Modifying Alcohol Consumption to Reduce Obesity: A Randomized Controlled Feasibility Study of a Complex Community-based Intervention for Men.

OBJECTIVES: Being obese and drinking more than 14 units of alcohol per week places men at very high risk of developing liver disease. This study assessed the feasibility of a trial to reduce alcohol consumption. It tested the recruitment strategy, engagement with the intervention, retention and study acceptability. METHODS: Men aged 35-64 years who drank >21 units of alcohol per week and had a BMI > 30 were recruited by two methods: from GP patient registers and by community outreach. The intervention was delivered by a face to face session followed by a series of text messages. Trained lay people (Study Coordinators) delivered the face to face session. Participants were followed up for 5 months from baseline to measure weekly alcohol consumption and BMI. RESULTS: The recruitment target of 60 was exceeded, with 69 men recruited and randomized. At baseline, almost all the participants (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease. The intervention was delivered with high fidelity. A very high follow-up rate was achieved (98%) and the outcomes for the full trial were measured. Process evaluation showed that participants responded as intended to key steps in the behaviour change strategy. The acceptability of the study methods was high: e.g. 80% of men would recommend the study to others. CONCLUSIONS: This feasibility study identified a group at high risk of liver disease. It showed that a full trial could be conducted to test the effectiveness and cost-effectiveness of the intervention. TRIAL REGISTRATION: Current controlled trials: ISRCTN55309164. TRIAL FUNDING: National Institute for Health Research Health Technology Assessment (NIHR HTA). SHORT SUMMARY: This feasibility study recruited 69 men at high risk of developing liver disease. The novel intervention, to reduce alcohol consumption through the motivation of weight loss, was well received. A very high follow-up rate was achieved. Process evaluation showed that participants engaged with key components of the behaviour change strategy.

Real Time Monitoring of Engagement with a Text Message Intervention to Reduce Binge Drinking Among Men Living in Socially Disadvantaged Areas of Scotland.

PURPOSE: This study identified the extent and nature of engagement with a theoretically based behaviour change text message intervention intended to reduce binge drinking. The data were from a randomised controlled trial tackling binge drinking among socially disadvantaged men. METHOD: An intervention, comprising 112 text messages, and based on the principles of the Health Action Process Approach, was delivered to 411 socially disadvantaged men. Participants sent almost 7500 responses to the text messages. Engagement was assessed by whether text message replies showed the intended response to key components of the behaviour change strategy. RESULTS: The median number of responses to the text messages was 17 per man (range 0-81). Men often gave detailed sensitive personal information about their drinking and the harms it caused them. They also described their attempts at drinking less, the setbacks encountered and the benefits they enjoy when they are successful at cutting down. Specific examples of engagement with the targeted messages include the following: of the 248 men who responded to the prompt on outcome expectancies, most (230) identified potential benefits of cutting down; for intention to reduce drinking, 260 men responded of whom 44% said they had thought about changing; of the 172 men who responded to the question on goal setting, 158 reported personal goals. CONCLUSIONS: The responses showed that most men engaged as intended with the key components of the intervention. Text message interventions should include questions addressing key components of the behaviour change strategy to determine whether there is effective engagement with intervention components.

The role of perceived barriers and objectively measured physical activity in adults aged 65-100.

OBJECTIVE: to test the predictive utility of perceived barriers to objectively measured physical activity levels in a stratified sample of older adults when accounting for social-cognitive determinants proposed by the Theory of Planned Behaviour (TPB), and economic and demographic factors. METHODS: data were analysed from the Physical Activity Cohort Scotland survey, a representative and stratified (65-80 and 80+ years; deprived and affluent) sample of 584 community-dwelling older people, resident in Tayside, Scotland. Physical activity was measured objectively by accelerometry. RESULTS: perceived barriers clustered around the areas of poor health, lack of interest, lack of safety and lack of access. Perceived poor health and lack of interest, but not lack of access or concerns about personal safety, predicted physical activity after controlling for demographic, economic and TPB variables. DISCUSSION: perceived person-related barriers (poor health and lack of interest) seem to be more strongly associated with physical activity levels than perceived environmental barriers (safety and access) in a large sample of older adults. Perceived barriers are modifiable and may be a target for future interventions.

