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BACKGROUND: Neonatal jaundice is a common condition that can lead to brain damage and disabilities when severe cases go undetected. Low- and middle-income countries often lack accurate methods for detecting neonatal jaundice and rely on visual assessment, resulting in a higher incidence of adverse consequences. Picterus Jaundice Pro (Picterus JP), an easy-to-use and affordable smartphone-based screening device for the condition, has demonstrated higher accuracy than visual assessment in Norwegian, Philippine and Mexican newborns. This study aimed to identify the barriers and facilitators to implementing Picterus JP in public health services in low-income settings in Mexico by exploring the current process of neonatal jaundice detection and stakeholders' perspectives in that context. METHODS: Qualitative data collection techniques, including one focus group, 15 semi-structured interviews and four observations, were employed in urban and rural health facilities in Oaxaca, Mexico. The participants included medical doctors, nurses and health administrators. The data were analysed by thematic analysis guided by the Consolidated Framework for Implementation Research. RESULTS: The analysis yielded four main themes: (I) the current state of neonatal care and NNJ detection, (II) the needs and desires for enhancing NNJ detection, (III) the barriers and facilitators to implementing Picterus JP in the health system and (IV) HCWs' expectations of Picterus JP. The findings identify deficiencies in the current neonatal jaundice detection process and the participants' desire for a more accurate method. Picterus JP was perceived as easy to use, useful and compatible with the work routine, but barriers to adoption were identified, including internet deficiencies and costs. CONCLUSIONS: The introduction of Picterus JP as a supporting tool to screen for neonatal jaundice is promising but contextual barriers in the setting must be addressed for successful implementation. There is also an opportunity to optimise visual assessment to improve detection of neonatal jaundice.
Assuntos
Grupos Focais , Icterícia Neonatal , Pesquisa Qualitativa , Telemedicina , Humanos , Icterícia Neonatal/diagnóstico , Recém-Nascido , México , Triagem Neonatal/métodos , Feminino , Masculino , Países em Desenvolvimento , Entrevistas como Assunto , SmartphoneRESUMO
BACKGROUND: Perinatal loss can have long-lasting adverse effects on a woman's psychosocial health, including during subsequent pregnancies. However, maternal mental health status after perinatal loss during subsequent pregnancy is understudied with very little data available for Scandinavian populations. AIMS: The primary aim of the study was to explore the association between previous perinatal loss and anxiety/depression symptoms of expectant mothers during the subsequent pregnancy. The secondary aim of this study was to explore possible determinants of maternal mental health during the subsequent pregnancy, independent of previous perinatal loss. METHOD: This case-cohort study is based on primary data from Scandinavian Successive Small-for-Gestational Age Births Study (SGA Study) in Norway and Sweden. The total case-cohort sample in the current study includes 1458 women. Cases include 401 women who had reported a previous perinatal loss (spontaneous abortion, stillbirth, or neonatal death) and who responded to two mental health assessment instruments, the State-Trait Anxiety Inventory (STAI), and the Centre for Epidemiological Studies Depression (CES-D) scale. Multiple linear regression models were used to assess the association between previous perinatal loss and maternal mental health in subsequent pregnancy. RESULTS: Scandinavian pregnant women with previous perinatal loss reported higher symptoms for both anxiety and depression during their subsequent pregnancy compared to mothers in the same cohort reported no previous perinatal loss. Multiple linear regression analyses showed a positive association between previous perinatal loss and per unit increase in both total anxiety score (ß: 1.22, 95% CI: 0.49-1.95) and total depression score (ß: 0.90, 95% CI: 0.06-1.74). We identified several factors associated with maternal mental health during pregnancy independent of perinatal loss, including unintended pregnancy despite 97% of our population being married/cohabitating. CONCLUSION: Women who have experienced previous perinatal loss face a significantly higher risk of anxiety and depression symptoms in their subsequent pregnancy.
