Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02744300
Study type Interventional
Source Brigham and Women's Hospital
Contact
Status Completed
Phase N/A
Start date September 2016
Completion date July 29, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT06099574 - A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora
Completed NCT02890693 - Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring N/A
Completed NCT02384226 - User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
Completed NCT02436551 - Gestational Diabetes in Central Asia: Prevalence and Management
Recruiting NCT02275845 - Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus Phase 3
Recruiting NCT04621396 - The Next Generation Longitudinal Birth Cohort Diabetes Study
Completed NCT01916694 - Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus N/A
Completed NCT01931280 - A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring N/A
Not yet recruiting NCT01637727 - Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women N/A
Completed NCT01565564 - Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes N/A
Recruiting NCT00550979 - Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk N/A
Completed NCT00460018 - Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial) Phase 2
Not yet recruiting NCT04915716 - Effect of Fasting Time Before Cesarean Section on Neonatal Blood Glucose in Pregnant Women With Gestational Diabetes Mellitus
Completed NCT04422821 - Flash Glucose Monitoring in Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial N/A
Recruiting NCT04369313 - Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers N/A
Recruiting NCT05348863 - SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes N/A
Recruiting NCT04272840 - The Impact of Glycemic Index Education on Lowering Dietary GI in Gestational Diabetes Mellitus N/A
Completed NCT02588729 - A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With GDM - RCT N/A
Completed NCT01922791 - Nutrition and Pregnancy Intervention Study N/A
Completed NCT01589757 - MAIN STUDY: Low Glycaemic Index (GI) Diet in the Management of GDM SUB-STUDY: The Breast Milk Sub-Study Phase 2/Phase 3