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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01344278
First received: April 27, 2011
Last updated: July 18, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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 ]

Enrollment: 2480
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: June 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
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344278

Locations
United States, California
Division of Research Northern California
Oakland, California, United States, 94612
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Assiamira Ferrara, MD, PhD Kaiser Permanente Northern California
  More Information

No publications provided by Kaiser Permanente

Additional 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: R01 HS19367-01
Study First Received: April 27, 2011
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 15, 2014