bluuebunny/crossref_metadata_2025_split huggingface dataset:
Treatment of Childhood Obesity Based on Brazilian Dietary Guidelines Plus Energy Restriction (PAPPAS HUPE Study): Protocol for a Randomized Clinical Trial
Authors: Brandao Joana Maia , Sichieri Rosely , Ribas Simone Augusta , Verly-Jr Eliseu , Pereira Rosangela Alves , Castro Inês Rugani Ribeiro De , Hassan Bruna Kulik , Oliveira Alessandra Silva Dias De , Marques Emanuele Souza , Cunha Diana Barbosa 
Published: May 2020

Background
The Food Guide for the Brazilian Population relies on natural or minimally processed foods mainly of plant origin such as beans and rice with low oil, salt, and sugar content and limited consumption of ultraprocessed foods. Reduction of ultraprocessed foods improves diet quality and energy consumption.

Objective
The goal of this study is to evaluate the effectiveness of an intervention for the treatment of obesity in children, with counseling based on the Brazilian Food Guide plus control of total energy intake.

Methods
A parallel, randomized clinical trial will include children aged 7 to 12 years. Randomization will be performed in blocks of 10 individuals using computer-generated random sequence numbers. Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide. These activities will be conducted at the University Hospital Toy Library, located in the pediatric outpatient clinic. For the intervention group, in addition to the educational activities, an individualized food plan based on the nutritional recommendations of the Brazilian Society of Pediatrics will be prescribed and discussed with the mothers and fathers. The primary outcome of the study will be variations in body mass index, and secondary outcomes will include analysis of insulin resistance, blood pressure, body fat percentage, and waist and neck circumference.

Results
This project was funded by the National Council for Scientific and Technological Development in December 2017 (grant no 408333/2017-0). Recruitment began in August 2018 and by September 2019, we had enrolled the 101 participants. In addition to the patients referred by the national system of regulation, recruitment was made by medical outpatient referral and external indication. This is an ongoing study. We expect the results to be published in November 2020.

Conclusions
At the end of the project, in case of a positive result, a protocol for the treatment of obesity based on the Brazilian Food Guide will be proposed to the Unified Health System. A successful method to reduce childhood obesity is expected.

Trial Registration
Brazilian Registry of Clinical Trials RBR-3st5sn; http://www.ensaiosclinicos.gov.br/rg/RBR-3st5sn

International Registered Report Identifier (IRRID)
DERR1-10.2196/16170
Recommendations for Developing Support Tools With People Suffering From Chronic Obstructive Pulmonary Disease: Co-Design and Pilot Testing of a Mobile Health Prototype
Authors: Davies Alan , Mueller Julia , Hennings Jean , Caress Ann-Louise , Jay Caroline 
Published: May 2020

Background
Gaps exist between developers, commissioners, and end users in terms of the perceived desirability of different features and functionalities of mobile apps.

Objective
The objective of this study was to co-design a prototype mobile app for people with chronic obstructive pulmonary disease (COPD). We present lessons learned and recommendations from working on a large project with various stakeholders to develop a mobile app for patients with COPD.

Methods
We adopted a user-centered, participatory approach to app development. Following a series of focus groups and interviews to capture requirements, we developed a prototype app designed to enable daily symptom recording (experience sampling). The prototype was tested in a usability study applying the think aloud protocol with people with COPD. It was then released via the Android app store, and experience sampling data and event data were captured to gather further usability data.

Results
A total of 5 people with COPD participated in the pilot study. Identified themes include familiarity with technology, appropriate levels for feeding back information, and usability issues such as manual dexterity. Moreover, 37 participants used the app over a 4-month period (median age 47 years). The symptoms most correlated to perceived well-being were tiredness (r=0.61; P<.001) and breathlessness (r=0.59; P<.001).

Conclusions
Design implications for COPD apps include the need for clearly labeled features (rather than relying on colors or symbols that require experience using smartphones), providing weather information, and using the same terminology as health care professionals (rather than simply lay terms). Target users, researchers, and developers should be involved at every stage of app development, using an iterative approach to build a prototype app, which should then be tested in controlled settings as well as in the wild (ie, when deployed and used in real-world settings) over longer periods.
A Mobile Health Intervention System for Women With Coronary Heart Disease: Usability Study
Authors: Sengupta Avijit , Beckie Theresa , Dutta Kaushik , Dey Arup , Chellappan Sriram 
Published: May 2020

Background
Coronary heart disease (CHD) is the leading cause of death and disability among American women. The prevalence of CHD is expected to increase by more than 40% by 2035. In 2015, the estimated cost of caring for patients with CHD was US $182 billion in the United States; hospitalizations accounted for more than half of the costs. Compared with men, women with CHD or those who have undergone coronary revascularization have up to 30% more rehospitalizations within 30 days and up to 1 year. Center-based cardiac rehabilitation is the gold standard of care after an acute coronary event, but few women attend these valuable programs. Effective home-based interventions for improving cardiovascular health among women with CHD are vital for addressing this gap in care.

