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.

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.

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.

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].

A mobile phone intervention to reduce binge drinking among disadvantaged men: study protocol for a randomised controlled cost-effectiveness trial.

BACKGROUND: Socially disadvantaged men are at a substantially higher risk of developing alcohol-related problems. The frequency of heavy drinking in a single session is high among disadvantaged men. Brief alcohol interventions were developed for, and are usually delivered in, healthcare settings. The group who binge drink most frequently, young to middle-aged disadvantaged men, have less contact with health services and there is a need for an alternative method of intervention delivery. Text messaging has been used successfully to modify other adverse health behaviours. This study will test whether text messages can reduce the frequency of binge drinking by disadvantaged men. METHODS/DESIGN: Disadvantaged men aged 25 to 44 years who drank >8 units of alcohol at least twice in the preceding month will be recruited from the community. Two recruitment strategies will be used: contacting men listed in primary care registers, and a community outreach method (time-space sampling). The intended sample of 798 men will be randomised to intervention or control, stratifying by recruitment method. The intervention group will receive a series of text messages designed to reduce the frequency of binge drinking through the formation of specific action plans. The control group will receive behaviourally neutral text messages intended to promote retention in the study. The primary outcome measure is the proportion of men consuming >8 units on at least three occasions in the previous 30 days. Secondary outcomes include total alcohol consumption and the frequency of consuming more than 16 units of alcohol in one session in the previous month. Process measures, developed during a previous feasibility study, will monitor engagement with the key behaviour change components of the intervention. The study will incorporate an economic evaluation comparing the costs of recruitment and intervention delivery with the benefits of reduced alcohol-related harm. DISCUSSION: This study will assess the effectiveness of a brief intervention, delivered by text messages, aimed at reducing the frequency of binge drinking in disadvantaged men. The process measures will identify components of the intervention which contribute to effectiveness. The study will also determine whether any benefit of the intervention is justified by the costs of intervening. TRIAL REGISTRATION: ISRCTN07695192. Date assigned: 14 August 2013.

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.

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.

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.

Reducing door-to-antibiotic time in community-acquired pneumonia: Controlled before-and-after evaluation and cost-effectiveness analysis.

BACKGROUND: Practice guidelines suggest that all patients hospitalised with community-acquired pneumonia (CAP) should receive antibiotics within 4 h of admission. An audit at our hospital during 1999-2000 showed that this target was achieved in less than two thirds of patients with severe CAP. METHODS: An experienced multidisciplinary steering group designed a management pathway to improve the early delivery of appropriate antibiotics to patients with CAP. This was implemented using a multifaceted strategy. The effect of implementation was evaluated using a controlled before-and-after study design over two winter seasons (November-April 2001-2 and 2002-3). Cost-effectiveness analyses were performed from the hospital's perspective. RESULTS: The proportion of patients receiving appropriate antibiotics within 4 h of admission to hospital increased from 33% to 56% at the intervention site, and from 32% to 36% at the control site (absolute change adjusted for differences in severity of illness 17%, p = 0.035). The cost per additional patient receiving appropriate antibiotics within 4 h was 132 pound with no post-implementation evaluation, and 456 pound for a limited post-implementation evaluation. Simple modelling from the results of a large observational study suggests that the cost per death prevented could be 3003 pound with no post-implementation evaluation, or 16,632 pound with a limited post-implementation evaluation. CONCLUSIONS: The intervention markedly improved door-to-antibiotic time, albeit at considerable cost. It might still be a cost-effective strategy, however, to reduce mortality in CAP. Uncertainty about the cost effectiveness of such interventions is likely to be resolved only by a well-designed, cluster randomised trial.

Why older people do not participate in leisure time physical activity: a survey of activity levels, beliefs and deterrents.

BACKGROUND: Regular physical activity has been shown to have many health benefits. However, many older people are physically inactive. OBJECTIVE: To investigate why older people are reluctant to participate in leisure time physical activity and to identify strategies to encourage increased activity. DESIGN: Cross-sectional survey. SETTING: 16 general practices in Dundee, Scotland. METHODS: 409 randomly selected older people (65-84 years) who lived independently were interviewed at home. Forty-six percent of those invited to take part were recruited into the study. RESULTS: Levels of knowledge about the specific health benefits of physical activity were high. Almost all participants (95%) believed that physical activity was beneficial and 79% believed that they did enough to keep healthy. However, 36% did no leisure time physical activity and a further 17% did less than 2 hours per week. Regression modelling identified 11 factors that exerted significant independent effects on levels of leisure time physical activity. The most powerful deterrent was lack of interest (OR = 7.8). Other factors included lack of daily access to a car, shortness of breath, joint pain, dislike of going out alone or in the evening, perceived lack of fitness, lack of energy, doubting that exercise can lengthen life, not belonging to a group and doubting that meeting new people is beneficial. CONCLUSIONS: Increasing leisure time physical activities poses major challenges. Beliefs about desirable levels of activity in older people would need to be changed. Action would be needed to relieve physical symptoms and address fears about perceived ability to undertake physical activity. Finally, easily accessible facilities would be needed to encourage participation in physical activity.