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Protocol of a randomized controlled trial of hearing protection interventions for farm operators.

ABSTRACT: Hearing loss and tinnitus are prevalent in America, and noise-induced hearing loss is a leading cause of hearing loss. Noise-induced hearing loss has negative impact on quality of life, physical and emotional functioning, social life, and employment. In addition, noise-induced hearing loss results in heavy social and economic burdens on families and communities from all ethnic and socioeconomic groups. Farmers are a group that is particularly high risk for noise-induced hearing loss, and is underserved by programs designed to limit that risk. They are among the most noise-exposed group of workers, and experience the second highest prevalence of noise-induced hearing loss among all occupational categories. In agriculture, 1.5 million workers (43.3%) report exposure to hazardous noise. Although use of hearing protection devices (HPDs) would protect them from noise-induced hearing loss, use among farmers is low.The purpose of this project is to compare the effectiveness of several approaches to influencing hearing protector use. Approaches include: a) an interactive, predictors-based intervention delivered via the Internet; b) a static informational web site; and c) a mailed sampler of hearing protectors. The goals are to further develop an intervention to promote farmers' use of HPDs, and compare the effectiveness of the interventions delivered in various combinations. Participants will include 701 farmers. Sites will be affiliates of a major farmer organization. Data will be collected at baseline, 6, and 12 months. A random intercept mixed model will be used to explore the fixed effects of the three NIHL prevention interventions over time while adjusting for age and gender. This project will involve a partnership between the University of Michigan and a major farmer organization to accomplish project aims.Results of this study will be used to inform future research-to-practice studies to increase hearing protector use. Increased use of hearing protectors is expected to reduce rates of noise-induced hearing loss and other negative effects of high noise exposure, and improve quality of life in this high-risk and underserved group.Clinicaltrials.gov NCT01454895 Registered 14 October, 2011.

SUBMITTER: McCullagh MC

PROVIDER: S-EPMC4412111 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Protocol of a randomized controlled trial of hearing protection interventions for farm operators.

McCullagh Marjorie C MC Ronis David L DL

BMC public health 20150418

<h4>Background</h4>Hearing loss and tinnitus are prevalent in America, and noise-induced hearing loss is a leading cause of hearing loss. Noise-induced hearing loss has negative impact on quality of life, physical and emotional functioning, social life, and employment. In addition, noise-induced hearing loss results in heavy social and economic burdens on families and communities from all ethnic and socioeconomic groups. Farmers are a group that is particularly high risk for noise-induced hearin ...[more]

PMID: 25927191

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Project description:BackgroundSkin cancer are increasing and some types of skin cancer are among the most lethal cancers yet are easily preventable. However, sun protection interventions are rarely implemented among outdoor workers. Our prior work shows that Michigan Operating Engineers (heavy equipment operators) spend an average of 4-5 hours in the sun, about one-third reported getting sun burned at least once a summer, and over half burned more than once a summer. About three-quarters of the sample never or only sometimes used sun block.Methods/designUsing the Health Belief Model as a guide, this randomized controlled trial (RCT) will test the efficacy of four sun protection interventions targeting Operating Engineers: a) education only; b) education and mailed sunscreen; c) education and text message reminders; and, d) education, mailed sunscreen, and text message reminders. Participations in the study will be offered during regularly scheduled safety trainings at the Local 324 Training Center. Pre- and post-intervention surveys will be collected to determine changes in sunscreen use and sun burning, the primary dependent variables. The analyses will include: a) paired t-tests to determine changes over time (from pre-intervention to post-intervention) in outcome variables (sunscreen use and burning) separately in the 4 intervention groups, b) Repeated Measures Analysis of Variance (RM-ANOVA) to compare the changes in outcomes across the 4 groups, and c) t-tests on change scores as follow-ups to the RM-ANOVA to determine exactly which groups differ from each other.DiscussionBased on the outcome of this study, we will develop a RO1 for wider scale testing and dissemination in conjunction with the International Training Center which services North America (including the US, Mexico, and Canada). Wide scale dissemination of an efficacious sun protection intervention has the potential to substantially impact skin cancer rates among this population. The ultimate goal is for high reach, high efficacy, and low cost.Trial registrationNCT01804595.

Project description:BACKGROUND: The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those with diabetes. The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in those with pre-diabetes. METHODS/DESIGN: The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 12 months at the Faculty of Medicine, University of Colombo, Sri Lanka. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo (EC/11/189). A total of 200 adults (age 18-60 years) with pre-diabetes will be recruited for the study. They will be stratified according to age, gender, and body mass index and randomly assigned into the test and placebo groups on a 1:1 ratio. The zinc capsules, each weighing 456 mg, will contain the following ingredients:zinc sulfate monohydrate 55.096 mg (elemental zinc 20 mg), lactose monohydrate 399.504 mg, and stearic acid 1.400 mg. The placebo capsule with the same weight will be comprised of lactose monohydrate 454.600 mg and stearic acid 1.400 mg. The subjects will receive either zinc 20 mg capsules or placebo daily for a period of 12 months. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 month (visit 2), 6 month (visit 3), and 12 month (visit 4). The following primary outcome measures will be evaluated:fasting plasma glucose (FPG), post oral glucose tolerance test (OGTT), serum insulin, HbA1c, total/low-density lipoprotein (LDL)/high-density lipoprotein (HDL) cholesterol, triglycerides, serum zinc, and appetite using a visual analog scale. Secondary outcome measures include: blood pressure, anthropometry, and dietary assessment using a validated food frequency questionnaire. Data will be analyzed using SPSS v16. DISCUSSION: The present protocol will aim to establish the beneficial effects of zinc supplementation on disease progression in those with pre-diabetes and also establish its effectiveness in the prevention of diabetes mellitus. TRIAL REGISTRATION: Sri Lanka Clinical Trial Registry: SLCTR/2012/010.

