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Clinical Trials/NCT01126762
NCT01126762
Completed
N/A

A Pilot Randomized Controlled Trial to Promote Healthful Fish Consumption in Pregnancy

Harvard Pilgrim Health Care1 site in 1 country61 target enrollmentMay 2010
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ConditionsNutrition

Overview

Phase
N/A
Intervention
Not specified
Conditions
Nutrition
Sponsor
Harvard Pilgrim Health Care
Enrollment
61
Locations
1
Primary Endpoint
Plasma elongated n-3 PUFA levels
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emily Oken

Associate Professor

Harvard Pilgrim Health Care

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Plasma elongated n-3 PUFA levels

Time Frame: 12 weeks

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

Secondary Outcomes

  • Whole blood mercury(12 weeks)
  • Fish consumption(12 weeks)

Study Sites (1)

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