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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilberto Kac, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01660165
First received: May 24, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.

Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mental Health and Nutritional Status During Pregnancy and Postpartum: A Prospective Study With a Nested Clinical Trial

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Major depressive episode [ Time Frame: 30-45 days postpartum ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Gestational weight gain [ Time Frame: 34-36 weeks of gestation ] [ Designated as safety issue: No ]
    Difference between last body weight measurement in pregnancy and the first assessment(8-13 weeks of gestation).

  • Birth weight [ Time Frame: Postpartum ] [ Designated as safety issue: No ]
    Neonatal birth weight (grams)


Other Outcome Measures:
  • Serum fatty acids composition [ Time Frame: 30-45 days of postpartum ] [ Designated as safety issue: No ]
    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

Fatty acids C-reactive protein Interleukin-6


Enrollment: 299
Study Start Date: November 2009
Study Completion Date: July 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational
Pregnant women

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

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women attending a health care center in the city of Rio de Janeiro, Brazil

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01660165

Locations
Brazil
Centro Municipal de Saúde Heitor Beltrão
Rio de Janeiro, Brazil, 20521-160
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
Study Chair: Gilberto Kac, Phd Universidade Federal do Rio de Janeiro
  More Information

No publications provided

Responsible Party: Gilberto Kac, Professor, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01660165     History of Changes
Other Study ID Numbers: CAAE 0139.0.314.000-09
Study First Received: May 24, 2012
Last Updated: January 16, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal do Rio de Janeiro:
Nutritional status
Mental Health
Omega-3
Pregnancy
Postpartum depression

ClinicalTrials.gov processed this record on August 01, 2014