Objective
The ubiquity of mobile phones has made mobile health (mHealth) behavioral interventions a viable option to improve healthy behaviors of both women and men with CHD. First, this study aimed to examine the usability of a prototypic mHealth intervention designed specifically for women with CHD (herein referred to as HerBeat). Second, we examined the influence of HerBeat on selected health behaviors (self-efficacy for diet, exercise, and managing chronic illness) and psychological (perceived stress and depressive symptoms) characteristics of the participants.

Methods
Using a single-group, pretest, posttest design, 10 women participated in the 12-week usability study. Participants were provided a smartphone and a smartwatch on which the HerBeat app was installed. Using a web portal dashboard, a health coach monitored participants’ ecological momentary assessment data, their behavioral data, and their heart rate and step count. Participants then completed a 12-week follow-up assessment.

Results
All 10 women (age: mean 64.4 years, SD 6.3 years) completed the study. The usability and acceptability of HerBeat were good, with a mean system usability score of 83.60 (SD 16.3). The participants demonstrated statistically significant improvements in waist circumference (P=.048), weight (P=.02), and BMI (P=.01). Furthermore, depressive symptoms, measured with the Patient Health Questionnaire-9, significantly improved from baseline (P=.04).

Conclusions
The mHealth prototype was feasible and usable for women with CHD. Participants provided data that were useful for further development of HerBeat. The mHealth intervention is expected to help women with CHD self-manage their health behaviors. A randomized controlled trial is needed to further verify the findings.
A Blended Physiotherapy Intervention for Persons With Hemophilic Arthropathy: Development Study
Authors: Timmer Merel A , Kloek Corelien J J , de Kleijn Piet , Kuijlaars Isolde A R , Schutgens Roger E G , Veenhof Cindy , Pisters Martijn F 
Published: May 2020

Background
Joint bleeds are the hallmark of hemophilia, leading to a painful arthritic condition called as hemophilic arthropathy (HA). Exercise programs are frequently used to improve the physical functioning in persons with HA. As hemophilia is a rare disease, there are not many physiotherapists who are experienced in the field of hemophilia, and regular physiotherapy sessions with an experienced physiotherapist in the field of hemophilia are not feasible for persons with HA. Blended care is an innovative intervention that can support persons with HA at home to perform the advised physical activities and exercises and provide self-management information.

Objective
The aim of this study was to develop a blended physiotherapy intervention for persons with HA.

Methods
The blended physiotherapy intervention, namely, e-Exercise HA was developed by cocreation with physiotherapists, persons with HA, software developers, and researchers. The content of e-Exercise HA was compiled using the first 3 steps of the Center for eHealth Research roadmap model (ie, contextual inquiry, value specification, and design), including people with experience in the development of previous blended physiotherapy interventions, a literature search, and focus groups.

Results
A 12-week blended intervention was developed, integrating face-to-face physiotherapy sessions with a web-based app. The intervention consists of information modules for persons with HA and information modules for physiotherapists, a graded activity program using a self-chosen activity, and personalized video-supported exercises. The information modules consist of text blocks, videos, and reflective questions. The patients can receive pop-ups as reminders and give feedback on the performance of the prescribed activities.

Conclusions
In this study, we developed a blended physiotherapy intervention for persons with HA, which consists of information modules, a graded activity program, and personalized video-supported exercises.
Perceptions About Mindfulness and Text Messaging for Smoking Cessation in Vietnam: Results From a Qualitative Study
Authors: Do Vuong Van , Spears Claire Adams , Van Minh Hoang , Huang Jidong , Redmon Pamela Buffington , Xuan Long Nguyen , Eriksen Michael Paul 
Published: May 2020

Background
With 15.6 million smokers, Vietnam is one of the top 10 largest cigarette-consuming countries in the world. Unfortunately, smoking cessation programs are still scarce in Vietnam. Mindfulness-based and text messaging–based interventions have been increasingly used in smoking cessation studies in developed countries, with promising results. Given the exponential growth of mobile phone usage in Vietnam in recent years, mobile health interventions could be a potential strategy to increase smoking cessation in Vietnam. However, substantial cultural adaptations are needed to optimize the effectiveness of these interventions among Vietnamese smokers.

