted
- 12 Apr 2010
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21435246
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Prevention in Women With a Recent History of Gestational Diabetes
- ClinicalTrials.gov ID
- NCT01102530
- Acronym / sponsor ID
- 2009p000042
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy women with a diagnosis of gestational diabetes during a pregnancy within the past 5 years
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosis of type 2 diabetes
- Non-English-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Derived from this study: PubMed 21435246Nicklas 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.
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue E Levkoff, ScD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01102530, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.