Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)
The main goal of this study is to examine the comparative effectiveness of diabetes prevention strategies in women with Gestational Diabetes Mellitus (GDM) on the control of the following conditions: obesity, hyperglycemia, hypertension and depression. This randomized lifestyle intervention study will be conducted at Kaiser Permanente Northern California. Women in the intervention will receive a letter on gestational weight gain during pregnancy and in the postpartum period, a curriculum of individualized lifestyle counseling via telephone, augmented with e-mail and an interactive Web site. Patients randomized to the usual care arm will receive the standard-care telephone calls from the Perinatal Center during pregnancy and the Center's printed educational materials postpartum. Outcomes will be assessed through the electronic medical record and patient surveys conducted during pregnancy and at 6-weeks, 6- months and 1-year postpartum.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||Comparative Effectiveness of Diabetes Prevention Strategies in Women With GDM|
- Primary outcome: meeting the postpartum weight goal [ Time Frame: through 12 months postpartum ] [ Designated as safety issue: No ]
Will be the proportion of women who reach their postpartum weight goal (based on their pre-pregnancy weight) and the total amount of weight change (in kilograms).
a) reaching pre-pregnancy weight if women had a normal pre-pregnancy weight; or b) achieving a 5% reduction from pre-pregnancy weight if overweight or obese prior to pregnancy.
- Blood pressure [ Time Frame: through 12 months postpartum ] [ Designated as safety issue: No ]
- Depression [ Time Frame: through 12 months postpartum ] [ Designated as safety issue: No ]
- Glycemia [ Time Frame: through 12 months postpartum ] [ Designated as safety issue: No ]
- percent of calories from fat [ Time Frame: through 12 months postpartum ] [ Designated as safety issue: No ]
- physical activity [ Time Frame: through 12 months postpartum ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|Experimental: Lifestyle Counseling||
Behavioral: Lifestyle Counseling
A lifestyle curriculum of individualized telephone counseling calls, augmented with e-mails and an interactive study Web site.
|No Intervention: Control|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344278
|United States, California|
|Division of Research Northern California|
|Oakland, California, United States, 94612|
|Principal Investigator:||Assiamira Ferrara, MD, PhD||Kaiser Permanente Northern California|