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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) is a unique Pubmed-indexed journal, publishing peer-reviewed, openly accessible research ideas and grant proposals, study and trial protocols, reports of ongoing research, current methods and approaches, and preliminary results from pilot studies or formative research informing the design of medical and health-related research and technology innovations.

JMIR Res Protoc is a journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (JMIR Impact Factor 2017: 4.671).

While the original focus was on eHealth studies, JMIR Res Protoc now publishes protocols and grant proposals in all areas of medicine (and their peer-review reports, if available), as well as feasibility studies, early reports and formative/process evaluations of ongoing studies and descriptions of the development and pilot evaluations of innovations and software applications or other interventions.

JMIR Res Protoc is fully open access, with full text articles deposited in PubMed Central.

Publishing research protocols, grant proposals, pilot/feasibility studies and early reports of ongoing and planned work encourages collaboration and early feedback, and reduces duplication of effort.

JRP is compatible with the concept of "Registered Reports" and since May 2018, published protocols receive a Registered Report Identifier (What is a Registered Report Identifier?) and acceptance of the subsequent results paper is "in principle" guaranteed in any JMIR journal and partner journals - see What is a Registered Report?

JMIR Res Protoc will be a valuable ressource for researchers who want to learn about current research methodologies and how to write a winning grant proposal.

JMIR Res Protoc creates an early scientific record for researchers who have developed novel methodologies, software, innovations or elaborate protocols.

JMIR Res Protoc provides a "dry-run" for peer-review of the final results paper, and allows feedback/critique of the methods, often while they still can be fixed.

JMIR Res Protoc faciliates subsequent publication of results demonstrating that the methodology has already been reviewed, and reduces the effort of writing up the results, as the protocol can be easily referenced.

JMIR Res Protoc demonstrates to reviewers of subsequent results papers that authors followed and adhered to carefully developed and described a-priori methods.

Studies whose protocols or grant proposal have been accepted in JMIR Res Protoc are "in principle accepted" for subsequent publication of results in other JMIR journals as long as authors adhere to their original protocol - regardless of study results (even if they are negative), reducing publication bias in medicine.

Authors publishing their protocols in JMIR Res Protoc will receive a 20% discount on the article processing fee if they publish their results in another journal of the JMIR journal family (for example, JMIR for ehealth studies, i-JMR for others).

JMIR Res Protoc is also a unique crowdfunding platform, allowing backers to crowdfund carefully peer-reviewed projects that are not junk-science, and giving researchers additional small funding to conduct and publish their research results. Each article is published with a crowdfunding widget, allowing readers to make nominal donations to the project, which benefit the authors (currently in beta).

Need more reasons? Read the Knowledge Base article on "Why should I publish my protocol/grant proposal"!

 
 

Recent Articles:

  • Dashboard for the TrueNTH Community of Wellness website (montage). Source: The Authors / Placeit; Copyright: JMIR Publications; URL: http://www.researchprotocols.org/2018/11/e11257/; License: Creative Commons Attribution (CC-BY).

    Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a...

    Abstract:

    Background: More than 3.1 million men in the United States are prostate cancer survivors. These men may improve their physical function, quality of life, and potentially their prognosis by adopting healthier lifestyle habits. The internet provides a scalable mechanism to deliver advice and support about improving physical activity and dietary habits, but the feasibility and acceptability of a Web-based lifestyle intervention and the dose of support necessary to improve health behaviors are not yet known. Objectives: The Community of Wellness is a Web-based intervention focused on supporting exercise and healthy dietary practices for men with prostate cancer. The objectives of this study were to determine the feasibility, acceptability, and preliminary efficacy of the Community of Wellness Web portal among prostate cancer survivors by conducting a randomized controlled trial (RCT) comparing 4 levels of additive Web-based content and interaction with participants: Level 1 (Teaching; Control), Level 2 (Teaching + Tailoring), Level 3 (Teaching + Tailoring + Technology), and Level 4 (Teaching + Tailoring + Technology + Touch). Methods: This is a single-blinded RCT comparing 3 levels of behavioral support within the Community of Wellness Web portal intervention (Levels 2 to 4) with each other and with the control condition (Level 1). The control condition receives general static Web-based educational information only on physical activity and dietary habits, self-efficacy for behavior change, motivation for physical activity, and changes in anxiety and treatment-related side effects. We will enroll and randomize 200 men with prostate cancer equally to 4 levels of the Community of Wellness Web-based intervention for 3 months (50 men per level). Surveys will be completed by self-report at baseline, 3 months (immediately postintervention), and 6 months (3 months postintervention). Feasibility and acceptability will be assessed by enrollment statistics, Web-based usage metrics, and surveys at the 3-month time point. We will also conduct focus groups after the postintervention follow-up assessment in a sample of enrolled participants to evaluate elements of usability and acceptability that cannot be obtained via surveys. Results: Enrollment is ongoing, with 124 enrolled. Study completion (6-month follow-up) is expected by July 2019. Conclusions: The goal of the study is to identify the level of support that is feasible, acceptable, promotes behavior change, and improves health in men with prostate cancer to inform future efforts to scale the program for broader reach. Trial Registration: ClinicalTrials.gov NCT03406013; https://clinicaltrials.gov/ct2/show/NCT03406013 (Archived by WebCite at http://www.webcitation.org/73YpDIoTX). International Registered Report Identifier (IRRID): PRR1-10.2196/11257

  • Electronic health–based implementation to facilitate the development of self-management skills among people with spinal cord injury (montage). Source: The Authors / Magic Mockups; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/11/e11069/; License: Creative Commons Attribution (CC-BY).

