PregnancyNCT01660165
Nutritional Status and Mental Health During Pregnancy and Postpartum: a Cohort Study in Rio de Janeiro, Brazil
An observational study of Pregnancy, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 299 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2009to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women attending a health care center in the city of Rio de Janeiro, Brazil
Who may be able to join
- aged 20 to 40
- up to 13 weeks of pregnancy
- free from chronic or infectious diseases (except obesity)
- residing in the study catchment area
Who cannot join
- twin pregnancies
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro Municipal de Saúde Heitor Beltrão
Rio de Janeiro, Rio de Janeiro, 20521-160
About this study
Official title: Mental Health and Nutritional Status During Pregnancy and Postpartum: A Prospective Study With a Nested Clinical Trial
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.
Read the 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:
- 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.
- Conditions
- Pregnancy
- Keywords
- Nutritional status, Mental Health, Omega-3, Pregnancy, Postpartum depression
- Medical subject headings
- Psychological Well-Being, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major depressive episode
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.
Measured: 30-45 days postpartum
Secondary outcomes (2)
Gestational weight gain
Difference between last body weight measurement in pregnancy and the first assessment(8-13 weeks of gestation).
Measured: 34-36 weeks of gestation
Birth weight
Neonatal birth weight (grams)
Measured: Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startNov 2009
- Primary completionNov 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilberto Kac, Universidade Federal do Rio de Janeiro
- Investigators
- Gilberto Kac, Phd, Study chair, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660165
- Sponsor's protocol ID
- CAAE 0139.0.314.000-09
- Status last verified
- Jan 2014
- First submitted
- 24 May 2012
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28599630
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health and Nutritional Status During Pregnancy and Postpartum: A Prospective Study With a Nested Clinical Trial
- ClinicalTrials.gov ID
- NCT01660165
- Acronym / sponsor ID
- CAAE 0139.0.314.000-09
- Conditions
- Pregnancy
- Keywords
- Nutritional status, Mental Health, Omega-3, Pregnancy, Postpartum depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | –Pregnant women |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women attending a health care center in the city of Rio de Janeiro, Brazil
Key inclusion criteria (4 listed)
- aged 20 to 40
- up to 13 weeks of pregnancy
- free from chronic or infectious diseases (except obesity)
- residing in the study catchment area
Key exclusion criteria (1 listed)
- twin pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Gestational weight gain
Time frame: 34-36 weeks of gestation
Birth weight
Time frame: Postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- Derived from this study: PubMed 28599630Vaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilberto Kac, Phd study chair
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major depressive episode (time frame: 30-45 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01660165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2014.