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BACKGROUND: The COVID-19 pandemic affected healthcare delivery globally, impacting care access and delivery of essential services. OBJECTIVES: We investigated the pandemic's impact on care for patients with type 2 diabetes and factors associated with care disruption in Kenya and Tanzania. METHODS: A cross-sectional study was conducted among adults diagnosed with diabetes pre-COVID-19. Data were collected in February-April 2022 reflecting experiences at two time-points, three months before and the three months most affected by the COVID-19 pandemic. A questionnaire captured data on blood glucose testing, changes in medication prescription and access, and healthcare provider access. RESULTS: We recruited 1000 participants (500/country). Diabetes care was disrupted in both countries, with 34.8% and 32.8% of the participants reporting change in place and frequency of testing in Kenya, respectively. In Tanzania, 12.4% and 17.8% reported changes in location and frequency of glucose testing, respectively. The number of health facility visits declined, 14.4% (p < 0.001) in Kenya and 5.6% (p = 0.001) in Tanzania. In Kenya, there was a higher likelihood of severe care disruption among insured patients (adjusted odds ratio [aOR] 1.56, 95% confidence interval [CI][1.05-2.34]; p = 0.029) and a lower likelihood among patients residing in rural areas (aOR, 0.35[95%CI, 0.22-0.58]; p < 0.001). Tanzania had a lower likelihood of severe disruption among insured patients (aOR, 0.51[95%CI, 0.33-0.79]; p = 0.003) but higher likelihood among patients with low economic status (aOR, 1.81[95%CI, 1.14-2.88]; p = 0.011). CONCLUSIONS: COVID-19 disrupted diabetes care more in Kenya than Tanzania. Health systems and emergency preparedness should be strengthened to ensure continuity of service provision for patients with diabetes.
Main findings: The COVID-19 pandemic disrupted diabetes care in Kenya and Tanzania resulting in changes in place and frequency of blood glucose testing, medication prescribed (less oral hypoglycaemics and more insulin), fewer health facility visits and more difficulty accessing healthcare providers.Added knowledge: This study quantifies the impact of the COVID-19 pandemic on diabetes care in Kenya and Tanzania, and describes the factors associated with care disruption in both countries.Global health impact for policy and action: Evidence on diabetes care disruption is useful in making plans and policies responsive to the needs of diabetes patients during pandemics or related emergency situations.
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COVID-19 , Diabetes Mellitus Tipo 2 , Acessibilidade aos Serviços de Saúde , Humanos , Quênia/epidemiologia , Tanzânia/epidemiologia , COVID-19/epidemiologia , Diabetes Mellitus Tipo 2/terapia , Diabetes Mellitus Tipo 2/epidemiologia , Masculino , Feminino , Estudos Transversais , Pessoa de Meia-Idade , Adulto , Idoso , SARS-CoV-2 , Atenção à Saúde/organização & administração , PandemiasRESUMO
OBJECTIVES: Given the decline in physical activity levels in Malawi, like other sub-Saharan African countries, and its implication for non-communicable disease (NCD) prevention, this study aimed to compare and contrast accounts of practices and attitudes towards physical activity among Malawian men and women (previously identified as having pre-diabetes) in urban and rural settings. SETTING: Two communities: one urban (Lilongwe) and one rural (Karonga). PARTICIPANTS: 14 men (urban N=6, rural N=8) and 18 women (urban N=9, rural N=9) classified as prediabetic during their participation in an NCD survey 3-5 years previously. DESIGN: A qualitative focus group study (N=4) and thematic analysis, with the ecological model used as a framework to characterise the types of physical activity people engaged in and potential ways to support them to exercise more. RESULTS: Participants reported undertaking different types of physical activity across all ecological model domains (household, occupational, transport, recreational). Rural participants reported more vigorous physical activities than urban participants, and women reported more household activities than men. Many participants recognised a need to promote physical activity in Malawi, and the health benefits of doing so, including the importance of physical activity in helping them stay strong to maintain physical functioning. Barriers to physical activity included competing priorities (especially urban men), societal expectations around wealth, use of motorised transport, lack of accessible facilities for women, ageing and ill health. CONCLUSIONS: Physical activity is declining in Malawi as working and transport practices change in response to economic development, making promotion of alternative forms of physical activity a public health priority. Multilevel interventions emphasising the personal benefits/value of physical activity for all ages, and routine and group-based exercising, as well as investment in accessible recreational facilities (including for women) and active travel infrastructure should be considered to improve physical activity levels in Malawi.