    Improving Self-Management Skills Among People With Spinal Cord Injury: Protocol for a Mixed-Methods Study

    Abstract:

    Background: Most people with spinal cord injury will develop secondary complications with potentially devastating consequences. Self-management is a key prevention strategy for averting the development of secondary complications and their recurrence. Several studies have shown that self-management programs improve self-management behaviors and health outcomes in individuals living with chronic conditions such as asthma, diabetes, hypertension, and arthritis. Given the burgeoning health care costs related to secondary complications, we developed an alternative electronic health–based implementation to facilitate the development of self-management skills among people with spinal cord injury. Objective: This study aims to evaluate the efficacy of a self-management app in spinal cord injury populations. The primary outcome is attainment of self-selected, self-management goals. Secondary outcomes include increases in general and self-management self-efficacy and reductions in self-reported health events, health care utilization, and secondary complications related to spinal cord injury. This study also aims to explore how the intervention was implemented and how the app was experienced by end users. Methods: This study will employ a mix of qualitative and quantitative methods. The quantitative portion of our study will involve a rater-blinded, randomized controlled trial with a stepped wedge design (ie, delayed intervention control group). The primary outcome is successful goal attainment, and secondary outcomes include increases in self-efficacy and reductions in self-reported health events, health care utilization, and secondary conditions related to spinal cord injury. The qualitative portion will consist of semistructured interviews with a subsample of the participants. Results: We expect that the mobile self-management app will help people with spinal cord injury to attain their self-management goals, improve their self-efficacy, reduce secondary complications, and decrease health care utilization. Conclusions: If the results are positive, this study will produce credible new knowledge describing multiple outcomes that people with spinal cord injury realize from an app-based self-management intervention and support its implementation in clinical practice. Trial Registration: ClinicalTrials.gov NCT03140501; http://clinicaltrials.gov/ct2/show/NCT03140501 (Archived by WebCite at http://www.webcitation.org/73Gw0ZlWZ) International Registered Report Identifier (IRRID): PRR1-10.2196/11069

  • Daily weight and shortness of breath self-monitoring. Source: The Authors; Copyright: Mahin Nomali; URL: http://www.researchprotocols.org/2018/11/e184/; License: Licensed by JMIR.

    Self-Monitoring by Traffic Light Color Coding Versus Usual Care on Outcomes of Patients With Heart Failure Reduced Ejection Fraction: Protocol for a...

    Abstract:

    Background: Patients with heart failure (HF) reduced ejection fraction (HFrEF) have symptoms that are more severe and experience a higher rate of hospitalization compared with HF preserved ejection fraction (HFpEF) patients. However, symptom recognition cannot be made by patients based on current approaches. This problem is a barrier to effective self-care that needs to be improved by new self-monitoring instruments and strategies. Objective: This study describes a protocol for the self-monitoring daily diaries of weight and shortness of breath (SOB) based on the traffic light system (TLS). The primary objective is to compare the self-care between the intervention and control group. Comparison of HF knowledge, HF quality of life (HFQOL), and all-cause hospitalization between the 2 groups are the secondary objectives. Methods: A single-blind randomized controlled trial is being conducted at the HF clinic at Tehran Heart Center (Tehran, Iran). Sixty-eight adult patients of both genders will be enrolled during admission to HF clinic. Eligible subjects will be assigned to either the intervention or control group by a block balanced randomization method. Baseline surveys will be conducted before random allocation. Participants in the intervention group will receive an integrated package consisting of (1) HF self-care education by an Australian Heart Foundation booklet on HF, (2) regular home self-monitoring of weight and SOB, and (3) scheduled call follow-ups for 3 months. Patients in the control group will receive no intervention and they only complete monthly surveys. Results: This study is ongoing and is expected to be completed by the end of 2018. Conclusions: This is the first trial with new self-monitoring instruments in Iran as a low and middle-income country. If the findings show a positive effect, the package will be applied in different regions with the same health care status. Trial Registration: Iranian Registry of Clinical Trials IRCT2017021032476N1; https://en.irct.ir/trial/25296?revision=25296 (Archived by WebCite at http://www.webcitation.org/73DLICQL8) International Registered Report Identifier (IRRID): PRR1-10.2196/9209

  • A person with inflammatory bowel disease, experiencing symptom exacerbation (ie, abdominal pain). Source: Pixabay; Copyright: Martin Büdenbender; URL: https://pixabay.com/en/abdominal-pain-attack-medical-2493327/; License: Public Domain (CC0).

    Living With Inflammatory Bowel Disease: Protocol for a Longitudinal Study of Factors Associated With Symptom Exacerbations

    Abstract:

