Game of Stones: Helping men to lose weight
| ISRCTN | ISRCTN91974895 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91974895 |
| IRAS number | 290955 |
| Secondary identifying numbers | CPMS 48967, IRAS 290955 |
- Submission date
- 01/04/2021
- Registration date
- 14/04/2021
- Last edited
- 17/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Some men want to lose some weight, and this, in turn, can make them feel better and help to reduce the risk of some future health problems. However, men rarely take part in weight loss services. Together with men who have tried to lose weight, the study team has designed a new weight loss service. This text messaging and incentive research has been designed with men and for men. It aims to help men to lose weight and keep it off for at least a year
The study aims to find out if text messages (with and without cash incentives) can help men to lose weight over 1 year and keep it off for another year compared to a waiting list group, to find out the costs and benefits to the health service, and men’s experiences.
Who can participate?
Adult men from varied backgrounds living in and around Glasgow, Belfast, or Bristol, with a BMI over 30 kg/m² who want to lose weight and have access to a mobile phone and can receive text messages
What does the study involve?
GP practices will send invitation letters and researchers will recruit men at community venues. Men will be allocated by chance to get text messages to help them to lose weight, or to be on the waiting list to receive the text messages. Participants will receive a step counter (pedometer) and access to a webpage with information and links about how to lose weight and maintain weight loss. Additionally, participants will receive a £20 voucher when they attend the 12 and 24 month appointments. Men will be weighed at 3, 6, 12, and 24 months, and asked questions about their health, quality of life, well-being, and experiences.
What are the possible benefits and risks of participating?
If participants take part in the trial, they will get help to lose weight, however, they may be on a 12-month waiting list for the text messages. Participants can choose how they lose weight and which information they follow. The main disadvantage of taking part is that losing weight is hard work and it can be upsetting when the desired results are not met. Participants are encouraged to come back for all appointments regardless of weight loss results, the research is interested in everybody. Participants will receive a £20 gift voucher at the 12- and 24-month appointments to thank them for their time taking part and helping with the research.
Where is the study run from?
University of Stirling (UK) Stirling in collaboration with Queen’s University Belfast (UK) and the University of Bristol (UK)
When is the study starting and how long is it expected to run for?
From October 2020 to November 2024
Who is funding the study?
The National Institute for Health Research (UK)
Who is the main contact?
Dr Lisa Macaulay, gameofstones@stir.ac.uk
Contact information
Scientific
NMAHP Research Unit
Pathfoot Building
Stirling University Innovation Park
Stirling
FK9 4LA
United Kingdom
 ORCID ID |
0000-0003-2906-8757 |
|---|---|
| Phone | +44 (0)1786 466118 |
| gameofstones@stir.ac.uk |
Scientific
NMAHP Research Unit
Pathfoot Building
Stirling University Innovation Park
Stirling
FK9 4LA
United Kingdom
| ORCID ID |
0000-0002-4372-9681 |
|---|---|
| Phone | +44 (0)1786 46394 |
| p.m.hoddinott@stir.ac.uk |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | A copy of the participant sheet is available from https://www.gameofstonesresearch.com or can be requested by emailing gameofstones@stir.ac.uk |
| Scientific title | Effectiveness and cost-effectiveness of text message and endowment incentives for weight management in men with obesity: The Game of Stones randomised controlled trial |
| Study hypothesis | Are automated ‘Short Message System’ (SMS) texts, delivered to support behaviour change, with or without endowment incentives, effective and cost-effective for weight-loss at 12 months compared to a waiting list control in men with obesity? |
| Ethics approval(s) | Approved 11/12/2020, North of Scotland Research Ethics Committee 2 (North of Scotland Research Ethics Service, Summerfield House, 2 Eday Road, Aberdeen AB15 6RE; +44 (0)1224 558458; gram.nosres@nhs.scot), ref: 20/NS/0141 |
| Condition | Obesity |
