Clinical trial NCT01660165: Nutritional Status and Mental Health During Pregnancy and Postpartum: a Cohort Study in Rio de Janeiro, Brazil
Official title: Mental Health and Nutritional Status During Pregnancy and Postpartum: A Prospective Study With a Nested Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Nutritional status
Mental Health
Omega-3
Pregnancy
Postpartum depression
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 299
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women attending a health care center in the city of Rio de Janeiro, Brazil

Brief summary: 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:

1. 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
2. To evaluate the effectiveness of daily omega-3 doses (fish oil) in preventing PPD.

Detailed description: The protocol predicts CMD mapping and monitoring of nutritional status throughout pregnancy and once in postpartum. Women are interviewed in four time points:

1. First trimester: 8th and 13th (baseline),
2. Second trimester: 22nd-24th gestational weeks,
3. Third trimester: 34th-36th gestational weeks,
4. Postpartum: 30-45 days

The following information will be gathered:

1. Common mental disorders (CMD): MINI International Neuropsychiatric Interview, symptoms of depression (Edinburgh scale - EPDS), anxiety (Trait Anxiety Inventory - TAI)
2. Dietary intake (food frequency questionnaire)
3. Anthropometric measure (stature and body weight) and physical activity
4. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Major depressive episode
timeFrame: 30-45 days postpartum
Secondary outcomes:
measure: Gestational weight gain
timeFrame: 34-36 weeks of gestation
measure: Birth weight
timeFrame: Postpartum
Other outcomes:
measure: Serum fatty acids composition
timeFrame: 30-45 days of postpartum
Locations:
city: Rio de Janeiro
country: Brazil
facility: Centro Municipal de Saúde Heitor Beltrão
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Gilberto Kac, Phd
role: STUDY_CHAIR
References:
citation: Vaz JDS, Farias DR, Adegboye ARA, Nardi AE, Kac G. Omega-3 supplementation from pregnancy to postpartum to prevent depressive symptoms: a randomized placebo-controlled trial. BMC Pregnancy Childbirth. 2017 Jun 9;17(1):180. doi: 10.1186/s12884-017-1365-x.