Trial record 1 of 1 for:    NCT01126762
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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
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

May 19, 2010
March 20, 2012
May 2010
March 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01126762 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Trial of Fish Intake Advice in Pregnancy
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Nutrition
  • Behavioral: Dietary advice
    Dietary advice regarding consumption of low mercury, high DHA fish
  • Behavioral: Control
    Advice regarding healthful diet during pregnancy, not focused on fish intake
  • 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
    Intervention: Behavioral: Dietary advice
  • Experimental: Dietary advice
    Dietary advice regarding consumption of low mercury, high DHA fish
    Intervention: Behavioral: Dietary advice
  • Placebo Comparator: Control
    General dietary advice not focused on fish intake
    Intervention: Behavioral: Control
Oken E, Guthrie LB, Bloomingdale A, Platek DN, Price S, Haines J, Gillman MW, Olsen SF, Bellinger DC, Wright RO. A pilot randomized controlled trial to promote healthful fish consumption during pregnancy: the Food for Thought Study. Nutr J. 2013 Mar 15;12:33. doi: 10.1186/1475-2891-12-33.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
June 2011
March 2011   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01126762
HPHCI Fish 0344, P30ES000002, P30DK040561, R01ES016314, K24HD069408
No
Emily Oken, Harvard Pilgrim Health Care
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)
Principal Investigator: Emily Oken, MD, MPH Harvard Pilgrim Health Care Institute
Harvard Pilgrim Health Care
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP