Nutritional Status and Mental Health During Pregnancy and Postpartum: a Cohort Study in Rio de Janeiro, Brazil

Study Overview
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Brief Summary
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There is increasing evidence that psychosocial factors may affect health by means of biological effects and changes in behavioral health. Observational studies suggest an association between low levels of one long chain n-3 fatty acids, DHA (docosahexaenoic acid), after pregnancy and the occurrence of postpartum depression (PPD). This is an observational cohort with 4 waves of follow-up and a nested clinical trial with pregnant women residing in the city of Rio de Janeiro. The general objective is to describe the magnitude and identify factors associated to common mental disorders (CMD) during pregnancy and postpartum giving emphasis to maternal nutritional status. Main specific objectives: To evaluate the effect of CMD in the pattern of occurrence of selected maternal and child outcomes (inadequacy of gestational weight gain, postpartum weight retention, low birthweight, small for gestational weight and prematurity), considering the effect of other determinant factors, and To evaluate the effectiveness of daily omega-3 doses (fish oil) in preventing PPD.

Detailed Description
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The protocol predicts CMD mapping and monitoring of nutritional status throughout pregnancy and once in postpartum. Women are interviewed in four time points: First trimester: 8th and 13th (baseline), Second trimester: 22nd-24th gestational weeks, Third trimester: 34th-36th gestational weeks, Postpartum: 30-45 days The following information will be gathered: Common mental disorders (CMD): MINI International Neuropsychiatric Interview, symptoms of depression (Edinburgh scale - EPDS), anxiety (Trait Anxiety Inventory - TAI) Dietary intake (food frequency questionnaire) Anthropometric measure (stature and body weight) and physical activity Biochemicals: fasting glucose, lipid profile (total cholesterol, HDL-c, LDL-c), serum fatty acid composition, inflammatory markers (C-reactive protein, interleukin-6), hormones (adiponectin, insulin, leptin). All women are followed throughout pregnancy constituting the observational cohort. In the second trimester, those women identified as being in risk for PPD [past history of depression (DSM-IV) or presenting a score of depression (Edinburgh scale) >= 9 at the baseline interview] are invited to participate in the clinical trial. These women will be randomly allocated in two groups: Intervention 1: Fish oil: [1,8 g/dia n-3 (1,08 g EPA e 0,72 g DHA)+ vit E (0,2 mg/g) Intervention 2: Placebo comparator: soybean oil + 1% fish oil + vit E (0,2 mg/g) The supplementation occurs from the 22nd-24th week of pregnancy for 16 weeks.

Official Title
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Mental Health and Nutritional Status During Pregnancy and Postpartum: A Prospective Study With a Nested Clinical Trial

Conditions
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Pregnancy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 20 to 40 up to 13 weeks of pregnancy free from chronic or infectious diseases (except obesity) residing in the study catchment area Exclusion Criteria: - twin pregnancies

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Pregnant women | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major depressive episode | Number of women with diagnostic of major depression in the postpartum visit (30-45 days after childbirth) using Edinburgh scale and the MINI psychiatry interview. | 30-45 days postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain | Difference between last body weight measurement in pregnancy and the first assessment(8-13 weeks of gestation). | 34-36 weeks of gestation | 
| Birth weight | Neonatal birth weight (grams) | Postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional status, Mental Health, Omega-3, Pregnancy, Postpartum depression