search
Back to results

Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)

Primary Purpose

Gestational Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Balance after Baby Lifestyle Intervention Program
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus focused on measuring Gestational diabetes mellitus (GDM) in the most recent pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy female with a diagnosis of gestational diabetes mellitus (GDM) by Carpenter-Coustan criteria (see below) in most recent singleton or twin pregnancy (Carpenter & Coustan, 1982)
  • Women with a glucose value >200 mg/dL after a 50-g glucose challenge test at >12 weeks' gestation will also be included
  • 18-45 years old
  • No personal history of Type 1 or 2 diabetes
  • Pre-pregnancy body mass index between 18 and 40 kg/m2
  • Six weeks postpartum body mass index between 25 and 50 kg/m2
  • Capable of providing informed consent

Exclusion Criteria:

  • Pre-pregnancy diagnosis of diabetes (type 1, 2, or a secondary form of diabetes)
  • Pre-pregnancy body mass index <18 kg/m2 (underweight) or >40 kg/m2 (morbidly obese)
  • Current pregnancy
  • Six weeks postpartum body mass index <25 kg/m2 or >50 kg/m2
  • Excessive alcohol intake defined as >1 beverage per night or past history of alcohol abuse (within the previous 5 years)
  • Current or past recreational drug use (within the previous 5 years)
  • Diagnosis of diseases associated with glucose metabolism
  • Taking certain prescription medication including glucocorticoids, atypical antipsychotics associated with weight gain (such as respirdal(respiradone), clozapine (klozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.) or weight loss medications including prescription, non-prescription or herbal medications
  • Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer
  • Personal history of cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression requiring hospitalization within the past 6 months, or non-pregnancy related illness requiring overnight hospitalization in the past 6 months
  • Underlying disease/treatment that might interfere with participation in/completion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
  • Other active medical problems detected by examination or laboratory testing
  • Plans to be in a different geographic area within the year
  • Unable to give informed consent
  • Non-English speaking

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lifestyle Intervention group

Post-gestational diabetes mellitus (GDM) Follow-up Group

Arm Description

Participants in this group will take part in the lifestyle intervention.

Participants in this group will not take part in the intervention.

Outcomes

Primary Outcome Measures

Postpartum weight loss
Postpartum weight loss for all subjects will be assessed.

Secondary Outcome Measures

Full Information

First Posted
June 28, 2010
Last Updated
December 21, 2012
Sponsor
Brigham and Women's Hospital
Collaborators
Centers for Disease Control and Prevention
search

1. Study Identification

Unique Protocol Identification Number
NCT01158131
Brief Title
Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)
Official Title
Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Many studies have shown that women with a history of gestational diabetes mellitus (GDM) have an increased risk of developing diabetes later in life. The purpose of the study is to test whether a web-based lifestyle intervention program adapted from the NIH sponsored Diabetes Prevention Program (DPP), modified specifically for women with a recent history of GDM, incorporating advice about diet and physical activity, delivered in the first 12 months after delivery will help women lose weight, improve overall health, and decrease their risk factors for type 2 diabetes.
Detailed Description
The landmark Diabetes Prevention Program (DPP) demonstrated that intensive lifestyle intervention in people with impaired glucose tolerance (IGT) could reduce the incidence of type 2 diabetes (Knowler, Barrett-Connor et al. 2002). These findings were consistent, regardless of ethnicity, age, body mass index (BMI), gender (Knowler, Barrett-Connor et al. 2002). However, the DPP lacks a specific focus on new mothers with a recent history of gestational diabetes despite their documented high risk for developing Type 2 diabetes. Although there are recommendations that all women with gestational diabetes mellitus (GDM) receive postpartum testing for diabetes and type 2 diabetes risk reduction, study findings suggest that women with a recent history of GDM may be unaware of their risk for future diabetes, and also do not take steps to reduce their risks (Kim et al., 2007). The postpartum period is also a time when many changes occur in a woman's life, with competing responsibilities often altering sleep patterns, work schedules, eating patterns, exercise regularity, and time allocation (Walker, 1999; Swan et al., 2007). New mothers may have difficulties engaging in healthy lifestyle programs because of lack of time and energy, and because of competing work and family demands, including child care (Swan, Kilmartin, and Liaw, 2007). Modeled around the barriers identified in literature and gleaned from the focus groups and informant interviews of the preliminary study (2009p-000042), we have created a lifestyle/behavioral intervention that utilizes a modified DPP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
Gestational diabetes mellitus (GDM) in the most recent pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention group
Arm Type
Experimental
Arm Description
Participants in this group will take part in the lifestyle intervention.
Arm Title
Post-gestational diabetes mellitus (GDM) Follow-up Group
Arm Type
No Intervention
Arm Description
Participants in this group will not take part in the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Balance after Baby Lifestyle Intervention Program
Intervention Description
Participants in this intervention will receive support from a lifestyle coach and gain access to a website with online presentations that contain healthy eating and physical activity educational tips. Weekly phone conversations with the lifestyle coach, as well as logging diet and physical activity will also be required of intervention participants.
Primary Outcome Measure Information:
Title
Postpartum weight loss
Description
Postpartum weight loss for all subjects will be assessed.
Time Frame
12 months after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy female with a diagnosis of gestational diabetes mellitus (GDM) by Carpenter-Coustan criteria (see below) in most recent singleton or twin pregnancy (Carpenter & Coustan, 1982) Women with a glucose value >200 mg/dL after a 50-g glucose challenge test at >12 weeks' gestation will also be included 18-45 years old No personal history of Type 1 or 2 diabetes Pre-pregnancy body mass index between 18 and 40 kg/m2 Six weeks postpartum body mass index between 25 and 50 kg/m2 Capable of providing informed consent Exclusion Criteria: Pre-pregnancy diagnosis of diabetes (type 1, 2, or a secondary form of diabetes) Pre-pregnancy body mass index <18 kg/m2 (underweight) or >40 kg/m2 (morbidly obese) Current pregnancy Six weeks postpartum body mass index <25 kg/m2 or >50 kg/m2 Excessive alcohol intake defined as >1 beverage per night or past history of alcohol abuse (within the previous 5 years) Current or past recreational drug use (within the previous 5 years) Diagnosis of diseases associated with glucose metabolism Taking certain prescription medication including glucocorticoids, atypical antipsychotics associated with weight gain (such as respirdal(respiradone), clozapine (klozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.) or weight loss medications including prescription, non-prescription or herbal medications Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer Personal history of cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression requiring hospitalization within the past 6 months, or non-pregnancy related illness requiring overnight hospitalization in the past 6 months Underlying disease/treatment that might interfere with participation in/completion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician) Other active medical problems detected by examination or laboratory testing Plans to be in a different geographic area within the year Unable to give informed consent Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen W Seely, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25162257
Citation
Nicklas JM, Zera CA, England LJ, Rosner BA, Horton E, Levkoff SE, Seely EW. A web-based lifestyle intervention for women with recent gestational diabetes mellitus: a randomized controlled trial. Obstet Gynecol. 2014 Sep;124(3):563-570. doi: 10.1097/AOG.0000000000000420.
Results Reference
derived
PubMed Identifier
23124798
Citation
Nicklas JM, Miller LJ, Zera CA, Davis RB, Levkoff SE, Seely EW. Factors associated with depressive symptoms in the early postpartum period among women with recent gestational diabetes mellitus. Matern Child Health J. 2013 Nov;17(9):1665-72. doi: 10.1007/s10995-012-1180-y.
Results Reference
derived

Learn more about this trial

Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)

We'll reach out to this number within 24 hrs