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
Funder: Chief Scientist Office, Scotland

Abstract: WHY? People with obesity are at greater risk of type two diabetes, some cancers, heart disease, stroke and mobility problems. Weight loss services (e.g. Weight Watchers) can improve health, but men rarely take part, particularly men from more disadvantaged areas._x000D_ _x000D_ PRELIMINARY STUDY: We designed a new weight loss service together with men who have tried to lose weight. NIHR funded us to review the literature and do a pilot study. ‘Game of Stones’ includes sending regular text messages alone, or with cash incentives based on how much weight men lose. In our pilot study, we compared the experiences of men using this service with men who received no texts or cash incentives but were on a waiting list to receive the text messages. We compared two types of texts. Most men liked the service and lost weight. Many of the men who took part lived in disadvantaged areas and these men were more likely to return at 12 months to be weighed._x000D_ _x000D_ AIMS: To find out if a text message service (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 the experiences of men taking part and people who make decisions about services. To understand the experiences of men living with obesity and multiple long-term conditions and/or mental health problems._x000D_ _x000D_ PLAN: Researchers in Glasgow, Belfast and Bristol will recruit 585 men from varied backgrounds at community and health centre venues. GP practices will send invitation letters to men who are known to have obesity. Researchers will also recruit men at community venues, so that men who do not visit a GP can participate. Men will be allocated by chance to one of three groups: texts with incentives; texts only; and a 12-month waiting list for texts. At the start, a mock cheque will be given to men in the incentive group. The full incentive is paid at 12 months only if all personal weight loss targets are met when men are weighed at 3, 6, and 12 months. Some money is lost for each target weight that is not met at 3, 6 and 12 months. Important weight loss for health after 12 months is the main outcome hoped for and this will be measured by a researcher who does not know which study group the man is in. At a 12-month appointment, men complete a questionnaire (online or paper) about their health, quality of life and well-being. To find out what happens when the texts and incentives stop, men are weighed 1 year later (24 months after the start). We will interview some men and service decision makers about their views of Game of Stones._x000D_ _x000D_ PATIENT AND PUBLIC INVOLVEMENT (PPI): Men’s Health Forum (GB and Ireland) are full team members, helping with all aspects of the study. They already worked with us to review the literature, design and conduct the pilot study. Men with obesity, Men’s Shed users and the University of Stirling PPI group helped too. Men chose the study name, helped to decide the outcomes that matter to men, write texts and leaflets. Two independent men will be on the steering group._x000D_ _x000D_ KEY QUESTIONS THIS STUDY WILL ANSWER: Can Game of Stones help men lose weight and keep it off? What will it cost the NHS? What are the benefits for men and the NHS? Does the service help men who are less well-off as well as the more well-off?_x000D_ _x000D_ THE FINDINGS will be shared with the public, men’s health groups, health service managers and staff through social media, blogs, reports, presentations and research papers.

Lay abstract: RESEARCH QUESTION_x000D_ Are automated ‘Short Message System’ (SMS) texts, delivered to support behaviour change, with or without endowment Incentives (I), effective and cost-effective for weight-loss at 12 months (M) compared to a waiting list control in men with obesity?_x000D_ _x000D_ BACKGROUND_x000D_ Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problems and some cancers, and its prevalence in rising. Men engage less than women in existing weight loss interventions. This trial builds on our Game of Stones NIHR PHR-funded feasibility study._x000D_ _x000D_ AIMS_x000D_ 1.Conduct a 3-arm RCT to estimate between group weight-loss difference at 12M for men with obesity who receive i) SMS+I; ii) SMS only; iii) 12M wait list for SMS_x000D_ 2.Assess differences between groups in secondary outcomes_x000D_ 3.Assess the cost-effectiveness of SMS+I and SMS only compared to a wait list control_x000D_ 4.Understand men’s experiences of the intervention with a focus on living with mental health conditions and multiple long term conditions; and service providers perspectives’_x000D_ 5.Follow up men at 24M (12M after intervention ceases) and request consent for linkage to long-term health outcome data_x000D_ 6.Refine the digital programming for future scalability and implementation._x000D_ _x000D_ METHODS_x000D_ Three-arm, assessor-blind, randomised controlled trial (1:1:1) recruiting 585 men with obesity via community venues (50%) or GP invitation letter (50%), purposively targeting disadvantaged areas; qualitative sub-study; cost-effectiveness modelling_x000D_ POPULATION: Adult men with Body Mass Index of 30kg/m2 or more_x000D_ SETTING: 3 centres (Glasgow, Belfast, Bristol) including GP practices and diverse venues_x000D_ INTERVENTIONS 1) SMS ONLY: daily texts for 12M with evidence and theory-based behaviour change techniques embedded; 2) SMS + I: as above + financial incentives based on loss aversion theory. The full incentive endowed at the start is paid at 12M if all verified weight loss targets from baseline are met: 5% of weight lost at 3M, 10% lost at 6M and 10% lost at 12M. Some money is lost for each target that is not met._x000D_ CONTROL: 12M wait list then SMS for 3M_x000D_ PRIMARY OUTCOME: mean between-group % differences in weight-loss at 12M from baseline_x000D_ POWERED TO DETECT 3% weight loss at 12M_x000D_ SECONDARY OUTCOMES: physical activity; alcohol consumption; smoking status; satisfaction; Warwick-Edinburgh Mental Well-Being Scale; PH-4; EQ5D-5L-AD; 24M weight loss; adverse events; EQ5D-5L. _x000D_ PROCESS OUTCOMES: incentives gained/targets met; SMS delivered; GP/Community recruitment strategy, socio-economic status, co-morbidity; behaviour strategies_x000D_ QUALITATIVE RESEARCH: telephone interviews with: i) 30 participants about their experiences at 12M and 24M; ii) 12-16 service commissioners about scalability, iii) 8 -12 participants about experiences of living with obesity and mental health conditions at 12M iv) 8-12 participants about experiences of living with obesity and multiple long-term conditions_x000D_ HEALTH ECONOMIC EVALUATION: Costs a) over the trial and b) over modelled lifetime: including health service resource-use and QALYs. A cost-utility analysis will report incremental cost per QALY gained._x000D_ _x000D_ TIMELINE_x000D_ M0-6 set-up; M7-15 recruitment (24 men/month/centre); M7-M27 3, 6 and 12M data collection; M28-33 data analysis; M19-36 qualitative study; M31-39 follow-up at 24M; M28-40 economic analysis; M40-42 final report and dissemination._x000D_ _x000D_ ANTICIPATED IMPACT AND DISSEMINATION_x000D_ We will work with PPI and service commissioners so that this open-source digital self-care intervention could be centrally or locally sustainable and scalable by a range of NHS or public services. Dissemination will be with Men’s Health Forum to men, the public, policy makers, NHS commissioners and staff via media, online fora, stakeholder events and publications.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;METABOLIC AND ENDOCRINE;ORAL AND GASTROINTESTINAL;STROKE