JMIR Research Protocols

Ongoing Trials, Grant Proposals, Formative Research, Methods, Early Results

Dietary AGE consumption as a direct modulator of insulin sensitivity in overweight humans: A study protocol for a double-blind, randomised two period cross-over trial

Abstract Background Advanced glycation end products (AGEs) are formed during the processing, storage and cooking of foods. As part of a western diet, AGEs are consumed in excess and impair glucose metabolism in patients with type 2 diabetes. In the absence of diabetes, AGE mediated decreases in insulin sensitivity and signalling have been postulated. However, randomised studies to test this relationship in humans are limited. Aims The primary aim of this trial is to determine whether dietary consumption of advanced glycation end products will decrease insulin sensitivity in healthy overweight adults. A secondary aim is to determine the effects of dietary AGEs on insulin secretion, circulating soluble receptor for AGEs, sRAGE and inflammation markers. Methods/Design Twenty overweight, but otherwise healthy non-diabetic adults aged between 18 and 50 years old, will complete a randomised cross-over design intervention study alternating 2-week duration low and high (4-fold increase) AGE diets. At baseline, participants will undergo a medical review including an intravenous glucose tolerance test (IVGTT), a hyperinsulinaemic-euglycaemic clamp, anthropometric measures and questionnaires assessing diet, physical activity and general wellness. Each test diet will be followed for 14 days, followed by a 4-week washout period before commencement of the second alternate dietary period. Energy, macronutrient and AGE intake will be calculated for each diet period. Additionally, the AGE content of foods used in the study will be measured by ultra performace liquid chromatography mass spectrometry. All measurements will be repeated at the beginning and end of each dietary period. Primary and secondary outcomes will be expressed as a changeover the dietary period for insulin sensitivity, secretion, anthropometric parameters, circulating soluble receptor for AGEs, sRAGE and inflammation markers and compared by paired t-test and ANOVA. Discussion: The proposed trial will provide much needed clinical evidence on the impact of excess dietary AGE consumption on insulin sensitivity and will indicate whether lowering dietary AGE intake can improve insulin sensitivity and/or secretion thereby decreasing risk for type 2 diabetes.

2015-02-19

We are pleased to announce our forthcoming new journals, all of which have currently no submission or publication fees, and all of which focus on emerging technologies and patient-centered innovations in specific areas, going beyond Internet/webbased interventions: * JMIR Cancer (http://cancer.jmir.org) * JMIR Medical Education (http://mededu.jmir.org) * JMIR Public Health and Surveillance (http://publichealth.jmir.org) We welcome submissions for the inaugural issues of these journals. The following journals have already published articles and are still free of charge to publish in (no submission or publication fees): * JMIR Human Factors (http://humanfactors.jmir.org) * JMIR Rehabilitation and Assistive Technologies (http://rehab.jmir.org) * JMIR Mental Health (http://mental.jmir.org) To submit to these journals, simply append /author to the URLs above (e.g. http://cancer.jmir.org/author), or submit to the main JMIR journal and use the dropdown-box in step 1 to change the journal name. All journals offer careful copyediting and typesetting of manuscripts, and submission to PubMed and PubMed Central (being new journals it may however take a few month until they appear in PubMed). We are also happy to announce that JMIR Medical Informatics and JMIR Serious Games are now indexed in PubMed.

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Journal Description

 

JMIR Research Protocols (ISSN 1929-0748) publishes 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 new journal spin-off of JMIR, the worlds' leading medical journal in health sciences / health services research and health informatics (Impact Factor: 4.7)
  • JMIR Res Protoc 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 
  • 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 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)
 
 

Recent Articles:

  • Recruiting Migrants for Health Research Through Social Network Sites: An Online Survey Among Chinese Migrants in Australia

    Abstract:

    Background: Traditionally, postal surveys or face to face interviews are the main approaches for health researchers to obtain essential research data. However, with the prevalence of information technology and Internet, Web-based surveys are gaining popularity in health research. Objective: This study aims to report the process and outcomes of recruiting Chinese migrants through social network sites in Australia and to examine the sample characteristics of online recruitment by comparing the sample which was recruited by an online survey to a sample of Australian Chinese migrants collected by a postal survey. Methods: Descriptive analyses were performed to describe and compare the process and outcomes of online recruitment with postal survey questionnaires. Chi square tests and t tests were performed to assess the differences between the two samples for categorical and continuous variables respectively. Results: In total, 473 Chinese migrants completed the online health survey from July to October 2013. Out of 426 participants recruited through the three Chinese social network sites in Australia, over 86.6% (369/426) were recruited within six weeks. Participants of the Web-based survey were younger, with a higher education level or had resided in Australia for less time compared to those recruited via a postal survey. However, there was no significant difference in gender, marital status, and professional occupation. Conclusions: The recruitment of Chinese migrants through social network sites in our online survey was feasible. Compared to a postal survey of Chinese migrants, the online survey attracted different group of Chinese migrants who may have diverse health needs and concerns. Our findings provided insightful information for researchers who are considering employing a Web-based approach to recruit migrants and ethnic minority participants.

