- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01178398
Understanding Fish Consumption Habits During Pregnancy
A Qualitative Study of Fish Consumption During Pregnancy
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Harvard Pilgrim Health Care Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- currently pregnant
- age at least 18 years
Exclusion Criteria:
- unable to speak or understand English
- consuming 2 or more weekly fish servings
- unable to eat fish (e.g. allergy, dietary restriction)
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily Oken, MD, MPH, Harvard Pilgrim Health Care Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0613
- P30ES000002 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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