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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01660165
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : January 17, 2014
Information provided by (Responsible Party):
Gilberto Kac, Universidade Federal do Rio de Janeiro

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.

Condition or disease

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.

Study Type : Observational
Actual Enrollment : 299 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Pregnant women

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. Birth weight [ Time Frame: Postpartum ]
    Neonatal birth weight (grams)

Other Outcome Measures:
  1. 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
Fatty acids C-reactive protein Interleukin-6

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01660165

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gilberto Kac, Professor, Universidade Federal do Rio de Janeiro Identifier: NCT01660165     History of Changes
Other Study ID Numbers: CAAE 0139.0.314.000-09
First Posted: August 8, 2012    Key Record Dates
Last Update Posted: January 17, 2014
Last Verified: January 2014

Keywords provided by Gilberto Kac, Universidade Federal do Rio de Janeiro:
Nutritional status
Mental Health
Postpartum depression