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BACKGROUND: Identifying factors that influence sustained implementation of hospital-based interventions is key to ensuring evidence-based best practice is maintained across the NHS. This study aimed to identify, appraise and synthesise the barriers and facilitators that influenced the delivery of sustained healthcare interventions in a hospital-based setting. METHODS: A systematic review reported in accordance with PRISMA. Eight electronic databases were reviewed in addition to a hand search of Implementation Science journal and reference lists of included articles. Two reviewers were used to screen potential abstracts and full text papers against a selection criteria. Study quality was also independently assessed by two reviewers. Barriers and facilitators were extracted and mapped to a consolidated sustainability framework. RESULTS: Our searching identified 154,757 records. We screened 14,626 abstracts and retrieved 431 full text papers, of which 32 studies met the selection criteria. The majority of studies employed a qualitative design (23/32) and were conducted in the UK (8/32) and the USA (8/32). Interventions or programmes were all multicomponent, with the majority aimed at improving the quality of patient care and/ or safety (22/32). Sustainability was inconsistently reported across 30 studies. Barriers and facilitators were reported in all studies. The key facilitators included a clear accountability of roles and responsibilities (23/32); ensuring the availability of strong leadership and champions advocating the use of the intervention (22/32), and provision of adequate support available at an organisational level (21/32). The most frequently reported barrier to sustainability was inadequate staff resourcing (15/32). Our review also identified the importance of inwards spread and development of the initiative over time, as well as the unpredictability of sustainability and the need for multifaceted approaches. CONCLUSIONS: This review has important implications for practice and research as it increases understanding of the factors that faciliate and hinder intervention sustainability. It also highlights the need for more consistent and complete reporting of sustainability to ensure that lessons learned can be of direct benefit to future implementation of interventions. TRIAL REGISTRATION: The review is registered on PROSPERO ( CRD42017081992 ).
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Atenção à Saúde/normas , Hospitais , Prática Clínica Baseada em Evidências , Humanos , Pesquisa QualitativaRESUMO
BACKGROUND: Prisoners are disproportionately affected by cardiovascular disease and its risk factors. However, primary prevention of cardiovascular disease in correctional settings has been widely neglected, and there is little information on interventions to improve the cardiovascular health of prisoners while incarcerated. OBJECTIVE: The aim of this study was to systematically review published literature to identify interventions to improve the health factors or behaviors of the cardiovascular health of prisoners during incarceration. METHODS: Selected databases were searched using terms related to prisoners and cardiovascular disease. Studies were included if they had prisoners as participants and measured outcomes of cardiovascular health. Narrative synthesis was used to organize the evidence from the studies. RESULTS: Twelve articles detailing 11 studies were identified. Most of the studies involved only men. Interventions were classified into 4 types: structured physical activity, nutrition, mixed with physical activity and educational sessions, and smoking cessation. Most studies measured short-term outcomes relating to cardiovascular health such as changes in blood pressure and weight. Only 4 studies were of high quality. Structured physical activity interventions, nutrition interventions, and smoking cessation interventions delivered in a group setting had significant effects on at least 1 measured outcome. The effect of mixed interventions could not be determined. CONCLUSIONS: Structured physical activity interventions, nutrition interventions, and smoking cessation interventions delivered in a group setting can improve health factors or behaviors of the cardiovascular health of prisoners during incarceration. More high-quality research is needed to increase the evidence base on the effectiveness of these interventions in the correctional setting.
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Doenças Cardiovasculares/prevenção & controle , Comportamentos Relacionados com a Saúde , Prisioneiros/psicologia , HumanosRESUMO
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.
