FINAL EXAM EP722 – STUDY 2
Specific Aims
Diabetes and depression are two highly prevalent conditions worldwide that occur together frequently and are hormonally and metabolically linked. Yet clinical research has largely studied these conditions in isolation. We recently reported that women with pre-gestational or gestational diabetes were twice as likely to develop postpartum depression compared to women without diabetes. Diabetes and depression have prenatal origins, affect the maternal-infant relationship, and result in a lifetime of adverse consequences for the offspring and the mother. We therefore propose an innovative, transdisciplinary study of the biological, psychological, and neurobehavioral processes that link perinatal diabetes to the mental and physical health of women and their infants.
Utilizing our long term collaborative relationship with the Minnesota-based Health Partners Research Foundation and HMO, we will assemble a cohort of 900 pregnant women (300 with pre-gestational- or gestational diabetes and 600 with no diabetes history), enrolled between 26-28 weeks gestation, and followed through 12 months post-partum. We will administer a comprehensive battery of behavioral and biological measurements to address the following specific aim:
1.Estimate the risk of postpartum depression as a consequence of pre-gestational or gestational diabetes:
- Compare the risk of major depression during the postpartum period among women with any form of diabetes (T2DM, T1DM, and gestational diabetes), to women without diabetes, and assess the confounding and effect modifying influence of a pre-gestational or prenatal history of depression.
- Determine to what extent the association between maternal diabetes and postpartum depression is mediated or modified by prenatal and postpartum glycemic management(HbA1C, and glycemic variability), change in insulin requirements (basal insulin, insulin sensitivity factor, and insulin to carb ratios), prenatal thyroid function (TSH), systemic markers of inflammation (CRP) and biological/psychological stress (Cortisol and validated questionnaire assessments) measured in the 3rd trimester.
- Identify protective factors and behaviors that reduce the risk of postpartum major depression in women with and without diabetes, focusing particularly on glycemic management, participation in prescribed treatments for pre-existing depression, and exclusive breast-feeding for 3 months, as well as following gestational weight gain, diet, and physical activity guidelines.
Our study findings will have the potential to impact prenatal and post-partum care, which has traditionally maintained a separation between psychiatric and metabolic disease. Results from this research will aid in establishing an evidence base for the etiology of maternal post-partum depression.
PART I
Within 4 pages (single spaced text, a space between paragraphs, 12 point font, 1 inch margins) write the Approach section for this grant based on the outline below. Create abbreviated subheadings for various sections as deemed appropriate that include all items listed below:
- Provide an overview of the study design (not the significance or background regarding the study rationale, but the approach to achieving the specific aims), not to exceed one or two paragraphs that captures the source of data, study design and data collection methods that will be used to answer the specific aims.
- Summarize the target population that will be used to identify the study participants.
- Describe the procedures that will be used to sample the 900 subjects for inclusion in the study.
- Provide details on how you will identify and select pregnant women with and without a history of pre-gestational or gestational diabetes for your study.
- Define how you plan to identify those who go on to develop postpartum depression.
- Explain other data needed to address the specific aims and how it will be collected.
- Summarize the strengths and limitations of this approach as a way to address the specific aims.
- Provide a timetable that illustrates how long this study will take from start to finish.