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Doenças não Transmissíveis , Estado Pré-Diabético , Masculino , Humanos , Feminino , Malaui , Pesquisa Qualitativa , Exercício Físico , População RuralRESUMO
This study mapped existing health-promotion provisions targeting adults in professional football clubs across England, the Netherlands, Norway, and Portugal, and explored motives behind the clubs' adoption of the European Fans in Training (EuroFIT) programme. We surveyed top-tier football clubs in the four countries and interviewed representatives from football clubs and the clubs' charitable foundation who delivered EuroFIT. The findings showed large between-country differences, with football clubs in England reporting far greater healthy lifestyle provision than other countries. Relatively few health-promotion programmes targeted adults, particularly in the Netherlands, Portugal, and Norway. Club representatives reported that the motives for adopting the EuroFIT programme often involved adhering to both the social objectives of the football club or club's foundation and business-related objectives. They viewed the scientific evidence and evaluation underpinning EuroFIT as helpful in demonstrating the value and potential future impact of both the programme and the clubs' wider corporate social responsibility provision.
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Promoção da Saúde , Motivação , Adulto , Dieta Saudável , Europa (Continente) , Feminino , Futebol Americano , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Avaliação de Programas e Projetos de Saúde , Participação dos Interessados/psicologia , Inquéritos e Questionários , Telefone , Adulto JovemRESUMO
Amidst public health campaigns urging people to sit less as well as being more physically active, this paper investigates how older adults make sense of their sedentary behaviour. Using an accounts framework focusing on how people rationalise their sitting practices, we analysed data from 44 qualitative interviews with older adults. All interviewees had received information about sedentary behaviour and health, visual feedback on their own objectively measured sitting over a week and guidance on sitting less. Participants used accounts to position sitting as a moral practice, distinguishing between 'good' (active/'busy') and 'bad' (passive/'not busy') sitting. This allowed them to align themselves with acceptable (worthwhile) forms of sitting and distance themselves from other people whose sitting they viewed as less worthwhile. However, some participants also described needing to sit more as they got older. The findings suggest that some public health messaging may lead to stigmatisation around sitting. Future sedentary behaviour guidelines and public health campaigns should consider more relatable guidelines that consider the lived realities of ageing, and the individual and social factors that shape them. They should advocate finding a balance between sitting and moving that is appropriate for each person.
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Promoção da Saúde , Comportamento Sedentário , Idoso , Humanos , Princípios MoraisRESUMO
OBJECTIVES: Increasing physical activity reduces the risk of chronic illness including Type 2 diabetes, cardiovascular disease and certain types of cancer. Lifestyle interventions can increase physical activity but few successfully engage men. This study aims to investigate the 5 year cost-effectiveness of EuroFIT, a program to improve physical activity tailored specifically for male football (soccer) fans compared to a no intervention comparison group. METHODS: We developed a Markov cohort model in which the impact of improving physical activity on five chronic health conditions (colorectal cancer, Type 2 diabetes, coronary heart disease, stroke and depression) and mortality was modelled. We estimated costs from a societal perspective and expressed benefits as quality adjusted life years (QALYs). We obtained data from a 4-country (England, Netherlands, Portugal and Norway) pragmatic randomised controlled trial evaluating EuroFIT, epidemiological and cohort studies, and meta-analyses. We performed deterministic and probabilistic sensitivity analyses to assess the impact of uncertainty in the model's parameter values on the cost-effectiveness results. We used Monte Carlo simulations to estimate uncertainty and presented this using cost-effectiveness acceptability curves (CEACs). We tested the robustness of the base case analysis using five scenario analyses. RESULTS: Average costs over 5 years per person receiving EuroFIT were 14,663 and per person receiving no intervention 14,598. Mean QALYs over 5 years were 4.05 per person for EuroFIT and 4.04 for no intervention. Thus, the average incremental cost per person receiving EuroFIT was 65 compared to no intervention, while the average QALY gain was 0.01. This resulted in an ICER of 5206 per QALY gained. CEACs show that the probability of EuroFIT being cost-effective compared to no intervention is 0.53, 0.56 and 0.58 at thresholds of 10,000, 22,000 and 34,000 per QALY gained, respectively. When using a time horizon of 10 years, the results suggest that EuroFIT is more effective and less expensive compared to (i.e. dominant over) no intervention with a probability of cost-effectiveness of 0.63 at a threshold of 22,000 per QALY gained. CONCLUSIONS: We conclude the EuroFIT intervention is not cost-effective compared to no intervention over a period of 5 years from a societal perspective, but is more effective and less expensive (i.e. dominant) after 10 years. We thus suggest that EuroFIT can potentially improve public health in a cost-effective manner in the long term.
