An interventional study of Lifestyle Counseling in Gestational Diabetes and Obesity, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-25.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's enrollment of 2,480 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Behavioral: Lifestyle Counseling
A lifestyle curriculum of individualized telephone counseling calls, augmented with e-mails and an interactive study Web site.
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.
Time frame: through 12 months postpartum
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
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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