Pre-pregnancy Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes in Overweight and Obese Women
Not Applicable
Completed
- Conditions
- Gestational Diabetes Mellitus
- Interventions
- Behavioral: Lifestyle interventionOther: Health Promotion
- Registration Number
- NCT02763150
- Lead Sponsor
- California Polytechnic State University-San Luis Obispo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 199
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lifestyle Intervention Lifestyle intervention Intervention group will receive a comprehensive, multicomponent weight loss intervention targeting diet, physical activity, and behavioral strategies. Health Promotion Health Promotion Health promotion group will receive education on healthy eating and activity before pregnancy.
- Primary Outcome Measures
Name Time Method Incidence of Gestational Diabetes Mellitus 26 weeks gestation
- Secondary Outcome Measures
Name Time Method Incidence of preeclampsia Delivery 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 Changes in maternal levels of systolic and diastolic blood pressure study entry, 16 weeks, 26 weeks gestation Daily caloric intake study entry, 16 weeks, 26 weeks gestation Changes in maternal levels of C-reactive protein study entry, 16 weeks, 26 weeks gestation Minutes per week of moderate physical activity study entry, 16 weeks, 26 weeks gestation Weight changes study entry, 16 weeks, 26 weeks gestation
Trial Locations
- Locations (2)
California Polytechnic State University
🇺🇸San Luis Obispo, California, United States
Miriam Hospital
🇺🇸Providence, Rhode Island, United States