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Exercício Físico/fisiologia , Condicionamento Físico Humano , Análise Custo-Benefício , Diabetes Mellitus Tipo 2 , Europa (Continente) , Humanos , Masculino , Condicionamento Físico Humano/economia , Condicionamento Físico Humano/estatística & dados numéricos , Anos de Vida Ajustados por Qualidade de Vida , Esportes/economia , Esportes/estatística & dados numéricosRESUMO
BACKGROUND: A healthy lifestyle program that appeals to, and supports, obese New Zealand (NZ) European, Maori (indigenous) and Pasifika men to achieve weight loss is urgently needed. In Scotland, Football Fans in Training (FFIT), a weight management and healthy lifestyle program for overweight and obese men aged 35-65 years , delivered by community coaching staff at professional football clubs, has been shown to be beneficial and cost-effective. A pilot program inspired by FFIT but delivered by professional rugby clubs in NZ (n = 96) was shown to be effective in weight loss, improved physiological outcomes, and adherence to healthy lifestyle behaviors in overweight and obese men. The objective of this trial is to determine the effectiveness and cost-effectiveness of the Rugby Fans in Training New Zealand (RUFIT-NZ) program. METHODS: A pragmatic, two-arm, multi-center, randomized controlled trial involving 308 overweight and obese men aged 30-65 years, randomized to either an intervention group (n = 154) or a wait-list control group (n = 154). The intervention-group participated in the 12-week RUFIT-NZ program, a gender-sensitized, healthy lifestyle intervention adapted to the environment and cultural diversity of NZ and delivered through professional rugby clubs. Participants in the intervention group undergo physical training sessions, in addition to workshop-based sessions to learn about nutrition, physical activity, sleep, sedentary behavior, and a range of behavior-change strategies for sustaining a healthier lifestyle. The control group receives the program after 52 weeks. The primary outcome is change in body weight from baseline to 52 weeks. Secondary outcomes include change in body weight at 12 weeks; waist circumference, blood pressure, fitness, and lifestyle behaviors at 12 and 52 weeks; and cost-effectiveness. A process evaluation informed by the RE-AIM framework will evaluate potential implementation of RUFIT-NZ as an ongoing program in NZ after the trial. DISCUSSION: This trial will investigate the effectiveness and cost-effectiveness of the RUFIT-NZ program in overweight and obese NZ men. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry, ACTRN12619000069156. Registered on 18 January 2019, according to the World Health Organization Trial Registration Data Set. Universal Trial Number, U1111-1245-0645.
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Academias de Ginástica , Futebol Americano , Estilo de Vida Saudável , Estudos Multicêntricos como Assunto , Obesidade/terapia , Ensaios Clínicos Pragmáticos como Assunto , Programas de Redução de Peso/economia , Programas de Redução de Peso/métodos , Adulto , Idoso , Análise Custo-Benefício , Exercício Físico , Comportamentos Relacionados com a Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Comportamento Sedentário , Circunferência da Cintura , Redução de PesoRESUMO
BACKGROUND: Reducing sitting time as well as increasing physical activity in inactive people is beneficial for their health. This paper investigates the effectiveness of the European Fans in Training (EuroFIT) programme to improve physical activity and sedentary time in male football fans, delivered through the professional football setting. METHODS AND FINDINGS: A total of 1,113 men aged 30-65 with self-reported body mass index (BMI) ≥27 kg/m2 took part in a randomised controlled trial in 15 professional football clubs in England, the Netherlands, Norway, and Portugal. Recruitment was between September 19, 2015, and February 2, 2016. Participants consented to study procedures and provided usable activity monitor baseline data. They were randomised, stratified by club, to either the EuroFIT intervention or a 12-month waiting list comparison group. Follow-up measurement was post-programme and 12 months after baseline. EuroFIT is a 12-week, group-based programme delivered by coaches in football club stadia in 12 weekly 90-minute sessions. Weekly sessions aimed to improve physical activity, sedentary time, and diet and maintain changes long term. A pocket-worn device (SitFIT) allowed self-monitoring of sedentary time and daily steps, and a game-based app (MatchFIT) encouraged between-session social support. Primary outcome (objectively measured sedentary time and physical activity) measurements were obtained for 83% and 85% of intervention and comparison participants. Intention-to-treat