| Intervention | Researchers will recruit men who want to lose weight from varied backgrounds. GP practices will send invitation letters and researchers will recruit men at community venues. After receiving written consent at the enrolment appointment, participants will be randomised using a secure remote web-based system provided by the CHaRT CTU. The CHaRT randomisation service is independent of the data management and statistical team at CHaRT who will be undertaking the outcome data analysis. Randomisation will be stratified by trial centre. Men will be randomly allocated (1:1) to receive text messages to help them to lose weight for 12 months, or to be on the 12-month waiting list to receive the text messages. Men will be weighed at 3, 6, 12, and 24 months and asked questions about their health, quality of life, well-being, and experiences at 12 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Weight loss is measured as % of baseline at 12 months measured using calibrated medical scales at baseline and 12 months |
| Secondary outcome measures | Current secondary outcome measures as of 18/05/2023: 1. Weight loss is measured in kg using calibrated medical scales at baseline, 3, 6, 12, and 24 months 2. Mental well being is measured by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline and 12 months, and the EuroQol 5-dimension (EQ-5D) quality of life questionnaire (Anxiety and Depression Dimension) and PHQ-4 at baseline, 12, and 24 months 3. Health economic outcomes are measured by the EQ-5D quality of life questionnaire and NHS Health care use questionnaires at baseline, 12, and 24 months 4. Health behaviours (physical activity, smoking status, and alcohol intake) measured using a self-report questionnaire at baseline and 12 months 5. Weight management strategies used measured by self-report questionnaire at baseline, 12, and 24 months 6. Confidence in ability to lose and maintain weight loss is measured by self-report questionnaire at baseline and 12 months 7. Weight stigma is measured by WSSQ at baseline and 12 months 8. Participant satisfaction is measured by self-report questionnaire at 12 months 9. Experience and behaviours is examined through qualitative data taken in interviews at 12 and 24 months _____ Previous secondary outcome measures as of 14/12/2021: 1. Weight loss is measured in kg using calibrated medical scales at baseline, 3, 6, 12, and 24 months 2. Mental well being is measured by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) and PHQ4 at baseline and 12 months 3. Health economic outcomes are measured by the EuroQol 5-dimension (EQ-5D) quality of life questionnaire and NHS Health care use questionnaires at baseline, 12, and 24 months 4. Health behaviours (physical activity, smoking status, and alcohol intake) measured using a self-report questionnaire at baseline and 12 months 5. Weight management strategies used measured by self-report questionnaire at baseline, 12, and 24 months 6. Confidence in ability to lose and maintain weight loss is measured by self-report questionnaire at baseline, 12, and 24 months 7. Weight stigma is measured by WSSQ at baseline and 12 months 8. Participant satisfaction is measured by self-report questionnaire at 12 and 24 months 9. Experience and behaviours is examined through qualitative data taken in interviews at 12 and 24 months _____ Previous secondary outcome measures: 1. Weight loss is measured in kg using calibrated medical scales at baseline, 3, 6, 12, and 24 months 2. Mental well being is measured by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline and 12 months 3. Health economic outcomes are measured by the EuroQol 5-dimension (EQ-5D) quality of life questionnaire and NHS Health care use questionnaires at baseline, 12, and 24 months 4. Health behaviours (physical activity, smoking status, and alcohol intake) measured using a self-report questionnaire at baseline and 12 months 5. Weight management strategies used measured by self-report questionnaire at baseline, 12, and 24 months 6. Confidence in ability to lose and maintain weight loss is measured by self-report questionnaire at baseline, 12, and 24 months 7. Participant satisfaction is measured by self-report questionnaire at 12 and 24 months 8. Experience and behaviours is examined through qualitative data taken in interviews at 12 and 24 months |
| Overall study start date | 01/10/2020 |
| Overall study end date | 30/11/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | Planned Sample Size: 585; UK Sample Size: 585 |
| Total final enrolment | 585 |
| Participant inclusion criteria | 1. Men aged ≥18 years 2. BMI ≥30 kg/m² 3. Understand study information and able to give informed consent 4. Resident in and around Glasgow, Belfast, or Bristol |
