Effectiveness and cost-effectiveness of text messages with or without endowment incentives for weight management in men with obesity (Game of Stones): study protocol for a randomised controlled trial.

BACKGROUND: Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problems and some cancers, and its prevalence is rising. Men engage less than women in existing weight loss interventions. Game of Stones builds on a successful feasibility study and aims to find out if automated text messages with or without endowment incentives are effective and cost-effective for weight loss at 12 months compared to a waiting list comparator arm in men with obesity. METHODS: A 3-arm, parallel group, assessor-blind superiority randomised controlled trial with process evaluation will recruit 585 adult men with body mass index of 30 kg/m2 or more living in and around three UK centres (Belfast, Bristol, Glasgow), purposively targeting disadvantaged areas. Intervention groups: (i) automated, theory-informed text messages daily for 12 months plus endowment incentives linked to verified weight loss targets at 3, 6 and 12 months; (ii) the same text messages and weight loss assessment protocol; (iii) comparator group: 12 month waiting list, then text messages for 3 months. The primary outcome is percentage weight change at 12 months from baseline. Secondary outcomes at 12 months are as follows: quality of life, wellbeing, mental health, weight stigma, behaviours, satisfaction and confidence. Follow-up includes weight at 24 months. A health economic evaluation will measure cost-effectiveness over the trial and over modelled lifetime: including health service resource-use and quality-adjusted life years. The cost-utility analysis will report incremental cost per quality-adjusted life years gained. Participant and service provider perspectives will be explored via telephone interviews, and exploratory mixed methods process evaluation analyses will focus on mental health, multiple long-term conditions, health inequalities and implementation strategies. DISCUSSION: The trial will report whether text messages (with and without cash incentives) can help men to lose weight over 1 year and maintain this for another year compared to a comparator group; the costs and benefits to the health service; and men's experiences of the interventions. Process analyses with public involvement and service commissioner input will ensure that this open-source digital self-care intervention could be sustainable and scalable by a range of NHS or public services. TRIAL REGISTRATION: ISRCTN 91974895 . Registered on 14/04/2021.

Rugby Fans in Training New Zealand (RUFIT NZ): a randomized controlled trial to assess the effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs.

BACKGROUND: A healthy lifestyle program that appeals to, and supports, overweight and obese New Zealand (NZ) European, Maori (indigenous) and Pasifika men to achieve weight loss is urgently needed. A pilot program inspired by the successful Football Fans in Training program but delivered via professional rugby clubs in NZ (n = 96) was shown to be effective in weight loss, adherence to healthy lifestyle behaviors, and cardiorespiratory fitness in overweight and obese men. A full effectiveness trial is now needed. AIMS: To determine the effectiveness and cost effectiveness of Rugby Fans In Training-NZ (RUFIT-NZ) on weight loss, fitness, blood pressure, lifestyle change, and health related quality of life (HRQoL) at 12- and 52-weeks. METHODS: We conducted a pragmatic, two-arm, multi-center, randomized controlled trial in NZ with 378 (target 308) overweight and obese men aged 30-65 years, randomized to an intervention group or wait-list control group. The 12-week RUFIT-NZ program was a gender-sensitised, healthy lifestyle intervention delivered through professional rugby clubs. Each intervention session included: i) a 1-h workshop-based education component focused on nutrition, physical activity, sleep, sedentary behavior, and learning evidence-based behavior change strategies for sustaining a healthier lifestyle; and 2) a 1-h group-based, but individually tailored, exercise training session. The control group were offered RUFIT-NZ after 52-weeks. The primary outcome was change in body weight from baseline to 52-weeks. Secondary outcomes included change in body weight at 12-weeks, waist circumference, blood pressure, fitness (cardiorespiratory and musculoskeletal), lifestyle behaviors (leisure-time physical activity, sleep, smoking status, and alcohol and dietary quality), and health-related quality of life at 12- and 52-weeks. RESULTS: Our final analysis included 200 participants (intervention n = 103; control n = 97) who were able to complete the RUFIT-NZ intervention prior to COVID-19 restrictions. At 52-weeks, the adjusted mean group difference in weight change (primary outcome) was -2.77 kg (95% CI -4.92 to -0.61), which favored the intervention group. The intervention also resulted in favorable significant differences in weight change and fruit and vegetable consumption at 12-weeks; and waist circumference, fitness outcomes, physical activity levels, and health-related quality of life at both 12 and 52 weeks. No significant intervention effects were observed for blood pressure, or sleep. Incremental cost-effective ratios estimated were $259 per kg lost, or $40,269 per quality adjusted life year (QALY) gained. CONCLUSION: RUFIT-NZ resulted in sustained positive changes in weight, waist circumference, physical fitness, self-reported physical activity, selected dietary outcomes, and health-related quality of life in overweight/obese men. As such, the program should be recommended for sustained delivery beyond this trial, involving other rugby clubs across NZ. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry, ACTRN12619000069156. Registered 18 January 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376740 Universal Trial Number, U1111-1245-0645.

Development and optimisation of a multi-component workplace intervention to increase cycling for the Cycle Nation Project.