Dog ownership and physical activity in later life: a cross-sectional observational study.

OBJECTIVE: To examine whether dog ownership amongst community dwelling older adults (≥ 65 years) is associated with objectively measured physical activity (PA). METHODS: We used data from the Physical Activity Cohort Scotland (PACS) which consists of 547 people aged 65 and over, resident in the community in Tayside, Scotland. The data was collected in 2009-2011. We assessed whether dog ownership is associated with objectively measured physical activity (accelerometry counts). RESULTS: The physical activity (PA) counts of 547 older people (mean age 79 (standard deviation (SD) 8 years, 54% female) were analysed. Linear mixed models showed that dog ownership was positively related to higher PA levels. This positive relationship remained after controlling for a large number of individual and contextual variables, including attitude towards exercise, physical activity intention and history of physical activity. Dog owners were found to be 12% more active (21,875 counts, 95% Confidence Interval (CI): 2810 to 40,939, p<0.05) than non-dog owners. CONCLUSION: Dog ownership is associated with physical activity in later life. Interventions to increase activity amongst older people might usefully attempt to replicate elements of the dog ownership experience.

Risky single-occasion drinking and disadvantaged men: will recruitment through primary care miss hazardous drinkers?

BACKGROUND: Men who are socially disadvantaged are at a substantially higher risk of developing alcohol-related diseases. People from deprived areas are known to be more difficult to recruit to research studies. As part of a feasibility assessment for an intervention study, 2 recruitment strategies were investigated. This article compares the drinking patterns of the disadvantaged men identified by the 2 strategies. METHODS: A cross-sectional survey compared 2 strategies for recruiting disadvantaged men to a study on alcohol consumption: recruitment through general practice (GP) registers and through a community outreach strategy, respondent-driven sampling (RDS). Men aged 25 to 44 years were recruited from deprived areas in the community. The entry criterion was binge drinking (≥8 units in a single session) at least twice in the previous 4 weeks. Demographic characteristics, total consumption of alcohol, frequency of binge drinking (≥8 units in a session), and heavy binge drinking (≥16 units in a session) were measured. RESULTS: Men recruited by RDS drank more than twice as much as the men recruited through GP (137 units in the previous 30 days compared with 62 units; p = 0.003). They also had many more binge drinking days: more than half (57%) of men from RDS had 6 or more binge drinking days in the previous 30 days, whereas only 16% of the GP sample had 6 or more binge drinking days (p = 0.001). Many more men recruited by RDS (37% vs. 5%; p = 0.002) had more than 5 very heavy drinking sessions in the previous month (≥16 units in a session). The RDS group also had fewer alcohol-free days. CONCLUSIONS: The 2 sampling strategies recruited different types of drinkers. The men recruited through RDS were much more likely to engage in frequent harmful drinking. The results indicate that the 2 methods recruit different samples of disadvantaged men. Intervention studies that are only conducted through primary care may miss many harmful drinkers.

Psychological theory in an interdisciplinary context: psychological, demographic, health-related, social, and environmental correlates of physical activity in a representative cohort of community-dwelling older adults.

BACKGROUND: Physical activity (PA) in older adults is influenced by a range of environmental, demographic, health-related, social, and psychological variables. Social cognitive psychological models assume that all influences on behaviour operate indirectly through the models constructs, i.e., via intention and self-efficacy. We evaluated direct, indirect, and moderating relationships of a broad range of external variables with physical activity levels alongside intention and self-efficacy. METHODS: We performed a cross-sectional survey of a representative and stratified (65-80 and 80+ years; deprived and affluent) sample of 584 community-dwelling people, resident in Scotland. Objectively measured physical activity and questionnaire data were collected. RESULTS: Self-efficacy showed unique relationships with physical activity, controlling for demographic, mental health, social, environmental, and weather variables separately, but the relationship was not significant when controlling for physical health. Overall, results indicating support for a mediation hypothesis, intention and self-efficacy statistically mediate the relationship of most domain variables with physical activity. Moderation analyses show that the relationship between social cognitions and physical activity was stronger for individuals with better physical health and lower levels of socio-economic deprivation. CONCLUSIONS: Social cognitive variables reflect a range of known environmental, demographic, health-related and social correlates of physical activity, they mediate the relationships of those correlates with physical activity and account for additional variance in physical activity when external correlates are controlled for, except for the physical health domain. The finding that the social cognition-physical activity relationship is higher for participants with better health and higher levels of affluence raises issues for the applicability of social cognitive models to the most disadvantaged older people.