    Background: There has been limited longitudinal research that has comprehensively evaluated possible factors in the exacerbation of inflammatory bowel disease (IBD) symptoms with or without associated inflammation. Evolving Web-based technologies facilitate frequent monitoring of patients’ experiences and allow a fine-grained assessment of disease course. Objective: We aimed to prospectively identify factors associated with symptom exacerbation and inflammation in IBD including psychological functioning, diet, health behaviors, and medication adherence. Methods: Between June 2015 and May 2017, we enrolled adults with IBD, recruited from multiple sources, who had been symptomatically active at least once within the prior 2 years. They completed a Web-based survey every 2 weeks for 1 year and submitted a stool sample at baseline, 26 weeks, and 52 weeks. Any participant reporting a symptom exacerbation was matched to a control within the cohort, based on disease type, sex, age, and time of enrollment; both were sent a supplemental survey and stool collection kit. Biweekly surveys included validated measures of the disease course, psychological functioning, health comorbidities, and medication use. Intestinal inflammation was identified through fecal calprotectin (positive level >250 μg/g stool). Results: There were 155 participants enrolled with confirmed IBD, 66.5% (103/155) with Crohn disease and 33.5% (52/155) with ulcerative colitis, of whom 98.7% (153/155) completed the study. Over the 1-year period, 47.7% (74/155) participants experienced a symptom exacerbation. The results of analyses on risk factors for symptom exacerbations are pending. Conclusions: We recruited and retained a longitudinal IBD cohort that will allow the determination of risk factors for symptom exacerbation with and without inflammation. This will increase understanding of symptom exacerbations among persons with IBD. International Registered Report Identifier (IRRID): RR1-10.2196/11317

  • 3R study logo. Source: Leicester Diabetes Centre; Copyright: Leicester Diabetes Centre; URL: http://www.researchprotocols.org/2018/11/e11289/; License: Creative Commons Attribution (CC-BY).

    The Ready to Reduce Risk (3R) Study for a Group Educational Intervention With Telephone and Text Messaging Support to Improve Medication Adherence for the...

    Abstract:

    Background: Poor adherence to cardiovascular medications is associated with worse clinical outcomes. Evidence for effective education interventions that address medication adherence for the primary prevention of cardiovascular disease is lacking. The Ready to Reduce Risk (3R) study aims to investigate whether a complex intervention, involving group education plus telephone and text messaging follow-up support, can improve medication adherence and reduce cardiovascular risk. Objective: This protocol paper details the design and rationale for the development of the 3R intervention and the study methods used. Methods: This is an open and pragmatic randomized controlled trial with 12 months of follow-up. We recruited participants from primary care and randomly assigned them at a 1:1 frequency, stratified by sex and age, to either a control group (usual care from a general practitioner) or an intervention group involving 2 facilitated group education sessions with telephone and text messaging follow-up support, with a theoretical underpinning and using recognized behavioral change techniques. The primary outcome was medication adherence to statins. The primary measure was an objective, novel, urine-based biochemical measure of medication adherence. We also used the 8-item Morisky Medication Adherence Scale to assess medication adherence. Secondary outcomes were changes in total cholesterol, blood pressure, high-density lipoprotein, total cholesterol to high-density lipoprotein ratio, body mass index, waist to hip ratio, waist circumference, smoking behavior, physical activity, fruit and vegetable intake, patient activation level, quality of life, health status, health and medication beliefs, and overall cardiovascular disease risk score. We also considered process outcomes relating to acceptability and feasibility of the 3R intervention. Results: We recruited 212 participants between May 2015 and March 2017. The 12-month follow-up data collection clinics were completed in April 2018, and data analysis will commence once all study data have been collected and verified. Conclusions: This study will identify a potentially clinically useful and effective educational intervention for the primary prevention of cardiovascular disease. Medication adherence to statins is being assessed using a novel urine assay as an objective measure, in conjunction with other validated measures. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN16863160; http://www.isrctn.com/ISRCTN16863160 (Archived by WebCite at http://www.webcitation.org/734PqfdQw) International Registered Report Identifier (IRRID): DERR1-10.2196/11289

  • Child signing into The Blue App. Source: Image created by the Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/11/e10121/; License: Creative Commons Attribution (CC-BY).

    Issues in Child and Adolescent Inpatient Assessment and Evaluation After Discharge: Protocol for App Development and a Randomized Controlled Trial

    Abstract:

    Background: New methods are needed for collecting data of in- and outpatients and for improving outpatient compliance after discharge. Mobile technologies, such as smartphone apps, have shown promising results, (eg, helping unwell people by offering support and resources). Screening for the condition, including comorbidities, is a vital part of psychiatric care. Comorbid conditions, especially in emergency evaluation, are often missed, leading to inaccurate diagnosis and treatment. One way of improving diagnostic accuracy is to use a structured diagnostic process. Digitalized screening and follow-up have the advantage of making administration and scoring easier and less time consuming, thereby increasing response rate. To address these problems, we decided to create a smartphone app called The Blue App. The Blue App was developed through 6 steps, described in the manuscript. Objective: The aim of this paper is to describe (1) the development of The Blue App and (2) 2 planned research studies to evaluate the app. Methods: Two studies will be performed. Study 1 has a descriptive design, mapping comorbidities before and after the introduction of The Blue App. Study 2 has a randomized controlled design, measuring compliance with outpatient treatments as well as depressive symptoms, rated as changes in Montgomery-Åsberg Depression Scale scores during a 1-year follow-up. Results: We have described app development. Data collection for Study 1 started in autumn 2017. Study 2 will start in autumn 2018. We expect to have enrolled the 150 patients in Study 2 by December 2019. Final results will be published in a scientific journal. Conclusions: A technically advanced and easy-to-use Web-based mobile phone app corresponding to the unit’s needs was developed, and 2 studies are planned to evaluate its usefulness. International Registered Report Identifier (IRRID): RR1-10.2196/10121

  • Child accessing Web-based interactive comic (montage). Source: Image created by the Authors; Copyright: May May Leung; URL: http://www.researchprotocols.org/2018/10/e10682/; License: Creative Commons Attribution (CC-BY).

