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Trial record 1 of 1 for:    NCT01126762
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Trial of Fish Intake Advice in Pregnancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01126762
First Posted: May 20, 2010
Last Update Posted: March 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Pilot Randomized Controlled Trial to Promote Healthful Fish Consumption in Pregnancy

Resource links provided by NLM:


Further study details as provided by Emily Oken, Harvard Pilgrim Health Care:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Whole blood mercury [ Time Frame: 12 weeks ]
    Change in whole blood total mercury level from recruitment to 12 weeks

  • Fish consumption [ Time Frame: 12 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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