Using "IF-THEN" plans to increase physical activity
| ISRCTN | ISRCTN58484767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58484767 |
| Secondary identifying numbers | 2019-7332-10682 |
- Submission date
- 04/06/2019
- Registration date
- 17/06/2019
- Last edited
- 06/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
C.Keyworth@leeds.ac.uk
Contact information
Public
University of Manchester
Coupland I
Coupland Street
Manchester
M13 9PT
United Kingdom
| Phone | +44 (0)1613060455 |
|---|---|
| epton.tracy@gmail.com |
Public
University of Manchester
Coupland I
Coupland Street
Manchester
M13 9PT
United Kingdom
| Phone | +44 (0)1613060455 |
|---|---|
| chris.armitage@manchester.ac.uk |
Public
University of Manchester
Coupland I
Coupland Street
Manchester
M13 9PT
United Kingdom
| Phone | +44 (0)161 3060455 |
|---|---|
| C.Keyworth@leeds.ac.uk |
Study information
| Study design | Three-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Using "IF-THEN" plans to increase physical activity |
| Study objectives | Current study hypothesis as of 18/10/2019: 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 developed 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) Previous 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2019 |
| Completion date | 28/02/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 3000 |
| Total final enrolment | 3085 |
| Key inclusion criteria | UK adults who are capable of engaging in physical activity |
| Key exclusion criteria | 1. Children 2. People who are not capable of engaging in physical activity 3. People not based in the UK |
| Date of first enrolment | 08/07/2019 |
| Date of final enrolment | 16/08/2019 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
University/education
Oxford Road
Manchester
M13 9PT
England
United Kingdom
| Phone | +44 (0)1613060455 |
|---|---|
| epton.tracy@gmail.com | |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 28/02/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. The statistical analysis plan has been uploaded as an additional file (added 31/10/2019) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 29/10/2019 | 31/10/2019 | No | No |
Additional files
- ISRCTN58484767_SAP_29Oct19.pdf
- uploaded 31/10/2019
Editorial Notes
06/09/2022: A contact email was updated.
31/10/2019: The statistical analysis plan has been uploaded as an additional file.
18/10/2019: The study hypothesis has been changed.
05/09/2019: The final enrolment number has been added.
16/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/07/2019 to 16/08/2019.
2. The overall trial end date was changed from 30/06/2020 to 28/02/2020.
3. The intention to publish date was changed from 01/01/2021 to 28/02/2021.
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.
