Vascular Lifestyle-Intervention and Screening in Pharmacy

Summary

The overall goal of the present project is to contribute to new knowledge about the effect of a low threshold population screening system for cardiovascular risk factors in Norway. Further, this project aim to study if identifying high cardiovascular risk itself may lead to beneficial changes in health behaviors such as physical activity, diet, tobacco and alcohol behavior together with reduced risk score of cardiovascular disease, across socioeconomic status. This fall, a nationwide, free screening of cardiovascular risk factors will be conducted in 150 pharmacies in Norway. All participants that consent to participate will measure full lipid-profile, blood pressure, HbA1c, body weight and height by health care providers in pharmacies. Based on their measurement levels, participants will be stratified into either a low or a high risk group. In the high risk group, participants will further be randomized to either the intervention group or one of the two control groups. Participants in the intervention group will be informed about all their measurement levels with comparison to the recommended levels. Contrary, participants randomized to the two control groups will have delayed information of their measured levels. Participants in the intervention group and the first control groups will receive general oral and written information about how to lower their measurement levels in 8 weeks. In the second control group, participants will not receive any information at the first visit. In this way the investigators may be able to isolate the effect of identifying high risk and high levels of the risk factors itself. All groups will be given a diet- and physical activity questionnaire at visit 1, and will be invited back after 8 weeks to once more perform the measurement screening and receive the same questionnaire. At visit 2, all participants will, after the measurement screening, be informed about their measured risk factors and receive information on how to lower their levels. 1 year after inclusion, all participants in the three groups will be invited back for a one-year follow up visit in pharmacy.

Conditions

• Cardiovascular Diseases
• Hypercholesterolemia
• Dyslipidemia
• Hypertensive Disease
• Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Information on high risk factor levels and lifestyle advice

This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks

BEHAVIORAL

No information on high risk factor levels but lifestyle advice

In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks

BEHAVIORAL

No information on high risk factor levels, nor lifestyle advice

In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.

Sponsors & Collaborators

• University of Tromso

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• Boots Norway AS

  collaborator UNKNOWN

• Mills DA

  collaborator INDUSTRY

• University of Oslo

  lead OTHER

Principal Investigators

• Karianne Svendsen, M.Sc. · University of Oslo

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2015-12-31

Completion

2022-02-28

Countries

• Norway

Study Locations