Trial of Fish Intake Advice in Pregnancy

March 20, 2012 updated by: Emily Oken, Harvard Pilgrim Health Care

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Harvard Pilgrim Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary advice and grocery store card
Dietary advice to consume low mercury, high DHA fish plus a grocery store gift card to support the purchase of fish
Behavioral: Dietary advice
Dietary advice regarding consumption of low mercury, high DHA fish
Experimental: Dietary advice
Dietary advice regarding consumption of low mercury, high DHA fish
Behavioral: Dietary advice
Dietary advice regarding consumption of low mercury, high DHA fish
Placebo Comparator: Control
General dietary advice not focused on fish intake
Behavioral: Control
Advice regarding healthful diet during pregnancy, not focused on fish intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole blood mercury
Time Frame: 12 weeks
Change in whole blood total mercury level from recruitment to 12 weeks
12 weeks
Fish consumption
Time Frame: 12 weeks
Change in fish consumption from recruitment to 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Pilgrim Health Care

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
Harvard University
Harvard School of Public Health (HSPH)

Investigators

  • Principal Investigator: Emily Oken, MD, MPH, Harvard Pilgrim Health Care Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 19, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Estimate)

March 22, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HPHCI Fish 0344
  • P30DK040561 (U.S. NIH Grant/Contract)
  • K24HD069408 (U.S. NIH Grant/Contract)
  • P30ES000002 (U.S. NIH Grant/Contract)
  • R01ES016314 (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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