NCT02883764

Brief Summary

Employees working at DSM workplaces with an onsite Healthyroads Wellness® biometrics screening program are being offered an opportunity to have their blood fatty acids levels, especially omega-3 fatty acids \[omega-3 index\] measured at no charge. At some locations, participants were offered a single coupon on a 90 day supply of omega-3 capsules. Three months later, all employees at these locations are given a second opportunity to have their blood omega-3 levels \[eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)\] measured. The goals are to: 1) survey dietary EPA+DHA intake and omega-3 blood levels of study population, 2) determine if dietary EPA+DHA intake and omega-3 blood levels change after people have learned their omega-3 index, and 3) determine if differences in omega-3 index concentrations can be detected 3 months later between locations receiving information alone vs information+coupon.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
834

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

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, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2016

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

August 19, 2016

Last Update Submit

February 15, 2017

Conditions

Keywords

eicosapentaenoic acidEPAdocosahexaenoic acidDHAomega-3 index

Outcome Measures

Primary Outcomes (1)

  • Cross-sectional survey of omega-3 fatty acid blood levels

    Single fingerstick to know blood levels of omega-3s

    one day

Secondary Outcomes (2)

  • Assessing blood levels of omega-3 fatty acids

    3 month followup

  • Assessing dietary behavior (questionnaire)

    3 month follow up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

DSM offers employees to voluntarily participate in a healthyroads employee wellness program. All DSM employees working at DSM workplaces with an onsite Healthyroads Wellness® biometrics screening program will be informed by email and onsite signs of upcoming Healthyroads wellness clinics. Participants signing up for a Healthyroads Wellness clinic will be invited to participate in an omega-3 research survey.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DSM Nutritional Products

Parsippany, New Jersey, 07054, United States

Location

Related Publications (1)

  • Harris WS, Von Schacky C. The Omega-3 Index: a new risk factor for death from coronary heart disease? Prev Med. 2004 Jul;39(1):212-20. doi: 10.1016/j.ypmed.2004.02.030.

Study Officials

  • Michael I McBurney, PhD

    DSM Nutritional Products, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 30, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 2, 2016

Last Updated

February 17, 2017

Record last verified: 2017-02

Locations