NutritionNCT01178398
Understanding Fish Consumption Habits During Pregnancy
An observational study of Nutrition, run by Harvard Pilgrim Health Care at 1 site in United States.
Trial summary
Many pregnant women in the US do not consume enough docosahexaenoic acid (DHA), an essential nutrient found in fish. Apparently conflicting findings that fish consumption is beneficial for the developing fetus, yet potentially toxic because of mercury contamination, have created uncertainty about the appropriate fish… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2010
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women aged 18+ who are currently pregnant and who consume <2 weekly fish servings
Who may be able to join
- currently pregnant
- age at least 18 years
Who cannot join
- unable to speak or understand English
- consuming 2 or more weekly fish servings
- unable to eat fish (e.g. allergy, dietary restriction)
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Pilgrim Health Care Institute
Boston, Massachusetts, 02215
About this study
Official title: A Qualitative Study of Fish Consumption During Pregnancy
Many pregnant women in the US do not consume enough docosahexaenoic acid (DHA), an essential nutrient found in fish. Apparently conflicting findings that fish consumption is beneficial for the developing fetus, yet potentially toxic because of mercury contamination, have created uncertainty about the appropriate fish consumption advice to provide pregnant women. The investigators objective was to determine knowledge, behaviors, and received advice regarding fish consumption among pregnant women who are infrequent consumers of fish.
Read the detailed description
Fish is a healthful food that is the primary dietary source of elongated n-3 polyunsaturated fatty acids (PUFA), nutrients essential for optimal neurodevelopment. Most pregnant women in the US do not consume adequate n-3 PUFA. However, fish also may be contaminated with methylmercury, and approximately 10% of women of childbearing age in the US have mercury levels higher than recommended. Because the same food contains both essential nutrients and harmful contaminants, substantial confusion reigns about the best course of action for pregnant women. Additionally, it is not clear what fish consumption advice would be most effective in changing women's fish consumption habits. The goal of this pilot study is to perform formative work to allow us to develop and refine an intervention to promote consumption of fish low in mercury and high in n-3 PUFA among pregnant women. This project, together with a pilot RCT already funded, will serve as preliminary data to support a larger RCT to evaluate the effects of the intervention on pregnancy outcomes and postpartum maternal and infant health.
Specific Aims Aim 1. Among pregnant women, identify: 1) knowledge of the potential risks and benefits associated with fish consumption during pregnancy; 2) awareness of current recommendations for fish consumption by pregnant women; 3) the sources of information from which they are learning about the health effects associated with fish intake; and 4) facilitators and barriers to fish consumption, such as cost, availability, taste, and habits. To achieve this aim, we will conduct focus groups with pregnant women in the Boston area who are infrequent consumers of fish (defined as <= 2 monthly fish servings).
Aim 2. Develop materials for a planned intervention to increase consumption of fish high in n-3 polyunsaturated fatty acids and low in methylmercury among pregnant women who are infrequent consumers of fish at baseline. We will use results from Aim 1 to inform the development of these materials.
- Conditions
- Nutrition
- Keywords
- fish, pregnancy, nutrition, mercury, focus group, omega-3 fatty acid, docosahexaenoic acid (DHA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Emily Oken, Harvard Pilgrim Health Care
- Investigators
- Emily Oken, MD, MPH, Principal investigator, Harvard Pilgrim Health Care Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178398
- Sponsor's protocol ID
- 0613
- Other IDs
- P30ES000002
- Status last verified
- Aug 2010
- First submitted
- 3 Aug 2010
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study of Fish Consumption During Pregnancy
- ClinicalTrials.gov ID
- NCT01178398
- Acronym / sponsor ID
- 0613
- Conditions
- Nutrition
- Keywords
- fish, pregnancy, nutrition, mercury, focus group, omega-3 fatty acid, docosahexaenoic acid (DHA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Harvard School of Public Health (HSPH)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Aug 2010 (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.
Many pregnant women in the US do not consume enough docosahexaenoic acid (DHA), an essential nutrient found in fish. Apparently conflicting findings that fish consumption is beneficial for the developing fetus, yet potentially toxic because of mercury contamination, have created uncertainty about the appropriate fish consumption advice to provide pregnant women. The investigators objective was to determine knowledge, behaviors, and received advice regarding fish consumption among pregnant women who are infrequent consumers of fish.
Detailed description
Fish is a healthful food that is the primary dietary source of elongated n-3 polyunsaturated fatty acids (PUFA), nutrients essential for optimal neurodevelopment. Most pregnant women in the US do not consume adequate n-3 PUFA. However, fish also may be contaminated with methylmercury, and approximately 10% of women of childbearing age in the US have mercury levels higher than recommended. Because the same food contains both essential nutrients and harmful contaminants, substantial confusion reigns about the best course of action for pregnant women. Additionally, it is not clear what fish consumption advice would be most effective in changing women's fish consumption habits. The goal of this pilot study is to perform formative work to allow us to develop and refine an intervention to promote consumption of fish low in mercury and high in n-3 PUFA among pregnant women. This project, together with a pilot RCT already funded, will serve as preliminary data to support a larger RCT to evaluate the effects of the intervention on pregnancy outcomes and postpartum maternal and infant health.
Specific Aims Aim 1. Among pregnant women, identify: 1) knowledge of the potential risks and benefits associated with fish consumption during pregnancy; 2) awareness of current recommendations for fish consumption by pregnant women; 3) the sources of information from which they are learning about the health effects associated with fish intake; and 4) facilitators and barriers to fish consumption, such as cost, availability, taste, and habits. To achieve this aim, we will conduct focus groups with pregnant women in the Boston area who are infrequent consumers of fish (defined as <= 2 monthly fish servings).
Aim 2. Develop materials for a planned intervention to increase consumption of fish high in n-3 polyunsaturated fatty acids and low in methylmercury among pregnant women who are infrequent consumers of fish at baseline. We will use results from Aim 1 to inform the development of these materials.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged 18+ who are currently pregnant and who consume <2 weekly fish servings
Key inclusion criteria (2 listed)
- currently pregnant
- age at least 18 years
Key exclusion criteria (3 listed)
- unable to speak or understand English
- consuming 2 or more weekly fish servings
- unable to eat fish (e.g. allergy, dietary restriction)
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
Not reported in the source record.
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 15 Sep 2025.
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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.
Emily Oken, MD, MPH principal investigator
Harvard Pilgrim Health Care Institute
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 Nutrition, run by Harvard Pilgrim Health Care at 1 site in United States.
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 2 inclusion and 3 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 15 Sep 2025. 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 United States. 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.
Where can I read the original study information?
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 15 Sep 2025.