Trial of Fish Intake Advice in Pregnancy

Not Applicable

Completed

• Conditions: Nutrition

• Registration Number: NCT01126762
• Lead Sponsor: Harvard Pilgrim Health Care

Brief Summary

The overall goal of this project is to establish a pilot study to develop and refine an intervention to promote consumption of fish low in mercury and high in n-3 PUFA among pregnant women. The investigators will demonstrate our ability to recruit pregnant women, influence their fish consumption, and measure changes in nutrient and toxicant biomarkers.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-20
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

• age 18 years or older
• Currently pregnant 12-22 weeks
• Singleton pregnancy
• Consuming fish <=2 times per month

Exclusion Criteria

• Inability to answer questionnaires in English
• Plans to leave study area prior to delivery
• Would never eat fish (e.g. vegan, allergy to fish)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plasma elongated n-3 PUFA levels	12 weeks	Change in plasma levels of elongated n-3 PUFA from recruitment to follow up at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Whole blood mercury	12 weeks	Change in whole blood total mercury level from recruitment to 12 weeks
Fish consumption	12 weeks	Change in fish consumption from recruitment to 12 weeks

Trial Locations

Locations (1)

Harvard Pilgrim Health Care; 🇺🇸 Boston, Massachusetts, United States