analyses showed a baseline-adjusted mean difference in sedentary time at 12 months of -1.6 minutes/day (97.5% confidence interval [CI], -14.3-11.0; p = 0.77) and in step counts of 678 steps/day (97.5% CI, 309-1.048; p < 0.001) in favor of the intervention. There were significant improvements in diet, weight, well-being, self-esteem, vitality, and biomarkers of cardiometabolic health in favor of the intervention group, but not in quality of life. There was a 0.95 probability of EuroFIT being cost-effective compared with the comparison group if society is willing to pay £1.50 per extra step/day, a maximum probability of 0.61 if society is willing to pay £1,800 per minute less sedentary time/day, and 0.13 probability if society is willing to pay £30,000 per quality-adjusted life-year (QALY). It was not possible to blind participants to group allocation. Men attracted to the programme already had quite high levels of physical activity at baseline (8,372 steps/day), which may have limited room for improvement. Although participants came from across the socioeconomic spectrum, a majority were well educated and in paid work. There was an increase in recent injuries and in upper and lower joint pain scores post-programme. In addition, although the five-level EuroQoL questionnaire (EQ-5D-5L) is now the preferred measure for cost-effectiveness analyses across Europe, baseline scores were high (0.93), suggesting a ceiling effect for QALYs. CONCLUSION: Participation in EuroFIT led to improvements in physical activity, diet, body weight, and biomarkers of cardiometabolic health, but not in sedentary time at 12 months. Within-trial analysis suggests it is not cost-effective in the short term for QALYs due to a ceiling effect in quality of life. Nevertheless, decision-makers may consider the incremental cost for increase in steps worth the investment. TRIAL REGISTRATION: International Standard Randomised Controlled Trials, ISRCTN-81935608.
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Exercício Físico/fisiologia , Promoção da Saúde/métodos , Aptidão Física/fisiologia , Avaliação de Programas e Projetos de Saúde/métodos , Comportamento Sedentário , Futebol/fisiologia , Adulto , Idoso , Europa (Continente)/epidemiologia , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Obesity is a major public health concern requiring innovative interventions that support people to lose weight and keep it off long term. However, weight loss maintenance remains a challenge and is under-researched, particularly in men. The Football Fans in Training (FFIT) programme engages men in weight management through their interest in football, and encourages them to incorporate small, incremental physical activity and dietary changes into daily life to support long-term weight loss maintenance. In 2011/12, a randomised controlled trial (RCT) of FFIT demonstrated effectiveness and cost-effectiveness at 12 months. The current study aimed to investigate long-term maintenance of weight loss, behavioural outcomes and lifetime cost-effectiveness following FFIT. METHODS: A longitudinal cohort study comprised 3.5-year follow-up of the 747 FFIT RCT participants. Men aged 35-65 years, BMI ≥ 28 kg/m2 at RCT baseline who consented to long-term follow-up (n = 665) were invited to participate: those in the FFIT Follow Up Intervention group (FFIT-FU-I) undertook FFIT in 2011 during the RCT; the FFIT Follow Up Comparison group (FFIT-FU-C) undertook FFIT in 2012 under routine (non-research) conditions. The primary outcome was objectively-measured weight loss (from baseline) at 3.5 years. Secondary outcomes included changes in self-reported physical activity and diet at 3.5 years. Cost-effectiveness was estimated at 3.5 years and over participants' lifetime. RESULTS: Of 665 men invited, 488 (73%; 65% of the 747 RCT participants) attended 3.5-year measurements. The FFIT-FU-I group sustained a mean weight loss of 2.90 kg (95% CI 1.78, 4.02; p < 0.001) 3.5 years after starting FFIT; 32.2% (75/233) weighed ≥5% less than baseline. The FFIT-FU-C group had lost 2.71 kg (1.65, 3.77; p < 0.001) at the 3.5-year measurements (2.5 years after starting FFIT); 31.8% (81/255) weighed ≥5% less than baseline. There were significant sustained improvements in self-reported physical activity and diet in both groups. The estimated incremental cost-effectiveness of FFIT was £10,700-£15,300 per QALY gained at 3.5 years, and £1790-£2200 over participants' lifetime. CONCLUSIONS: Participation in FFIT under research and routine conditions leads to long-term weight loss and improvements in physical activity and diet. Investment in FFIT is likely to be cost-effective as part of obesity management strategies in countries where football is popular. TRIAL REGISTRATION: ISRCTN32677491 , 20 October 2011.