  • First step.
Photograph by Fredrik Holländare.

    Internet-Based Cognitive Behavioral Therapy for Residual Symptoms in Bipolar Disorder Type II: A Single-Subject Design Pilot Study

    Abstract:

    Background: Bipolar disorder is a chronic condition with recurring episodes that often lead to suffering, decreased functioning, and sick leave. Pharmacotherapy in the form of mood stabilizers is widely available, but does not eliminate the risk of a new depressive or (hypo)manic episode. One way to reduce the risk of future episodes is to combine pharmacological treatment with individual or group psychological interventions. However, access to such interventions is often limited due to a shortage of trained therapists. In unipolar depression there is now robust evidence of the effectiveness of Internet-based psychological interventions, usually comprising psychoeducation and cognitive behavioral therapy (CBT). Internet-based interventions for persons suffering from bipolar disorder could increase access to psychological treatment. Objective: The aim of this study was to investigate the feasibility of an Internet-based intervention, as well as its effect on residual depressive symptoms in persons diagnosed with bipolar disorder type II (BP-II). The most important outcomes were depressive symptoms, treatment adherence, and whether the patient perceived the intervention as helpful. Methods: A total of 7 patients diagnosed with bipolar disorder type II at a Swedish psychiatric outpatient clinic were offered the opportunity to participate. Of the 7 patients, 3 (43%) dropped out before treatment began, and 4 (57%) were treated by means of an online, Internet-based intervention based on CBT (iCBT). The intervention was primarily aimed at psychoeducation, treatment of residual depressive symptoms, emotion regulation, and improved sleep. All patients had ongoing pharmacological treatment at recruitment and established contact with a psychiatrist. The duration of BP-II among the treated patients was between 6 and 31 years. A single-subject design was used and the results of the 4 participating patients were presented individually. Results: Initiating treatment was perceived as too demanding under current life circumstances for 3 patients who consequently dropped out during baseline assessment. Self-ratings using the Montgomery-Åsberg Depression Rating Scale—Self-rated (MADRS-S) showed symptom reduction in 3 (75%) of the 4 treated cases during iCBT. In the evaluation of the treatment, 2 patients reported that they perceived that the treatment had reduced symptoms a little, 1 that it had reduced symptoms very much, and 1 not at all. Treatment adherence (ie, module completion) was fairly high in 3 cases. In general, the modules were perceived as fairly helpful or very helpful by the patients. In one case, there was a reliable change—according to the Reliable Change Index—in self-rated symptoms of depression and perseverative thinking. Conclusions: The treatment seemed to have acceptable feasibility. The iCBT intervention could be an effective way to treat residual symptoms in some patients with bipolar disorder type II. This should be investigated in a larger study. Trial Registration: ClinicalTrials.gov NCT01742351; https://clinicaltrials.gov/ct2/show/NCT01742351 (Archived by WebCite at http://www.webcitation.org/6XnVpv4C3).

  • Image from guidebook, attributed to Ms Niamh Aspell, RelAte Team.

    A Shared Mealtime Approach to Improving Social and Nutritional Functioning Among Older Adults Living Alone: Study Protocol for a Randomized Controlled Trial

    Abstract:

    Background: Older adults living alone are at increased risk of malnutrition as well as social isolation. Previous research has evaluated psychosocial interventions aimed at improving social support for older adults living alone. One meta-analysis in particular has suggested that multimodal psychosocial interventions are more effective than unimodal interventions. As such, it may be more effective to deliver an intervention which combines nutritional and social support together. Consequently, we designed the RelAte intervention, which focuses on shared mealtimes as a source of combined social and nutritional support for older adults living alone who are at risk of social isolation. Objective: The objective of the RelAte trial was to evaluate the impact of such an intervention on energy intake, anthropometric measurements, and nutritional social cognitive variables among older adults living alone in the community. Methods: There are 100 participants that will be recruited and randomized to either the treatment (n=50) or the control group. The treatment group will receive a visit from a trained peer volunteer once weekly for a period of 8 weeks. Outcomes of interest include: energy intake, social cognitive factors related to diet, abdominal circumference, body mass index, psychosocial well-being, frailty, nutritional status, and health utilities. Outcomes will be obtained at baseline, immediately postintervention (8 weeks after baseline), 12-week follow-up, and 26-week follow-up by assessors blinded to participants’ randomized assignment. Results: The Relate trial is currently active. We are currently at data analysis stage. The study started in June 2013 and will run until June 2015. Conclusions: Results from this study will primarily describe the effectiveness of a shared mealtime intervention for older adults living alone in terms of their dietary well-being, physical health, and psychosocial well-being. Trial Registration: Trial Registration: Clinicaltrials.gov NCT02007551; http://clinicaltrials.gov/ct2/show/NCT00102401 (Archived by WebCite at http://www.webcitation/6WptuVTtz).

