Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM) - Full Text View

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 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

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:

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 Outcome Measures:

Blood pressure [ Time Frame: through 12 months postpartum ]
Depression [ Time Frame: through 12 months postpartum ]
Glycemia [ Time Frame: through 12 months postpartum ]
percent of calories from fat [ Time Frame: through 12 months postpartum ]
physical activity [ Time Frame: through 12 months postpartum ]


Enrollment:	2480
Study Start Date:	April 2011
Study Completion Date:	September 2015
Primary Completion Date:	December 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 (Adult, Senior)
Sexes 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

Agency for Healthcare Research and Quality (AHRQ)

Investigators


Principal Investigator:	Assiamira Ferrara, MD, PhD	Kaiser Permanente Northern California

More Information

Additional Information:

GEM Trial Publication This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ferrara A, Hedderson MM, Brown SD, Albright CL, Ehrlich SF, Tsai AL, Caan BJ, Sternfeld B, Gordon NP, Schmittdiel JA, Gunderson EP, Mevi AA, Herman WH, Ching J, Crites Y, Quesenberry CP Jr. The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster Randomized Controlled Trial. Diabetes Care. 2016 Jan;39(1):65-74. doi: 10.2337/dc15-1254. Epub 2015 Dec 9.

Ferrara A, Hedderson MM, Albright CL, Brown SD, Ehrlich SF, Caan BJ, Sternfeld B, Gordon NP, Schmittdiel JA, Gunderson EP, Mevi AA, Tsai AL, Ching J, Crites Y, Quesenberry CP Jr. A pragmatic cluster randomized clinical trial of diabetes prevention strategies for women with gestational diabetes: design and rationale of the Gestational Diabetes' Effects on Moms (GEM) study. BMC Pregnancy Childbirth. 2014 Jan 15;14:21. doi: 10.1186/1471-2393-14-21.


Responsible Party:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT01344278 History of Changes
Other Study ID Numbers:	R01HS019367-01 ( U.S. AHRQ Grant/Contract )
Study First Received:	April 27, 2011
Last Updated:	April 22, 2016

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes, Gestational Glucose Metabolism Disorders	Metabolic Diseases Endocrine System Diseases Pregnancy Complications

ClinicalTrials.gov processed this record on July 17, 2017