Condition category
Not Applicable
Date applied
04/06/2019
Date assigned
17/06/2019
Last edited
05/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Implementation intentions (i.e., making if-then plans) are effective at changing behaviour. However, despite many studies showing this effect there are few studies that have been conducted on large samples and for more than a short term follow up. The aim of this study is to test the effectiveness of using two different interventions (standard volitional help sheet and single situation volitional help sheet) at increasing physical activity in comparison to a control group.

Who can participate?
UK adults who are capable of engaging in physical activity

What does the study involve?
Participants complete a series of questionnaires about their physical activity and are then randomly allocated to one of the three groups. The standard volitional help sheet includes a list of situations when people might not want to be physically active (e.g., If I’m tempted not to be physically active when I’m under a lot of stress) and a list of solutions to overcoming these (e.g., then I will make myself do some physical activity anyway because I know I will feel better afterward). Participants are asked to draw a line from the situations that are relevant to them to their chosen solutions. They can create as many situation and solution pairs as they want. The single situation volitional help sheet includes a stem but not a specific situation (e.g., If I’m tempted not to be physically active…) and a list of solutions to overcoming this (e.g., then I will make myself do some physical activity anyway because I know I will feel better afterward). Participants are asked to draw a line from the stem to them to their chosen solutions. They can create as many pairs as they want. The control group includes the same list as the standard volitional help sheet but people are asked just to tick situation and solutions that are relevant to them. After 6 months participants are asked the same physical activity questions to see if the intervention has increased their physical activity and also find who it will work best for.

What are the possible benefits and risks of participating?
The benefits of participating are that participants may increase their physical activity. There are no risks of participating.

Where is the study run from?
University of Manchester (UK)

When is the study starting and how long is it expected to run for?
May 2019 to June 2020

Who is funding the study?
Tesco (UK)

Who is the main contact?
1. Dr Tracy Epton
epton.tracy@gmail.com
2. Prof. Chris J Armitage
chris.armitage@manchester.ac.uk
3. Dr Christopher Keyworth
christopher.keyworth@manchester.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Tracy Epton

ORCID ID

Contact details

University of Manchester
Coupland I
Coupland Street
Manchester
M13 9PT
United Kingdom
+44 (0)1613060455
epton.tracy@gmail.com

Type

Public

Additional contact

Prof Chris J Armitage

ORCID ID

Contact details

University of Manchester
Coupland I
Coupland Street
Manchester
M13 9PT
United Kingdom
+44 (0)1613060455
chris.armitage@manchester.ac.uk

Type

Public

Additional contact

Dr Christopher Keyworth

ORCID ID

Contact details

University of Manchester
Coupland I
Coupland Street
Manchester
M13 9PT
United Kingdom
+44 (0)161 3060455
christopher.keyworth@manchester.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2019-7332-10682

Study information

Scientific title

Using "IF-THEN" plans to increase physical activity

Acronym

Study hypothesis

1. The two conditions that complete a volitional help sheet (standard VHS and single situation VHS) will report greater physical activity and lower sedentariness at follow up than the control condition
2. Increases in physical activity/reductions in sedentariness will be associated with improved subjective well-being
3. The VHS interventions will be most effective for those who have high habits, awareness of standards, self-monitoring, self-regulatory effort, capabilities, opportunities and motivations to increase physical activity and are currently not meeting health behaviour guidelines (including physical activity, smoking, alcohol consumption and diet)

Ethics approval

Approved 21/06/2019, University Research Ethics Committee at the University of Manchester (Research Governance, Ethics and Integrity, 2nd Floor Christie Building, The University of Manchester, Oxford Road, Manchester, M13 9PL; 0161 275 2206/2674; research.ethics@manchester.ac.uk), ref: 2019-7332-10682

Study design

Three-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Physical activity

Intervention

Participants complete a series of questionnaires about their physical activity and are then randomly assigned to one of the three conditions:

1. The standard volitional help sheet includes a list of situations when people might not want to be physically active (e.g., If I’m tempted not to be physically active when I’m under a lot of stress) and a list of solutions to overcoming these (e.g., then I will make myself do some physical activity anyway because I know I will feel better afterward). People are asked to draw a line from the situations that are relevant to them to their chosen solutions. They can create as many situation and solution pairs as they want.
2. The single situation volitional help sheet includes a stem but not a specific situation (e.g., IIf I’m tempted not to be physically active… ) and a list of solutions to overcoming this (e.g., then I will make myself do some physical activity anyway because I know I will feel better afterward). People are asked to draw a line from the stem to them to their chosen solutions. They can create as many pairs as they want.
3. The control condition includes the same list as the standard volitional help sheet but people are asked just to tick situation and solutions that are relevant to them.

After 6 months participants are asked the same physical activity questions to see if the intervention has increased their physical activity and also find who it will work best for.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Physical activity is measured using the Sport England: Short active lives questionnaire and the IPAQ at baseline and 6 months follow up
2. Sedentary behaviour is measured using a sedentary behaviour questionnaire at baseline and 6 months follow up

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
2. Habit is measured using the self-reported habit index (automaticity scale) at baseline and 6 months follow up
3. State self-regulation is measured at baseline and 6 months follow up (Sniehotta, F. F., Scholz, U., & Schwarzer, R. (2005). Bridging the intention-behavior gap: Planning, self-efficacy, and action control in the adoption and maintenance of physical activity. Psychology & Health, 20, 143–160. http://dx.doi.org/10.1080/08870440512331317670)
4. Daily smoking, weekly alcohol consumption and daily fruit and vegetable intake measured using three questions at baseline and 6 months follow up
5. Subjective well-being measured using the Office of National statistics measure of wellbeing at baseline and 6 months follow up

Overall trial start date

01/05/2019

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

UK adults who are capable of engaging in physical activity

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

3000

Participant exclusion criteria

1. Children
2. People who are not capable of engaging in physical activity
3. People not based in the UK

Recruitment start date

08/07/2019

Recruitment end date

30/07/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

YouGov will be distributing the questionnaires via its online platform
-
United Kingdom

Sponsor information

Organisation

University of Manchester

Sponsor details

Oxford Road
Manchester
M13 9PT
United Kingdom
+44 (0)1613060455
epton.tracy@gmail.com

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Tesco

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers will share all documents used in the study, statistical analysis plan and data on OSF. Planned publication in a high impact peer-reviewed journal

IPD sharing statement
The data will be shared via OSF. However, people can contact Dr Tracy Epton (epton.tracy@gmail.com). The data will be available for 10 years, data will be freely available for anyone who wishes to use it. Consent from participants was obtained. The data will be fully anonymised.

Intention to publish date

01/01/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/07/2019: The following changes were made to the trial record: 1. The ethics approval was added. 2. The recruitment start date was changed from 14/06/2019 to 08/07/2019. 3. The recruitment end date was changed from 30/06/2019 to 30/07/2019. 03/07/2019: The following changes were made to the trial record: 1. The overall trial end date was changed from 31/12/2019 to 30/06/2020. 2. The intention to publish date was changed from 31/01/2020 to 01/01/2021. 12/06/2019: Trial's existence confirmed by ethics committee.