NCT02763150
Completed
Not Applicable
Gestational Diabetes Prevention Program
California Polytechnic State University-San Luis Obispo2 sites in 1 country199 target enrollmentDecember 15, 2017
ConditionsGestational Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes Mellitus
- Sponsor
- California Polytechnic State University-San Luis Obispo
- Enrollment
- 199
- Locations
- 2
- Primary Endpoint
- Incidence of Gestational Diabetes Mellitus
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.
Investigators
Suzanne Phelan
Professor
California Polytechnic State University-San Luis Obispo
Eligibility Criteria
Inclusion Criteria
- •Prior diagnosis of gestational diabetes.
- •BMI \> 25 kg/m2
- •Planning to have a baby in the next 1-3 years
- •English or Spanish speaking
Exclusion Criteria
- •Age less than 18 years
- •Women with Type 2 or Type 1 diabetes
- •Current pregnancy
- •Relocating in the next 2 years
- •Medications that affect weight/diabetes
- •Serious current physical disease
- •History of eating disorders
- •History of bariatric surgery
- •Current problems with drug abuse
- •Current treatment of a serious psychological disorder
Outcomes
Primary Outcomes
Incidence of Gestational Diabetes Mellitus
Time Frame: 26 weeks gestation
Secondary Outcomes
- Changes in maternal levels of fasting glucose(study entry, 16 weeks, 26 weeks gestation)
- Changes in maternal levels of fasting insulin(study entry, 16 weeks, 26 weeks gestation)
- Incidence of cesarean delivery(Delivery)
- Daily caloric intake(study entry, 16 weeks, 26 weeks gestation)
- Changes in maternal levels of systolic and diastolic blood pressure(study entry, 16 weeks, 26 weeks gestation)
- Changes in maternal levels of C-reactive protein(study entry, 16 weeks, 26 weeks gestation)
- Incidence of preeclampsia(Delivery)
- Minutes per week of moderate physical activity(study entry, 16 weeks, 26 weeks gestation)
- Weight changes(study entry, 16 weeks, 26 weeks gestation)
Study Sites (2)
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