Balance After Baby Intervention for Women With Recent Gestational Diabetes

Completed · Not applicable

Conditions studied: Gestational Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02744300

Run by

Brigham and Women's Hospital

People needed

180

Starts

2016-09-01

Expected to finish

2019-07-29

Last updated by the study team

2021-07-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado Denver — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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