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Depressão , Gestantes , Recém-Nascido , Feminino , Gravidez , Humanos , Gestantes/psicologia , Depressão/epidemiologia , Depressão/psicologia , Estudos de Coortes , Ansiedade/epidemiologia , Ansiedade/psicologia , Natimorto/epidemiologia , Natimorto/psicologia , Países Escandinavos e Nórdicos/epidemiologiaRESUMO
BACKGROUND: The paper explores how age, social position or class, and linguistic and cultural background intersect and place women in varying positions of control and vulnerability to obstetric violence in state health institutions in Colombo district, Sri Lanka. Obstetric violence occurs during pregnancy, childbirth and the immediate postpartum period; hence, it is violence that directly affects women. The authors aim to break the traditional culture of silence around obstetric violence and bring attention to the resulting implications for quality of care and patient trust in obstetric care facilities or providers. METHODS: Five focus group discussions were held with 28 public health midwives who had prior experience working in labor rooms. Six focus group discussions were held with 38 pregnant women with previous childbirth experience. Additionally, 10 of the 38 women, whom felt they had experienced excessive pain, fear, humiliation, and/or loss of dignity as patients in labor, participated in individual in-depth interviews. An intersectional framework was used to group the qualitative data into categories and themes for analysis. RESULTS: Obstetric violence appears to intersect with systems of power and oppression linked to structural gender, social, linguistic and cultural inequities in Sri Lanka. In our dataset, younger women, poorer women, and women who did not speak Sinhala seemed to experience more obstetric violence than those with relevant social connections and better economic positions. The women in our study rarely reported obstetric violence to legal or institutional authorities, nor within their informal social support networks. Instead, they sought obstetric care, particularly for childbirth, in other state hospitals in subsequent pregnancies. CONCLUSIONS: The quality of obstetric care in Sri Lanka needs improvement. Amongst other initiatives, policies and practices are required to sensitize health providers about the existence of obstetric violence, and repercussions are required for abusive or discriminatory practices. The ethics of care should be further reinforced in the professional training of obstetric health providers.
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Atitude do Pessoal de Saúde , Parto Obstétrico/psicologia , Exposição à Violência , Enfermeiros Obstétricos/psicologia , Gestantes/psicologia , Violência/psicologia , Adulto , Feminino , Grupos Focais , Humanos , Serviços de Saúde Materna/normas , Tocologia/métodos , Tocologia/normas , Parto/psicologia , Gravidez , Logradouros Públicos/normas , Pesquisa Qualitativa , Qualidade da Assistência à Saúde , Sri Lanka , ConfiançaRESUMO
BACKGROUND: Gestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Lifestyle intervention can prevent progression to type 2 diabetes in high risk populations. We designed a randomised controlled trial (RCT) to evaluate the effectiveness of an established lifestyle intervention compared to standard care for delaying diabetes onset in European women with recent GDM. Recruitment into the RCT was more challenging than anticipated with only 89 of 410 (22%) women agreeing to participate. This paper identifies factors that could enhance participation of the target population in future interventions. METHODS: We hypothesised that women who agreed to participate would have higher diabetes risk profiles than those who declined, and secondly that it would be possible to predict participation on the bases of those risk factors. To test our hypothesis, we identified the subset of women for whom we had comprehensive data on diabetes risks factors 3-5 years following GDM, reducing the sample to 43 participants and 73 decliners. We considered established diabetes risk factors: smoking, daily fruit and vegetable intake, participation in exercise, family history of diabetes, glucose values and BMI scores on post-partum re-screens, use of insulin during pregnancy, and age at delivery. We also analysed narrative data from 156 decliners to further understand barriers to and facilitators of participation. RESULTS: Two factors differentiated participants and decliners: age at delivery (with women older than 34 years being more likely to participate) and insulin use during pregnancy (with women requiring the use of insulin in pregnancy less likely to participate). Binary logistic regression confirmed that insulin use negatively affected the odds of participation. The most significant barriers to participation included the accessibility, affordability and practicality of the intervention. CONCLUSIONS: Women with recent GDM face multiple barriers to lifestyle change. Intervention designers should consider: (i) the practicalities of participation for this population, (ii) research designs that capitalise on motivational differences between participants, (iii) alleviating concerns about long-term diabetes management. We hope this work will support future researchers in developing interventions that are more relevant, effective and successful in recruiting the desired population. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41202110.