Maternal feeding behaviour and young children's dietary quality: a cross-sectional study of socially disadvantaged mothers of two-year old children using the Theory of Planned Behaviour.

BACKGROUND: Having breakfast, eating food 'cooked from scratch' and eating together as a family have health and psychosocial benefits for young children. This study investigates how these parentally determined behaviours relate to children's dietary quality and uses a psychological model, the Theory of Planned Behaviour (TPB), to investigate socio-cognitive predictors of these behaviours in socially disadvantaged mothers of young children in Scotland. METHOD: Three hundred mothers of children aged 2 years (from 372 invited to participate, 81% response rate), recruited via General Practitioners, took part in home-based semi-structured interviews in a cross-sectional survey of maternal psychological factors related to their children's dietary quality. Regression analyses examined statistical predictors of maternal intentions and feeding behaviours. RESULTS: Mothers of children with poorer quality diets were less likely than others to provide breakfast every day, cook from 'scratch' and provide 'proper sit-down meals'. TPB socio-cognitive factors (intentions, perceived behavioural control) significantly predicted these three behaviours, and attitudes, norms, and perceived behavioural control significantly predicted mothers' intentions, with medium to large effect sizes. CONCLUSIONS: Interventions to improve young children's dietary health could benefit from a focus on modifying maternal motivations and attitudes in attempts to improve feeding behaviours.

Changes in the social class gradient of cirrhosis mortality in England and Wales across the 20th century.

AIM: To explore the nature of the social class gradient of cirrhosis mortality in England and Wales across the 20th century. METHODS: Data on male cirrhosis mortality by social class were obtained from the Registrar General's Decennial Supplements for the years 1921-1991. Data for 1941 were not collected because of the second World War. RESULTS: In 1921, cirrhosis mortality was substantially higher among the professional and managerial classes (I and II) than among the other social classes (III-V). This marked social class difference persisted until 1961 when the differences between the social classes were inconsistent. By 1991, the gradient had reversed and the lower social classes (IV and V) had the higher mortality. The excess mortality was greatest for social class V. The change in the mortality gradient is stark: in 1921social classes I and II had a cirrhosis mortality at least twice that of social classes IV and V, but by 1991 this ratio had reversed. CONCLUSIONS: The reversal in the social class gradient of cirrhosis mortality indicates a major change in risk factor distribution across social classes. Differential changes in alcohol consumption are a possible explanation for this change, although the 1991 social class gradient in cirrhosis is inconsistent with alcohol consumption data from national surveys. Further research is required to clarify the explanation for the observed gradient, so that appropriate preventive measures can be put into place.

The rising tide of liver Cirrhosis mortality in the UK: can its halt be predicted?

AIM: To explore whether it is possible to predict future United Kingdom (UK) death rate of liver cirrhosis based on birth cohort models. METHOD: Routinely available mortality data were plotted graphically to display the trends in cirrhosis mortality by birth cohort in several countries. Data for Italy, France, Portugal, USA, Canada, Scotland and England & Wales were plotted by birth cohort. RESULTS: The current increase in cirrhosis mortality in the UK countries is being driven by a birth cohort effect. Later birth cohorts have much higher death rates than preceding ones. This pattern was seen in Western European and North American countries, which had also experienced increases in liver cirrhosis mortality. However, after the increases, those countries had sudden and persistent falls in death rates. For each country, the dramatic reversal of death rates occurred at a single calendar period and in every age group simultaneously. CONCLUSION: Prediction of future death rates using information from previous cohorts is not possible due to the occurrence of sudden reversals in death rates. The sudden fall in the death rates of several birth cohorts suggests that reversing the current UK trend of rising liver cirrhosis deaths is possible.

