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

NCT01344278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2480

Last updated 2016-04-25

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Lifestyle Counseling

A lifestyle curriculum of individualized telephone counseling calls, augmented with e-mails and an interactive study Web site.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Assiamira Ferrara, MD, PhD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-12-31
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01344278 on ClinicalTrials.gov