Skip to main content
OpenTrials
Completed

NCT Number: NCT01344278

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gestational Diabetes Body Weight Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Division of Research Northern California

Oakland, California, 94612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Counseling

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Comparative Effectiveness of Diabetes Prevention Strategies in Women With GDM

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Apr 29, 2011
Registry last updated
Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.