Lifestyle Intervention for the Prevention of Gestational Diabetes in Pregnant Overweight/Obese Latina-Lola Grant Proposal Open Access

Cardona, Saumeth (2016)

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This thesis develops a public health grant proposal to prevent Gestational Diabetes Mellitus (GDM), which is a form of diabetes that develops during pregnancy, usually during the second trimester and resolves after delivery. Women with GDM are at risk of future development of type 2 diabetes, with about half of patients developing diabetes during the next 10 years. Overweight, obesity and excessive gestational weight gain are among the most important risk factors associated with GDM, in particular in minority populations. In the United States the prevalence of overweight and obesity is increasing among pregnant women and recent CDC data estimate that more than one-third of women of reproductive age are overweight and two thirds of women gain more weight than the Institute of Medicine (IOM) recommendations.

Latina women are 30% more likely to be overweight than non-Hispanic white women. Hispanic women with GDM are at higher risk of developing diabetes within 5 year of index pregnancy, indicating the need for intensive screening and interventions to prevent excessive weight gain and GDM-associated maternal and fetal complications.

Increasing evidence indicates that lifestyle intervention programs based on diet and exercise can prevent the development of diabetes in high risk populations. Such programs have reported mixed results in Caucasians, with some studies reporting positive effects of increasing exercise and improved nutrition, and reduction in excessive weight gain in Caucasian and African American women. Few lifestyle intervention studies have been conducted in Latino women at risk of GDM.

This proposal will determine if a culturally-grounded lifestyle intervention program started in early pregnancy in overweight/obese Latina women will result in higher compliance with IOM weight gain guidelines when compared to women receiving standard obstetrical care. We hypothesize that lifestyle modifications will prevent excessive weight gain during pregnancy and may reduce risk of GDM and maternal and neonatal complications. By limiting excessive gestational weight gain, this lifestyle intervention program may prevent the burden of obesity-related complications during pregnancy and reduce risk of subsequently developing overt diabetes.

Table of Contents

Table of Contents

Definition of Terms: 1

Chapter I. 2

Introduction. 2

Problem Statement 3

Prevalence of Gestational Diabetes in Georgia. 4

Significance Statement 6

Target Audience. 8

Recruitment 9

Enrollment 9

Screening: 10

Randomization. 10

Content of Educational Sessions. 10

Lifestyle Intervention Program. 11

Ethical Considerations. 11

Chapter II-Literature Review.. 13

Introduction. 13

Pathophysiology of Gestational Diabetes. 13

Gestational Diabetes Risk Factors. 14

Screening and Diagnosis of Gestational Diabetes Mellitus. 15

American College of Obstetrician and Gynecologists (ACOG) 16

The Endocrine Society (TES) 16

U.S. Preventive Service Task Force (USPSTF) 17

Maternal and fetal complications. 17

Prevention Studies. 18

Methodology. 18

Relevant Studies. 19

Diet Only Interventions: 19

Physical Activity Intervention. 22

Combined Interventions. 24

Need for Intervention Programs in obese/overweight Hispanic women. 26

Summary: 26

Chapter III: Proposal Review Methodology. 30

Introduction. 30

Potential Funding. 30

Five Expert Reviewers. 32

Review Criteria and Scoring. 35

Overall Impact 36

Scored Review Criteria. 37

Significance. 37

Innovation. 37

Approach. 39

Environment 39

Additional Review Criteria. 40

Protections for Human Subjects. 40

Inclusion of Women, Minorities, and Children. 40

Review and Scoring Procedures. 40

Criterion Scoring. 41

Chapter IV: Proposal Review Results. 44

Reviewer 1 comments: 44

Significance. 44

Innovation. 45

Approach. 45

Environment 46

Overall Impact 46

Additional Criteria Strengths: 47

Reviewer 2 comments: 47

Significance. 47

Innovation. 48

Approach. 50

Environment 50

Overall Impact 50

Additional Review Criteria. 52

Reviewer 3 comments: 52

Significance. 52

Innovation. 53

Approach. 53

Environment: 54

Overall Impact: 54

Additional Review Criteria. 55

Reviewer 4 comments: 55

Significance. 55

Innovation. 57

Approach. 58

Environment 60

Additional Review Criteria: 61

Reviewer 5 comments: 61

Significance. 61

Innovation. 63

Approach. 64

Environment 67

Overall Impact: 68

Additional Review Criteria: 69

Summary: 70

Chapter V: Final version of the Proposal 72

A. Introduction: 72

II. Significance. 73

III. Innovation. 75

IV. Preliminary Data. 76

V. Study Design. 79

V.A. Aim # 1. 79

VI. Aim # 2. 85

VII. Aim # 3. 87

VIII. Schedule of Data Collection Visits. 88

IX. Human Subjects. 89

X. Timeline Implementation. 90

XI. Dissemination of Results. 91

XII. References. 91

Budget justification: 98


References: 102

Appendix A: 108

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