Project description:BackgroundOne-third or more of breast cancer survivors report stress and other psychological and physical complaints that can negatively impact their quality of life. Psychosocial stress management interventions, shown to mitigate the negative impact of these complaints, can now be delivered as accessible and convenient (for the patient and provider) eHealth interventions. In this randomized controlled trial (RCT), Coping After Breast Cancer (CABC), 2 modified versions of the stress management eHealth intervention program StressProffen were created: one with predominantly cognitive behavioral stress management content (StressProffen-cognitive behavioral therapy intervention [StressProffen-CBI]) and another with predominantly mindfulness-based stress management content (StressProffen-mindfulness-based intervention [StressProffen-MBI]).ObjectiveThis study aims to investigate the effects in breast cancer survivors of using StressProffen-CBI and StressProffen-MBI compared with a control group (treatment as usual).MethodsWomen diagnosed with breast cancer (stage I-III, unequivocally human epidermal growth factor receptor 2-positive or estrogen receptor-negative tumors) or ductal carcinoma in situ (DCIS) aged 21-69 years who completed the Cancer Registry of Norway-initiated health survey on quality of life are invited to the CABC trial about 7 months after diagnosis. Women who give consent to participate are randomized (1:1:1) to either the StressProffen-CBI, StressProffen-MBI, or control group. Both StressProffen interventions consist of 10 modules of stress management content delivered through text, sound, video, and images. The primary outcome is between-group changes in perceived stress at 6 months, assessed with Cohen 10-item Perceived Stress Scale. The secondary outcomes comprise changes in quality of life, anxiety, depression, fatigue, sleep, neuropathy, coping, mindfulness, and work-related outcomes approximately 1, 2, and 3 years after diagnosis. Long-term effects of the interventions on work participation, comorbidities, relapse or new cancers, and mortality will be assessed using data from national health registries.ResultsRecruitment is scheduled from January 2021 to May 2023. The goal is to recruit 430 participants (100 in each group). As of April 14 2023, 428 participants have been enrolled.ConclusionsThe CABC trial is possibly the largest ongoing psychosocial eHealth RCT in patients with breast cancer. If 1 or both interventions prove to be effective in reducing stress and improving psychosocial and physical complains, the StressProffen eHealth interventions could be beneficial, inexpensive, and easily implementable tools for breast cancer survivors when coping with late effects after cancer and cancer treatments.Trial registrationClinicaltrials.gov NCT04480203; https://clinicaltrials.gov/ct2/show/NCT04480203.International registered report identifier (irrid)DERR1-10.2196/47195.

Project description:BackgroundAnxiety disorders are prevalent among adolescents and may have long-lasting negative consequences for the individual, the family and society. Cognitive behavioral therapy (CBT) is an effective treatment. However, many anxious youth do not seek treatment. Low-intensity CBT in schools may improve access to evidence-based services. We aim to investigate the efficacy of two CBT youth anxiety programs with different intensities (i.e., number and length of sessions), both group-based and administered as early interventions in a school setting. The objectives of the study are to examine the effects of school-based interventions for youth anxiety and to determine whether a less intensive intervention is non-inferior to a more intensive intervention.Methods/designThe present study is a randomized controlled trial comparing two CBT interventions to a waitlist control group. A total of 18 schools participate and we aim to recruit 323 adolescents (12-16 years). Youth who score above a cutoff on an anxiety symptom scale will be included in the study. School nurses recruit participants and deliver the interventions, with mental health workers as co-therapists and/or supervisors. Primary outcomes are level of anxiety symptoms and anxiety-related functional impairments. Secondary outcomes are level of depressive symptoms, quality of life and general psychosocial functioning. Non-inferiority between the two active interventions will be declared if a difference of 1.4 or less is found on the anxiety symptom measure post-intervention and a difference of 0.8 on the interference scale. Effects will be analyzed by mixed effect models, applying an intention to treat procedure.DiscussionThe present study extends previous research by comparing two programs with different intensity. A brief intervention, if effective, could more easily be subject to large-scale implementation in school health services.Trial registrationClinicalTrials.gov, NCT02279251 . Registered on 15 October 2014. Retrospectively registered.

Project description:The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed.This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect.This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice.Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.

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Protocol of a randomized controlled trial of hearing protection interventions for farm operators.

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Protocol of a randomized controlled trial of hearing protection interventions for farm operators.

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