NCT01126762

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

10 months

First QC Date

May 19, 2010

Last Update Submit

March 20, 2012

Conditions

Nutrition

Keywords

Docosahexaenoic acidfishpregnancymethylmercuryn-3 polyunsaturated fatty acid

Outcome Measures

Primary Outcomes (1)

  • Plasma elongated n-3 PUFA levels

    Change in plasma levels of elongated n-3 PUFA from recruitment to follow up at 12 weeks

    12 weeks

Secondary Outcomes (2)

  • Whole blood mercury

    12 weeks

  • Fish consumption

    12 weeks

Study Arms (3)

Dietary advice and grocery store card

EXPERIMENTAL

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

EXPERIMENTAL

Dietary advice regarding consumption of low mercury, high DHA fish

Behavioral: Dietary advice

Control

PLACEBO COMPARATOR

General dietary advice not focused on fish intake

Behavioral: Control

Interventions

Dietary adviceBEHAVIORAL

Dietary advice regarding consumption of low mercury, high DHA fish

Dietary adviceDietary advice and grocery store card
ControlBEHAVIORAL

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

Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years or older
  • Currently pregnant 12-22 weeks
  • Singleton pregnancy
  • Consuming fish \<=2 times per month

You may not qualify if:

  • Inability to answer questionnaires in English
  • Plans to leave study area prior to delivery
  • Would never eat fish (e.g. vegan, allergy to fish)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard Pilgrim Health Care

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • 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.

    PMID: 23883550DERIVED

  • 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.

    PMID: 23496848DERIVED

MeSH Terms

Interventions

Nutrition Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Emily Oken, MD, MPH

    Harvard Pilgrim Health Care Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 20, 2010

Study Start

May 1, 2010

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations

US(1)