  • Screenshot of video of a priest is included to illustrate the authority figures represented.

    An Interactive, Bilingual, Culturally Targeted Website About Living Kidney Donation and Transplantation for Hispanics: Development and Formative Evaluation

    Abstract:

    Background: As the kidney shortage continues to grow, patients on the waitlist are increasingly turning to live kidney donors for transplantation. Despite having a disproportionately higher prevalence of end-stage kidney disease (ESKD), fewer waitlisted Hispanic patients received living donor kidney transplants (LDKTs) than non-Hispanic whites in 2014. Although lack of knowledge has been identified as a barrier to living kidney donation (LKD) among Hispanics, little is known about information needs, and few bilingual educational resources provide transplant-related information addressing Hispanics’ specific concerns. Objective: This paper describes the process of developing a bilingual website targeted to the Hispanic community. The website was designed to increase knowledge about LKD among Hispanic patients with ESKD, their families, and the public, and was inspired by educational sessions targeted to Hispanic transplant patients provided by Northwestern University’s Hispanic Kidney Transplant Program. Methods: Northwestern faculty partnered with the National Kidney Foundation of Illinois for expertise in ESKD and Hispanic community partners across the Chicago area. We established a Community Advisory Board (CAB) of 10 Chicago-area Hispanic community leaders to provide insight into cultural concerns and community and patients’ needs. Website content development was informed by 9 focus groups with 76 adult Hispanic kidney transplant recipients, living kidney donors, dialysis patients, and the general Hispanic public. The website development effort was guided by community input on images, telenovela scripts, and messages. After initial development, formal usability testing was conducted with 18 adult Hispanic kidney transplant recipients, dialysis patients, and living kidney donors to identify ways to improve navigability, design, content, comprehension, and cultural sensitivity. Usability testing revealed consistently high ratings as “easy to navigate”, “informative”, and “culturally appropriate”. Bandura’s Social Cognitive Theory and Gagne’s Conditions of Learning Theory guided website design to facilitate adult learning. Results: The website, “Infórmate: Living Kidney Donation for Hispanics/Latinos” (Infórmate Acerca de la Donación de Riñón en Vida), includes six sections: Treatment Options, Donation: Step-by-Step, Benefits and Risks, Financial Issues, Immigrant Issues, and Cultural Beliefs and Myths. Sections host 5-10 interactive messages that summarize important points and link to detailed explanations for users interested in learning more about specific issues. The website hosts interactive videos, multimedia testimonials, telenovelas, games, and quizzes. Photographs and videos of Hispanic living donors are shown to promote pride and ownership. Conclusions: Our success in developing a website was driven by a development team with expertise in transplantation, social science, evaluation, instructional design, and Hispanic perspectives, and by a patient-centered approach toward content and design. Based on feedback from usability testing and our CAB, the website is sensitive to Hispanic cultural sensibilities. We have nearly completed a formal evaluation of the website’s impact on increasing Hispanics’ knowledge about LKD and will disseminate the website thereafter.

  • Mid rectal T3 tumor < 5 mm EMD and predicted CRM > 1mm. No suspicious lymph nodes and no EMVI. T: primary tumor; EMD: extramural depth of invasion; CRM: circumferential resection margin; and EMVI: extramural venous invasion.

    QuickSilver: A Phase II Study Using Magnetic Resonance Imaging Criteria to Identify “Good Prognosis” Rectal Cancer Patients Eligible for Primary Surgery

    Abstract:

