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Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results
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"!
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Background: Smoking is considered the main cause of preventable illness and premature deaths worldwide. The treatment usually prescribed to subjects who wish to quit smoking is a multidisciplinary int...
Background: Smoking is considered the main cause of preventable illness and premature deaths worldwide. The treatment usually prescribed to subjects who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt. Objective: This paper presents a study protocol of a 12-month randomized open-label parallel-group trial which primary objective is to analyze the efficacy and efficiency of the usual psycho-pharmacological therapy plus Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared to usual psycho-pharmacological therapy (control group). Methods: The target population consist of smokers attending the Smoking Cessation Unit at Virgen del Rocío University Hospital. Social-Local-Mobile is an innovative intervention based on mobile technologies and its capacity to trigger behavioral changes. The App is a complement to pharmacological therapies to quit smoking providing personalised motivational messages, physical activity monitoring, lifestyle advices and distractions (mini-games) to help pass the cravings. Usual pharmacological therapy consists of bupropion (Zyntabac® 150 mg) or varenicline (Champix® 0.5 mg or 1 mg). The main clinical outcome will be the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests. The result of cost-effectiveness analysis will be expressed in terms of incremental cost-effectiveness ratio. Secondary objectives are to analyze safety of pharmacological therapy; to analyze health-related quality of life of patients; and to monitor healthy lifestyle and physical exercise habits. Results: We identified 548 patients using the hospital’s electronic records system. From this initial selection, 308 patients were excluded: 188 declined to participate and 120 not meeting the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psycho-pharmacological therapy, while the intervention group (n=120) will receive usual psycho-pharmacological therapy plus the So-Lo-Mo app. Conclusions: Nowadays, social networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project (GA 681120), this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking. Clinical Trial: ClinicalTrials.gov identifier: NCT03553173. Retrospectively registered, 12 June 2018.
Background: While maintaining a healthy weight and physical conditioning are requirements of active military duty, many U.S. veterans rapidly gain weight and lose conditioning when they separate from...
Background: While maintaining a healthy weight and physical conditioning are requirements of active military duty, many U.S. veterans rapidly gain weight and lose conditioning when they separate from active duty service. Mobile health (mHealth) interventions that incorporate wearables for activity monitoring have become common, but how to optimize engagement over time is unclear. Personalized health coaching, either through tailored automated messaging or by individual health coaches has the potential to increase the efficacy of mHealth programs. In an attempt to preserve conditioning and ward off weight gain we developed Stay Strong, a mobile app tailored to younger veterans that tracks physical activity monitored by Fitbit Charge 2 devices, and weight measured on a Bluetooth enabled scale. Objective: The goal of this study is to determine the effect of activity monitoring plus health coaching, compared to activity monitoring alone. Methods: In this randomized controlled trial, we sought to enroll 350 veterans who received an mHealth lifestyle intervention that combines the use of a wearable physical activity tracker and a Bluetooth enabled weight scale, with Stay Strong, a mobile app designed specifically for younger veterans. The Stay Strong app displays physical activity and weight data trends over time. Enrolled participants are randomized to receive either the Stay Strong app (active comparator arm) or Stay Strong app + Coaching, an enhanced version of the program that adds coaching features (automated tailored messaging with weekly physical activity goal, as well as up to three telephone calls with a health coach) (intervention arm), for one year. Our primary outcome is change at 12 months in physical activity, with weight, pain, patient activation, and depression serving as secondary outcome measures. All processes related to recruitment, eligibility screening, informed consent, HIPAA authorization, baseline assessment, randomization, the bulk of intervention delivery, and outcome assessment will be accomplished via the internet or smartphone app. Results: Study recruitment began in September 2017 and data collection is expected to conclude in 2019. A total of 465 participants consented to participate and 357 (77%) provided baseline levels of physical activity and were randomized to one of the two interventions. Conclusions: This novel randomized control trial will provide much-needed findings about whether the addition of telephone-based human coaching and other automated supportive coaching features will improve physical activity compared to using a smartphone app linked to a wearable device alone. Clinical Trial: Clinicaltrials.gov NCT02360293
This manuscript needs more reviewersPeer-Review Me
Background: The impact of integrating video into health education delivery has been extensively investigated, however the effect of integrating video on a learner’s subsequent performance in an onli...
