Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)
Primary Purpose
Gestational Diabetes, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Counseling
Sponsored by
About this trial
This is an interventional health services research trial for Gestational Diabetes
Eligibility 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.
Sites / Locations
- Division of Research Northern California
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifestyle Counseling
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Blood pressure
Depression
Glycemia
percent of calories from fat
physical activity
Full Information
NCT ID
NCT01344278
First Posted
April 27, 2011
Last Updated
April 22, 2016
Sponsor
Kaiser Permanente
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT01344278
Brief Title
Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)
Official Title
Comparative Effectiveness of Diabetes Prevention Strategies in Women With GDM
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Obesity
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2480 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Counseling
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Counseling
Intervention Description
A lifestyle curriculum of individualized telephone counseling calls, augmented with e-mails and an interactive study Web site.
Primary Outcome Measure Information:
Title
Primary outcome: meeting the postpartum weight goal
Description
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.
Time Frame
through 12 months postpartum
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
through 12 months postpartum
Title
Depression
Time Frame
through 12 months postpartum
Title
Glycemia
Time Frame
through 12 months postpartum
Title
percent of calories from fat
Time Frame
through 12 months postpartum
Title
physical activity
Time Frame
through 12 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assiamira Ferrara, MD, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Research Northern California
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30376391
Citation
Gadgil MD, Ehrlich SF, Zhu Y, Brown SD, Hedderson MM, Crites Y, Ferrara A. Dietary Quality and Glycemic Control Among Women with Gestational Diabetes Mellitus. J Womens Health (Larchmt). 2019 Feb;28(2):178-184. doi: 10.1089/jwh.2017.6788. Epub 2018 Oct 30.
Results Reference
derived
PubMed Identifier
29669736
Citation
Hedderson MM, Brown SD, Ehrlich SF, Tsai AL, Zhu Y, Quesenberry CP, Crites Y, Ferrara A. A Tailored Letter Based on Electronic Health Record Data Improves Gestational Weight Gain Among Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster-Randomized Controlled Trial. Diabetes Care. 2018 Jul;41(7):1370-1377. doi: 10.2337/dc17-1133. Epub 2018 Apr 18.
Results Reference
derived
PubMed Identifier
26657945
Citation
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.
Results Reference
derived
PubMed Identifier
24423410
Citation
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/26657945
Description
GEM Trial Publication
Learn more about this trial
Diabetes Prevention Strategies in Women With Gestational Diabetes Mellitus (GDM)
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