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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01158131
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : December 24, 2012
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Ellen W. Seely, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Behavioral: Balance after Baby Lifestyle Intervention Program Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)
Study Start Date : November 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lifestyle Intervention group
Participants in this group will take part in the lifestyle intervention.
Behavioral: Balance after Baby Lifestyle Intervention Program
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.

No Intervention: Post-gestational diabetes mellitus (GDM) Follow-up Group
Participants in this group will not take part in the intervention.

Primary Outcome Measures :
  1. Postpartum weight loss [ Time Frame: 12 months after delivery ]
    Postpartum weight loss for all subjects will be assessed.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01158131

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Centers for Disease Control and Prevention
Principal Investigator: Ellen W Seely, MD Brigham and Women's Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ellen W. Seely, Ellen W. Seely, MD, Brigham and Women's Hospital Identifier: NCT01158131     History of Changes
Other Study ID Numbers: 2009p002118
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: December 24, 2012
Last Verified: December 2012

Keywords provided by Ellen W. Seely, Brigham and Women's Hospital:
Gestational diabetes mellitus (GDM) in the most recent pregnancy

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