Objective
This study aims to involve qualitative research to inform the development of a mindfulness-based text messaging smoking cessation intervention for Vietnamese smokers.

Methods
A total of 10 focus groups were conducted with 71 Vietnamese male smokers aged between 18 and 65 years (5-9 participants per focus group). Overall, 5 focus groups were conducted with smokers who had the intention to quit (ie, preparation stage of change in the transtheoretical model), and 5 focus groups were conducted with smokers who did not have the intention to quit (contemplation or precontemplation stage). The focus groups were audio recorded, transcribed verbatim, and analyzed using NVivo 12 software (QSR International).

Results
The major themes included smoking triggers, barriers and facilitators for quitting, the perceptions of text messaging and mindfulness approaches for smoking cessation, and suggestions for the development of a text messaging–based smoking cessation program. Common smoking triggers included stress, difficulties concentrating, and fatigue. Frequently encountering other people who were smoking was a common barrier to quitting. However, participants indicated that concerns about the harmful effects of smoking on themselves and their wives and children, and encouragement from family members could motivate them to quit. The participants preferred diverse message content, including information about the consequences of smoking, encouragement to quit, and tips to cope with cravings. They suggested that text messages be clear and concise and use familiar language. Most smokers perceived that mindfulness training could be useful for smoking cessation. However, some suggested that videos or in-person training may also be needed to supplement teaching mindfulness through text messages.

Conclusions
This study provides important insights to inform the development of a text messaging–based smoking cessation program that incorporates mindfulness for Vietnamese male smokers. The results could also be useful for informing similar programs in other low- and middle-income countries.
The Ubiquitous Cognitive Assessment Tool for Smartwatches: Design, Implementation, and Evaluation Study
Authors: Hafiz Pegah , Bardram Jakob Eyvind 
Published: May 2020

BackgroundCognitive functioning plays a significant role in individuals’ mental health, since fluctuations in memory, attention, and executive functions influence their daily task performance. Existing digital cognitive assessment tools cannot be administered in the wild and their test sets are not brief enough to capture frequent fluctuations throughout the day. The ubiquitous availability of mobile and wearable devices may allow their incorporation into a suitable platform for real-world cognitive assessment.ObjectiveThe aims of this study were threefold: (1) to evaluate a smartwatch-based tool for the assessment of cognitive performance, (2) to investigate the usability of this tool, and (3) to understand participants’ perceptions regarding the application of a smartwatch in cognitive assessment.MethodsWe built the Ubiquitous Cognitive Assessment Tool (UbiCAT) on a smartwatch-based platform. UbiCAT implements three cognitive tests—an Arrow test, a Letter test, and a Color test—adapted from the two-choice reaction-time, N-back, and Stroop tests, respectively. These tests were designed together with domain experts. We evaluated the UbiCAT test measures against standard computer-based tests with 21 healthy adults by applying statistical analyses significant at the 95% level. Usability testing for each UbiCAT app was performed using the Mobile App Rating Scale (MARS) questionnaire. The NASA-TLX (Task Load Index) questionnaire was used to measure cognitive workload during the N-back test. Participants rated perceived discomfort of wearing a smartwatch during the tests using a 7-point Likert scale. Upon finishing the experiment, an interview was conducted with each participant. The interviews were transcribed and semantic analysis was performed to group the findings.ResultsPearson correlation analysis between the total correct responses obtained from the UbiCAT and the computer-based tests revealed a significant strong correlation (r=.78, P<.001). One-way analysis of variance (ANOVA) showed a significant effect of the N-back difficulty level on the participants' performance measures. The study also demonstrated usability ratings above 4 out of 5 in terms of aesthetics, functionality, and information. Low discomfort (<3 out of 7) was reported by our participants after using the UbiCAT. Seven themes were extracted from the transcripts of the interviews conducted with our participants.ConclusionsUbiCAT is a smartwatch-based tool that assesses three key cognitive domains. Usability ratings showed that participants were engaged with the UbiCAT tests and did not feel any discomfort. The majority of the participants were interested in using the UbiCAT, although some preferred computer-based tests, which might be due to the widespread use of personal computers. The UbiCAT can be administered in the wild with mentally ill patients to assess their attention, working memory, and executive function.
A Novel Narrative E-Writing Intervention for Parents of Children With Chronic Life-Threatening Illnesses: Protocol for a Pilot, Open-Label Randomized Controlled Trial
Authors: Ho Andy Hau Yan , Dutta Oindrila , Tan-Ho Geraldine , Tan Toh Hsiang Benny , Low Xinyi Casuarine , Ganapathy Sashikumar , Car Josip , Ho Ringo Moon-Ho , Miao Chun Yan 
Published: May 2020

Background
A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses. NeW-I is informed by an international systematic review and a Singapore-based qualitative inquiry on the lived experience of parental bereavement and supported by literature on anticipatory grief interventions for improving the holistic well-being of parent caregivers of seriously ill children.

