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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

April 27, 2011
July 18, 2014
April 2011
June 2013   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01344278 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)
Comparative Effectiveness of Diabetes Prevention Strategies in Women With 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
  • Gestational Diabetes
  • Obesity
Behavioral: Lifestyle Counseling
A lifestyle curriculum of individualized telephone counseling calls, augmented with e-mails and an interactive study Web site.
  • Experimental: Lifestyle Counseling
    Intervention: Behavioral: Lifestyle Counseling
  • No Intervention: Control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2480
December 2015
June 2013   (final data collection date for primary outcome measure)

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.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01344278
R01 HS19367-01
Yes
Kaiser Permanente
Kaiser Permanente
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Assiamira Ferrara, MD, PhD Kaiser Permanente Northern California
Kaiser Permanente
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP