Trial of Fish Intake Advice in Pregnancy

Harvard Pilgrim Health Care

Status: Completed

Conditions: Nutrition

Treatments: Behavioral: Dietary advice; Behavioral: Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01126762

P30DK040561

HPHCI Fish 0344

R01ES016314 (U.S. NIH Grant/Contract)

P30ES000002 (U.S. NIH Grant/Contract)

K24HD069408 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

61 participants in 3 patient groups, including a placebo group

Dietary advice and grocery store card

Experimental group

Description:

Dietary advice to consume low mercury, high DHA fish plus a grocery store gift card to support the purchase of fish

Treatment:

Behavioral: Dietary advice

Dietary advice

Experimental group

Description:

Dietary advice regarding consumption of low mercury, high DHA fish

Treatment:

Behavioral: Dietary advice

Control

Placebo Comparator group

Description:

General dietary advice not focused on fish intake

Treatment:

Behavioral: Control