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

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ClinicalTrials.gov Identifier: NCT01344278
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : April 25, 2016
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Obesity Behavioral: Lifestyle Counseling Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2480 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Measures :
  1. 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.



Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: through 12 months postpartum ]
  2. Depression [ Time Frame: through 12 months postpartum ]
  3. Glycemia [ Time Frame: through 12 months postpartum ]
  4. percent of calories from fat [ Time Frame: through 12 months postpartum ]
  5. physical activity [ Time Frame: through 12 months postpartum ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Locations
United States, California
Division of Research Northern California
Oakland, California, United States, 94612
Sponsors and Collaborators
Kaiser Permanente
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Assiamira Ferrara, MD, PhD Kaiser Permanente

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01344278     History of Changes
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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications