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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01178398
Other study ID # 0613
Secondary ID P30ES000002
Status Completed
Phase N/A
First received August 3, 2010
Last updated August 9, 2010
Start date October 2009
Est. completion date March 2010

Study information

Verified date August 2010
Source Harvard Pilgrim Health Care
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States Harvard Pilgrim Health Care Institute Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Harvard Pilgrim Health Care HSPH-NIEHS Center for Environmental Health, National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

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