ClinicalTrials.gov

History of Changes for Study: NCT05377814
Using Implementation Intentions Plans to Support Public Use of Face Coverings
Latest version (submitted May 19, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 May 11, 2022 None (earliest Version on record)
2 May 19, 2022 Recruitment Status, Study Status, References, Outcome Measures and Study Description
Comparison Format:

Scroll up to access the controls

Study NCT05377814
Submitted Date:  May 11, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2021-13300-21577
Brief Title: Using Implementation Intentions Plans to Support Public Use of Face Coverings
Official Title: Using Implementation Intentions Plans to Support Public Use of Face Coverings
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2022
Overall Status: Not yet recruiting
Study Start: May 30, 2022
Primary Completion: December 31, 2022 [Anticipated]
Study Completion: December 31, 2022 [Anticipated]
First Submitted: May 11, 2022
First Submitted that
Met QC Criteria:
May 11, 2022
First Posted: May 17, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
May 11, 2022
Last Update Posted: May 17, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Manchester
Responsible Party: Principal Investigator
Investigator: Dr Chris Keyworth
Official Title: Lecturer in Psychology
Affiliation: University of Manchester
Collaborators: University of Leeds
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary:

The aim of the present research is to test the effectiveness of an implementation intention-based intervention for promoting the wearing of face coverings in three key settings, namely: transport, workplaces and leisure activities.

Each participant will be randomly allocated to one of two conditions. The two conditions are: (1) a control condition, and (2) intervention (form multiple implementation intentions from a drop-down menu). The main outcome measure will be use of face coverings.

Detailed Description:

Background and study aims

Our previous research showed high levels of adherence to government instructions among a representative sample of the UK adult population during the COVID-19 pandemic (April 2020) https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-021-10574-6. We were also able to provide concrete recommendations for interventions to support people's capabilities, opportunities and motivations in order to sustain behaviour change in the long term. One key recommendation was that interventions designed to bolster people's "automatic motivation" (i.e., habits, emotions) would likely lead to the largest improvements in adherence.

However, the research is limited by not looking separately at face coverings, which were not recommended at the time (April 2020), but were made mandatory in certain settings by July 2020. Since July 2020 Government guidance on whether or not people should wear face coverings to protect themselves and others in various settings has fluctuated and is currently (Feb 10 2022) 'recommended'. Vacillations in government advice may undermine future attempts to reinstate mandatory wearing of face coverings, when the need arises.

Our more recent work (http://repository.londonmet.ac.uk/7154/) on the wearing of face coverings specifically, carried out with opportunistic samples of 297 participants from two UK Universities, showed high levels of adherence to face coverings and similarly found that interventions designed to target automatic motivation would similarly have the largest benefits for increasing adherence.

The question then arises as to how one changes automatic motivation at scale in a public health setting. There is a long track record of research showing that implementation intentions (Gollwitzer, 1993) are an effective means of changing behaviour, and that such changes in behaviour can be sustained over years. Implementation intentions help people overcome automatic motivation by making the critical situations that may elicit unwanted habits more salient, and ensuring that alternative strategies are deployed. They are best thought of as "if-then" plans: specifying an "if" ensures that triggers to unwanted habits receive greater attention and linking "ifs" with "thens" (e.g., seeking help from someone) ensures that the appropriate responses are automatized and replace the unwanted habit. Forming "if-then" plans thus overcome habits (ref: https://pubmed.ncbi.nlm.nih.gov/27054302/).

Aims

To test the effectiveness of an implementation intention-based intervention for promoting the wearing of face coverings in three key settings, namely: transport, workplaces and leisure activities.

Who can participate?

Adults aged over 18 years of age and have good verbal and written understanding of English

What does the study involve?

Participants complete a series of questionnaires about their wearing of face coverings and are then randomly allocated to one of the two groups. In the intervention group (volitional help sheet), participants will be presented with the stem "If I am tempted not to wear a face covering consistently…" and given 10 options with which to complete as many "if-then" plans as they like. These ten options have been taken from the literature and have been shown to be effective with respect to changing numerous behaviours, including self-harm, smoking, alcohol consumption and physical activity. Participants are asked to make a link (using drop-down menus as part of the online questionnaire) from the situation to their chosen solutions. They can create as many situation and solution pairs as they want. The (passive) control condition includes the same questionnaire as the experimental group (participants are not presented with the intervention). After 6 months participants are asked the same face covering questions to see if the intervention has increased adherence to wearing face coverings.

What are the possible benefits and risks of participating?

By taking part, participants will be helping to understand more about brief interventions to support increased adherence to wearing face coverings. By constructing their own "IF-THEN" plans participants are encouraged to construct their own action plans to deal with potential situations where face coverings would be beneficial.

Below are the main ethical issues and how they will be addressed:

Before giving consent (which will be online, as this is an online-based questionnaire), all project participants will be informed that YouGov will ensure that all data collected is stored confidentially in accordance with their privacy policy.

Participants are still free to withdraw themselves/their data until the data is anonymised (one week after the follow-up questionnaire). There will be no personally identifiable data in the research publication or in the SPSS file that YouGov send to the research team.

