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.|
|ClinicalTrials.gov Identifier: NCT01344278|
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : April 25, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes Obesity||Behavioral: Lifestyle Counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2480 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Comparative Effectiveness of Diabetes Prevention Strategies in Women With GDM|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||September 2015|
|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|
- 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).
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 ]
- 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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344278
|United States, California|
|Division of Research Northern California|
|Oakland, California, United States, 94612|
|Principal Investigator:||Assiamira Ferrara, MD, PhD||Kaiser Permanente|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Kaiser Permanente|
|Other Study ID Numbers:||
R01HS019367-01 ( U.S. AHRQ Grant/Contract )
|First Posted:||April 29, 2011 Key Record Dates|
|Last Update Posted:||April 25, 2016|
|Last Verified:||April 2016|
Glucose Metabolism Disorders
Endocrine System Diseases
Female Urogenital Diseases and Pregnancy Complications