Strategies for achieving a high response rate in a home interview survey.

BACKGROUND: Response rates in surveys have been falling over the last 20 years, leading to the need for novel approaches to enhance recruitment. This study describes strategies used to maximise recruitment to a home interview survey of mothers with young children living in areas of high deprivation. METHODS: Mothers of two year old children received a letter from their GP inviting them to take part in a survey on diet. Participants were subsequently recruited by a researcher. The researcher first tried to contact potential participants by telephone, to discuss the study and make an appointment to conduct a home interview. Where telephone numbers for women could not be obtained from GP records, web searches of publicly available databases were conducted. After obtaining correct telephone numbers, up to six attempts were made to establish contact by telephone. If this was unsuccessful, a postal request for telephone contact was made. Where no telephone contact was achieved, the researcher sent up to two appointments by post to conduct a home interview. RESULTS: Participating GPs invited 372 women to take part in a home based interview study. GP practices provided telephone numbers for 162 women, of which 134 were valid numbers. The researcher identified a further 187 numbers from electronic directories. Further searches of GP records by practice staff yielded another 38 telephone numbers. Thus, telephone numbers were obtained for 99% of potential participants.The recruitment rate from telephone contacts was 77%. Most of the gain was achieved within four calls. For the remaining women, contact by post and home visits resulted in 18 further interviews, corresponding to 35% of the women not recruited by telephone. The final interview rate was 82%. This was possible because personal contact was established with 95% of potential participants. CONCLUSION: This study achieved a high response rate in a hard to reach group. This was mainly achieved by first establishing contact by telephone. The use of multiple sources identified the telephone numbers of almost all the sample. Multiple attempts at telephone contact followed by postal approaches led to a high home interview rate.

What maternal factors influence the diet of 2-year-old children living in deprived areas? A cross-sectional survey.

OBJECTIVE: To investigate the maternal factors associated with poor diet among disadvantaged children. DESIGN: Survey of 300 mothers of 2-year-old children from areas of high deprivation in Scotland (response rate 81 %). A diet quality score was derived from reported consumption of carbohydrates, protein, fruit and vegetables, dairy products and restriction of sugary fatty foods. RESULTS: Most children (85 %) were classified as having a poor quality diet (low diet quality score). Mothers' general knowledge about healthy eating was high, but did not predict the quality of the children's diet. Lower frequencies of food preparation and serving, such as cooking with raw ingredients, providing breakfast daily and the family eating together, were also associated with a poorer diet. Regression modelling identified five significant factors. An increased risk of a poor diet was associated with mothers being unlikely to restrict sweets (OR = 21.63, 95 % CI 2.70, 173.30) or finding it difficult to provide 2-3 portions of fruit daily (OR = 2.94, 95 % CI 1.09, 7.95). Concern that the child did not eat enough increased the risk of a poor diet (OR = 2.37, 95 % CI 1.09, 5.16). Believing a healthy diet would help the child eat more reduced the risk of having a poor diet (OR = 0.28, 95 % CI 0.11, 0.74), as did providing breakfast daily (OR = 0.22, 95 % CI 0.05, 0.99). CONCLUSIONS: Interventions to improve children's diet could promote more positive intentions about preparing and serving of foods, particularly of specific meals at which the family eats together. The benefits of these behaviours to the child (improved diet, weight control) should be emphasised.

Design and development of a complex narrative intervention delivered by text messages to reduce binge drinking among socially disadvantaged men.