Assuntos
Diabetes Mellitus Tipo 2/prevenção & controle , Diabetes Gestacional , Cooperação do Paciente/psicologia , Recusa de Participação/psicologia , Fatores Etários , Exercício Físico , Feminino , Humanos , Insulina/uso terapêutico , Estilo de Vida , Gravidez , Fatores de Risco , Inquéritos e QuestionáriosRESUMO
The phenomenon of obstetric violence has been documented widely in maternity care settings worldwide, with scholars arguing that it is a persistent, common, but preventable impediment to attaining dignified health care. However, gaps remain in understanding local expressions of the phenomenon, associations with other types of violence against women, and implications for women's trust and confidence in health providers and services. We focused on these issues in this cross-sectional study of 1314 women in Sri Lanka's Colombo district. Specifically, in this study, we used Sinhalese and Tamil translations of the NorVold Abuse Questionnaire and the Abuse Assessment Screen to measure prevalence of women's experiences with obstetric violence in maternity care and lifetime and pregnancy-specific domestic violence. Then, the results were interpreted by considering the women's sociodemographic characteristics, such as age, ethnicity, and family income, to reveal previously undocumented associations between obstetric and domestic violence during pregnancy, as well as other factors associated with experiencing obstetric violence. We argue that obstetric violence is prevalent in government-sector (public) maternity care facilities in the Colombo district and is associated with young age, lower family income, non-majority ethnicity, and rural residency. Significantly, this study sheds light on a serious concern that has been underexamined, wherein women who report experiencing obstetric violence are also less likely to be asked by a health care provider about domestic violence experiences. Further research at the clinical level needs to focus on appropriate training and interventions to ensure women's safety and cultivate relationships between patients and health care providers characterized by trust, confidence, and respect.
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Violência Doméstica , Serviços de Saúde Materna , Estudos Transversais , Feminino , Humanos , Índia , Gravidez , Gestantes , Sri Lanka/epidemiologiaRESUMO
Women globally experience mistreatment by health providers during childbirth. Researchers have identified strategies to counteract this type of abuse in health care, but few have been evaluated. We used a theater technique, Forum Play, in a brief training intervention to increase awareness of abuse in health care and promote taking action to reduce or prevent it. The intervention was implemented in four workshops with 50 participating physicians and nurses from three hospitals in Colombo, Sri Lanka. This article reports the views of 23 workshop participants who also took part in four focus group discussions on the acceptability and feasibility of the method. The participants reported that the intervention method stimulated dialogue and critical reflection and increased their awareness of the everyday nature of abuses experienced by patients. Participants appreciated the participatory format of Forum Play, which allowed them to re-enact scenarios they had experienced and rehearse realistic actions to improve patient care in these situations. Structural factors were reported as limitations to the effectiveness of the intervention, including under-developed systems for protecting patient rights and reporting health provider abuses. Nonetheless, the study indicates the acceptability and feasibility of a theater-based training intervention for reducing the mistreatment of patients by health care providers in Sri Lanka.
Assuntos
Atenção à Saúde , Pessoal de Saúde , Serviços de Saúde Materna , Relações Profissional-Paciente , Adulto , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Gravidez , Sri LankaRESUMO
BACKGROUND: There is significant evidence of the prevalence and factors associated with domestic violence in high and low-income country settings. However, men's views on domestic violence are still understudied and have never been reported in Nepali society. OBJECTIVE: The aim of the study was to explore Nepali men's perceptions regarding domestic violence in their communities. METHOD: The authors undertook a qualitative study using focus group discussions. RESULTS: Sixty-six married men, considered they were responsible for upholding family discipline and physically demonstrating their masculinity, and they suggested that violence was a mean for achieving this. Men's frustration when unable to fulfil their family's expectations or material needs, and cultural attitudes that precluded interference in other families' lives, were perceived as factors contributing to domestic violence. The men held the opinion that women also perpetrated domestic violence. Some men were reluctant to accept domestic violence as a norm in Nepali families and were aware of recent changes in societal expectations regarding gender roles. CONCLUSION: Overall, the Nepali men who participated in the study held different and sometimes opposing views on domestic violence, ranging from violence justified as a necessity for family discipline, uneasy acceptance that violence was commonplace in families, to definite opposition to the use of domestic violence. The study's findings provide information for identifying points of intervention for violence-prevention efforts and strategies to alter the social and cultural norms that lead to acceptance of domestic violence.
