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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gestational Diabetes Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Lifestyle Counseling

Group Type EXPERIMENTAL

Lifestyle Counseling

Intervention Type BEHAVIORAL

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle Counseling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No