    Background: Recently, two nonrandomized, prospective cohort studies used magnetic resonance imaging (MRI) to assess the circumferential resection margin to identify “good prognosis” rectal tumors eligible for primary surgery and have reported favorable outcomes. Objective: The objective of this project was to conduct a Phase II trial to assess the safety and feasibility of MRI criteria to identify “good prognosis” rectal tumors eligible for primary surgery in the North American setting. Methods: Patients with newly diagnosed primary rectal cancer attending surgical clinics at participating centers will be invited to participate in the study. The inclusion criteria for the study are: (1) diagnosis of rectal cancer (0-15 cm) from the anal verge on endoscopy and proximal extent of tumor at or below the sacral promontory on computed tomography (CT) or MRI; (2) meets all MRI criteria for “good prognosis” rectal tumor as defined by the study protocol; (3) 18 years or older; and (4) able to provide written consent. The initial assessment will include: (1) clinical and endoscopic examination of the primary tumor; (2) CT chest, abdomen, and pelvis; and (3) pelvic MRI. All potentially eligible cases will be presented at a multidisciplinary cancer conference to assess for eligibility based on the MRI criteria for “good prognosis” tumor which include: (1) predicted circumferential resection margin (CRM) > 1 mm; (2) definite T2, T2/early T3, or definite T3 tumor with < 5 mm of extramural depth of invasion (EMD); (3) any N0, N1, or N2; and (4) absence of extramural venous invasion (EMVI). All patients fulfilling the MRI criteria for “good prognosis” rectal cancer and the inclusion and exclusion criteria will be invited to participate in the study and proceed to primary surgery. The safety of the MRI criteria will be evaluated by assessing the positive CRM rate and is the primary outcome for the study. Results: We expect to have a minimum of 300 potentially eligible patients, and based on a 30% eligibility rate and 80% participation rate, it is expected that 75 patients will be recruited over the two year study period. A Data Safety Monitoring Committee has been organized, and the study will be stopped if a positive CRM of >10% is reported at any interim assessment, which will occur after every 25 patients accrued in the study. Conclusions: It is expected that the results of this study will show that use of MRI criteria to identify “good prognosis” rectal cancers eligible for primary surgery will be safe (ie, positive margin less than 10%). Therefore, these results will have significant potential to change the current management of rectal cancer in North America and result in improved quality of life for rectal cancer patients and survivors, while reducing overall health care costs. Trial Registration: ISRCTN05107772; http://www.controlled-trials.com/ISRCTN05107772/ (Archived by WebCite at http://www.webcitation/6WhhUhXkA).

  • Example of virtual grocery store tour.

    The Use of Virtual World-Based Cardiac Rehabilitation to Encourage Healthy Lifestyle Choices Among Cardiac Patients: Intervention Development and Pilot Study...

    Abstract:

    Background: Despite proven benefits through the secondary prevention of cardiovascular disease (CVD) and reduction of mortality, cardiac rehabilitation (CR) remains underutilized in cardiac patients. Underserved populations most affected by CVD including rural residents, low socioeconomic status patients, and racial/ethnic minorities have the lowest participation rates due to access barriers. Internet-and mobile-based lifestyle interventions have emerged as potential modalities to complement and increase accessibility to CR. An outpatient CR program using virtual world technology may provide an effective alternative to conventional CR by overcoming patient access limitations such as geographics, work schedule constraints, and transportation. Objective: The objective of this paper is to describe the research protocol of a two-phased, pilot study that will assess the feasibility (Phase 1) and comparative effectiveness (Phase 2) of a virtual world-based (Second Life) CR program as an extension of a conventional CR program in achieving healthy behavioral change among post-acute coronary syndrome (ACS) and post-percutaneous coronary intervention (PCI) patients. We hypothesize that virtual world CR users will improve behaviors (physical activity, diet, and smoking) to a greater degree than conventional CR participants. Methods: In Phase 1, we will recruit at least 10 patients enrolled in outpatient CR who were recently hospitalized for an ACS (unstable angina, ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction) or who recently underwent elective PCI at Mayo Clinic Hospital, Rochester Campus in Rochester, MN with at least one modifiable, lifestyle risk factor target (sedentary lifestyle, unhealthy diet, and current smoking). Recruited patients will participate in a 12-week, virtual world health education program which will provide feedback on the feasibility, usability, and design of the intervention. During Phase 2, we will conduct a 2-arm, parallel group, single-center, randomized controlled trial (RCT). Patients will be randomized at a 1:1 ratio to adjunct virtual world-based CR with conventional CR or conventional CR only. The primary outcome is a composite including at least one of the following (1) at least 150 minutes of physical activity per week, (2) daily consumption of five or more fruits and vegetables, and (3) smoking cessation. Patients will be assessed at 3, 6, and 12 months. Results: The Phase 1 feasibility study is currently open for recruitment which will be followed by the Phase 2 RCT. The anticipated completion date for the study is May 2016. Conclusions: While research on the use of virtual world technology in health programs is in its infancy, it offers unique advantages over current Web-based health interventions including social interactivity and active learning. It also increases accessibility to vulnerable populations who have higher burdens of CVD. This study will yield results on the effectiveness of a virtual world-based CR program as an innovative platform to influence healthy lifestyle behavior and self-efficacy.

  • (cc) Blanc et al. CC-BY-SA-2.0, please cite as (http://www.researchprotocols.org/article/viewFile/3615/1/56403).

