Skip to main content
OpenTrials
Completed

NCT Number: NCT01126762

Trial of Fish Intake Advice 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nutrition

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Harvard Pilgrim Health Care

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dietary Advice

Behavioral

Dietary advice regarding consumption of low mercury, high DHA fish

Control

Behavioral

Advice regarding healthful diet during pregnancy, not focused on fish intake

Primary outcomes

  1. 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

  1. Whole blood mercury

    Time frame: 12 weeks

    Change in whole blood total mercury level from recruitment to 12 weeks

  2. Fish consumption

    Time frame: 12 weeks

    Change in fish consumption from recruitment to 12 weeks

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 20, 2010
Registry last updated
Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.