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CompletedNCT01178398Updated Sep 15, 2025

Understanding Fish Consumption Habits During Pregnancy

An observational study in Nutrition, sponsored by Harvard Pilgrim Health Care. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Harvard Pilgrim Health Care · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
22
Ages
18 Years to 50 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Nutrition

Keywords

  • fish
  • pregnancy
  • nutrition
  • mercury
  • focus group
  • omega-3 fatty acid
  • docosahexaenoic acid (DHA)
03

In context

Lead sponsor

Harvard Pilgrim Health Care is the lead sponsor of 35 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women aged 18+ who are currently pregnant and who consume \<2 weekly fish servings

Inclusion criteria

  • currently pregnant
  • age at least 18 years

Exclusion criteria

Exclusion Criteria:

  • unable to speak or understand English
  • consuming 2 or more weekly fish servings
  • unable to eat fish (e.g. allergy, dietary restriction)
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
22 participants (actual)
06

Study locations

1 site
  • Harvard Pilgrim Health Care Institute
    Boston, Massachusetts 02215, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01178398
Lead sponsor
Harvard Pilgrim Health Care
Collaborators
National Institute of Environmental Health Sciences (NIEHS), Harvard School of Public Health (HSPH)
Responsible party
Emily Oken (Professor, Harvard Pilgrim Health Care) — Principal investigator
First posted
Aug 10, 2010
Start date
Oct 2009
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Sep 15, 2025

Study contacts

Emily Oken, MD, MPH
principal investigator · Harvard Pilgrim Health Care Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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