Background: The impact of integrating video into health education delivery has been extensively investigated, however the effect of integrating video on a learner’s subsequent performance in an online educational setting is much less frequently reported. A lack of findings exists associated with the relationship learner online video viewing has on subsequent progression toward health behavior change in a self-directed online educational session. Objective: Determine relationship of viewing a Health eKitchen (HeK) online video with key engagement performance indicators associated with WIC online nutrition education. Methods: This study involved a retrospective cohort of users with groups defined based on whether HeK exposure occurred before or after completing a nutrition education lesson. A two-sample test for equality of proportions was performed to test the difference in the likelihood of progression between groups overall and stratified by lesson type as defined by whether it was food preparation focused. Welch’s two-sample t-tests were performed to test the difference in average link depth and duration of use between groups overall and stratified by lesson type. Logistic regression was conducted to validate the impact of a video view prior to lesson completion while controlling for lesson type and factors known to be associated with WIC KPIs. Results: Greater stage of change progression was observed for both food-preparation (2=12.6, p=0.0004) and non-food preparation (2=62.8, p<0.0001) lessons among early stage users who had a HeK video view prior to completing a lesson. Time spent viewing educational learning resource links within the lesson was also significantly longer for both food preparation (t=7.8, p<0.0001) and non-food preparation (t=2.5, p=0.0116) lessons when these groups where compared. Logistic regression corroborated these results while controlling for known confounding. Odds of user progression was nearly three times greater among those that viewed a HeK video prior to lesson completion (OR=2.61; 95%CI=2.08,3.29). Type of lesson (food vs. non-food preparation) was the strongest predictor of progression odds (OR=3.12; 95%CI=2.47,3.95). Conclusions: User access of a HeK video prior to completing an online educational session had a significant impact on achieving lesson goals, regardless of food preparation focus. This observation suggests the potential benefit of providing an application-oriented video at the onset of online nutrition education lessons.
This manuscript needs more reviewersPeer-Review Me
BACKGROUND: Sleep disruptions are common during pregnancy, and associated with increased risk for adverse maternal outcomes such as pre-eclampsia, gestational diabetes, prolonged labor, and cesarean b...
BACKGROUND: Sleep disruptions are common during pregnancy, and associated with increased risk for adverse maternal outcomes such as pre-eclampsia, gestational diabetes, prolonged labor, and cesarean birth. Given the morbidity associated with poor sleep, cost-effective approaches to improving sleep that can be disseminated in community or clinical settings are needed. Personal health monitoring (PHM) devices offer an opportunity to promote behavior change, but their acceptability and efficacy at improving sleep in pregnant women are unknown. OBJECTIVE: To describe the protocol for an ongoing pilot randomized controlled trial that aims to establish the feasibility, acceptability and preliminary efficacy of using a PHM device (Misfit Shine 2) to promote sleep during pregnancy. METHODS: The proposed pilot study is a 12-week, parallel arm, randomized controlled trial. Pregnant women, at 24 weeks gestation, will be randomized at 1:1 ratio into a 12-week sleep education plus PHM device or sleep education alone comparison group. The primary outcomes will be measures of feasibility (i.e., recruitment, enrollment, adherence) and acceptability (i.e., participant satisfaction). The secondary outcomes will be self-reported sleep quality and duration, excessive daytime sleepiness, fatigue, depressive symptoms, and birth outcomes (e.g., delivery methods). DISCUSSION: This study will be the first to apply a PHM device as a tool for promoting self-management of sleep among pregnant women. PHM devices have the potential to facilitate behavioral interventions as they include theory-driven, self-regulatory techniques such as behavioral self-monitoring. The results of the study will inform the development of a sleep health intervention for pregnant women.
Background: There is a growing understanding that wellbeing and mental illness are two separate dimensions of mental health. Positive mental health is associated with decreased risk of disease and men...
Background: There is a growing understanding that wellbeing and mental illness are two separate dimensions of mental health. Positive mental health is associated with decreased risk of disease and mental illness and increased longevity. Objective: This randomized controlled trial aims to test the efficacy of a mobile phone based intervention on positive mental health. Methods: Two-armed randomized controlled trial of university students in Sweden. Recruitment will last for 6 months by digital advertising (e.g. university websites). Participants will be randomly allocated to either an intervention (fully automated mobile-phone based mental health intervention) or control group (treatment as usual). The Primary outcome will be self-assessed positive mental health (Mental Health Continuum Short Form, MHC-SF). Secondary outcomes will be self-assessed depression anxiety symptomatology (Hospital Anxiety Depression Scale), emotional well-being, psychological functioning and social well-being (MHC-SF). Outcomes will be investigated at baseline, at 3- 6- and 12 months follow-up. Mediators (positive emotions and cognitions) will be investigated at baseline, mid-intervention and at 3 months follow-up using two single face-valid items. Results: Recruitment of participants will begin in mid-October 2018. Discussion: This study will add knowledge to the efficacy of a fully automated positive psychology intervention. Strengths and limitations of the study are discussed.