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Violência Doméstica , Masculinidade , Homens , Adulto , Atitude , Feminino , Grupos Focais , Humanos , Masculino , Casamento , Homens/psicologia , Nepal , Pobreza , Pesquisa Qualitativa , Adulto JovemRESUMO
BACKGROUND: Sexual harassment occurs within the nursing profession globally, challenging the health and safety of nurses and the quality and efficiency of health systems. In Sri Lanka, no studies have explored this issue in the health sector; however, female employees face sexual harassment in other workplace settings. OBJECTIVE: To explore female nurses' perceptions of workplace sexual harassment in a large state hospital in Sri Lanka. METHODS: This is a qualitative study conducted in an urban, mainly Buddhist and Singhalese context. We invited all female senior and ward nurses working in the hospital to participate in the study. We conducted individual in-depth interviews with four senior nurses and focus group discussions with 29 nurses in three groups. RESULTS: The nurses described a variety of perceived forms of sexual harassment in the hospital. They discussed patient-perpetrated incidents as the most threatening and the clearest to identify compared with incidents involving doctors and other co-workers. There was significant ambiguity regarding sexual consent and coercion in relationships between female nurses and male doctors, which were described as holding potential for exploitation or harassment. The nurses reported that typical reactions to sexual harassment were passive. Alternatively, they described encountering inaction or victim blaming when they attempted to formally report incidents. They perceived that workplace sexual harassment has contributed to negative societal attitudes about the nursing profession and discussed various informal strategies, such as working in teams, to protect themselves from sexual harassment in the hospital. CONCLUSIONS: Sexual harassment was a perceived workplace concern for nurses in this hospital. To develop effective local prevention and intervention responses, further research is required to determine the magnitude of the problem and explore differences in responses to and consequences of sexual harassment based on perpetrator type and intent, and personal vulnerabilities of the victims, among other factors.
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Conhecimentos, Atitudes e Prática em Saúde , Assédio Sexual , Local de Trabalho , Adulto , Feminino , Grupos Focais , Hospitais Estaduais , Humanos , Entrevistas como Assunto , Pesquisa Qualitativa , Sri LankaRESUMO
Obstetric violence refers to the mistreatment of women in pregnancy and childbirth care by their health providers. It is linked to poor quality of care, lack of trust in health systems, and adverse maternal and neonatal outcomes. Evidence of interventions to reduce and prevent obstetric violence is limited. We developed a training intervention using a participatory theatre technique called Forum Play inspired by the Theatre of the Oppressed for health providers in Sri Lanka. This paper assesses the potential of the training method to increase staff awareness of obstetric violence and promote taking action to reduce or prevent it. We conducted four workshops with 20 physicians and 30 nurses working in three hospitals in Colombo, Sri Lanka. Participants completed a questionnaire before and three-to-four months after the intervention. At follow-up, participants more often reported that they had been involved in situations of obstetric violence, indicating new knowledge of the phenomenon and/or an increase in their ability to conceptualise it. The intervention appears promising for improving the abilities of health care providers to recognise obstetric violence, the first step in counteracting it. The study demonstrates the value of developing further studies to assess the longitudinal impacts of theatre-based training interventions to reduce obstetric violence and, ultimately, improve patient care.
Assuntos
Atenção à Saúde/organização & administração , Relações Profissional-Paciente , Violência , Adulto , Feminino , Humanos , Projetos Piloto , Gravidez , Sri LankaRESUMO
BACKGROUND: Globally, knowledge of health sector options to respond to domestic violence during pregnancy is increasing, but this topic is under-investigated in Nepal. This gap affects the provision of adequate antenatal care services and understanding of factors that influence women's willingness and ability to use available services. It is critical to know more about the social norms in a community that promote and prevent women experiencing domestic violence from seeking antenatal care. OBJECTIVE: To explore community perceptions of domestic violence against pregnant women. METHODS: A qualitative study was conducted in Dhulikhel municipality, involving 41 men and 76 women in 12 focus group discussions in different gender and family role separated groups. The interviews were recorded, transcribed in verbatim, and analyzed using content analysis. A socio-ecological model was used as a theoretical framework to illustrate linkages between individual, relationship, community, and societal influences on perceptions of domestic violence during pregnancy. RESULTS: The community recognized different forms of violence during pregnancy threatening women's physical and psychological health and presenting obstacles to seeking antenatal care. Some types of culturally specific violence were considered particularly harmful, such as pressure to give birth to sons, denial of food, and forcing pregnant women to do hard physical work during pregnancy, which may leave daughters-in-law vulnerable to domestic violence in extended families. A culture where violence is normalized and endurance and family reconciliation are promoted above individual health was perceived to cause women to tolerate and accept the situation. Participants suggested actions and strategies to address continuing violence, which indicated a societal transition toward increased awareness and changing attitudes and practices. CONCLUSIONS: Domestic violence during pregnancy needs to be addressed at different levels in Nepal, where women are often dependent on others for access to health care. Social norms were perceived to be shifting toward reduced acceptance of violence against women, but restrictions on women's life options, movement, and decision-making authority were still considered impediments to pregnant women's health.