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Consumo de Bebidas Alcoólicas/epidemiologia , Consumo de Bebidas Alcoólicas/prevenção & controle , Intervenção Médica Precoce/métodos , Obesidade/epidemiologia , Obesidade/terapia , Saúde Pública/métodos , Adulto , Consumo de Bebidas Alcoólicas/psicologia , Estudos de Viabilidade , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Entrevista Motivacional/métodos , Obesidade/psicologia , Método Simples-CegoRESUMO
ISSUES: Alcohol marketing on social media platforms is pervasive and effective, reaching wide audiences and allowing interaction with users. We know little about the gendered nature of digital alcohol marketing, including how women and men are portrayed, how different genders respond and implications for gender relations. This review aimed to identify how males, females and other genders are targeted and represented in digital alcohol marketing, and how they are encouraged to engage with digital alcohol marketing content. APPROACH: A narrative synthesis approach was employed. Academic literature and research reports were searched for studies on digital alcohol marketing published within the previous 10 years with a range of methods and designs. We reviewed the studies, extracted data relevant to gender and synthesised findings thematically. KEY FINDINGS: The review included 17 articles and 7 reports with a range of designs and methods, including content analyses of digital material, interviews, focus groups and surveys. Our analysis identified three conceptual themes that captured many of the gendered results, namely: (i) leveraging a diversity of idealised femininities; (ii) amplifying hegemonic masculinity; and (iii) infiltrating everyday gendered life. IMPLICATIONS AND CONCLUSION: Alcohol marketing on social media is highly gendered and is designed to embed itself into everyday life in agile ways that reinforce traditional and evolving gendered stereotypes, activities, lifestyles and roles. Gendered engagement strategies are widely used to link alcohol to everyday gendered activities and identities to encourage alcohol purchase and consumption. This marketing normalises alcohol consumption and reproduces harmful gender norms and stereotypes.
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INTRODUCTION: High alcohol availability is related to increased alcohol consumption and harms. Existing quantitative research provides potential explanations for this relationship but there is little understanding of how people experience local alcohol availability. This is the first review to synthesise qualitative research exploring the relationship between alcohol availability and other factors in local alcohol environments. METHODS: The scoping review includes qualitative studies exploring community-level alcohol availability and other factors, facilitating the purchase and consumption of alcohol. We included studies focusing on children and adolescents as well as adults. Study findings were brought together using thematic analysis and the socio-environmental context model, which explains how certain environments may facilitate drinking. RESULTS: The review includes 34 articles. The majority of studies were conducted since 2012. Most studies were conducted in the United Kingdom, Australia and South Africa. The physical availability of alcohol and proximity to local amenities and temporal aspects, like late night opening hours, may be linked to social factors, such as normalisation of drinking and permissive drinking environments. The review highlights the importance of social and cultural factors in shaping interactions with local alcohol environments. DISCUSSION AND CONCLUSION: This qualitative scoping review advances understanding of the pathways linking alcohol availability and alcohol harms by showing that availability, accessibility and visibility of alcohol may contribute towards permissive drinking environments. Further research is needed to better understand how people experience alcohol availability in their local environment and how this can inform alcohol control policies.
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Consumo de Bebidas Alcoólicas , Adulto , Adolescente , Criança , Humanos , Consumo de Bebidas Alcoólicas/epidemiologia , Pesquisa Qualitativa , Austrália , Reino Unido , África do SulRESUMO
INTRODUCTION: Minimum unit pricing (MUP) may reduce harmful drinking in the general population, but there is little evidence regarding its impact on marginalised groups. Our study is the first to explore the perceptions of MUP among stakeholders working with people experiencing homelessness following its introduction in Scotland in May 2018. METHODS: Qualitative semi-structured interviews were conducted with 41 professional stakeholders from statutory and third sector organisations across Scotland. We explored their views on MUP and its impact on people experiencing homelessness, service provision and implications for policy. Data were analysed using thematic analysis. RESULTS: Participants suggested that the introduction of MUP in Scotland had negligible if any discernible impact on people experiencing homelessness and services that support them. Most service providers felt insufficiently informed about MUP prior to its implementation. Participants reported that where consequences for these populations were evident, they were primarily anticipated although some groups were negatively affected. People experiencing homelessness have complex needs in addition to alcohol addiction, and changes in the way services work need to be considered in future MUP-related discussions. DISCUSSION AND CONCLUSIONS: This study suggests that despite initial concerns about potential unintended consequences of MUP, many of these did not materialise to the levels anticipated. As a population-level health policy, MUP is likely to have little beneficial impact on people experiencing homelessness without the provision of support to address their alcohol use and complex needs. The additional needs of certain groups (e.g., people with no recourse to public funds) need to be considered.