    Retrieval of Publications Addressing Shared Decision Making: An Evaluation of Full-Text Searches on Medical Journal Websites

    Abstract:

    Background: Full-text searches of articles increase the recall, defined by the proportion of relevant publications that are retrieved. However, this method is rarely used in medical research due to resource constraints. For the purpose of a systematic review of publications addressing shared decision making, a full-text search method was required to retrieve publications where shared decision making does not appear in the title or abstract. Objective: The objective of our study was to assess the efficiency and reliability of full-text searches in major medical journals for identifying shared decision making publications. Methods: A full-text search was performed on the websites of 15 high-impact journals in general internal medicine to look up publications of any type from 1996-2011 containing the phrase “shared decision making”. The search method was compared with a PubMed search of titles and abstracts only. The full-text search was further validated by requesting all publications from the same time period from the individual journal publishers and searching through the collected dataset. Results: The full-text search for “shared decision making” on journal websites identified 1286 publications in 15 journals compared to 119 through the PubMed search. The search within the publisher-provided publications of 6 journals identified 613 publications compared to 646 with the full-text search on the respective journal websites. The concordance rate was 94.3% between both full-text searches. Conclusions: Full-text searching on medical journal websites is an efficient and reliable way to identify relevant articles in the field of shared decision making for review or other purposes. It may be more widely used in biomedical research in other fields in the future, with the collaboration of publishers and journals toward open-access data.

  • Image Source: Greg Clarke https://www.flickr.com/photos/46018179@N00/5246855663 licensed under Creative Commons CC BY-ND 2.0.

    Mobile Phone and Tablet Apps to Support Young People’s Management of Their Physical Long-Term Conditions: A Systematic Review Protocol

    Abstract:

    Background: The prevalence of long-term or chronic conditions that limit activity and reduce quality of life in young people aged 10-24 years is rising. This group has distinct health care needs and requires tailored support strategies to facilitate increasing personal responsibility for the management of their condition wherever possible, as they mature. Mobile phone and tablet mobile technologies featuring software program apps are already well used by young people for social networking or gaming. They have also been utilized in health care to support personal condition management, using condition-specific and patient-tailored software. Such apps have much potential, and there is an emerging body of literature on their use in a health context making this review timely. Objective: The objective of this paper is to develop a systematic review protocol focused on identifying and assessing the effectiveness of mobile phone and tablet apps that support young people’s management of their chronic conditions. Methods: The search strategy will include a combination of standardized indexed search terms and free-text terms related to the key concepts of young people; long-term conditions and mobile technology. Peer-reviewed journal articles published from 2003 that meet the inclusion and exclusion criteria will be identified through searching the generated hits from 5 bibliographical databases. Two independent reviewers will screen the titles and abstracts to determine which articles focus on testing interventions identified as a mobile phone or tablet apps, and that have been designed and delivered to support the management of long-term conditions in young people aged 10-24 years. Data extraction and quality assessment tools will be used to facilitate consistent analysis and synthesis. It is anticipated that several studies will meet the selection criteria but that these are likely to be heterogeneous in terms of study design, reported outcomes, follow-up times, participants’ age, and health condition. Sub-group analyses will be undertaken and where possible meta-analyses will take place. Results: This review will synthesize available knowledge surrounding tablet and mobile phone apps that support management of long term physical health conditions in young people. The findings will be synthesized to determine which elements of the technologies were most effective for this population. Conclusions: This systematic review aims to synthesize existing literature in order to generate findings that will facilitate the development of an app intervention. The review will form the first phase of development and evaluation of a complex intervention as recommended by the United Kingdom Medical Research Council. The knowledge gained from the review will be verified in subsequent phases, which will include primary qualitative work with health professionals and young people with long term conditions as research participants. Young people living with long-term conditions will be involved as co-researchers and consumer advisors in all subsequent phases to develop and evaluate an app to support the management of long-term physical health conditions. Trial Registration: PROSPERO International prospective register of systematic reviews: CRD42014015418; http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42014015418#.VRqCpTpnL8E (Archived by Webcite at http://www.webcitation.org/6XREcWqQY).

  • Developing a Healthy Web-Based Cookbook for Pediatric Cancer Patients and Survivors: Rationale and Methods

    Abstract:

    Background: Obesity has been a growing problem among children and adolescents in the United States for a number of decades. Childhood cancer survivors (CCS) are more susceptible to the downstream health consequences of obesity such as cardiovascular disease, endocrine issues, and risk of cancer recurrence due to late effects of treatment and suboptimal dietary and physical activity habits. Objective: The objective of this study was to document the development of a Web-based cookbook of healthy recipes and nutrition resources to help enable pediatric cancer patients and survivors to lead healthier lifestyles. Methods: The Web-based cookbook, named “@TheTable”, was created by a committee of researchers, a registered dietitian, patients and family members, a hospital chef, and community advisors and donors. Recipes were collected from several sources including recipe contests and social media. We incorporated advice from current patients, parents, and CCS. Results: Over 400 recipes, searchable by several categories and with accompanying nutritional information, are currently available on the website. In addition to healthy recipes, social media functionality and cooking videos are integrated into the website. The website also features nutrition information resources including nutrition and cooking tip sheets available on several subjects. Conclusions: The “@TheTable” website is a unique resource for promoting healthy lifestyles spanning pediatric oncology prevention, treatment, and survivorship. Through evaluations of the website’s current and future use, as well as incorporation into interventions designed to promote energy balance, we will continue to adapt and build this unique resource to serve cancer patients, survivors, and the general public.

