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

NCT ID: NCT01660165

Last Updated: 2014-01-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 299 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-07-31

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.

Conditions

Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observational

Pregnant women

No interventions assigned to this group

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Gilberto Kac

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gilberto Kac, Phd

Role: STUDY_CHAIR

Universidade Federal do Rio de Janeiro

Locations

Centro Municipal de Saúde Heitor Beltrão

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 28599630 (View on PubMed)

Other Identifiers

CAAE 0139.0.314.000-09

Identifier Type: -

Identifier Source: org_study_id