Data will not be shared with any researcher or organisation other than in ways detailed on the PIS. Data (which will be anonymised with no identifiable personal information) may be used for secondary analysis within the research team only.

Where is the study run from?

The University of Manchester (UK)

When is the study starting and how long is it expected to run for?

May 2022 to January 2023

Who is funding the study?

This work was supported by funding from the PROTECT COVID-19 National Core Study on transmission and environment, managed by the Health and Safety Executive on behalf of HM Government

Who is the main contact?

  1. Prof Christopher J. Armitage Chris.armitage@manchester.ac.uk
  2. Dr Chris Keyworth c.keyworth@leeds.ac.uk

Scientific title

Using IF-THEN plans to support public use of face coverings

Study hypothesis

Current study hypothesis as of 14/04/2022:

The condition that completes a volitional help sheet will report higher adherence to wearing of face coverings at follow-up than the control condition

Study design

Two-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Increased adherence to wearing face coverings

Intervention

Participants complete a series of questionnaires about their current use of face coverings and are then randomly assigned to one of the two conditions:

  1. Participants in the intervention group will additionally be asked to form implementation intentions with respect to wearing face coverings. Participants will be presented with the stem "If I am tempted not to wear a face covering consistently…" and given 10 options with which to complete as many "if-then" plans as they like. These ten options have been taken from the literature and have been shown to be effective with respect to changing numerous behaviours, including self-harm, smoking, alcohol consumption and physical activity.
  2. The (passive) control condition includes the same questionnaire as the experimental group (participants are not presented with the intervention).

After 6 months participants are asked to report how often they have worn face coverings to see if the intervention has increased adherence to wearing face coverings.

Intervention type

Behavioural

Primary outcome measure

1. Use of face coverings are measured at baseline and 6 months.

Secondary outcome measures

1. Capability, opportunity and motivation (based on COM-B model) is measured using the COM questionnaire at baseline and 6 months follow up.

Data analysis plan

Randomisation checks

The investigators will run tests on all outcome and demographic variables to determine if there are any baseline differences in any of these between conditions: chi square will be used for categorical variables and ANOVA for continuous variables.

The effect of the intervention on frequency of wearing face coverings will be tested using mixed-measures ANCOVA with condition (intervention versus control) as the between participants variable and time (baseline versus 6-month follow-up) as the within-participants variable.

Planned contrasts will be used to clarify the anticipated time x condition interactions. For the analyses SES, age and gender will be used as covariates.

Scoring the main outcome measures

Use of face coverings

Participants will be asked to rate the extent to which they wear face coverings on 0-100% scales using the items, "Of the time you spent at work / on public transport / doing leisure activities that brought you into contact with other people in indoor spaces (e.g., cinemas, theatres, live music, nightclubs) in the last 7 days, roughly what percentage of it did you spend wearing a face covering?"

COM (capabilities, opportunities and motivations)

Measured using the Capability, Opportunity, Motivation questionnaire (https://pubmed.ncbi.nlm.nih.gov/32314500/). Each of the items (0-10 scale) will be analysed separately as these each measure a separate construct. Higher scores indicate higher agreement with statements.

Open or close this module Conditions
Conditions: Increased Adherence to Wearing Face Coverings
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 6000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
No Intervention: Passive control
The (passive) control condition includes the same questionnaire as the experimental group, however participants are not presented with the intervention.
Experimental: Intervention (volitional help sheet)
Participants in the intervention group will be asked to form implementation intentions with respect to wearing face coverings. Participants will be presented with the stem "If I am tempted not to wear a face covering consistently…" and given 10 options with which to complete as many "if-then" plans as they like. These ten options have been taken from the literature and have been shown to be effective with respect to changing numerous behaviours, including self-harm, smoking, alcohol consumption and physical activity.
Behavioral: Volitional help sheet
Participants are asked to choose from a list of strategies for increasing physical activity
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Use of face coverings
[ Time Frame: 6 months ]

Participants will be asked to rate the extent to which they wear face coverings on 0-100% scales using the items, "Of the time you spent at work / on public transport / doing leisure activities that brought you into contact with other people in indoor spaces (e.g., cinemas, theatres, live music, nightclubs) in the last 7 days, roughly what percentage of it did you spend wearing a face covering?"
Secondary Outcome Measures:
1. Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model)
[ Time Frame: 6 months ]

Measured using the Capability, Opportunity, Motivation questionnaire (https://pubmed.ncbi.nlm.nih.gov/32314500/). Each of the items (0-10 scale) will be analysed separately as these each measure a separate construct. Higher scores indicate higher agreement with statements.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

Aged 18 and over Good verbal and written understanding of English

Exclusion Criteria:

Aged under 18 years of age Poor verbal and written understanding of English

Open or close this module Contacts/Locations
Locations: United Kingdom
The University of Manchester
Manchester, United Kingdom, M13 9PL
Contact:Contact: Chris Keyworth, PhD 0161 275 2589 c.keyworth@leeds.ac.uk
Contact:Contact: Chris Armitage, PhD 01613066000 chris.armitage@manchester.ac.uk
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services