ObesityNCT03040518
Game of Stones: A Research Study That Texts Men to Help Them Lose Weight
A study testing Narrative SMS and Endowment Incentive in people with Obesity, run by University of Stirling at 2 sites in United Kingdom.
Trial summary
In 2014, 24% of UK men were obese. However men rarely participate in weight loss programmes. This study looks at whether two interventions which show promise can help obese men lose weight and keep it off. INTERVENTION 1: Sending text messages to a mobile phone. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Narrative SMS and Endowment Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Mar 2017to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese adult men aged 18 or over with and without known health conditions, who do or do not access GP services. Obesity is defined as a BMI equal to or over 30 and/or a waist circumference measurement equal to or above 40 inches (102cm)
Who cannot join
- Insufficient English language for SMS intervention; no mobile phone access.
- Planning to move out of the area within 12 months.
- Current or recent participation in a research weight loss intervention study (in the last 3 months).
- For GP recruitment: severe medical, terminal or psychiatric illness (patient or close family member)
- Impaired cognitive function that would limit understanding of study information and SMS messages.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NHS Greater Glasgow and Clyde
Glasgow
NHS Forth Valley
Stirling
About this study
Official title: Feasibility Study of How Best to Engage Obese Men in Narrative SMS (Short Message System) and Incentive Interventions for Weight Loss, to Inform a Future Effectiveness and Cost-effectiveness Trial
In 2014, 24% of UK men were obese. However men rarely participate in weight loss programmes. This study looks at whether two interventions which show promise can help obese men lose weight and keep it off.
INTERVENTION 1: Sending text messages to a mobile phone. These will be written as though they come from other men who are also losing weight and include 'how to do it' diet and physical activity tips, combined with friendly humour and support.
Read more
INTERVENTION 2: The same texts plus promising men money at the start contingent on weight loss achievement. The money will vary over a year according to whether weight targets are met. This is called an endowment incentive and is based on research showing that modest payment helps people change their diet and physical activity. At the 3, 6 and 12 month weighing appointments, men will have the option of continuing with the original weight loss targets of 5%, 10% and 10% or setting lower targets of 5% of body weight at 6 months and 5% at 12 months. This is to maintain motivation and hope for men who do not meet the more ambitious weight loss targets.
This study examines if the texts work better with incentives than alone. Both interventions are delivered from a computer and have potential to reach large numbers, including men who don't use health services. This work is done together with obese men and a charity for men to help us find the best ways to deliver the interventions to as many men as possible, including men in difficult life situations.
This study will examine whether it is acceptable and feasible to randomise obese men to three groups: texts only; texts and incentive; or to a 'control group' who wait a year and then get the texts for 3 months. The feasibility of recruiting 105 obese men from two regions of Scotland will be assessed. Half of the men will get an invitation letter from their GP. The other half will be approached in the community, given information about the study and invited to take part. Men can take part if their waist circumference is 40 inches and more or their Body Mass Index is 30 or higher. The study examines how long it takes to find 105 obese men who want to take part, how many come back to suitable venues at 3, 6 and 12 months to get weighed and answer questions about their quality of life, lifestyle and motivation. At the end participants will report about their experiences of weight loss and of being in the study.
- Conditions
- Obesity
- Being tested
- Narrative SMS, Endowment Incentive
- Keywords
- Behaviour change, Male obesity, SMS, Financial Incentive, Endowment incentive
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative SMSBehavioural
Narrative SMS have been defined as interactive life stories based around a range of characters (varying in age and socio-demographics) which can simulate the processes that make group-based interventions successful: humour, banter, peer support, facts about diet and PA and evidence based BCTs. The narrative form draws on real world learning from the film, television and games industry. When theorised, the narrative enables engagement with characters who convey the message of the intervention, and facilitate the viewer's empathy. Through creating an empathic bond with the character, users pay more attention to and become engaged and immersed within the story. This appears to lead to optimal learning and conceptualisation of the target information.