  • Example of Social Jet Lag video for viewing on Tumblr, with the attached segment from the linked survey that younger workers used to assess the activity.

    Focus Groups Move Online: Feasibility of Tumblr Use for eHealth Curriculum Development

    Abstract:

    Background: Constructing successful online programs requires engaging potential users in development. However, assembling focus groups can be costly and time consuming. Objective: The aim of this study is to assess whether Tumblr can be used to prioritize activities for an online younger worker risk reduction and health promotion program. Methods: Younger summer parks and recreation employees were encouraged to visit Tumblr using weekly announcements and competitions. Each week, new activities were posted on Tumblr with linked survey questions. Responses were downloaded and analyzed. Results: An average of 36 young workers rated each activity on its likeability and perceived educational value. The method was feasible, efficient, and sustainable across the summer weeks. Ratings indicated significant differences in likeability among activities (P<.005). Conclusions: Tumblr is a means to crowdsource formative feedback on potential curricular components when assembling an online intervention. This paper describes its initial use as well as suggestions for future refinements.

  • Photograph illustrating blood processing.

    Determinants of Weight Gain Prevention in Young Adult and Midlife Women: Study Design and Protocol of a Randomized Controlled Trial

    Abstract:

    Background: Treatment of overweight and obesity through body weight reduction has been monumentally ineffective as few individuals are able to sustain weight loss. Rather than treating weight gain once it has become problematic, prevention of weight gain over time may be more effective. Objective: The aim of this research is to preclude the burden of adult obesity in women by identifying the determinants of weight gain prevention. The objective of this randomized controlled trial (RCT) is to compare a weight gain prevention intervention delivered by the registered dietitian versus counselor. Methods: This is a 12-month parallel-arm weight gain prevention RCT designed to increase self-efficacy, self-regulation, outcome expectations and family and social support through the use of a nutrition education intervention in women, aged 18-45 years, from the Urbana-Champaign (Illinois, USA) area. Women have been randomized to registered dietitian, counselor or wait-list control groups (August 2014) and are undergoing weekly nutrition education sessions for four months, followed by monthly sessions for eight months (through August 2015). Outcome measures, including: (1) dietary intake, (2) physical activity, (3) anthropometric and blood pressure measurements, (4) biochemical markers of health, (5) eating behaviors and health perceptions, and (6) mediators of behavior change, were collected before the intervention began (baseline) and will be collected at 3, 6, 9, and 12 months of the study. Results: In total, 87 women have been randomized to intervention groups, and 81 women have completed first week of the study. Results are expected in early 2016. Conclusions: This RCT is one of the first to examine weight gain prevention in women across normal, overweight, and obese body mass index categories. Results of this research are expected to have application to evidence-based practice in weight gain prevention for women and possibly have implication for policy regarding decreasing the encumbrance of overweight and obesity in the United States.

  • Regular physical activity helps children to develop healthfully. © Canadian Obesity Network.

    Working With Parents to Prevent Childhood Obesity: Protocol for a Primary Care-Based eHealth Study

    Abstract:

