Bmc Public Health
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Randomized Controlled Trial
Babies Living Safe & Smokefree: randomized controlled trial of a multilevel multimodal behavioral intervention to reduce low-income children's tobacco smoke exposure.
Addressing children's tobacco smoke exposure (TSE) remains a public health priority. However, there is low uptake and ineffectiveness of treatment, particularly in low-income populations that face numerous challenges to smoking behavior change. A multilevel intervention combining system-level health messaging and advice about TSE delivered at community clinics that disseminate the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), combined with nicotine replacement and intensive multimodal, individual-level behavioral intervention may improve TSE control efforts in such high-risk populations. ⋯ This study tests an innovative community-based, multilevel and integrated multimodal approach to reducing child TSE in a vulnerable, low-income population. The approach is sustainable and has potential for wide reach because WIC can integrate the tobacco intervention prompts into routine workflow and refer smokers to free evidence-based behavioral counseling interventions, such as state quitlines.
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Randomized Controlled Trial
Prevalence of intimate partner violence and abuse and associated factors among women enrolled into a cluster randomised trial in northwestern Tanzania.
Intimate partner violence (IPV) is recognised as an important public health and social problem, with far reaching consequences for women's physical and emotional health and social well-being. Furthermore, controlling behaviour by a partner has a similar impact on women's well-being, yet little is known about the prevalence of this type of behaviour and other related abuses in Tanzania and in other sub-Saharan African countries. ⋯ The high prevalence of IPV and abuses and its strong links with symptoms of poor mental health underline the urgent need for developing and testing appropriate interventions in settings like Tanzania to tackle both violence and abusive behaviours among intimate partners.
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Randomized Controlled Trial
A participatory supportive return to work program for workers without an employment contract, sick-listed due to a common mental disorder: an economic evaluation alongside a randomized controlled trial.
Mental disorders are associated with high costs for productivity loss, sickness absence and unemployment. A participatory supportive return to work (RTW) program was developed in order to improve RTW among workers without an employment contract, sick-listed due to a common mental disorder. The program contained a participatory approach, integrated care and direct placement in a competitive job. The aim of this study was to evaluate the cost-effectiveness and cost-utility of this new program, compared to usual care. In addition, its return on investment was evaluated. ⋯ From the societal perspective, the new program was neither cost-effective in improving sustainable RTW nor in gaining QALYs. From the social insurer's perspective, the program did not result in a positive financial return. Therefore, the present study provided no evidence to support its implementation.
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Randomized Controlled Trial Multicenter Study
A two-site, two-arm, 34-week, double-blind, parallel-group, randomized controlled trial of reduced nicotine cigarettes in smokers with mood and/or anxiety disorders: trial design and protocol.
The U.S. Food and Drug Administration can set standards for cigarettes that could include reducing their nicotine content. Such a standard should improve public health without causing unintended serious consequences for sub-populations. This study evaluates the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxicant exposure, and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders using a two-site, two-arm, double-blind, parallel group, randomized controlled trial (RCT) in four phases over 34 weeks. ⋯ Results from this study will inform FDA on the potential effects of regulating the nicotine content of cigarettes and help determine whether smokers with mood and/or anxiety disorders can safely transition to significantly reduced nicotine content cigarettes.
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Randomized Controlled Trial Multicenter Study
Study Protocol: The Norfolk Diabetes Prevention Study [NDPS]: a 46 month multi - centre, randomised, controlled parallel group trial of a lifestyle intervention [with or without additional support from lay lifestyle mentors with Type 2 diabetes] to prevent transition to Type 2 diabetes in high risk groups with non - diabetic hyperglycaemia, or impaired fasting glucose.
This 7 year NIHR programme [2011-2018] tests the primary hypothesis that the NDPS diet and physical activity intervention will reduce the risk of transition to type 2 diabetes (T2DM) in groups at high risk of Type 2 diabetes. The NDPS programme recognizes the need to reduce intervention costs through group delivery and the use of lay mentors with T2DM, the realities of normal primary care, and the complexity of the current glycaemic categorisation of T2DM risk. ⋯ The NDPS programme reports in 2018 and will provide trial outcome data for a group delivered diabetes prevention intervention, supported by lay mentors with T2DM, with intervention in multiple at risk glycaemic categories, and that takes into account the realities of normal clinical practice.