Trial of Fish Intake Advice in Pregnancy

NCT ID: NCT01126762

Last Updated: 2012-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Dietary advice

Intervention Type BEHAVIORAL

Dietary advice regarding consumption of low mercury, high DHA fish

Dietary advice

Dietary advice regarding consumption of low mercury, high DHA fish

Group Type EXPERIMENTAL

Dietary advice

Intervention Type BEHAVIORAL

Dietary advice regarding consumption of low mercury, high DHA fish

Control

General dietary advice not focused on fish intake

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

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

Interventions

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Dietary advice

Dietary advice regarding consumption of low mercury, high DHA fish

Intervention Type BEHAVIORAL

Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Harvard Pilgrim Health Care

OTHER

Sponsor Role lead

Responsible Party

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Emily Oken

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emily Oken, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard Pilgrim Health Care Institute

Locations

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Harvard Pilgrim Health Care

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Oken E, Guthrie LB, Bloomingdale A, Gillman MW, Olsen SF, Amarasiriwardena CJ, Platek DN, Bellinger DC, Wright RO. Assessment of dietary fish consumption in pregnancy: comparing one-, four- and thirty-six-item questionnaires. Public Health Nutr. 2014 Sep;17(9):1949-59. doi: 10.1017/S1368980013001985. Epub 2013 Jul 24.

Reference Type DERIVED
PMID: 23883550 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23496848 (View on PubMed)

Other Identifiers

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P30ES000002

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30DK040561

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01ES016314

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K24HD069408

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HPHCI Fish 0344

Identifier Type: -

Identifier Source: org_study_id

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