    Testing a Web-Based Interactive Comic Tool to Decrease Obesity Risk Among Minority Preadolescents: Protocol for a Pilot Randomized Control Trial

    Abstract:

    Background: Childhood obesity is a public health crisis, particularly in low-income, minority populations in the United States. Innovative and technology-enhanced interventions may be an engaging approach to reach at-risk youth and their parents to improve dietary behaviors and feeding practices. However, such tools are limited, especially ones that are theory-based; co-developed with user-centered approaches; tailored to low-income, minority preadolescents; and include parent-focused content. Objective: The objectives of this study include assessing the feasibility and acceptability and exploring the potential impact of the Intervention INC (Interactive Nutrition Comics for urban, minority preadolescents) Web-based tool, which is focused on decreasing childhood obesity risk in black/African American and Latino children aged 9 to 12 years. Methods: Intervention INC is underpinned by the narrative transportation theory, social cognitive theory, and health belief model, and it was co-developed by children and parents from the intended population. The child component consists of a 6-chapter interactive nutrition comic optimized for use on tablet devices, a goal-setting and self-assessment feature, and weekly text/email messages and reminders. The parental component consists of 6 Web-based newsletters, access to the child comic, and weekly text/email messages and reminders. The tool was evaluated using a pilot, single-blind, 2-group randomized controlled study design. Child-parent dyads were randomized to either the experimental or comparison group and assigned to a targeted behavior (increase fruit/vegetable or water intake) based on initial screening questions. Data were collected at 4 time points: baseline (T1), intervention midpoint (T2), intervention endpoint (T3), and 3 months postintervention (T4). Primary measures comprise usage, usability, and feasibility of the Web-based tool. Secondary measures comprise dietary knowledge, preferences, and intake and anthropometric measures (for child) and feeding practices and home food environment (for parent). Results: Study enrollment was completed in November 2017. A total of 89 child-parent dyads were randomized to either the experimental (n=44) or comparison (n=45) group. Data analysis is currently being conducted. Conclusions: This study aims to implement and assess an innovative approach to deliver health messages and resources to at-risk minority preadolescents and their parents. If found to be acceptable, engaging, feasible, and a potential approach to improve dietary behaviors, a full-fledged randomized controlled trial will be conducted to assess its efficacy and potential impact. Trial Registration: ClinicalTrials.gov NCT03165474; https://clinicaltrials.gov/ct2/show/NCT03165474 (Archived by WebCite at http://www.webcitation.org/73122IjgP) International Registered Report Identifier (IRRID): RR1-10.2196/10682

  • Supported housing resident using smart home technology via tablet. Source: The Authors / Summer Foundation Ltd; Copyright: The Authors / Summer Foundation Ltd; URL: https://www.researchprotocols.org/2018/11/e10451/; License: Fair use/fair dealings.

    Evaluating the Use of Smart Home Technology by People With Brain Impairment: Protocol for a Single-Case Experimental Design

    Abstract:

    Background: Smart home technologies are emerging as a useful component of support delivery for people with brain impairment. To promote their successful uptake and sustained use, focus on technology support services, including training, is required. Objective: The objective of this paper is to present a systematic smart home technology training approach for people with brain impairment. In addition, the paper outlines a multiple-baseline, single-case experimental design methodology to evaluate training effectiveness. Methods: Adult participants experiencing acquired brain impairment who can provide consent to participate and who live in housing where smart home technology is available will be recruited. Target behaviors will be identified in consultation with each participant based on his or her personal goals for technology use. Target behaviors may include participant knowledge of the number and type of technology functions available, frequency of smart home technology use, and number of function types used. Usage data will be gathered via log-on smart home technology servers. A smart technology digital training package will also be developed and left on a nominated device (smartphone, tablet) with each participant to use during the trial and posttrial, as desired. Measures of the target behavior will be taken throughout the baseline, intervention, and postintervention phases to provide the evidence of impact of the training on the target behaviors and ascertain whether utilization rates are sustained over time. In addition, trial results will be analyzed using structured visual analysis, supplemented with statistical analysis appropriate to single-case methodology. Results: While ascertaining the effectiveness of this training protocol, study results will offer new insights into technology-related training approaches for people with brain impairment. Preliminary data collection has been commenced at one supported housing site, with further scoping work continuing to recruit participants from additional sites. Conclusions: Evaluation evidence will assist in planning for the smart technology set-up as well as training and support services necessary to accompany the provision of new devices and systems. International Registered Report Identifier (IRRID): RR1-10.2196/10451

  • Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/doctor-speaking-on-phone-and-looking-away_2994300.htm; License: Licensed by JMIR.

    Patterns of Patients’ Interactions With a Health Care Organization and Their Impacts on Health Quality Measurements: Protocol for a Retrospective Cohort Study

    Abstract:

