COVID-19: The Effectiveness of Free Face Mask Distribution

April 19, 2022 updated by: Norwegian Institute of Public Health

The Effectiveness of Distributing Free Face Masks to Increase Use of Face Masks During the COVID-19 Pandemic. A Randomised Experiment in Stovner District, Oslo, Norway

The investigators will carry out a randomised trial of free face mask distribution in Stovner District, Oslo, Norway. Ten grocery stores will serve as study sites. Over three weeks the stores will be randomised daily to having "corona hosts" outside their entrance, handing out face masks to customers. The investigators will compare the proportion of customers who wear face masks as they enter the store in stores with or without face mask distribution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Stover District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

All grocery stores in the Stovner district are eligible as long as they have not, or only sporadically, had free distribution of face masks previously.

At the customer level, we will only include those 12 years or older (age based on the outcome assessor's judgement).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Business as usual.
Experimental: Distribution of free face masks
Face masks will be handed out for free to all customers entering the grocery stores.
Behavioral: Distribution of free face masks
"Corona hosts" will be placed at the entrance of the intervention stores, and hand out face masks to customers entering the store.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Face mask use
Time Frame: Through study completion, 3 weeks.
Proportion of customers wearing a face mask
Through study completion, 3 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correct use of face masks
Time Frame: Through study completion, 3 weeks
Proportion of customers wearing a face mask correctly (i.e. covering mouth and nose)
Through study completion, 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian Institute of Public Health

Collaborators

Stovner District, City of Oslo, Norway

Investigators

  • Principal Investigator: Atle Fretheim, PhD, Norwegian Institute of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Actual)

May 21, 2021

Study Completion (Actual)

May 21, 2021

Study Registration Dates

First Submitted

April 15, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FaceMaskRCT Stovner

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will share the full dataset as soon as it as ready. All data are anonymous, so there are no person data issues to take into consideration.

IPD Sharing Time Frame

From early June 2021, and for all foreseeable future.

IPD Sharing Access Criteria

None - anyone will have access to the dataset.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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