Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)
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Purpose
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 | Intervention |
|---|---|
|
Gestational Diabetes Obesity |
Behavioral: Lifestyle Counseling |
| Study Type: | Interventional |
| 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).
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.
- 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 ]
| Estimated Enrollment: | 2500 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Assiamira Ferrara, MD,PhD | 510-891-3588 | assiamira.ferrara@kp.org |
| Contact: Samantha F Ehrlich, MPH,PhD | 510-891-3505 | samantha.ehrlich@kp.org |
| United States, California | |
| Division of Research Northern California | Recruiting |
| Oakland, California, United States, 94612 | |
| Contact: Samatha F Ehrlich, MPH,PhD 510-891-3503 samanatha.ehrlich@kp.org | |
| Contact: Ashley A Mevi, MPH 510-891-3896 Ashley.A.Mevi@nsmtp.kp.org | |
| Principal Investigator: Assiamira Ferrara, MD,PhD | |
| Principal Investigator: | Assiamira Ferrara, MD, PhD | Kaiser Permanente Northern California |
More Information
No publications provided
| Responsible Party: | Kaiser Permanente |
| ClinicalTrials.gov Identifier: | NCT01344278 History of Changes |
| Other Study ID Numbers: | R01 HS19367-01 |
| Study First Received: | April 27, 2011 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Obesity Diabetes, Gestational Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Pregnancy Complications |
ClinicalTrials.gov processed this record on May 19, 2013