    Background: Data collected by health care organizations consist of medical information and documentation of interactions with patients through different communication channels. This enables the health care organization to measure various features of its performance such as activity, efficiency, adherence to a treatment, and different quality indicators. This information can be linked to sociodemographic, clinical, and communication data with the health care providers and administrative teams. Analyzing all these measurements together may provide insights into the different types of patient behaviors or more accurately to the different types of interactions patients have with the health care organizations. Objective: The primary aim of this study is to characterize usage profiles of the available communication channels with the health care organization. The main objective is to suggest new ways to encourage the usage of the most appropriate communication channel based on the patient’s profile. The first hypothesis is that the patient’s follow-up and clinical outcomes are influenced by the patient’s preferred communication channels with the health care organization. The second hypothesis is that the adoption of newly introduced communication channels between the patient and the health care organization is influenced by the patient’s sociodemographic or clinical profile. The third hypothesis is that the introduction of a new communication channel influences the usage of existing communication channels. Methods: All relevant data will be extracted from the Clalit Health Services data warehouse, the largest health care management organization in Israel. Data analysis process will use data mining approach as a process of discovering new knowledge and dealing with processing data extracted with statistical methods, machine learning algorithms, and information visualization tools. More specifically, we will mainly use the k-means clustering algorithm for discretization purposes and patients’ profile building, a hierarchical clustering algorithm, and heat maps for generating a visualization of the different communication profiles. In addition, patients’ interviews will be conducted to complement the information drawn from the data analysis phase with the aim of suggesting ways to optimize existing communication flows. Results: The project was funded in 2016. Data analysis is currently under way and the results are expected to be submitted for publication in 2019. Identification of patient profiles will allow the health care organization to improve its accessibility to patients and their engagement, which in turn will achieve a better treatment adherence, quality of care, and patient experience. Conclusions: Defining solutions to increase patient accessibility to health care organization by matching the communication channels to the patient’s profile and to change the health care organization’s communication with the patient to a highly proactive one will increase the patient’s engagement according to his or her profile. International Registered Report Identifier (IRRID): RR1-10.2196/10734

  • Climate School Combined (CSC) study logo. Source: The Authors; Copyright: The Authors; URL: http://www.researchprotocols.org/2018/11/e11372/; License: Licensed by JMIR.

    Evaluating the Long-Term Effectiveness of School-Based Depression, Anxiety, and Substance Use Prevention Into Young Adulthood: Protocol for the Climate...

    Abstract:

    Background: Mental health and substance use disorders are the leading causes of global disability in children and youth. Both tend to first onset or escalate in adolescence and young adulthood, calling for effective prevention during this time. The Climate Schools Combined (CSC) study was the first trial of a Web-based combined universal approach, delivered through school classes, to prevent both mental health and substance use problems in adolescence. There is also limited evidence for the cost-effectiveness of school-based prevention programs. Objective: The aim of this protocol paper is to describe the CSC follow-up study, which aims to determine the long-term efficacy and cost-effectiveness of the CSC prevention program for depression, anxiety, and substance use (alcohol and cannabis use) up to 7 years post intervention. Methods: A cluster randomized controlled trial (the CSC study) was conducted with 6411 participants aged approximately 13.5 years at baseline from 2014 to 2016. Participating schools were randomized to 1 of 4 conditions: (1) control (health education as usual), (2) Climate Substance Use (universal substance use prevention), (3) Climate Mental Health (universal mental health prevention), or (4) CSC (universal substance use and mental health prevention). It was hypothesized that the CSC program would be more effective than conditions (1) to (3) in reducing alcohol and cannabis use (and related harms), anxiety, and depression symptoms as well as increasing knowledge related to alcohol, cannabis, anxiety, and depression. This long-term study will invite follow-up participants to complete 3 additional Web-based assessments at approximately 5, 6, and 7 years post baseline using multiple sources of locator information already provided to the research team. The primary outcomes include alcohol and cannabis use (and related harms) and mental health symptoms. An economic evaluation of the program will also be conducted using both data linkage as well as self-report resource use and quality of life measures. Secondary outcomes include self-efficacy, social networks, peer substance use, emotion regulation, and perfectionism. Analyses will be conducted using multilevel mixed-effects models within an intention-to-treat framework. Results: The CSC long-term follow-up study is funded from 2018 to 2022 by the Australian National Health and Medical Research Council (APP1143555). The first follow-up wave commences in August 2018, and the results are expected to be submitted for publication in 2022. Conclusions: This is the first study to provide a long-term evaluation of combined universal substance use and mental health prevention up to 7 years post intervention. Evidence of sustained benefits into early adulthood would provide a scalable, easy-to-implement prevention strategy with the potential for widespread dissemination to reduce the considerable harms, burden of disease, injury, and social costs associated with youth substance use and mental disorders. International Registered Report Identifier (IRRID): PRR1-10.2196/11372

  • Source: Unsplash; Copyright: Sai De Silva; URL: https://unsplash.com/photos/4-gFGb12hFA; License: Licensed by the authors.

    Parental Activation and Obesity-Related Health Behaviors Among a Racially and Ethnically Diverse Population of Low-Income Pediatric Patients: Protocol for a...

    Abstract:

    Background: Despite a recent decline in the obesity prevalence among preschool-aged children, obesity remains disproportionately high among children from low-income racial or ethnic minority families. Promoting healthy lifestyles (eg, obesity-preventative behaviors) in primary care settings is particularly important for young children, given the frequency of preventative health visits and parent-provider interactions. Higher adoption of specific health behaviors is correlated with increased patient activation (ie, skill, confidence, and knowledge to manage their health care) among adults. However, no published study, to date, has examined the relationship between parental activation and obesity-related health behaviors among young children. Objective: The goal of this study is to measure parental activation in low-income parents of preschoolers in 2 large health systems and to examine the association with diet, screen-time, and physical activity behaviors. Methods: We will conduct a cross-sectional study of parents of preschool-aged patients (2-5 years) receiving primary care at multiple clinic sites within 2 large health care systems. Study participants, low-income black, Hispanic, and white parents of preschool-aged patients, are being recruited across both health systems to complete orally administered surveys. Results: Recruitment began in December 2017 and is expected to end in May 2018. A total of 267 low-income parents of preschool-aged children have been enrolled across both clinic sites. We are enrolling an additional 33 parents to reach our goal sample size of 300 across both health systems. The data analysis will be completed in June 2018. Conclusions: This protocol outlines the first study to fully examine parental activation and its relationship with parent-reported diet, physical activity, and screen-time behaviors among low-income preschool-aged patients. It involves recruitment across 2 geographically distinct areas and resulting from a partnership between researchers at 2 different health systems with multiple clinical sites. This study will provide new knowledge about how parental activation can potentially be incorporated as a strategy to address childhood obesity disparities in primary care settings. International Registered Report Identifier (IRRID): RR1-10.2196/9688

  • Source: FreeDigitalPhotos.net; Copyright: Theeradech Sanin; URL: http://www.freedigitalphotos.net/images/Smoking_g375-Film_Xray_And_Cigarette_p78202.html; License: Licensed by the authors.