BACKGROUND: Socially disadvantaged men are at high risk of suffering from alcohol-related harm. Disadvantaged groups are less likely to engage with health promotion. There is a need for interventions that reach large numbers at low cost and which promote high levels of engagement with the behaviour change process. The aim of this study was to design a theoretically and empirically based text message intervention to reduce binge drinking by socially disadvantaged men. RESULTS: Following MRC guidance, the intervention was developed in four stages. Stage 1 developed a detailed behaviour change strategy based on existing literature and theory from several areas. These included the psychological theory that would underpin the intervention, alcohol brief interventions, text message interventions, effective behaviour change techniques, narratives in behaviour change interventions and communication theory. In addition, formative research was carried out. A logic model was developed to depict the pathways between intervention inputs, processes and outcomes for behaviour change. Stage 2 created a narrative which illustrated and modelled key steps in the strategy. Stage 3 rendered the intervention into a series of text messages and ensured that appropriate behavioural change techniques were incorporated. Stage 4 revised the messages to ensure comprehensive coverage of the behaviour change strategy and coherence of the narrative. It also piloted the intervention and made final revisions to it. CONCLUSIONS: The structured, systematic approach to design created a narrative intervention which had a strong theoretical and empirical basis. The use of a narrative helped make the intervention realistic and allowed key behaviour change techniques to be modelled by characters. The narrative was intended to promote engagement with the intervention. The intervention was rendered into a series of short text messages, and subsequent piloting showed they were acceptable in the target group. Delivery of an intervention by text message offers a low-cost, low-demand method that can reach large numbers of people. This approach provides a framework for the design of behaviour change interventions which could be used for interventions to tackle other health behaviours.

Design and feasibility testing of a novel group intervention for young women who binge drink in groups.

BACKGROUND: Young women frequently drink alcohol in groups and binge drinking within these natural drinking groups is common. This study describes the design of a theoretically and empirically based group intervention to reduce binge drinking among young women. It also evaluates their engagement with the intervention and the acceptability of the study methods. METHODS: Friendship groups of women aged 18-35 years, who had two or more episodes of binge drinking (>6 UK units on one occasion; 48g of alcohol) in the previous 30 days, were recruited from the community. A face-to-face group intervention, based on the Health Action Process Approach, was delivered over three sessions. Components of the intervention were woven around fun activities, such as making alcohol free cocktails. Women were followed up four months after the intervention was delivered. RESULTS: The target of 24 groups (comprising 97 women) was recruited. The common pattern of drinking was infrequent, heavy drinking (mean consumption on the heaviest drinking day was UK 18.1 units). Process evaluation revealed that the intervention was delivered with high fidelity and acceptability of the study methods was high. The women engaged positively with intervention components and made group decisions about cutting down. Twenty two groups set goals to reduce their drinking, and these were translated into action plans. Retention of individuals at follow up was 87%. CONCLUSIONS: This study successfully recruited groups of young women whose patterns of drinking place them at high risk of acute harm. This novel approach to delivering an alcohol intervention has potential to reduce binge drinking among young women. The high levels of engagement with key steps in the behavior change process suggests that the group intervention should be tested in a full randomised controlled trial.

Texting to Reduce Alcohol Misuse (TRAM): main findings from a randomized controlled trial of a text message intervention to reduce binge drinking among disadvantaged men.

AIMS: To test the effectiveness of a theoretically based text-message intervention to reduce binge drinking among socially disadvantaged men. DESIGN: A multi-centre parallel group, pragmatic, individually randomized controlled trial. SETTING: Community-based study conducted in four regions of Scotland. PARTICIPANTS: A total of 825 men aged 25-44 years recruited from socially disadvantaged areas who had two or more episodes of binge drinking (> 8 UK units on a single occasion) in the preceding 28 days: 411 men were randomized to the intervention and 414 to the control. INTERVENTION AND COMPARATOR: A series of 112 interactive text messages was delivered by mobile phone during a 12-week period. The intervention was structured around the Health Action Process Approach, a comprehensive model which allows integration of a range of evidence-based behaviour change techniques. The control group received 89 texts on general health, with no mention of alcohol or use of behaviour change techniques. MEASUREMENTS: The primary outcome measure was the proportion of men consuming > 8 units on three or more occasions (in the previous 28 days) at 12 months post-intervention. FINDINGS: The proportion of men consuming > 8 units on three or more occasions (in the previous 28 days) was 41.5% in the intervention group and 47.8% in the control group. Formal analysis showed that there was no evidence that the intervention was effective [odds ratio (OR) = 0.79, 95% confidence interval (CI) = 0.57-1.08; absolute reduction 5.7%, 95% CI = -13.3 to 1.9]. The Bayes factor for this outcome was 1.3, confirming that the results were inconclusive. The retention was high and similar in intervention (84.9%) and control (86.5%) groups. Most men in the intervention group engaged with the text messages: almost all (92%) replied to text messages and 67% replied more than 10 times. CONCLUSIONS: A theoretically based text-messaging intervention aimed at reducing binge drinking in disadvantaged men was not found to reduce prevalence of binge drinking at 12-month follow-up.