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Alcoolismo , Pessoas Mal Alojadas , Humanos , Bebidas Alcoólicas , Consumo de Bebidas Alcoólicas/epidemiologia , Política de Saúde , Custos e Análise de CustoRESUMO
BACKGROUND: Alcohol Minimum Unit Pricing (MUP) was introduced in Scotland in May 2018. Existing evidence suggests MUP can reduce alcohol consumption in the general population, but there is little research about its impact on vulnerable groups. This qualitative study explored experiences of MUP among people with experience of homelessness. METHODS: We conducted qualitative semi-structured interviews with a purposive sample of 46 people with current or recent experience of homelessness who were current drinkers when MUP was introduced. Participants (30 men and 16 women) were aged 21 to 73 years. Interviews focused on views and experiences of MUP. Data were analysed using thematic analysis. RESULTS: People with experience of homelessness were aware of MUP but it was accorded low priority in their hierarchy of concerns. Reported impacts varied. Some participants reduced their drinking, or moved away from drinking strong white cider, in line with policy intentions. Others were unaffected because the cost of their preferred drink (usually wine, vodka or beer) did not change substantially. A minority reported increased involvement in begging. Wider personal, relational and social factors also played an important role in responses to MUP. CONCLUSION: This is the first qualitative study to provide a detailed exploration of the impact of MUP among people with experience of homelessness. Our findings suggest that MUP worked as intended for some people with experience of homelessness, while a minority reported negative consequences. Our findings are of international significance to policymakers, emphasising the need to consider the impact of population level health policies on marginalised groups and the wider contextual factors that affect responses to policies within these groups. It is important to invest further in secure housing and appropriate support services and to implement and evaluate harm reduction initiatives such as managed alcohol programmes.
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Bebidas Alcoólicas , Pessoas Mal Alojadas , Masculino , Humanos , Feminino , Consumo de Bebidas Alcoólicas/epidemiologia , Cerveja , Custos e Análise de CustoRESUMO
BACKGROUND: People who identify as LGBTQ+ are more likely to drink excessively compared to heterosexual and cisgender people. Perceived barriers to accessing alcohol services may further increase the potential for alcohol related harm for LGBTQ+ people. This qualitative study explores the experiences of LGBTQ+ people who have used alcohol services, including peer support groups, in Scotland and their suggestions for how alcohol services could be improved. METHODS: Participants were recruited using social media adverts, dating websites, organisations that work with LGBTQ+ clients and snowball sampling. Participants' (n = 14) experiences of alcohol services and peer support groups were explored through semi-structured interviews. Data were analysed using the Framework Approach and thematic analysis. RESULTS: Many participants thought their drinking was closely associated with their LGBTQ+ identity, as a response to shame, stigma, or family rejection. Some service users had positive experiences of alcohol services. However, participants were rarely asked about their sexuality / gender identity and some reported a lack of discussion about how identity might impact drinking. There were common views across the sample that barriers experienced by others in the LGBTQ+ community were amplified for trans people. Service users recommended that services need to signal LGBTQ+ inclusivity and provide a safe space to discuss multiple issues (e.g., alcohol use, mental health, gender identity). Participants highlighted the importance of alcohol-free spaces in the LGBTQ+ communities. CONCLUSION: The study has clear practice and policy implications. Alcohol services should provide a safe space for LGBTQ+ people and clearly indicate that. Service providers should be trained to discuss potential connections between LGBTQ+ identity and substance use. At a broader level, alcohol-free social spaces would help reduce alcohol-related harm in LGBTQ+ communities.