    Lung Function in Users of a Smoke-Free Electronic Device With HeatSticks (iQOS) Versus Smokers of Conventional Cigarettes: Protocol for a Longitudinal Cohort...

    Abstract:

    Background: Chronic obstructive pulmonary disease (COPD) is a global public health problem. It is the third-leading cause of death in the world, the fourth leading cause of death in Kazakhstan, and is strongly associated with smoking. Smoking cessation reduces the severity of respiratory symptoms and COPD exacerbations. Heated tobacco products, such as HeatSticks heated by the iQOS device, a smoke-free electronic device, may serve as less risky alternatives to conventional combustible cigarettes. Objective: The purpose of this study is to evaluate frequency of exacerbations, respiratory symptoms, physical exercise intolerance, and abnormal lung functions, as well as other parameters and comorbidities among men and women aged 40-59 residing in Almaty, Kazakhstan, who use iQOS with HeatSticks compared to smokers of conventional cigarettes. Methods: This is a 5-year single-center cohort observational study. It includes two cohorts of participants consisting of men and women aged 40-59 residing in the city of Almaty, Kazakhstan: (1) smokers of combustible cigarettes (control group) and (2) users of iQOS with HeatSticks (exposure group). The study has baseline and periodic (ie, annual) comprehensive clinical assessments, as well as continuous COPD case-finding activities and registration of acute respiratory exacerbations over the course of the 5-year observation period. Study measures include spirometry, chest computed tomography, electrocardiography, physical exams, laboratory testing of serum for biomarkers of inflammation and metabolic syndrome, anthropometry, and the 6-minute walk test. Information about COPD symptoms will be collected using the COPD Assessment Test. Results: Participant recruitment began December 2017, and enrollment is expected to last until late summer 2018. Conclusions: This is the first cohort observational study in Kazakhstan to assess differences in lung function between users of the heated tobacco product, iQOS with HeatSticks, and smokers of conventional combustible cigarettes. The study results will add to knowledge on whether switching from combustible cigarettes to iQOS with HeatSticks affects respiratory symptoms and diseases, including the development and progression of COPD. Trial Registration: ClinicalTrials.gov NCT03383601; https://clinicaltrials.gov/ct2/show/NCT03383601 (Archived by WebCite at http://www.webcitation.org/72BYoAKxa) International Registered Report Identifier (IRRID): PRR1-10.2196/10006

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    Open Peer Review Period: Nov 17, 2018 - Nov 23, 2018

    Background: Excess weight is a major risk factor for chronic diseases. In Australia over 60% of adults are now overweight or obese. The overconsumption of energy-dense nutrient poor (EDNP) foods and l...

    Background: Excess weight is a major risk factor for chronic diseases. In Australia over 60% of adults are now overweight or obese. The overconsumption of energy-dense nutrient poor (EDNP) foods and low physical activity (PA) levels are key factors contributing to population obesity. New cost-effective approaches to improve population diet and PA behaviors are needed. Objective: This 1-year randomized controlled trial (6-month intervention; 6-month follow-up) aims to investigate whether a tailored intervention using mobile technology can improve diet and PA behaviors leading to weight loss in adults (18-65 years) who are overweight or obesity, recruited through a social marketing campaign (LiveLighter®). Methods: All eligible participants will complete demographics and lifestyle behaviors online at baseline, 6- and 12-months. Using a two stage randomization they will be allocated into one of three groups: 1) tailored feedback (TF) delivered via email at seven time points informed by objective dietary (mobile food record application™) and activity (wearable activity monitor) assessment; 2) active control (AC) receiving no tailored feedback, but undergoing the same objective assessments as TF; and 3) online control (OC) receiving no tailored feedback or objective assessments. Primary outcome measures at 6- and 12-months are changes in body mass, EDNP foods and beverage consumption and daily moderate-to-vigorous PA (measured via accelerometery). Secondary outcomes include change in fruit and vegetable consumption, daily sedentary behaviors and cost-effectiveness. Results: Enrolment commenced in August 2017. Primary outcomes at 12-months will be available for analysis from September 2019. Conclusions: Tailored email feedback provided to individuals may provide a cost effective strategy to overcome existing barriers to improving diet and PA. If shown to be successful and cost-effective, upscaling this intervention for inclusion in larger-scale interventions is highly feasible. Clinical Trial: Australian New Zealand Clinical Trials Registry ACTRN12617000554369.

  • Identification of Motor Symptoms Related to Parkinson's Disease Using Motion Tracking Sensors at Home (KÄVELI)

    Date Submitted: Nov 13, 2018

    Open Peer Review Period: Nov 17, 2018 - Nov 21, 2018

    Background: Clinical motion characterization in patients with Parkinson’s disease (PD) is challenging: symptom progression, suitability of medication, and level of independence in the home environme...