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Avaliação de Programas e Projetos de Saúde/métodos , Futebol , Programas de Redução de Peso/economia , Programas de Redução de Peso/métodos , Adulto , Idoso , Índice de Massa Corporal , Estudos de Coortes , Análise Custo-Benefício , Dieta , Exercício Físico , Seguimentos , Promoção da Saúde/métodos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Obesidade/complicações , Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Although many smartphone apps and wearables have been designed to improve physical activity, their rapidly evolving nature and complexity present challenges for evaluating their impact. Traditional methodologies, such as randomized controlled trials (RCTs), can be slow. To keep pace with rapid technological development, evaluations of mobile health technologies must be efficient. Rapid alternative research designs have been proposed, and efficient in-app data collection methods, including in-device sensors and device-generated logs, are available. Along with effectiveness, it is important to measure engagement (ie, users' interaction and usage behavior) and acceptability (ie, users' subjective perceptions and experiences) to help explain how and why apps and wearables work. OBJECTIVES: This study aimed to (1) explore the extent to which evaluations of physical activity apps and wearables: employ rapid research designs; assess engagement, acceptability, as well as effectiveness; use efficient data collection methods; and (2) describe which dimensions of engagement and acceptability are assessed. METHOD: An interdisciplinary scoping review using 8 databases from health and computing sciences. Included studies measured physical activity, and evaluated physical activity apps or wearables that provided sensor-based feedback. Results were analyzed using descriptive numerical summaries, chi-square testing, and qualitative thematic analysis. RESULTS: A total of 1829 abstracts were screened, and 858 articles read in full. Of 111 included studies, 61 (55.0%) were published between 2015 and 2017. Most (55.0%, 61/111) were RCTs, and only 2 studies (1.8%) used rapid research designs: 1 single-case design and 1 multiphase optimization strategy. Other research designs included 23 (22.5%) repeated measures designs, 11 (9.9%) nonrandomized group designs, 10 (9.0%) case studies, and 4 (3.6%) observational studies. Less than one-third of the studies (32.0%, 35/111) investigated effectiveness, engagement, and acceptability together. To measure physical activity, most studies (90.1%, 101/111) employed sensors (either in-device [67.6%, 75/111] or external [23.4%, 26/111]). RCTs were more likely to employ external sensors (accelerometers: P=.005). Studies that assessed engagement (52.3%, 58/111) mostly used device-generated logs (91%, 53/58) to measure the frequency, depth, and length of engagement. Studies that assessed acceptability (57.7%, 64/111) most often used questionnaires (64%, 42/64) and/or qualitative methods (53%, 34/64) to explore appreciation, perceived effectiveness and usefulness, satisfaction, intention to continue use, and social acceptability. Some studies (14.4%, 16/111) assessed dimensions more closely related to usability (ie, burden of sensor wear and use, interface complexity, and perceived technical performance). CONCLUSIONS: The rapid increase of research into the impact of physical activity apps and wearables means that evaluation guidelines are urgently needed to promote efficiency through the use of rapid research designs, in-device sensors and user-logs to assess effectiveness, engagement, and acceptability. Screening articles was time-consuming because reporting across health and computing sciences lacked standardization. Reporting guidelines are therefore needed to facilitate the synthesis of evidence across disciplines.