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Identidade de Gênero , Minorias Sexuais e de Gênero , Feminino , Humanos , Masculino , Pesquisa Qualitativa , Comportamento Sexual , Estigma SocialRESUMO
INTRODUCTION: Gender and sexual minority populations are more likely to drink excessively compared to heterosexual and cisgender people. Existing reviews of alcohol interventions focus on specific subgroups within the lesbian, gay, bisexual, trans*, queer, questioning or otherwise gender or sexuality diverse (LGBTQ+) population and neither identify their theoretical basis nor examine how interventions are tailored to meet the needs of specific subgroups. METHODS: This systematic review includes published studies reporting the effectiveness of interventions to reduce alcohol use in LGBTQ+ people. The review followed PRISMA guidelines. Quality was assessed using the Effective Public Health Practice Project (EPHPP) Quality Assessment Tool. RESULTS: The review includes 25 studies, with the earliest published in 2005. The majority (n = 20) focused on men who have sex with men; only two included sexual minority women and three included trans* people. Most studies were conducted in the USA (n = 21) and used a randomised design (n = 15). Five studies were assessed to be of strong quality, seven moderate and 13 weak. Interventions were mainly delivered face-to-face (n = 21). The most common approaches used to inform interventions were Motivational Interviewing (n = 8) and Cognitive Behavioural Therapy (n = 8). Nineteen studies reported a significant reduction in alcohol consumption. DISCUSSION AND CONCLUSIONS: This review suggests that for interventions to be effective in reducing alcohol consumption in LGBTQ+ people, they need to be informed by theory and adapted for the target population. Alcohol interventions that focus on sexual minority women, trans* people and people with other gender identities are needed. The findings have implications for professionals who need to identify when gender and/or sexuality are peripheral or central to alcohol use.
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Homossexualidade Masculina , Minorias Sexuais e de Gênero , Adulto , Feminino , Identidade de Gênero , Humanos , Masculino , Comportamento Sexual , Sexualidade/psicologiaRESUMO
INTRODUCTION: Type 2 diabetes is a chronic health condition that requires ongoing self-management. This often includes changes in diet, which may be open to influences from relatives. Family support in terms of diet may be linked with gender and the assumption that meal preparation is a traditionally female activity. This article looks at the role of gender in diet management in people with type 2 diabetes and their relatives. METHODS: Seventeen semi-structured interviews were conducted with 23 participants (10 people with type 2 diabetes, 13 relatives of people with type 2 diabetes) in Scotland, UK. The aim was to uncover changes people have made to their diet following diagnosis of type 2 diabetes in oneself or a family member. Data were analysed using Framework Approach.Findings: Female relatives were more likely to manage the patient's diet while male relatives provided support but were less likely to monitor the person's diet. Female patients may prioritise the needs of their family while male patients are more likely to rely on their female relatives in terms of diet management. DISCUSSION: The study findings have implications for family-based interventions as gender may play a crucial role in the management of type 2 diabetes.