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BACKGROUND: Skin bleaching is a widespread phenomenon in spite of their potentially toxic health effects. OBJECTIVES: This study aimed to determine if such products are used in Sweden in particular by pregnant women, furthermore to explore immigrant women's view skin bleaching. METHODS: 455 pregnant women completed a questionnaire, which were statistically analysed. Focus groups and individual interviews were conducted with immigrant women, content analysis was used to assess the data. RESULTS: Skin bleaching products were used by 2.6% of pregnant women, significantlly more by women born in non-European countries. Motivating factors were associated with the concept of beauty together with social and economic advantages. The women had low awareness of the potential health risks of the products. Regulations on the trade of skin bleaching products have not effectively reduced the availability of the products in Sweden nor the popularity of skin bleaching. CONCLUSION: There is need for further research especially among pregnant women and possible effects on newborns. Products should be tested for toxicity. Public health information should be developed and health care providers educated and aware of this practice, due to their potential negative health implications.
Assuntos
Emigrantes e Imigrantes/psicologia , Motivação , Preparações Clareadoras de Pele/toxicidade , Pigmentação da Pele/efeitos dos fármacos , Adulto , Povo Asiático/etnologia , População Negra/etnologia , Emigrantes e Imigrantes/estatística & dados numéricos , Feminino , Grupos Focais , Humanos , Pessoa de Meia-Idade , Gravidez , Pesquisa Qualitativa , Inquéritos e Questionários , SuéciaRESUMO
Domestic violence in pregnancy is a significant health concern for women around the world. Globally, much has been written about how the health sector can respond effectively and comprehensively to domestic violence during pregnancy via antenatal services. The evidence from low-income settings is, however, limited. Sri Lanka is internationally acknowledged as a model amongst low-income countries for its maternal and child health statistics. Yet, very little research has considered the perspectives and experiences of the key front line health providers for pregnant women in Sri Lanka, public health midwives (PHMs). We address this gap by consulting PHMs about their experiences identifying and responding to pregnant women affected by domestic violence in an underserved area: the tea estate sector of Badulla district. Over two months in late 2014, our interdisciplinary team of social scientists and medical doctors met with 31 estate PHMs for group interviews and a participatory workshop at health clinics across Badulla district. In the paper, we propose a modified livelihoods model to conceptualise the physical, social and symbolic assets, strategies and constraints that simultaneously enable and limit the effectiveness of community-based health care responses to domestic violence. Our findings also highlight conceptual and practical strategies identified by PHMs to ensure improvements in this complex landscape of care. Such strategies include estate-based counselling services; basic training in family counselling and mediation for PHMs; greater surveillance of abusive men's behaviours by male community leaders; and performance evaluation and incentives for work undertaken to respond to domestic violence. The study contributes to international discussions on the meanings, frameworks, and identities constructed at the local levels of health care delivery in the global challenge to end domestic violence. In turn, such knowledge adds to international debates on the roles and responsibilities of health care professionals in responding to and preventing domestic violence.
