Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01344278
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : April 25, 2016
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Kaiser Permanente

April 27, 2011
April 29, 2011
April 25, 2016
April 2011
December 2013   (Final data collection date for primary outcome measure)
Primary outcome: meeting the postpartum weight goal [ Time Frame: through 12 months postpartum ]
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). Weight goals: 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.
Same as current
Complete list of historical versions of study NCT01344278 on Archive Site
  • Blood pressure [ Time Frame: through 12 months postpartum ]
  • Depression [ Time Frame: through 12 months postpartum ]
  • Glycemia [ Time Frame: through 12 months postpartum ]
  • percent of calories from fat [ Time Frame: through 12 months postpartum ]
  • physical activity [ Time Frame: through 12 months postpartum ]
Same as current
Not Provided
Not Provided
Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)
Comparative Effectiveness of Diabetes Prevention Strategies in Women With 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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
  • Gestational Diabetes
  • Obesity
Behavioral: Lifestyle Counseling
A lifestyle curriculum of individualized telephone counseling calls, augmented with e-mails and an interactive study Web site.
  • Experimental: Lifestyle Counseling
    Intervention: Behavioral: Lifestyle Counseling
  • No Intervention: Control

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2015
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

All women, 18 years of age or older, receiving medical care at Kaiser Permanente Northern California with a pregnancy complicated by gestational diabetes between March 2011 and May 2012 that have a telephone or cellular phone will be eligible.

Exclusion Criteria:

Women with overt diabetes not recognized prior to pregnancy (any women with fasting plasma glucose > 126 mg/dl, or any plasma glucose level over 200 mg/dl on more than 1 occasion during pregnancy) will be excluded from the analyses but will be eligible for the lifestyle intervention.

Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01HS019367-01( U.S. AHRQ Grant/Contract )
Not Provided
Not Provided
Kaiser Permanente
Kaiser Permanente
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Assiamira Ferrara, MD, PhD Kaiser Permanente
Kaiser Permanente
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP