Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)
|Gestational Diabetes Mellitus||Behavioral: Balance after Baby Lifestyle Intervention Program||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||Diabetes Prevention in Women With a Recent History of Gestational Diabetes Mellitus (GDM)|
- Postpartum weight loss [ Time Frame: 12 months after delivery ]Postpartum weight loss for all subjects will be assessed.
|Study Start Date:||November 2009|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158131
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Ellen W Seely, MD||Brigham and Women's Hospital|