Pre-pregnancy Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes in Overweight and Obese Women

Study Overview
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Brief Summary
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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.

Official Title
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Gestational Diabetes Prevention Program

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Lifestyle intervention
* Other: Health Promotion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Intervention<br>Intervention group will receive a comprehensive, multicomponent weight loss intervention targeting diet, physical activity, and behavioral strategies. | Behavioral: Lifestyle intervention<br>* Intervention group will receive comprehensive behavioral weight loss program.<br>|
| Active Comparator: Health Promotion<br>Health promotion group will receive education on healthy eating and activity before pregnancy. | Other: Health Promotion<br>* The health promotion group will receive education on healthy eating and activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Gestational Diabetes Mellitus |  | 26 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Incidence of cesarean delivery |  | Delivery | 
| Weight changes |  | study entry, 16 weeks, 26 weeks gestation | 
| Daily caloric intake |  | study entry, 16 weeks, 26 weeks gestation | 
| Minutes per week of moderate physical activity |  | study entry, 16 weeks, 26 weeks gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational Diabetes Prevention