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Diabetes Mellitus Tipo 2 , Autogestão , Dieta , Família , Feminino , Promoção da Saúde , Humanos , MasculinoRESUMO
INTRODUCTION: It is unknown whether male body dissatisfaction is related to anxiety and depression. This study investigates whether there is an association between body dissatisfaction and self-reported anxiety and/or depression in otherwise healthy adult males. METHOD: A systematic review was conducted using Preferred Reporting Items for Systematic Reviews and Meta Analyses as the reporting guideline. Four databases including CINAHL complete, Health Source: Nursing/Academic Edition, MEDLINE and PsycINFO were searched for observational studies with a correlational design. Studies were appraised using the Appraisal tool for Cross-Sectional Studies to measure quality and risk of bias. Data were extracted from studies to analyse and synthesise findings using content analysis and random effects meta-analyses in male body dissatisfaction and anxiety, depression, and both anxiety and depression. RESULTS: Twenty-three cross-sectional studies were included in the review. Nineteen studies found positive correlations between male body dissatisfaction and anxiety and/or depression. Meta-analyses of Pearson's correlation coefficients found statistically significant associations with body satisfaction for anxiety 0.40 (95% CI 0.28 to 0.51) depression 0.34 (95% CI 0.22 to 0.45) and both anxiety and depression outcomes 0.47 (95% CI 0.33 to 0.59). The quality appraisal found study samples were homogeneous being mostly ascertained through academic institutions where participants were predominantly young, Caucasian and with relatively high educational attainment. Measures of body satisfaction focused predominantly on muscularity and thinness. DISCUSSION: This study provides the first pooled estimates of the correlation between body dissatisfaction and anxiety and depression in men. Findings need to be interpreted with respect to the samples and outcomes of the included studies. It is recommended that future research should increase the diversity of men in studies. Studies should measure a wider range of body dissatisfaction types found in men. CONCLUSION: The findings demonstrate that an association between male body dissatisfaction and anxiety and depression is likely to exist. Future research should address the temporal relationship between body dissatisfaction and anxiety and depression.
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Transtornos de Ansiedade/epidemiologia , Insatisfação Corporal/psicologia , Transtorno Depressivo/epidemiologia , Qualidade de Vida , Autorrelato , Transtornos de Ansiedade/psicologia , Transtorno Depressivo/psicologia , Humanos , Incidência , Masculino , Saúde do HomemRESUMO
AIMS: To explore the potential of type 2 diabetes diagnosis to be a "teachable moment". METHODS: Semi-structured interviews were conducted with 23 participants (10 people with type 2 diabetes, 13 relatives of people with type 2 diabetes) in Scotland, UK. They explored cognitive, emotional and behavioural changes following diagnosis of type 2 diabetes in oneself or in a relative. Data were analysed using Framework approach. RESULTS: Strong emotional responses are not always related to the occurrence of a teachable moment. Risk perception and outcome expectancy were found to be teachable moment factors for patients with type 2 diabetes and their offspring, but not their partners. Change in self-concept increases the likelihood of type 2 diabetes diagnosis to be a teachable moment for patients but not for relatives. In some cases, type 2 diabetes is perceived as incompatible with current roles thus hindering diabetes self-management. Relatives often engage in caring for patients and "policing" their behaviour but did not report perceived changes in social roles. CONCLUSIONS: The study suggests that diagnosis of type 2 diabetes is a teachable moment for some patients and their relatives. These findings have implications for interventions to address diabetes self-management in patients and primary prevention in their relatives.
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Diabetes Mellitus Tipo 2/diagnóstico , Comportamentos Relacionados com a Saúde/fisiologia , Adulto , Idoso , Diabetes Mellitus Tipo 2/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa QualitativaRESUMO
BACKGROUND: People's personal perceptions, or illness representations, of type 2 diabetes can act as barriers to successful self-management. INTRODUCTION: Understanding patients' subjective perceptions of type 2 diabetes can aid the design of evidence-based care and appropriate educational programmes. This scoping review provides a narrative account of previous knowledge of patients' illness representations of type 2 diabetes. METHODS: Quantitative and qualitative studies that explored patients' illness representations of type 2 diabetes, as defined by Leventhal's Common Sense Model, were included. RESULTS: Thirty four studies were identified for this review, but only 14 studies were carried out in a general population of people with diabetes. Illness representations varied across study populations. While it is clear that the perceptions of ethnic minorities and marginalised groups are embedded in their historical and cultural backgrounds, it is also important to understand the views of the wider population. CONCLUSION: The review highlights the need for self-management interventions to reflect the target population's representations of type 2 diabetes in order to inform interventions and clinical practice.