The Cycle Nation Project (CNP) aimed to develop, test the feasibility of and optimize a multi-component individual-/social-level workplace-based intervention to increase cycling among office staff at a multinational bank (HSBC UK). To do this, we first explored barriers to cycling in a nationally-representative survey of UK adults, then undertook focus groups with bank employees to understand any context-specific barriers and ways in which these might be overcome. These activities led to identification of 10 individual-level, two social-level, and five organizational-level modifiable factors, which were mapped to candidate intervention components previously identified in a scoping review of cycling initiatives. Interviews with HSBC UK managers then explored the practicality of implementing the candidate intervention components in bank offices. The resultant pilot CNP intervention included 32 core components across six intervention functions (education, persuasion, incentivisation, training, environmental restructuring, enablement). Participants received a loan bike for 12-weeks (or their own bike serviced), and a 9-week cycle training course (condensed to 6 weeks for those already confident in basic cycling skills), including interactive information sharing activities, behavior change techniques (e.g., weekly goal setting), bike maintenance training, practical off-road cycling skill games and on-road group rides. Sessions were delivered by trained bank staff members who were experienced cyclists. The CNP pilot intervention was delivered across three sites with 68 participants. It was completed in two sites (the third site was stopped due to COVID-19) and was feasible and acceptable to both women and men and across different ethnicities. In addition, the CNP intervention was successful (at least in the short term) in increasing cycling by 3 rides/week on average, and improving perceptions of safety, vitality, confidence, and motivation to cycle. Following minor modifications, the long-term effectiveness and cost-effectiveness of the CNP intervention should be tested in a full-scale randomized controlled trial.

The impact of the initial Covid-19 lockdown upon regular sports bettors in Britain: Findings from a cross-sectional online study.

BACKGROUND: In Britain, unprecedented restrictions on daily life associated with the Covid-19 pandemic included the suspension of professional sports events during the initial 'lockdown'. This provides opportunities to observe changes in sports bettors' behaviour when their primary form of activity is removed and assess the impact of Covid-19 related circumstances upon gambling. METHODS: In July 2020, we conducted an online cross-sectional survey of people who bet regularly (at least monthly) on sports before Covid-19 (n = 3866). Bi-variate analyses compared changes in gambling behaviours before and during the initial lockdown. Multi-variate logistic regression models explored associations between problem gambling (men) and moderate risk or problem gambling (MRPG) (women) with changes in Covid-19 related circumstances and changing gambling behaviours during Britain's initial 'lockdown' (March-June 2020). RESULTS: 29.8% of male sports bettors and 33.4% of female sports bettors stopped gambling altogether during the initial Covid-19 lockdown, though 17.3% of men and 16.5% of women started a new form of gambling during lockdown. Among men, adjusted odds ratios of problem gambling were higher among those starting a new gambling activity during lockdown (OR = 2.50 [95% CI 1.38-4.53]). Among women, adjusted odds ratios of MRPG were higher among those whose frequency of gambling on any activity increased during lockdown (OR = 4.21 [1.99-8.92] and among those shielding for health reasons. Poorer wellbeing was associated with problem gambling for men and MRPG for women. CONCLUSIONS: Those changing gambling behaviours during the initial Covid-19 lockdown (e.g. increasing gambling frequency or starting a new gambling activity) are potentially vulnerable to gambling harms.

Protocol for a Mixed-Method Investigation of the Impact of the COVID-19 Pandemic and Gambling Practices, Experiences and Marketing in the UK: The "Betting and Gaming COVID-19 Impact Study".

The COVID-19 pandemic led to unprecedented restrictions on people's movements and interactions, as well as the cancellation of major sports events and social activities, directly altering the gambling landscape. There is urgent need to provide regulators, policy makers and treatment providers with evidence on the patterns and context of gambling during COVID-19 and its aftermath. This protocol describes a study addressing the following three questions: (1) How has COVID-19 changed gambling practices and the risk factors for, and experience of, gambling harms? (2) What is the effect of COVID-19 on gambling marketing? (3) How has COVID-19 changed high risk groups' gambling experiences and practices? This mixed-method study focuses on two groups, namely young adults and sports bettors. In workpackage-1, we will extend an existing longitudinal survey of gambling in young adults (aged 16-24 years) (first wave conducted June-August 2019), adding COVID-19-related questions to the second wave (July-August 2020) and extending to a third wave in 2021; and undertake a survey of sports bettors in the UK (baseline n = 4000, ~July-August 2020), with follow-ups in ~October-November 2020 and ~February-March 2021. In workpackage-2, we will examine changes in expenditure on paid-for gambling advertising from January 2019 to July 2021 and undertake a mixed-method content analysis of a random sample of paid-for gambling advertising (n ~ 200) and social media marketing (n ~ 100) during the initial COVID-19 "lockdown". Workpackage-3 will involve qualitative interviews with a purposive sample of (a) young adults (aged 18-24 years) and (b) sports bettors.

Correction to: Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength.

An amendment to this paper has been published and can be accessed via the original article.

Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength.

BACKGROUND: Resistance exercise is known to be effective in reducing glycated haemoglobin (HbA1c) in people with type 2 diabetes. However, studies, so far, have employed supervised resistance exercise in a laboratory or gym facility which limits the future translation of such exercise in to clinical practice and recommendations. Our primary aim, therefore, is to test the hypothesis, in a randomized controlled trial, that home-based resistance exercise training and gym-based resistance exercise training both reduce HbA1c levels in people with type 2 diabetes compared to control. We will also investigate the effects of home- and gym-based resistance exercise training on muscle strength and body composition. METHODS: The current study is a three-arm randomised controlled trial which will be conducted with 150 eligible people with type 2 diabetes to compare home-and gym-based resistance exercise training with usual care in Kuwait. The interventions will be delivered by exercise specialists and last for 32 weeks. The primary outcomes are HbA1c with secondary outcomes measuring muscle function, body composition, physical activity and quality of life. DISCUSSION: Ethical approval has been granted by the Dasman Diabetes Institute ethical review committee (RA/197/2019). Study findings will be disseminated through presentation at scientific conferences and in scientific journals. TRIAL REGISTRATION: NCT04136730: Retrospectively registered on 21 October 2019.