    Background: Clinical motion characterization in patients with Parkinson’s disease (PD) is challenging: symptom progression, suitability of medication, and level of independence in the home environment can vary across time and from patient to patient. Appointments at the neurological outpatient clinic provide a limited understanding of the overall situation. In order to follow up on variations in the state of PD and heterogenity of symptoms, longer-term measurements performed outside the clinic could help to optimize and personalize therapies. Several wearable sensors have been used and algorithms have been developed to estimate the severity of symptoms in PD; however, large volumes of longitudinal recordings are rare. Home recordings have the potential benefit of providing more thorough and objective follow-up about the disease, while providing more information about the possible need to change medications or consider invasive secondary treatments. Objective: The primary objective of this study is to detect PD-related changes in walking patterns at home. The movement data are collected continuously and remotely at home during the normal lives of patients with Parkinson’s disease, as well as controls. The secondary objective is to study whether the registered medication intake can be identified from the collected movement data. Methods: The study protocol measures the activity using three different devices: (1) a smartphone with a built-in accelerometer, gyroscope, and phone orientation sensor, (2) a Movesense® smart sensor to measure movement data from the wrist, and (3) a Forciot® smart insole to measure the temporal and spatial distributions of the forces applied on the feet. The measurements are first collected during the appointment at the clinic through background interviews, a comprehensive Unified Parkinson’s Disease Rating Scale (UPDRS) test, and a 20-step walking test conducted by a trained clinical physiotherapist. Next, the subjects are asked to wear the smartphone at home for three consecutive days, and the data are transferred from the smartphone to a personal computer (PC) securely. Results: Data collection began in March 2018. The subject recruitment and data collection continued until the end of December 2018. The intended sample was 150 subjects, 100 of which were diagnosed with PD and 50 of which were control subjects. Conclusions: This study aims to produce an extensive movement sensor dataset recorded from PD patients in various phases of the disease, as well as a group of control subjects for effective and impactful comparison studies. The study also aims to develop data analysis methods to monitor PD symptoms and the effects of medication intake during normal life and outside of the clinic. Further applications of these methods may include tools for healthcare professionals to better monitor PD remotely or apply the tool to other movement disorders. Clinical Trial: This study is registered under ClinicalTrials.gov (NCT03366558). https://clinicaltrials.gov/ct2/show/NCT03366558?term=k%C3%A4veli&rank=1. Accessed: 2018-08-29. Archived at: http://www.webcitation.org/721n3uIqR

  • Protocol for the 3PS randomized controlled trial to promote family routines and positive parenting for obesity prevention: a pilot study

    Date Submitted: Nov 11, 2018

    Open Peer Review Period: Nov 12, 2018 - Nov 26, 2018

    Background: Childhood obesity is a pervasive and challenging public health issue, with 30% of children aged 2-4 years classified as being overweight or obese in New Zealand. This is concerning, given...

    Background: Childhood obesity is a pervasive and challenging public health issue, with 30% of children aged 2-4 years classified as being overweight or obese in New Zealand. This is concerning, given that up to 90% of obese 3-year-old children are overweight or obese by the time they reach adolescence. Interventions that specifically target this age range often fail to demonstrate long-term effectiveness, and primarily focus on traditional weight-related behaviours, including diet, physical activity, and sedentary behaviour. However, recent research suggests that targeting non-traditional weight-related behaviours, such as sleep, screen time, and family meals, may be appropriate and more effective approach in this age group, given the immense challenges in changing traditional weight-related behaviours long-term. Objective: The aim of the proposed study was to develop and pilot the 3 Pillars Study (3PS), a 6-week program for parents of New Zealand toddlers and preschoolers aged 2-4 years to promote positive parent-child interactions during three family routines, specifically, adequate sleep, regular family meals, and restricted screen time. Methods: The effects of the program on screen time (primary endpoint), frequency of family meals, parent feeding practices, diet quality, and sleep duration will be piloted using a randomized controlled trial, with outcomes compared between the active intervention group and a wait-list control group at 6 weeks (at the end of the programme) and 12 weeks (at final follow-up). We aim to recruit 50 participants (25 per arm). Eligibility criteria include parents of children aged 2-4 years of age who are currently exceeding screen use recommendations (that is, greater than 1 hour of screen time per day). The 3PS program involves a half-day workshop, run by a community worker trained to deliver the program content, and 6-week access to a study website that contains in-depth information about the program. All participants will also receive a study pack, which includes resources to encourage engagement in the three family routines promoted by the program. Study data will be collected in REDCap. All statistical analyses will be performed using SAS version 9.4, and have been specified a priori in a statistical analysis plan prepared by the study statistician. Results: Trial recruitment opened in July 2018. Final follow-up is expected in December 2018, with trial findings expected to be available in early 2019. Conclusions: Findings from this pilot study will provide relevant data to inform the design of a larger effectiveness study of the 3PS program. Clinical Trial: Australia New Zealand Clinical Trials Register ACTRN12618000823279

  • Policies and programs for the prevention and control of breast cancer in Mexican and Central American women: protocol for a scoping review

    Date Submitted: Nov 10, 2018

    Open Peer Review Period: Nov 10, 2018 - Nov 24, 2018

    Background: Breast cancer has become one of the main public health problems all around the world, especially in Central America and Mexico. Self-exploration and early diagnosis are the best ways to lo...