Endowment IncentiveBehavioural
All participants will be 'endowed' with an incentive at the start of the trial. It will be placed into a hypothetical personal account which is theirs for a year (no withdrawals). Participants will be able to secure money for verified weight loss at 3, 6, and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Narrative SMS | Experimental | Participants will receive narrative SMS for 12 months.
Participants in all three trial arms will receive information (web or print) about weight loss and a pedometer. Receives: Behavioral: Narrative SMS |
| Narrative SMS and Endowment Incentive | Experimental | Participants will receive narrative SMS for 12 months. In addition, they will receive an endowment incentive for verified weight loss.
Participants in all three trial arms will receive information (web or print) about weight loss and a pedometer. Receives: Behavioral: Narrative SMS; Behavioral: Endowment Incentive |
| Waiting List Control Group | No intervention | Participants will be on a waiting list for 12 months to receive the narrative SMS which will commence after 12 month outcome data has been collected. There will be no interim measurements or contacts by the research team. Men are therefore free to choose whether to try to lose weight during the 12 months. Participants in all three trial arms will receive information (web or print) about weight loss and a pedometer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision whether to proceed to full RCT (Composite Measure)
A decision whether to proceed to a full effectiveness and cost-effectiveness RCT for the SMS intervention, with or without an incentive, compared to a waiting list control. This will be based on the progression criteria:
- Acceptability of the intervention and the control group (willingness to be randomised, intervention engagement, participant retention, qualitative views)
- Feasibility of recruiting 105 men in 4 months
- 12 month outcomes on at least 72 % of men randomised per group
- Evidence of mean weight loss of at least 3% of baseline weight at 12 months in any intervention group
An Independent Trial Steering Committee will decide whether the findings support a two or three arm trial or not
Measured: 12 months
Secondary outcomes (10)
Weight
Measured: 3, 6 and 12 months
BMI
Measured: 3, 6 and 12 months
Waist circumference
Measured: 3, 6 and 12 months
Fruit and vegetable consumption
"How many portions of fruit and vegetables (including pulses, salad, vegetables, fruit juices and fresh, dried and canned fruit) did you eat yesterday?" Answered on a scale of none to 7 or more
Measured: 6 and 12 months
Physical activity
International Physical Activity Questionnaire items:
'During the last 7 days, on how many days do you do moderate physical activities like carrying light loads, bicycling at a regular pace or walking?' Answered on a scale of days per week (none to 7) 'During the last 7 days, how much time did you spend sitting?' On a week day? (Answered in hours and minutes) On a weekend day? (Answered in hours and minutes)
Measured: 6 and 12 months
Smoking status
'Do you currently smoke or have you ever smoked?' Choose from; Yes, I currently smoke every day; Yes, I currently smoke, but not every day; Yes, I used to smoke but have quit or No, I have never smoked.
Measured: 6 and 12 months
Alcohol consumption
'During the last month, how many days did you usually have any kind of drink containing alcohol?' Choose from: Everyday; 5 to 6 times a week; 3 to 4 times a week; twice a week; once a week; 2 to 3 times a month; once a month or never
Measured: 6 and 12 months
EQ-5D-5L
EQ-5D-5L
Measured: 6 and 12 months
Health Service Use
Over the LAST 3 MONTHS, have you used any of the following NHS Services? Choose from: Your GP or another GP Nurse Doctor or nurse in an emergency department (causality/ A\&E) Outpatient appointments Inpatient stay
Yes/No
Measured: 6 and 12 months
Wellbeing
Warwick and Edinburgh wellbeing questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stirling
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aberdeen, Glasgow Caledonian University, University of Glasgow, University of Dundee, Queen's University, Belfast, University of New Brunswick
- Responsible party
- Principal investigator, Pat Hoddinott, University of Stirling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040518
- Sponsor's protocol ID
- 14/185/09
- Status last verified
- Apr 2020
- First submitted
- 16 Dec 2016
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDonald MD, Dombrowski SU, Skinner R, Calveley E, Carroll P, Elders A, Gray CM, Grindle M, Harris FM, Jones C, Hoddinott P; Game of Stones team. Recruiting men from across the socioeconomic spectrum via GP registers and community outreach to a weight management feasibility randomised controlled trial. BMC Med Res Methodol. 2020 Oct 6;20(1):249. doi: 10.1186/s12874-020-01136-2.