'Carers' of people with mental health problems: proposals in current public mental health policy in nine countries.

This study investigates how public mental health policy addresses the role and needs of those who care for people with mental health problems. Public mental health policy recognises that carers are at increased risk of poor health. Countries want to ensure that mental health services are responsive to the needs of "carers", that carers participate in the planning and implementation of services and that more information should be made available to carers. Respite care is recommended as a way to improve the health of both carers and service users. Unfortunately, policies only identify possibilities for intervention, and rarely identify specific actions to be taken or clarify who has responsibility for delivering interventions. Further the financial implications of the proposals and the need for additional trained staff are seldom discussed. Current proposals for helping carers are inadequate.

When "no" might not quite mean "no"; the importance of informed and meaningful non-consent: results from a survey of individuals refusing participation in a health-related research project.

BACKGROUND: Low participation rates can lead to sampling bias, delays in completion and increased costs. Strategies to improve participation rates should address reasons for non-participation. However, most empirical research has focused on participants' motives rather than the reasons why non-participants refuse to take part. In this study we investigated the reasons why older people choose not to participate in a research project. METHODS: Follow-up study of people living in Tayside, Scotland who had opted-out of a cross-sectional survey on activities in retirement. Eight hundred and eighty seven people aged 65-84 years were invited to take part in a home-based cross-sectional survey. Of these, 471 refused to take part. Permission was obtained to follow-up 417 of the refusers. Demographic characteristics of people who refused to take part and the reasons they gave for not taking part were collected. RESULTS: 54% of those invited to take part in the original cross-sectional survey refused to do so. However, 61% of these individuals went on to participate in the follow-up study and provided reasons for their original refusal. For the vast majority of people initial non-participation did not reflect an objection to participating in research in principle but frequently stemmed from barriers or misunderstandings about the nature or process of the project itself. Only 28% indicated that they were "not interested in research". The meaningfulness of expressions of non-consent may therefore be called into question. Hierarchical log-linear modelling showed that refusal was independently influenced by age, gender and social class. However, this response pattern was different for the follow-up study in which reasons for non-participation in the first survey were sought. This difference in pattern and response rates supports the likely importance of recruitment issues that are research and context specific. CONCLUSION: An expression of non-consent does not necessarily mean that a fully informed evaluation of the pros and cons of participation and non-participation has taken place. The meaningfulness of expressions of non-consent may therefore be a cause for concern and should be subject to further research. Many reasons for non-participation may be specific to a particular research topic or population. Information sheets should reflect this by going beyond standardised guidelines for their design and instead proactively seek out and address areas of concern or potential misunderstanding. The use of established behavioural theory in their design could also be considered.

Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone.

