Balance After Baby Intervention for Women With Recent Gestational Diabetes (BABI2)
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About
Women with a history of gestational diabetes mellitus (GDM) have an increased risk of developing type 2 diabetes later in life. In our 2012 pilot study we created and tested 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. This program, delivered in the first year postpartum, encouraged weight loss, dietary changes, and physical activity. The purpose of the current study, called Balance After Baby Intervention 2 (BABI-2), is to study a larger group of women with two years of follow-up. We will assess whether women assigned to the intervention group lose more weight and decrease their risk factors for type 2 diabetes.
Participants assigned to the BAB lifestyle 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.
Participants assigned to the post-GDM follow-up group will have access to a website containing links to information about diabetes prevention.
Full description
The landmark Diabetes Prevention Program (DPP) demonstrated that an intensive lifestyle intervention in people with impaired glucose tolerance (IGT) could reduce the incidence of type 2 diabetes. These findings were consistent, regardless of ethnicity, age, body mass index (BMI), gender. However, the DPP does not have a specific focus on new mothers with a recent history of gestational 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.
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. New mothers may have difficulty engaging in healthy lifestyle programs because of lack of time and energy, and because of competing work and family demands, including child care. In response to the barriers identified in literature and gleaned from the focus groups and informant interviews of a preliminary study (2009p000042), we created a lifestyle/behavioral intervention that utilizes a modified DPP.
In 2012 we completed a one year pilot study (2009p002118) to assess the feasibility and effectiveness of the lifestyle/behavioral intervention. The pilot study demonstrated that women in the intervention group lost more weight and were closer to pre-pregnancy weight that the control group.
Our goals in Phase 2 of the study are: to gather more data about the effects of the intervention at 12 months; to determine if the greater weight loss observed in the pilot intervention arm at 12 months can be replicated with a larger number of women and maintained at 24 months; and to see whether there is a significant effect on glucose tolerance in the intervention arm at 24 months.
Enrollment
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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 years of age or older
- No personal history of Type 1 or 2 diabetes
- Pre-pregnancy body mass index between 18 and 50 kg/m2
- Six weeks postpartum body mass index between 24 and 50 kg/m2 (>22 for Asians)
- Daily access to the internet
- English or Spanish speaking
- Capable of providing informed consent
Exclusion criteria
- Pre-pregnancy diagnosis of diabetes (type 1, 2, or a secondary form of diabetes)
- Current pregnancy
- Premature delivery < 34 weeks gestation
- Diagnosis of diseases associated with glucose metabolism
- Current or planned participation in a commercial weight loss program (i.e. Jenny Craig) over the duration of the study
- Taking certain prescription medications including high dose glucocorticoids, atypical antipsychotics associated with weight gain (such as risperdal (risperidone), clozapine (clozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.), or other prescription weight loss 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 next 6 months
- Unable to give informed consent
Trial design
Primary purpose
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Interventional model
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180 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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