    Background: Parents play a central role in preventing childhood obesity. There is a need for innovative, scalable, and evidence-based interventions designed to enhance parents’ motivation to support and sustain healthy lifestyle behaviors in their children, which can facilitate obesity prevention. Objective: (1) Develop an online screening, brief intervention, and referral to treatment (SBIRT) eHealth tool to enhance parents’ concern for, and motivation to, support children’s healthy lifestyle behaviors, (2) refine the SBIRT eHealth tool by assessing end-user acceptability, satisfaction, and usability through focus groups, and (3) determine feasibility and preliminary effectiveness of the refined SBIRT eHealth tool through a randomized controlled trial. Methods: This is a three-phase, multi-method study that includes SBIRT eHealth tool development (Phase I), refinement (Phase II), and testing (Phase III). Phase I: Theoretical underpinnings of the SBIRT tool, entitled the Resource Information Program for Parents on Lifestyle and Education (RIPPLE), will be informed by concepts applied within existing interventions, and content will be based on literature regarding healthy lifestyle behaviors in children. The SBIRT platform will be developed in partnership between our research team and a third-party intervention development company. Phase II: Focus groups with parents, as well as health care professionals, researchers, and trainees in pediatrics (n=30), will explore intervention-related perceptions and preferences. Qualitative data from the focus groups will inform refinements to the aesthetics, content, structure, and function of the SBIRT. Phase III: Parents (n=200) of children—boys and girls, 5 to 17 years old—will be recruited from a primary care pediatric clinic while they await their children’s clinical appointment. Parents will be randomly assigned to one of five groups—four intervention groups and one control group—as they complete the SBIRT. The randomization function is built into the tool. Parents will complete the eHealth SBIRT using a tablet that will be connected to the Internet. Subsequently, parents will be contacted via email at 1-month follow-up to assess (1) change in concern for, and motivation to, support children’s dietary and physical activity behaviors (primary outcome), and (2) use of online resources and referrals to health services for obesity prevention (secondary outcome). Results: This research was successfully funded and received ethics approval. Development of the SBIRT started in summer 2012, and we expect all study-related activities to be completed by fall 2016. Conclusions: The proposed research is timely and applies a novel, technology-based application designed to enhance parents concern for, and motivation to, support children’s healthy lifestyle behaviors and encourage use of online resources and community services for childhood obesity prevention. Overall, this research builds on a foundation of evidence supporting the application of SBIRTs to encourage or “nudge” individuals to make healthy lifestyle choices. Findings from Phase III of this project will directly inform a cluster randomized controlled trial to study the effectiveness of our intervention across multiple primary care-based settings. Trial Registration: ClinicalTrials.gov NCT02330588; http://clinicaltrials.gov/ct2/show/NCT02330588 (Archived by WebCite at http://www.webcitation.org/6WyUOeRlr).

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  • Dietary AGE consumption as a direct modulator of insulin sensitivity in overweight humans: A study protocol for a double-blind, randomised two period cross-over trial

    Date Submitted: Apr 17, 2015

    Open Peer Review Period: Apr 19, 2015 - May 3, 2015

    Abstract Background Advanced glycation end products (AGEs) are formed during the processing, storage and cooking of foods. As part of a western diet, AGEs are consumed in excess and impair glucose me...

    Abstract Background Advanced glycation end products (AGEs) are formed during the processing, storage and cooking of foods. As part of a western diet, AGEs are consumed in excess and impair glucose metabolism in patients with type 2 diabetes. In the absence of diabetes, AGE mediated decreases in insulin sensitivity and signalling have been postulated. However, randomised studies to test this relationship in humans are limited. Aims The primary aim of this trial is to determine whether dietary consumption of advanced glycation end products will decrease insulin sensitivity in healthy overweight adults. A secondary aim is to determine the effects of dietary AGEs on insulin secretion, circulating soluble receptor for AGEs, sRAGE and inflammation markers. Methods/Design Twenty overweight, but otherwise healthy non-diabetic adults aged between 18 and 50 years old, will complete a randomised cross-over design intervention study alternating 2-week duration low and high (4-fold increase) AGE diets. At baseline, participants will undergo a medical review including an intravenous glucose tolerance test (IVGTT), a hyperinsulinaemic-euglycaemic clamp, anthropometric measures and questionnaires assessing diet, physical activity and general wellness. Each test diet will be followed for 14 days, followed by a 4-week washout period before commencement of the second alternate dietary period. Energy, macronutrient and AGE intake will be calculated for each diet period. Additionally, the AGE content of foods used in the study will be measured by ultra performace liquid chromatography mass spectrometry. All measurements will be repeated at the beginning and end of each dietary period. Primary and secondary outcomes will be expressed as a changeover the dietary period for insulin sensitivity, secretion, anthropometric parameters, circulating soluble receptor for AGEs, sRAGE and inflammation markers and compared by paired t-test and ANOVA. Discussion: The proposed trial will provide much needed clinical evidence on the impact of excess dietary AGE consumption on insulin sensitivity and will indicate whether lowering dietary AGE intake can improve insulin sensitivity and/or secretion thereby decreasing risk for type 2 diabetes.

  • Business modeling to implement an eHealth portal for infection control: a reflection on co-creation with stakeholders

    Date Submitted: Apr 13, 2015

    Open Peer Review Period: Apr 16, 2015 - Apr 30, 2015

    Background: It is acknowledged that the success and uptake of eHealth improves with involvement of users and stakeholders to make technology reflect their needs. Involving stakeholders in implementati...