INTRODUCTION AND AIMS: Disadvantaged men suffer substantial harm from heavy drinking. This feasibility study developed and evaluated the methods for a trial of a brief intervention delivered by text messages to disadvantaged men. It aimed to test the methods for recruitment and retention, to monitor engagement with the intervention and assess the overall acceptability of study methods. DESIGN AND METHODS: Disadvantaged men aged 25-44 years who had ≥2 episodes of binge drinking (≥8 units in one session) in the preceding month were recruited. Two recruitment strategies were assessed: recruitment from general practice registers and by a community outreach strategy. Theoretically and empirically based text messages were tailored to the target group. RESULTS: The study recruited 67 disadvantaged men at high risk of alcohol-related harm, exceeding the target of 60. Evaluation showed that 95% of text messages were delivered, and the men engaged enthusiastically with the intervention. Retention at follow up was 96%. Outcomes were successfully measured on all men followed up. This provided data for the sample size calculation for the full trial. Post-study evaluation showed high levels of satisfaction with the study. DISCUSSION AND CONCLUSIONS: This study has shown that disadvantaged men can be recruited and follow-up data obtained in an alcohol intervention study. The study methods were acceptable to the participants. The men recruited were at high risk of alcohol-related harms. It also clarified ways in which the recruitment strategy, the baseline questionnaire and the intervention could be improved. The full trial is currently underway. [Crombie IK, Irvine L, Falconer DW, Williams B, Ricketts IW, Jones C, Humphris G, Norrie J, Slane P, Rice P. Alcohol and disadvantaged men: A feasibility trial of an intervention delivered by mobile phone. Drug Alcohol Rev 2017;36:468-476].

Modifying Alcohol Consumption to Reduce Obesity (MACRO): development and feasibility trial of a complex community-based intervention for men.

BACKGROUND: Obese men who consume alcohol are at a greatly increased risk of liver disease; those who drink > 14 units of alcohol per week have a 19-fold increased risk of dying from liver disease. OBJECTIVES: To develop an intervention to reduce alcohol consumption in obese men and to assess the feasibility of a randomised controlled trial (RCT) to investigate its effectiveness. DESIGN OF THE INTERVENTION: The intervention was developed using formative research, public involvement and behaviour change theory. It was organised in two phases, comprising a face-to-face session with trained laypeople (study co-ordinators) followed by a series of text messages. Participants explored how alcohol consumption contributed to weight gain, both through direct calorie consumption and through its effect on increasing food consumption, particularly of high-calorie foodstuffs. Men were encouraged to set goals to reduce their alcohol consumption and to make specific plans to do so. The comparator group received an active control in the form of a conventional alcohol brief intervention. Randomisation was carried out using the secure remote web-based system provided by the Tayside Clinical Trials Unit. Randomisation was stratified by the recruitment method and restricted using block sizes of randomly varying lengths. Members of the public were involved in the development of all study methods. SETTING: Men were recruited from the community, from primary care registers and by time-space sampling (TSS). The intervention was delivered in community settings such as the participant's home, community centres and libraries. PARTICIPANTS: Men aged 35-64 years who had a body mass index (BMI) of > 30 kg/m2 and who drank > 21 units of alcohol per week. RESULTS: The screening methods successfully identified participants meeting the entry criteria. Trial recruitment was successful, with 69 men (36 from 419 approached in primary care, and 33 from 470 approached via TSS) recruited and randomised in 3 months. Of the 69 men randomised, 35 were allocated to the intervention group and 34 to the control group. The analysis was conducted on 31 participants from the intervention group and 30 from the control group. The participants covered a wide range of ages and socioeconomic statuses. The average alcohol consumption of the men recruited was 47.2 units per week, more than twice that of the entry criterion (> 21 units per week). Most (78%) engaged in binge drinking (> 8 units in a session) at least weekly. Almost all (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease (BMI of > 30 kg/m2 and > 14 units of alcohol per week). Despite this, they believed that they were at low risk of harm from alcohol, possibly because they seldom suffered acute harms (e.g. hangovers) and made few visits to a general practitioner or hospital. INTERVENTION: The intervention was delivered with high fidelity. A high follow-up rate was achieved (98%) and the outcomes for the full RCT were measured. A process evaluation showed that participants engaged with the main components of the intervention. The acceptability of the study methods was high. CONCLUSIONS: This feasibility study developed a novel intervention and evaluated all of the stages of a RCT that would test the effectiveness of the intervention. The main stages of a trial were completed successfully: recruitment, randomisation, intervention delivery, follow-up and measurement of study outcomes. Most of the men recruited drank very heavily and were also obese. This places them at a very high risk of liver disease, making them a priority for intervention. FUTURE WORK: A RCT to test the effectiveness and cost-effectiveness of the intervention. TRIAL REGISTRATION: Current Controlled Trials ISRCTN55309164. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 19. See the NIHR Journals Library website for further project information.

