A study of a goal-setting intervention for staff in workplaces enrolled in health and wellbeing programmes
| ISRCTN | ISRCTN17828539 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17828539 |
- Submission date
- 08/04/2022
- Registration date
- 07/06/2022
- Last edited
- 08/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
It is important that employees of any organisation are well, both physically and mentally. Preventing problems with health and wellbeing at work can mean that employees take fewer days off sick from work, are more productive at work, and are less likely to quit their jobs because they are too sick to go to work. This project conducts research to understand how to prevent problems with ill health at work.
One part of the research will involve a trial in the West Midlands. The trial will test the effectiveness of an established behavioural intervention called mental contrasting. Key aspects of mental contrasting include articulating goals and how to address barriers to achieving them, which our public contributors identified as important drivers of health behaviours.
Who can participate?
Organisations who are taking part in a local government workplace health and wellbeing initiative will be able to participate. Individual staff members who are aged 16 years and older and willing to consent to take part can participate.
What does the study involve?
The study involves attending group meetings with other colleagues and a researcher. During the meetings, participants will be asked to answer some questions about health and wellbeing at work. Some groups will receive extra help for their health and wellbeing at work by proving support achieving health and wellbeing goals.
What are the possible benefits and risks of participating?
Sometimes people benefit from taking part in research like this because they pay more attention to their own health and wellbeing as a result, which can improve it. It is an opportunity to contribute to improving our understanding of health and wellbeing, which may benefit people if this knowledge is successfully applied later on to improve health and wellbeing. There are minimal risks involved with participation in this research, although the researchers will ask for some of the participants' time that they could spend doing other things.
When is the study starting and how long is it expected to run for?
July 2021 to October 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Laura Kudrna
l.kudrna@bham.ac.uk
Contact information
Principal Investigator
Institute of Applied Health Research
Murray Learning Centre
University of Birmingham
Birmingham
B15 2FG
United Kingdom
 ORCID ID |
0000-0002-8163-7112 |
|---|---|
| Phone | +44 (0)121 414 3344 |
| l.kudrna@bham.ac.uk |
Study information
| Study design | Mixed methods cluster randomized waitlist-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Workplace |
| Study type | Prevention |
| Participant information sheet | Please use contact details to request participant information sheet |
| Scientific title | A cluster randomised waitlist-controlled trial of a goal-setting behaviour change intervention for employees in workplaces enrolled in workplace health and wellbeing initiatives |
| Study objectives | 1. Does the intervention result in participants perceiving they have made progress towards achieving their health and wellbeing goals? 2. Does the intervention change employees’ perceptions of their health, health behaviour, and wellbeing? 3. What barriers, enablers, and mechanisms do employees perceive as related to the effectiveness of the intervention? |
| Ethics approval(s) | Approved 04/05/2022, the University of Birmingham Technology, Engineering and Mathematics Ethical Review Committee (Finance Office, University of Birmingham, c\o Room 106 Aston Webb, B Block, Edgbaston, Birmingham, B15 2TT, UK; Tel: not applicable; aer-ethics@contacts.bham.ac.uk), ref: ERN_21-0744A |
| Health condition(s) or problem(s) studied | Self-reported progress towards goal attainment, health and wellbeing |
| Intervention | Group 1 (intervention arm) at baseline receives the intervention, which is mental contrasting plus implementation intentions, and has a general discussion about health and wellbeing at work. The intervention is delivered once in a group setting lasting around one hour. The endline follow up period is a minimum of 4 weeks. Group 2 (waitlist control warm) at baseline only has a general discussion about health and wellbeing at work and does not receive the intervention. The endline follow up period is a minimum of 4 weeks. The intervention (mental contrasting plus implementation intentions) is delivered after endline follow up in a group setting lasting around 1 hour. Randomisation: All workplaces will be assigned an anonymous ID. An independent statistician will generate an allocation sequence using the random number generator in Stata v16.1 with assignments to the intervention or control group stratified by company size. Random block sizes of two and four will be used to maintain both balance within stratum and prevent lack of allocation concealment. A company will be considered small if there are less than 50 employees, medium is 51 to 250 employees and large is more than 250 employees. The independent statistician will retain this list and it will be kept concealed from the study team. After baseline data collection has occurred in each workplace, its assignment will be revealed based on the next assignment in the sequence for its particular stratum. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-reported progress towards goal attainment is measured with the item, “So far, how much progress would you say that you have made towards what you wished to do for your health and wellbeing?” (1-7) at endline (minimum of 4 weeks) |
