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临床试验/NCT02883764
NCT02883764已完成不适用

Cross-sectional Survey of Omega-3 Fatty Acid Blood Levels

DSM Nutritional Products, Inc.1 个研究点 分布在 1 个国家目标入组 834 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
834
试验地点
1
主要终点
Cross-sectional survey of omega-3 fatty acid blood levels

研究概览

简要总结

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.

详细描述

Email messages and posters announcing onsite HealthyRoads Wellness biometric screening clinics will inform ~1,800 DSM employees at 19 locations of the opportunity to participate in an omega-3 research study and have their blood omega-3 levels measured.

  • Participants attending a Healthyroads Wellness® biometrics screening clinic will be invited to participate. If they agree and sign an Informed Consent form, they need to complete an Omega-3 Index Test Request form, and write their name, date of birth and collection date on the filter paper. The request form includes some dietary questions about fish/meat consumption.
  • Omega-3 research participants will proceed to the biometric screening station where blood obtained from the finger stick for blood cholesterol measurements will be applied to a filter paper by a Healthyroads Wellness® professional.
  • The filter paper, the Omega-3 Index Test Request, and Informed Consent form will be stapled together, packaged with all other samples obtained at that location, and shipped by DSM to a CLIA-approved laboratory.
  • Within about a week of receiving the blood sample, the Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory (#43D1105229) will email the Omega-3 Index Test results directly to each participant.

Locations will be randomized such that approximately 50% of participants will receive a coupon for a discount on a 90 day supply of omega-3 capsules. These coupons will be offered to participants in order to determine rates of coupon redemption. If a coupon is offered at a biometrics screening site, a single coupon will be offered to each participant at that location. The coupon will be offered after the finger stick procedure so that it is not an incentive for participation.

Three-four months later, all employees at each location will be offered a second opportunity to have their omega-3 index measured. The filter paper, the Omega-3 Index Test Request, and Informed Consent form will be stapled together, packaged with all other samples obtained at that location, and shipped by DSM to a CLIA-approved laboratory. Based on email address, birthdate, date of collection, and gender, data will be identified as a new participant or second omega-3 index determination. This data will allow for anonymized comparison of first versus second determination of blood omega-3 index measurement to assess the impact of providing participants with information on their omega-3 status vs information + coupon.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •There are no exclusion criteria. These employees are 18y of age and older.

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: one day

Single fingerstick to know blood levels of omega-3s

次要结局

  • Assessing blood levels of omega-3 fatty acids(3 month followup)
  • Assessing dietary behavior (questionnaire)(3 month follow up)

研究者

发起方
DSM Nutritional Products, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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