| Participant exclusion criteria | 1. Inability to understand the trial or the English language SMS intervention 2. No mobile phone access 3. Planning to move out of the area within 12 months 4. Current or recent (within last 6 months) participation in a research weight loss intervention study (participants from the feasibility study are welcome to participate in this RCT) 5. Plan to have bariatric surgery within 12 months 6. For GP screening prior to sending invitation letters: 6.1. Known terminal illness or severe psychiatric illness 6.2. Known impaired cognitive or visual function that would limit understanding of study information and SMS 7. Whilst there is no upper age limit exclusion to this trial, researchers taking consent will be trained to consider whether participation is appropriate for individual participants (for example the levels of frailty allowing standard weighing procedures to be followed or sufficient cognition to understand consent and participation procedures) |
| Recruitment start date | 13/07/2021 |
| Recruitment end date | 24/05/2022 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
Study participating centres
Pathfoot Building
Stirling
FK9 4LA
United Kingdom
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
University Road
Belfast
BT7 1NN
United Kingdom
Sponsor information
University/education
Research and Enterprise Office
3B1 Cottrell Building
Stirling
FK9 4LA
Scotland
United Kingdom
| Phone | +44 (0)1786466196 |
|---|---|
| rachel.beaton@stir.ac.uk | |
| Website | http://www.stir.ac.uk/ |
"ROR" |
https://ror.org/045wgfr59 |
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 | 14/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Current publication and dissemination plan as of 11/11/2024: The primary outcome results were published in JAMA in May 2024: JAMA. 2024;332(1):31-40. doi:10.1001/jama.2024.7064. The findings were widely shared with the public, men’s health groups, and health service staff via newsletters, dissemination events, conference presentations, and a variety of media coverage. Previous publication and dissemination plan: Planned publication in a high-impact peer-reviewed journal. The findings will be shared with the public, men’s health groups, and health service staff through social media, blogs, reports, presentations, and research papers. |
| IPD sharing plan | Direct access will be granted to authorised representatives from the Sponsor, host institution and the regulatory authorities to permit trial-related monitoring, audits and inspections- in line with participant consent. Any hard copy data will be stored at Stirling University and requests to access data are administered through the University’s data archive DataSTORRE. The investigator site files will be archived at each centre. Following publication of the results, an anonymised participant level dataset and statistical code for generating the results will be available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 22/07/2022 | 25/07/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Statistical Analysis Plan | version 2.0 | 21/06/2023 | 21/11/2023 | No | No |
| Results article | 14/05/2024 | 15/05/2024 | Yes | No | |
| Statistical Analysis Plan | version 1.2 | 25/06/2024 | 28/06/2024 | No | No |
Additional files
Editorial Notes
17/01/2025: A contact was changed.
11/11/2024: The intention to publish date was changed from 01/04/2025 to 14/05/2024. Publication and dissemination plan updated.
28/06/2024: Statistical analysis plan V1.2 added.
15/05/2024: Publication reference added.
21/11/2023: The following changes were made:
1. Statistical analysis plan added.
2. The overall study end date was changed from 31/03/2024 to 30/11/2024.
3. The study website was changed from "https://www.gameofstonesresearch.com"; to "https://fundingawards.nihr.ac.uk/award/NIHR129703";.
23/05/2023: The secondary outcome measures were changed.
25/07/2022: Publication reference added.
08/06/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2022 to 24/05/2022.
2. The total final enrolment was added.
23/03/2022: The following changes have been made:
1. The recruitment start date has been changed from 24/05/2021 to 13/07/2021.
2. The recruitment end date has been changed from 31/12/2021 to 30/06/2022.
14/12/2021: The following changes were made to the trial record:
1. The secondary outcome measures were changed.
2. The data sharing statement was added.
17/05/2021: The recruitment start date was changed from 01/04/2021 to 24/05/2021.
01/04/2021: Trial’s existence confirmed by the National Institute for Health Research (NIHR).