| Secondary outcome measures | 1. Self-reported progress in changing behaviour related to goal attainment is measured with the item, “And how much progress in changing your behaviour would you say you have made towards what you wished to do for your health and wellbeing?” (1-7) at endline (minimum of 4 weeks) 2. Self-rated general health is measured with the item, “Overall, how would you rate your health? (poor, fair, good, very good, excellent) at baseline and endline 3. Self-rated empowerment to change health and wellbeing is measured at baseline and endline with the items: 3.1. I am confident in my ability to look after my health and wellbeing, 1-5 3.2. I know what to do to improve my health and wellbeing, 1-5 3.3. When problems arise with my health and wellbeing, I handle them well, 1-5 3.4. I am confident that I can make the best choices to look after my health and wellbeing, 1-5 4. Psychological wellbeing measured at baseline and endlineL life and job satisfaction, hedonic wellbeing, eudemonic experiences are measured with the items (all 0-10 scale): 4.1. Overall, how satisfied are you with your life nowadays? 4.2. Overall, how satisfied are you with your job nowadays? 4.3. Overall, to what extent do you feel the things you do in your life are worthwhile? 4.4. Overall, how happy did you feel yesterday? 4.5. Overall, how anxious did you feel yesterday? 4.6. How meaningful do the activities that you do at work feel to you? 4.7. How enjoyable do the activities that you do at work feel to you? 4. Mental wellbeing is measured using the short form of the Warwick Edinburgh mental wellbeing scale at baseline and endline |
| Overall study start date | 28/07/2021 |
| Completion date | 16/10/2023 |
Eligibility
| Participant type(s) | Employee |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 60 workplaces including at least 3 and no more than 30 employees per organisation |
| Total final enrolment | 225 |
| Key inclusion criteria | Current inclusion criteria as of 14/12/2022: Workplace eligibility criteria (cluster-level): 1. Signed up to participate in the WHI in any geographic region 2. Willing and able to allow at least three employees to participate in data collection activities Employee eligibility criteria (individual-level): 1. Aged 16 years of age or older 2. Willing to provide written consent Previous inclusion criteria as of 10/10/2022 to 14/12/2022: Workplace eligibility criteria (cluster-level): 1. Signed up to participate in the WHI in any geographic region 2. Willing and able to allow at least ten employees to participate in data collection activities Employee eligibility criteria (individual-level): 1. Aged 16 years of age or older 2. Willing to provide written consent Previous inclusion criteria: Workplace eligibility criteria (cluster-level): 1. Signed up to participate in the Coventry WHI 2. Willing and able to allow at least ten employees to participate in data collection activities Employee eligibility criteria (individual-level): 1. Aged 16 years of age or older 2. Willing to provide written consent |
| Key exclusion criteria | Current exclusion criteria as of 14/12/2022: Workplace exclusion criteria (cluster-level): 1. Not signed up to participate in the Coventry WHI 2. Not willing and able to allow at least three employees to participate in data collection activities Employee exclusion criteria (individual-level): 1. Aged less than 16 years of age 2. Not willing to provide written consent Previous exclusion criteria: Workplace exclusion criteria (cluster-level): 1. Not signed up to participate in the Coventry WHI 2. Not willing and able to allow at least ten employees to participate in data collection activities Employee exclusion criteria (individual-level): 1. Aged less than 16 years of age 2. Not willing to provide written consent |
| Date of first enrolment | 13/06/2022 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Earl Street
Coventry
CV1 5RR
United Kingdom
Sponsor information
University/education
Institute of Applied Health Research
Murray Learning Centre
Birmingham
B152FG
England
United Kingdom
| Phone | +44 (0)121 414 3344 |
|---|---|
| iahradmin@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed academic journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Laura Kudrna (l.kudrna@bham.ac.uk) for anonymous participant-level quantitative datasets after publication in a peer-reviewed journal. Access criteria will be based on evaluating if the reason for access is ethical. Data may be shared via email. Participants are informed that their anonymised data will be stored for 10 years according to the University of Birmingham’s guidelines. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 28/09/2023 | 29/09/2023 | Yes | No | |
| Results article | 08/03/2025 | 08/05/2025 | Yes | No |
Editorial Notes
08/05/2025: Publication reference and total final enrolment added.
29/09/2023: Publication reference added.
07/09/2023: The overall study end date was changed from 31/03/2023 to 16/10/2023 and the plain English summary was updated accordingly.
27/02/2023: The recruitment end date was changed from 28/02/2023 to 31/03/2023.
16/01/2023: The recruitment end date was changed from 31/01/2023 to 28/02/2023.
14/12/2022: The following changes have been made:
1. The inclusion criteria were updated.
2. The target number of participants has been changed from "60 workplaces including at least 10 and no more than 30 employees per organisation" to "60 workplaces including at least 3 and no more than 30 employees per organisation".
3. The exclusion criteria were updated.
10/10/2022: The inclusion criteria were updated.
06/06/2022: Trial's existence confirmed by the University of Birmingham Technology, Engineering and Mathematics Ethical Review Committee.
