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Trial of Fish Intake Advice in Pregnancy

This study has been completed.
Sponsor:
Collaborators:
Harvard School of Public Health
Harvard University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Emily Oken, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier:
NCT01126762
First received: May 19, 2010
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Nutrition
 Behavioral: Dietary advice
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Pilot Randomized Controlled Trial to Promote Healthful Fish Consumption in Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Mercury
U.S. FDA Resources

Further study details as provided by Harvard Pilgrim Health Care:

Primary Outcome Measures:
  • Plasma elongated n-3 PUFA levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in plasma levels of elongated n-3 PUFA from recruitment to follow up at 12 weeks


Secondary Outcome Measures:
  • Whole blood mercury [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Change in whole blood total mercury level from recruitment to 12 weeks

  • Fish consumption [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in fish consumption from recruitment to 12 weeks


Enrollment: 61
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126762

Locations
United States, Massachusetts
Harvard Pilgrim Health Care
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Harvard Pilgrim Health Care
Harvard School of Public Health
Harvard University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Emily Oken, MD, MPH Harvard Pilgrim Health Care Institute
  More Information

No publications provided

Responsible Party: Emily Oken, Associate Professor, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT01126762     History of Changes
Other Study ID Numbers: HPHCI Fish 0344, P30ES000002, P30DK040561, R01ES016314, K24HD069408
Study First Received: May 19, 2010
Last Updated: March 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Harvard Pilgrim Health Care:
Docosahexaenoic acid
fish
pregnancy
methylmercury
n-3 polyunsaturated fatty acid

ClinicalTrials.gov processed this record on October 17, 2012