Assuntos
Atitude do Pessoal de Saúde , Violência Doméstica/prevenção & controle , Tocologia/educação , Cuidado Pré-Natal/métodos , Adulto , Serviços de Saúde Comunitária , Atenção à Saúde , Violência Doméstica/psicologia , Feminino , Identidade de Gênero , Humanos , Masculino , Gravidez , Pesquisa Qualitativa , Sri Lanka , Direitos da MulherRESUMO
BACKGROUND: The risks associated with gestational diabetes mellitus (GDM) are well recognized, and there is increasing evidence to support treatment of the condition. However, clear guidance on the ideal approach to screening for GDM is lacking. Professional groups continue to debate whether selective screening (based on risk factors) or universal screening is the most appropriate approach. Additionally, there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment. Furthermore, the implications of possible screening options on health care costs are not well established. In response to this uncertainty there have been repeated calls for well-designed, randomised trials to determine the efficacy of screening, diagnosis, and management plans for GDM. We describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings. METHODS/DESIGN: This will be an unblinded, two-group, parallel randomised controlled trial (RCT). The target population includes 784 women presenting for their first antenatal visit at 12 to 18 weeks gestation at two hospitals in the west of Ireland: Galway University Hospital and Mayo General Hospital. Participants will be offered universal screening for GDM at 24 to 28 weeks gestation in either primary care (n=392) or secondary care (n=392) locations. The primary outcome variable is the uptake rate of screening. Secondary outcomes include indicators of clinical effectiveness of screening at each screening site (primary and secondary) including gestational week at time of screening, time to access antenatal diabetes services for women diagnosed with GDM, and pregnancy and neonatal outcomes for women with GDM. In addition, parallel economic and qualitative evaluations will be conducted. The trial will cover the period from the woman's first hospital antenatal visit at 12 to 18 weeks gestation, until the completion of the pregnancy. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN02232125.
Assuntos
Diabetes Gestacional/diagnóstico , Diabetes Gestacional/economia , Teste de Tolerância a Glucose/economia , Custos de Cuidados de Saúde , Aceitação pelo Paciente de Cuidados de Saúde , Cuidado Pré-Natal/economia , Atenção Primária à Saúde/economia , Projetos de Pesquisa , Atenção Secundária à Saúde/economia , Biomarcadores/sangue , Glicemia/metabolismo , Protocolos Clínicos , Análise Custo-Benefício , Diabetes Gestacional/sangue , Diabetes Gestacional/terapia , Feminino , Idade Gestacional , Humanos , Irlanda , Valor Preditivo dos Testes , Gravidez , Resultado da Gravidez , Fatores de TempoRESUMO
BACKGROUND: Universal screening using the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria has identified a prevalence of gestational diabetes mellitus (GDM) of 12.4% in women living in Ireland. Women with prior GDM are at increased risk of developing type 2 diabetes later in life. A number of risk factors linked to the development of type 2 diabetes are potentially modifiable through lifestyle and behaviour changes, and medical management. No previous Irish studies have adequately investigated the efficacy of lifestyle intervention programmes in reducing these risk factors in women with prior GDM. Through a two-group, parallel randomised controlled trial (RCT), this study aims to assess the clinical impact, cost-effectiveness and psychological experience of the Croí MyAction intensive lifestyle modification programme for women with prior GDM. METHODS/DESIGN: A total of 54 women with a history of GDM and persistent post-partum glucose dysfunction (impaired glucose tolerance (IGT) or impaired fasting glucose (IFG)), are randomly assigned to a control arm (n=27) or to the Croí MyAction intervention group (n=27). The control arm receives usual health care advice--written information on diet and lifestyle changes for reducing diabetes risks and visits with general practitioners as required. The intervention group receives usual health care as per the control group in addition to attending a 12-week intensive lifestyle modification programme known as Croí MyAction. Croí MyAction involves 2.5 hour sessions once per week (for 12 weeks) comprising a group exercise programme, group health promotion or education seminars, and one-to-one meetings with a multidisciplinary health care team to personalise risk factor reductions. Randomisation and allocation to the intervention arms is carried out by an independent researcher, ensuring that the allocation sequence is concealed from study researchers until the interventions are assigned. The primary analysis is based on glucose dysfunction, comparing a mean reduction in fasting plasma glucose (FPG) levels on a 75 gram oral glucose tolerance test (OGTT) in the two groups at a one-year, post-intervention follow-up. The trial is funded by the Irish Health Research Board (HRB). Ethics approval was obtained on 27 March 2012 from the Clinical Research Ethics Committee, Galway University Hospitals, Health Service Executive of Ireland (Ref: C.A.691). TRIAL REGISTRATION: Current Controlled Trials ISRCTN41202110.