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

Obesity Clinical Trial

Official title:

Comparative Effectiveness of Diabetes Prevention Strategies in Women With GDM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344278
• Other study ID #: R01HS019367-01
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: April 22, 2016
• Start date: April 2011
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2480
• Est. completion date: September 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Division of Research Northern California	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: meeting the postpartum weight goal	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.	through 12 months postpartum	No
Secondary	Blood pressure		through 12 months postpartum	No
Secondary	Depression		through 12 months postpartum	No
Secondary	Glycemia		through 12 months postpartum	No
Secondary	percent of calories from fat		through 12 months postpartum	No
Secondary	physical activity		through 12 months postpartum	No

External Links

•   GEM Trial Publication