Nutritional Status and Mental Health During Pregnancy and Postpartum: a Cohort Study in Rio de Janeiro, Brazil
|ClinicalTrials.gov Identifier: NCT01660165|
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : January 17, 2014
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||299 participants|
|Official Title:||Mental Health and Nutritional Status During Pregnancy and Postpartum: A Prospective Study With a Nested Clinical Trial|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||July 2012|
- Major depressive episode [ Time Frame: 30-45 days postpartum ]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.
- Gestational weight gain [ Time Frame: 34-36 weeks of gestation ]Difference between last body weight measurement in pregnancy and the first assessment(8-13 weeks of gestation).
- Birth weight [ Time Frame: Postpartum ]Neonatal birth weight (grams)
- Serum fatty acids composition [ Time Frame: 30-45 days of postpartum ]Change in n-3 (DHA, EPA) fatty acid composition (mg/dl or % of total fatty acids) throughout pregnancy and 30-45 postpartum.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660165
|Centro Municipal de Saúde Heitor Beltrão|
|Rio de Janeiro, Brazil, 20521-160|
|Study Chair:||Gilberto Kac, Phd||Universidade Federal do Rio de Janeiro|