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

Phase 2

Completed

• Conditions: Gestational Diabetes Mellitus
• Interventions: Behavioral: Balance after Baby Lifestyle Intervention Program

• Registration Number: NCT01158131
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-21
• Last Update Posted: 2012-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention group	Balance after Baby Lifestyle Intervention Program	Participants in this group will take part in the lifestyle intervention.

Primary Outcome Measures

Name	Time	Method
Postpartum weight loss	12 months after delivery	Postpartum weight loss for all subjects will be assessed.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States