    Background: It is acknowledged that the success and uptake of eHealth improves with involvement of users and stakeholders to make technology reflect their needs. Involving stakeholders in implementation research is therefore a crucial element in developing eHealth technology. Business modeling is an approach to guide implementation research for eHealth. Stakeholders have to be involved in business modeling by identifying stakeholders, conducting value co-creation dialogues with these stakeholders, and co-creating a business model. Comprehensive and applicable approaches geared towards business modeling in eHealth are scarce as implementation activities are often underestimated as a crucial step while developing eHealth. Objective: This article demonstrates the potential of several stakeholder-oriented analysis methods and their practical application demonstrated with the Infectionmanager.com example case. In this paper we aim to demonstrate how business modeling, with a focus on stakeholder involvement, can be used to co-create an implementation for eHealth. Methods: We divided business modeling in four main research steps: as part of (1) stakeholder identification we performed literature scans, expert recommendations and snowball sampling. For (2) stakeholder analysis we performed ‘basic stakeholder analysis’, stakeholder salience and ranking/analytic hierarchy process. For (3) value co-creation dialogues we performed a process analysis and stakeholder interviews based on the business model canvas. Finally, for (4) business model generation we combined all findings into the business model canvas. Results: Based on the applied methods, we synthesized a guideline for business modeling with stakeholder-oriented analysis methods that we value suitable for implementing eHealth. Conclusions: The guideline for business modeling with stakeholder involvement enables eHealth researchers to apply a systematic and multidisciplinary, co-creative approach for implementing eHealth. Business modeling becomes an active part in the entire development process of eHealth and starts implementation research a priori. With this early focus on implementation, stakeholders can help to co-create the basis necessary for a satisfying success and uptake of the eHealth technology.

  • Contraception Behavior Model in Mexican Women: A Mixed Method Protocol

    Date Submitted: Apr 13, 2015

    Open Peer Review Period: Apr 16, 2015 - Apr 30, 2015

    Background: Introducción: Los embarazos no planeados son un problema de salud reproductiva, se reporta que cerca de 200,000 mujeres mueren por consecuencias del embarazo, parto y puerperio. Una de la...

    Background: Introducción: Los embarazos no planeados son un problema de salud reproductiva, se reporta que cerca de 200,000 mujeres mueren por consecuencias del embarazo, parto y puerperio. Una de las estrategias para disminuir este problema es la ampliación de la cobertura del uso de métodos anticonceptivos, en especial de aquellos altamente efectivos y reversibles, como los anticonceptivos hormonales. A pesar de los esfuerzos y de reconocerse las problemáticas sociales y personales que representa un embarazo no planeado, el porcentaje de uso de anticonceptivos es muy bajo. No se han encontrado modelos que expliquen la conducta anticonceptiva de las mujeres y son pocos los estudios que lo han hecho desde una perspectiva de promoción de la salud. La conducta anticonceptiva ha sido estudiada desde la perspectiva cuantitativa en mayor medida, sin embargo esto no ha dado una idea acabada del fenómeno por lo que es necesario abordarlo de una forma holística y completa. Los métodos mixtos son una estrategia que ayudarían a dar una mayor explicación y profundidad al tema y permitiría construir un modelo más completo. Objective: Objetivos: Desarrollar un modelo explicativo de la conducta anticonceptiva en mujeres Mexicanas utilizando metodología mixta. Methods: Métodos: Se realizará un estudio mixto concurrente transformativo en mujeres de 18 a 24 años de edad. Se proponen tres etapas: 1) la fase cuantitativa, tendrá por objeto evaluar el modelo propuesto inicialmente a través de instrumentos con características psicométricas aceptables; 2) la fase cualitativa, en la que realizarán entrevistas semi-estructuradas para encontrar posibles variables que complementen el modelo; y 3) la fase mixta, en la que se transformarán las variables para integrarlas en el modelo final. Para el análisis de los datos cuantitativos se proponen regresiones lineales múltiples y logísticas y para los datos cualitativos la interpretación basada en teoría fundamentada. En la fase mixta los datos cualitativos se codificarán, después se cuantificarán y se transformarán en datos cuantitativos. Results: Resultados: Se obtuvo aprobación del Comité de Ética en Investigación de la Facultad de Enfermería, UANL. Se realizó una prueba piloto con 29 mujeres al norte de México a las cuales se les aplicaron los instrumentos con la finalidad de evaluar el tiempo del llenado y la claridad de las preguntas. Se realizaron tres entrevistas semi-estructuradas con la finalidad de evaluar la guía de entrevista. Los resultados estarán disponibles a finales del 2015 Conclusions: Conclusiones: El uso de métodos mixtos es muy adecuado para obtener profundidad y amplitud en la explicación del tema así como para proponer un modelo integral que explique fenómenos complejos, como la conducta anticonceptiva de las mujeres. Se recomienda utilizar esta metodología para abordar fenómenos relacionados con la salud reproductiva de la mujer.