A review of major influences on current public health policy in developed countries in the second half of the 20th century.

Public health policy underwent substantial transformation during the latter half of the 20th century. The landmark statement was the 1948 World Health Organization (WHO) constitution, which identified good health as a fundamental right and gave the responsibility to governments to achieve it for all their people. However, following World War II, developed countries made substantial investment in health care with less attention paid to public health. The importance of public health was slowly recognised over the period from 1970 to 2000 with the publication of several reports from different organisations. The first authoritative policy statement that the important determinants of health lay outside health care was in the Lalonde Report from Canada. These ideas were subsequently expressed in the WHO Alma-Ata declaration and were emphasised a year later by the US Surgeon General. The idea of setting goals for health improvement also began in the 1970s. The Lalonde Report and the United Kingdom Black Report recommended that targets be used, but the first explicitly stated health targets were set by the US in 1979. WHO also identified the need for such targets at this time, but did not introduce them until 1984. Since then health targets have become a central feature of public health policy in developed countries. The Ottawa Conference on Health Promotion in 1986 championed the view that health promotion was central to achieving health goals internationally. It helped clarify the types of actions needed: that individuals need to be provided with the supportive environment and economic resources to be able to lead healthy lives. In a further development, the Healthy Cities Project was launched with the specific aim of involving political decision-makers in building a strong lobby for public health at the local level. The Healthy Cities Project illustrates how to provide means and opportunity for interventions to be implemented in communities. Concerns with inequalities in health were emphasised in the WHO declaration of Alma-Ata, and were the focus of the United Kingdom Black Report. The Jakarta Conference on Health Promotion in 1997 urged international action on poverty, as it is the major threat to health. International acceptance of the need to tackle inequalities took longer than the acceptance of health targets, but it is now an important feature of public health policy. The advent of the 21st century marked the coming of age of public health. The renewed version of 'Health for All', 'Health for All in the 21st Century', emphasised the one constant goal of WHO that all individuals should achieve their full health potential. Public health is now regarded internationally as being a priority with this WHO goal being adopted as the overarching goal of policy. The challenges it faces in tackling problems such as obesity, inequalities in health, smoking, alcohol and substance abuse are great and will require policies which tackle the economic, social and environmental determinants of health.

Polarised views on treating neurogenic pain.

This study aimed to identify areas of disagreement in the management of neurogenic pain. A short questionnaire was mailed to 179 consultants with an interest in chronic pain (response rate 89%). The questionnaire listed 11 specific conditions involving nerve pain (e.g., post-herpetic neuralgia, causalgia) together with 11 treatments (e.g., antidepressants, neurectomy). Consultants were asked to rate the use of each treatment for each condition as 'appropriate', 'no value or positively harmful' or 'no opinion'. Much disagreement emerged about the value of each therapy for each condition: in almost every instance at least some consultants disagreed with the majority view. The dissenting minority was greater than 20% of those who gave an opinion for 48 of the 121 applications of therapy asked about. The appropriateness of treatments for trigeminal neuralgia, amputation stump pain and phantom pain was most often in dispute and there was little consensus on the value of nerve blocks. There were a few areas of near agreement. Antidepressants and anticonvulsants were mostly identified as appropriate for all the conditions listed and there was some agreement that strong opioids and the neuroablative techniques were appropriate for cancer pressure or infiltration of nerves but, with a few exceptions, of no value for all other neurogenic pain conditions. Divergence of views about treatments may indicate a lack of credible evidence on the value of therapies or a lack of professional knowledge. Where published evidence is clear, the consequences for patients may be under-use of useful therapies or potential iatrogenic harm.