PubMed 33023501Dombrowski SU, McDonald M, van der Pol M, Grindle M, Avenell A, Carroll P, Calveley E, Elders A, Glennie N, Gray CM, Harris FM, Hapca A, Jones C, Kee F, McKinley MC, Skinner R, Tod M, Hoddinott P. Game of Stones: feasibility randomised controlled trial of how to engage men with obesity in text message and incentive interventions for weight loss. BMJ Open. 2020 Feb 25;10(2):e032653. doi: 10.1136/bmjopen-2019-032653.
PubMed 32102807
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of How Best to Engage Obese Men in Narrative SMS (Short Message System) and Incentive Interventions for Weight Loss, to Inform a Future Effectiveness and Cost-effectiveness Trial
- ClinicalTrials.gov ID
- NCT03040518
- Acronym / sponsor ID
- 14/185/09
- Conditions
- Obesity
- Keywords
- Behaviour change, Male obesity, SMS, Financial Incentive, Endowment incentive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Collaborators
- University of Aberdeen, Glasgow Caledonian University, University of Glasgow, University of Dundee, Queen's University, Belfast, University of New Brunswick
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 2014, 24% of UK men were obese. However men rarely participate in weight loss programmes. This study looks at whether two interventions which show promise can help obese men lose weight and keep it off.
INTERVENTION 1: Sending text messages to a mobile phone. These will be written as though they come from other men who are also losing weight and include 'how to do it' diet and physical activity tips, combined with friendly humour and support.
INTERVENTION 2: The same texts plus promising men money at the start contingent on weight loss achievement. The money will vary over a year according to whether weight targets are met. This is called an endowment incentive and is based on research showing that modest payment helps people change their diet and physical activity. At the 3, 6 and 12 month weighing appointments, men will have the option of continuing with the original weight loss targets of 5%, 10% and 10% or setting lower targets of 5% of body weight at 6 months and 5% at 12 months. This is to maintain motivation and hope for men who do not meet the more ambitious weight loss targets.
This study examines if the texts work better with incentives than alone. Both interventions are delivered from a computer and have potential to reach large numbers, including men who don't use health services. This work is done together with obese men and a charity for men to help us find the best ways to deliver the interventions to as many men as possible, including men in difficult life situations.
This study will examine whether it is acceptable and feasible to randomise obese men to three groups: texts only; texts and incentive; or to a 'control group' who wait a year and then get the texts for 3 months. The feasibility of recruiting 105 obese men from two regions of Scotland will be assessed. Half of the men will get an invitation letter from their GP. The other half will be approached in the community, given information about the study and invited to take part. Men can take part if their waist circumference is 40 inches and more or their Body Mass Index is 30 or higher. The study examines how long it takes to find 105 obese men who want to take part, how many come back to suitable venues at 3, 6 and 12 months to get weighed and answer questions about their quality of life, lifestyle and motivation. At the end participants will report about their experiences of weight loss and of being in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Narrative SMS | Experimental | Behavioral: Narrative SMSParticipants will receive narrative SMS for 12 months. Participants in all three trial arms will receive information (web or print) about weight loss and a pedometer. |
| Narrative SMS and Endowment Incentive | Experimental | Behavioral: Narrative SMS, Behavioral: Endowment IncentiveParticipants will receive narrative SMS for 12 months. In addition, they will receive an endowment incentive for verified weight loss. Participants in all three trial arms will receive information (web or print) about weight loss and a pedometer. |
| Waiting List Control Group | No intervention | –Participants will be on a waiting list for 12 months to receive the narrative SMS which will commence after 12 month outcome data has been collected. There will be no interim measurements or contacts by the research team. Men are therefore free to choose whether to try to lose weight during the 12 months. Participants in all three trial arms will receive information (web or print) about weight loss and a pedometer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese adult men aged 18 or over with and without known health conditions, who do or do not access GP services. Obesity is defined as a BMI equal to or over 30 and/or a waist circumference measurement equal to or above 40 inches (102cm)
Key exclusion criteria (5 listed)
- Insufficient English language for SMS intervention; no mobile phone access.