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BACKGROUND: Effective approaches that engage men in weight loss and lifestyle change are important because of worldwide increases, including in Canada, in obesity and chronic diseases. Football Fans in Training (FFIT), developed in Scotland, successfully tackled these problems by engaging overweight/obese male football fans in sustained weight loss and positive health behaviours, through program deliveries at professional football stadia. METHODS: Aims: 1) Adapt FFIT to hockey within the Canadian context and integrate with HealtheSteps™ (evidence-based lifestyle program) to develop Hockey Fans in Training (Hockey FIT); 2) Explore potential for Hockey FIT to help overweight/obese men lose weight and improve other outcomes by 12 weeks, and retain these improvements to 12 months; 3) Evaluate feasibility of recruiting and retaining overweight/obese men; 4) Evaluate acceptability of Hockey FIT; and 5) Conduct program optimization via a process evaluation. We conducted a two-arm pilot pragmatic randomized controlled trial (pRCT) whereby 80 overweight/obese male hockey fans (35-65 years; body-mass index ≥28 kg/m2) were recruited through their connection to two junior A hockey teams (London and Sarnia, ON) and randomized to Intervention (Hockey FIT) or Comparator (Wait-List Control). Hockey FIT includes a 12-week Active Phase (classroom instruction and exercise sessions delivered weekly by trained coaches) and a 40-week Maintenance Phase. Data collected at baseline and 12 weeks (both groups), and 12 months (Intervention only), will inform evaluation of the potential of Hockey FIT to help men lose weight and improve other health outcomes. Feasibility and acceptability will be assessed using data from self-reports at screening and baseline, program fidelity (program observations and coach reflections), participant focus group discussions, coach interviews, as well as program questionnaires and interviews with participants. This information will be analyzed to inform program optimization. DISCUSSION: Hockey FIT is a gender-sensitive program designed to engage overweight/obese male hockey fans to improve physical activity and healthy eating choices, thereby leading to weight loss and other positive changes in health outcomes. We expect this study to provide evidence for a full-scale confirmatory pRCT. TRIAL REGISTRATION: NCT02396524 (Clinicaltrials.gov). Date of registration: Feb 26, 2015.
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Exercício Físico , Comportamentos Relacionados com a Saúde , Promoção da Saúde/métodos , Estilo de Vida Saudável , Hóquei , Obesidade/terapia , Redução de Peso , Adulto , Peso Corporal , Canadá , Humanos , Londres , Masculino , Pessoa de Meia-Idade , Obesidade/prevenção & controle , Sobrepeso/prevenção & controle , Projetos Piloto , Avaliação de Programas e Projetos de Saúde , Projetos de Pesquisa , Escócia , Autorrelato , Fatores Sexuais , Instalações Esportivas e Recreacionais , Inquéritos e QuestionáriosRESUMO
Active videogames have the potential to enhance population levels of physical activity but have not been successful in achieving this aim to date. This article considers a range of principles that may be important to the design of effective and efficient active videogames from diverse discipline areas, including behavioral sciences (health behavior change, motor learning, and serious games), business production (marketing and sales), and technology engineering and design (human-computer interaction/ergonomics and flow). Both direct and indirect pathways to impact on population levels of habitual physical activity are proposed, along with the concept of a game use lifecycle. Examples of current active and sedentary electronic games are used to understand how such principles may be applied. Furthermore, limitations of the current usage of theoretical principles are discussed. A suggested list of principles for best practice in active videogame design is proposed along with suggested research ideas to inform practice to enhance physical activity.
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Controle Comportamental/métodos , Exercício Físico/psicologia , Promoção da Saúde/métodos , Design de Software , Jogos de Vídeo/psicologia , Educação em Saúde/métodos , Humanos , Comunicação Interdisciplinar , Marketing de Serviços de Saúde/métodos , Motivação , Destreza Motora , Comunicação Persuasiva , Comportamento Sedentário , Interface Usuário-ComputadorRESUMO
BACKGROUND: The prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans. METHODS: We did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35-65 years with a body-mass index (BMI) of 28 kg/m(2) or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2-9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491. FINDINGS: 374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95-5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64-5·08), both in favour of the intervention (p<0·0001). Eight serious adverse events were reported, five in the intervention group (lost consciousness due to drugs for pre-existing angina, gallbladder removal, hospital admission with suspected heart attack, ruptured gut, and ruptured Achilles tendon) and three in the comparison group (transient ischaemic attack, and two deaths). Of these, two adverse events were reported as related to participation in the programme (gallbladder removal and ruptured Achilles tendon). INTERPRETATION: The FFIT programme can help a large proportion of men to lose a clinically important amount of weight; it offers one effective strategy to challenge male obesity. FUNDING: Scottish Government and The UK Football Pools funded delivery of the programme through a grant to the Scottish Premier League Trust. The National Institute for Health Research Public Health Research Programme funded the assessment (09/3010/06).