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Diabetes Mellitus Tipo 2/psicologia , Percepção/fisiologia , Autocuidado/psicologia , Cultura , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/terapia , Etnicidade , Conhecimentos, Atitudes e Prática em Saúde , Humanos , AutoeficáciaRESUMO
INTRODUCTION: Sustaining effective interventions in hospital environments is essential to improving health outcomes, and reducing research waste. Current evidence suggests many interventions are not sustained beyond their initial delivery. The reason for this failure remains unclear. Increasingly research is employing theoretical frameworks and models to identify critical factors that influence the implementation of interventions. However, little is known about the value of these frameworks on sustainability. The aim of this review is to examine the evidence regarding the use of theoretical frameworks to maximise effective intervention sustainability in hospital-based settings in order to better understand their role in supporting long-term intervention use. METHODS AND ANALYSIS: Systematic review. We will systematically search the following databases: Medline, AMED, CINAHL, Embase and Cochrane Library (CENTRAL, CDSR, DARE, HTA). We will also hand search relevant journals and will check the bibliographies of all included studies. Language and date limitations will be applied. We will include empirical studies that have used a theoretical framework (or model) and have explicitly reported the sustainability of an intervention (or programme). One reviewer will remove obviously irrelevant titles. The remaining abstracts and full-text articles will be screened by two independent reviewers to determine their eligibility for inclusion. Disagreements will be resolved by discussion, and may involve a third reviewer if required. Key study characteristics will be extracted (study design, population demographics, setting, evidence of sustained change, use of theoretical frameworks and any barriers or facilitators data reported) by one reviewer and cross-checked by another reviewer. Descriptive data will be tabulated within evidence tables, and key findings will be brought together within a narrative synthesis. ETHICS AND DISSEMINATION: Formal ethical approval is not required as no primary data will be collected. Dissemination of results will be through peer-reviewed journal publications, presentation at an international conference and social media. PROSPERO REGISTRATION NUMBER: CRD42017081992.
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Atenção à Saúde/métodos , Atenção à Saúde/normas , Melhoria de Qualidade/organização & administração , Humanos , Projetos de Pesquisa , Revisões Sistemáticas como AssuntoRESUMO
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.
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Terapia Comportamental/métodos , Consumo Excessivo de Bebidas Alcoólicas/terapia , Adulto , Consumo Excessivo de Bebidas Alcoólicas/psicologia , Aconselhamento , Estudos de Viabilidade , Feminino , Humanos , Projetos de Pesquisa , Resultado do Tratamento , Adulto JovemRESUMO
The relatives and partners of people with type 2 diabetes are at increased risk of developing type 2 diabetes. This systematic review examines randomized controlled trials, written in English that tested an intervention, which aimed to modify behaviors known to delay or prevent type 2 diabetes, among the relatives or partners of people with type 2 diabetes. Study quality was assessed using the Cochrane Collaboration's tool for assessing risk of bias. Seven studies met the inclusion criteria. The majority of studies were at low risk of bias. Six studies tested an intervention in first-degree relatives of people with type 2 diabetes and one in partners. Intervention components and intervention intensity across studies varied, with those targeting diet and physical activity reporting the most significant changes in primary outcomes. Only one study did not observe significant changes in primary outcomes. There were three main recruitment approaches: advertising in the community, recruiting people through their relatives with diabetes, or identifying people as high risk by screening of their own health care contacts. Some evidence was found for potentially successful interventions to prevent type 2 diabetes among the relatives and partners of people with type 2 diabetes, although finding simple and effective methods to identify and recruit them remains a challenge. Future studies should explore the effect of patients' perceptions on their family members' behavior and capitalize on family relationships in order to increase intervention effectiveness.
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Diabetes Mellitus Tipo 2/genética , Diabetes Mellitus Tipo 2/prevenção & controle , Família , Prevenção Primária/métodos , Cônjuges , Adulto , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Dieta Saudável , Exercício Físico , Feminino , Predisposição Genética para Doença , Hereditariedade , Humanos , Masculino , Pessoa de Meia-Idade , Linhagem , Fenótipo , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Fatores de Risco , Comportamento de Redução do Risco , Resultado do TratamentoRESUMO
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.