- Planning to move out of the area within 12 months.
- Current or recent participation in a research weight loss intervention study (in the last 3 months).
- For GP recruitment: severe medical, terminal or psychiatric illness (patient or close family member)
- Impaired cognitive function that would limit understanding of study information and SMS messages.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative SMSNarrative SMS have been defined as interactive life stories based around a range of characters (varying in age and socio-demographics) which can simulate the processes that make group-based interventions successful: humour, banter, peer support, facts about diet and PA and evidence based BCTs. The narrative form draws on real world learning from the film, television and games industry. When theorised, the narrative enables engagement with characters who convey the message of the intervention, and facilitate the viewer's empathy. Through creating an empathic bond with the character, users pay more attention to and become engaged and immersed within the story. This appears to lead to optimal learning and conceptualisation of the target information. | Behavioural | Narrative SMS, Narrative SMS and Endowment Incentive |
| Endowment IncentiveAll participants will be 'endowed' with an incentive at the start of the trial. It will be placed into a hypothetical personal account which is theirs for a year (no withdrawals). Participants will be able to secure money for verified weight loss at 3, 6, and 12 months. | Behavioural | Narrative SMS and Endowment Incentive |
Primary outcome
Decision whether to proceed to full RCT (Composite Measure)
Time frame: 12 months
A decision whether to proceed to a full effectiveness and cost-effectiveness RCT for the SMS intervention, with or without an incentive, compared to a waiting list control. This will be based on the progression criteria: 1. Acceptability of the intervention and the control group (willingness to be randomised, intervention engagement, participant retention, qualitative views) 2. Feasibility of recruiting 105 men in 4 months 3. 12 month outcomes on at least 72 % of men randomised per group 4. Evidence of mean weight loss of at least 3% of baseline weight at 12 months in any intervention group An Independent Trial Steering Committee will decide whether the findings support a two or three arm trial or not
10 secondary outcomes
Weight
Time frame: 3, 6 and 12 months
BMI
Time frame: 3, 6 and 12 months
Waist circumference
Time frame: 3, 6 and 12 months
Fruit and vegetable consumption
Time frame: 6 and 12 months
Physical activity
Time frame: 6 and 12 months
Smoking status
Time frame: 6 and 12 months
Alcohol consumption
Time frame: 6 and 12 months
EQ-5D-5L
Time frame: 6 and 12 months
Health Service Use
Time frame: 6 and 12 months
Wellbeing
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Derived from this study: PubMed 33023501McDonald MD, Dombrowski SU, Skinner R, Calveley E, Carroll P, Elders A, Gray CM, Grindle M, Harris FM, Jones C, Hoddinott P; Game of Stones team. Recruiting men from across the socioeconomic spectrum via GP registers and community outreach to a weight management feasibility randomised controlled trial. BMC Med Res Methodol. 2020 Oct 6;20(1):249. doi: 10.1186/s12874-020-01136-2.
- Derived from this study: PubMed 32102807Dombrowski SU, McDonald M, van der Pol M, Grindle M, Avenell A, Carroll P, Calveley E, Elders A, Glennie N, Gray CM, Harris FM, Hapca A, Jones C, Kee F, McKinley MC, Skinner R, Tod M, Hoddinott P. Game of Stones: feasibility randomised controlled trial of how to engage men with obesity in text message and incentive interventions for weight loss. BMJ Open. 2020 Feb 25;10(2):e032653. doi: 10.1136/bmjopen-2019-032653.
- Main results paper in BMJ OpenLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative SMS and Endowment Incentive in people with Obesity, run by University of Stirling at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision whether to proceed to full RCT (Composite Measure) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03040518, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.