NutritionNCT01126762
Trial of Fish Intake Advice in Pregnancy
A study testing Dietary advice in people with Nutrition, run by Harvard Pilgrim Health Care at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition
- What is being tested?
- Dietary advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older
- Currently pregnant 12-22 weeks
- Singleton pregnancy
- Consuming fish <=2 times per month
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Harvard Pilgrim Health Care
Boston, Massachusetts, 02215
About this study
Official title: 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.
- Conditions
- Nutrition
- Being tested
- Dietary advice, Control
- Keywords
- Docosahexaenoic acid, fish, pregnancy, methylmercury, n-3 polyunsaturated fatty acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary adviceBehavioural
Dietary advice regarding consumption of low mercury, high DHA fish
ControlBehavioural
Advice regarding healthful diet during pregnancy, not focused on fish intake
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Dietary advice |
| Dietary advice | Experimental | Dietary advice regarding consumption of low mercury, high DHA fish Receives: Behavioral: Dietary advice |
| Control | Placebo comparator | General dietary advice not focused on fish intake Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma elongated n-3 PUFA levels
Change in plasma levels of elongated n-3 PUFA from recruitment to follow up at 12 weeks
Measured: 12 weeks
Secondary outcomes (2)
Whole blood mercury
Change in whole blood total mercury level from recruitment to 12 weeks
Measured: 12 weeks
Fish consumption
Change in fish consumption from recruitment to 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), 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)
- Responsible party
- Principal investigator, Emily Oken, Harvard Pilgrim Health Care
- Investigators
- Emily Oken, MD, MPH, Principal investigator, Harvard Pilgrim Health Care Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126762
- Sponsor's protocol ID
- HPHCI Fish 0344
- Other IDs
- P30ES000002, P30DK040561, R01ES016314, K24HD069408
- Status last verified
- Mar 2012
- First submitted
- 19 May 2010
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23883550Oken 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.
PubMed 23496848
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial to Promote Healthful Fish Consumption in Pregnancy
- ClinicalTrials.gov ID
- NCT01126762
- Acronym / sponsor ID
- HPHCI Fish 0344
- Conditions
- Nutrition
- Keywords
- Docosahexaenoic acid, fish, pregnancy, methylmercury, n-3 polyunsaturated fatty acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), 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)
- Study start
- May 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary advice and grocery store card | Experimental | Behavioral: Dietary adviceDietary advice to consume low mercury, high DHA fish plus a grocery store gift card to support the purchase of fish |
| Dietary advice | Experimental | Behavioral: Dietary adviceDietary advice regarding consumption of low mercury, high DHA fish |
| Control | Placebo comparator | Behavioral: ControlGeneral dietary advice not focused on fish intake |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older
- Currently pregnant 12-22 weeks
- Singleton pregnancy
- Consuming fish <=2 times per month
Key exclusion criteria (3 listed)
- Inability to answer questionnaires in English
- Plans to leave study area prior to delivery
- Would never eat fish (e.g. vegan, allergy to fish)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary adviceDietary advice regarding consumption of low mercury, high DHA fish | Behavioural | Dietary advice, Dietary advice and grocery store card |
| ControlAdvice regarding healthful diet during pregnancy, not focused on fish intake | Behavioural | Control |
Primary outcome
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
2 secondary outcomes
Whole blood mercury
Time frame: 12 weeks
Fish consumption
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
- Derived from this study: PubMed 23883550Oken 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.
- Derived from this study: PubMed 23496848Oken 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Oken, MD, MPH principal investigator
Harvard Pilgrim Health Care Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary advice in people with Nutrition, run by Harvard Pilgrim Health Care at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma elongated n-3 PUFA levels (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01126762, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.