    Background: Breast cancer has become one of the main public health problems all around the world, especially in Central America and Mexico. Self-exploration and early diagnosis are the best ways to look after this type of cancer. In Mexico and Central America, as in many other countries, breast cancer prevention and control activities are performed permanently; but, there are no comprehensive public reports that could provide information on the policies that originated the programs, the number, type, and scope of these activities as well as the impact of the performed programs and actions. Objective: Therefore, this document’s goal is to present the design of a Scoping Review protocol about the policies and action programs for breast cancer care in Mexico and Central America, as well as its objectives and implementation plan. Methods: This Scoping Review protocol was developed on the basis of the methodological reference framework of Arksey and O’Malley (2005). A systematic search of the following electronic databases will be performed: MEDLINE (PubMed), MEDLINE (EbscoHost), CINAHL (EbscoHost), Academic Search Complete (EbscoHost), ERIC, ISI Web of Science (Science Citation Index) in English, Cochrane, and MEDES-MEDicina in Spanish. The time scope of the search will be from 2000 trough 2018. Results: Since the data will not be obtained from primary sources, the approval of an ethics and research committee is not necessary. Data will be analyzed and presented in descriptive statistics and qualitative content analyses with analysis matrixes and semantic networks. The intention is to present the results to health authorities, conferences and publish them in an indexed journal. Conclusions: According to this proposal, we present a protocol for a Scoping Review-type literature revision based on the Arksey and O’Malley (2005) methodology during the first semester of 2019. According to this five-stage methodology, we will identify the scientific publications that present or analyze first-level action policies and programs for Breast Cancer care in Mexican women, as well as their results, if any. The outcome of this review will be used to define the bases of a research project intended to design an educational intervention strategy for the general public in Mexico, in order to deal with this important public health problem.

  • Integrating PrEP into Family Planning Services at Title X Clinics in the Southeastern US – Phase 1 (ATN 155)

    Date Submitted: Nov 8, 2018

    Open Peer Review Period: Nov 9, 2018 - Nov 23, 2018

    Background: Black adolescent and young adult women (AYAW) in the Southern United States (US) are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individu...

    Background: Black adolescent and young adult women (AYAW) in the Southern United States (US) are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to health services that AYAW already trust, access routinely, and deem useful for their sexual health offers an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. These services include those of family planning (FP) providers in high HIV incidence settings. However, PrEP has not been widely integrated into FP services, including Title X-funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern US are uniquely positioned to be focal sites for conceptually-informed and thoroughly-evaluated PrEP implementation science studies. Objective: Assess inner and outer context factors (barriers and facilitators) that may influence the adoption of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern US. Methods: Phase 1 of Planning4PrEP is an explanatory sequential, mixed methods study consisting of a geographically-targeted online survey of Title X clinic administrators and providers in the Southern US, followed by key informant interviews (KIIs) among a purposively-selected subset of responders to more comprehensively access inner and outer context factors that may influence adoption and implementation of PrEP in Title X FP clinics in the South. Results: Phase 1 of Planning4PrEP research activities began in October 2017and are ongoing. To date, survey and KII administration is near completion with quantitative and qualitative data analysis scheduled to begin soon after data collection completion Conclusions: This study seeks to assess inner and outer contextual factors (barriers and facilitators) that may influence the adoption and integration of PrEP prescription and treatment services in Title X clinics serving AYAW in the Southern US.

  • Utilizing Biomarker Feedback Documenting Child Exposure to Tobacco Toxins to Promote Smoke-Free Homes: Study Protocol for a Randomized Clinical Trial

    Date Submitted: Oct 30, 2018

    Open Peer Review Period: Nov 3, 2018 - Dec 29, 2018

    Background: Background: Exposure to second-hand smoke (SHS) early in life increases the risk of SIDS, asthma and respiratory illnesses. Since children’s primary exposure to SHS occurs in the home,...

    Background: Background: Exposure to second-hand smoke (SHS) early in life increases the risk of SIDS, asthma and respiratory illnesses. Since children’s primary exposure to SHS occurs in the home, these most vulnerable members of our society are not fully protected by recent increases in the adoption of smoking bans in public spaces. Although exposure to SHS is a readily addressed cause of excess morbidity, few low-income homes strictly enforce smoking restrictions. Objective: Objective: To test a novel approach to motivate the adoption of home smoking restrictions (HSR) and to eliminate child SHS exposure by providing parents with objective, biomarker documentation of child exposure to tobacco toxins. Methods: Methods: From 2011 to 2013, 195 low-income, female smokers with children ≤ 10 years old, residing in their homes were recruited into a two-arm randomized clinical trial. Participants were assigned to one of two groups: Biomarker Feedback (n = 98) vs. Health Education, (n = 97). In-home assessments were administered at baseline, week 16 and week 26. Child urine nicotine, cotinine and NNAL (a metabolite of the known tobacco carcinogen, NNK), an objective measure of home SHS exposure (i.e., passive nicotine dosimeter) and a surface sample of residual (ie, third-hand) tobacco smoke were collected at all three time points. Primary outcome was dosimeter-verified, complete home smoking restrictions at 6-months post-randomization. Secondary outcomes included parental self report of smoking behavior change and child urine biomarker change. Results: Results : Data collection and analyses are complete and results are being interpreted. Conclusions: Discussion: The study protocol describes the development of a novel community-based controlled trial designed to examine the efficacy of biomarker feedback documenting a child’s exposure to enviornmental tobacco smoke on parental smoking behavior change. Clinical Trial: Trial Registration: ClinicalTrials.gov Identifier: NCT01574560

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