Objective
This study's aim was to provide an accessible platform, NeW-I—which is a strengths- and meaning-focused and therapist-facilitated mobile app and web-based counseling platform—that aims to enhance quality of life, spiritual well-being, hope, and perceived social support and reduce depressive symptoms, caregiver burden, and risk of complicated grief among parents of children with chronic life-threatening illnesses.

Methods
The NeW-I therapist-facilitated web-based platform comprises a mobile app and a website (both of which have the same content
and functionality). NeW-I has been implemented in Singapore as a pilot open-label randomized controlled trial comprising intervention and control groups. Both primary and secondary outcomes will be self-reported by participants through questionnaires. In collaboration with leading pediatric palliative care providers in Singapore, the trial aims to enroll 36 participants in each group (N=72), so that when allowing for 30% attrition at follow-up, the sample size will be adequate to detect a small effect size of 0.2 in the primary outcome measure, with 90% power and two-sided significance level of at least .05. The potential effectiveness of NeW-I and the accessibility and feasibility of implementing and delivering the intervention will be assessed.

Results
Funding support and institutional review board approval for this study have been secured. Data collection started in January 2019 and is ongoing.

Conclusions
NeW-I aspires to enhance holistic pediatric palliative care services through a structured web-based counseling platform that is sensitive to the unique cultural needs of Asian family caregivers who are uncomfortable with expressing emotion even during times of loss and separation. The findings of this pilot study will inform the development of a full-scale NeW-I protocol and further research to evaluate the efficacy of NeW-I in Singapore and in other Asian communities around the world.

Trial Registration
ClinicalTrials.gov NCT03684382; https://clinicaltrials.gov/ct2/show/NCT03684382

International Registered Report Identifier (IRRID)
DERR1-10.2196/17561
Using an Interactive App for Symptom Reporting and Management Following Pancreatic Cancer Surgery to Facilitate Person-Centered Care: Descriptive Study
Authors: Gustavell Tina , Sundberg Kay , Langius-Eklöf Ann 
Published: May 2020

Background
Pancreatic and periampullary cancers are rare but have high mortality rates. The only hope for cure is surgical removal of the tumor. Following pancreatic surgery, the patients have a great deal of responsibility for managing their symptoms. Patients report a lack of sufficient knowledge of self-care and unmet supportive care needs. This necessitates a health care system responsive to these needs and health care professionals who pay close attention to symptoms. Person-centered care is widely encouraged and means a shift from a model in which the patient is the passive object of care to a model involving the patient as an active participant in their own care. To address the challenges in care following pancreatic cancer surgery, an interactive app (Interaktor) was developed in which patients regularly report symptoms and receive support for self-care. The app has been shown to reduce patients’ symptom burden and to increase their self-care activity levels following pancreaticoduodenectomy due to cancer.

Objective
The aim of the study was to describe how patients used the Interaktor app following pancreaticoduodenectomy due to cancer and their experience with doing so.

Methods
A total of 115 patients were invited to use Interaktor for 6 months following pancreaticoduodenectomy. Of those, 35 declined, 8 dropped out, and 46 did not meet the inclusion criteria after surgery, leaving 26 patients for inclusion in the analysis. The patients were instructed to report symptoms daily through the app for up to 6 months following surgery. In case of alerting symptoms, they were contacted by their nurse. Data on reported symptoms, alerts, and viewed self-care advice were logged and analyzed with descriptive statistics. Also, the patients were interviewed about their experiences, and the data were analyzed using thematic analysis.

Results
The patients’ median adherence to symptom reporting was 82%. Fatigue and pain were the most reported symptoms. Alerting symptoms were reported by 24 patients, and the most common alert was fever. There were variations in how many times the patients viewed the self-care advice (range 3-181 times). The most commonly viewed advice concerned pancreatic enzyme supplements. Through the interviews, the overarching theme was “Being seen as a person,” with the following 3 sub-themes: “Getting your voice heard,” “Having access to an extended arm of health care,” and “Learning about own health.”

Conclusions
Interaktor proved to be well accepted. It made patients feel reassured at home and offered support for self-care. The app facilitated person-centered care by its multiple features targeting individual supportive care needs and enabled participation in their own care. This supports our recent studies showing that patients using the app had less symptom burden and higher self-care activity levels than patients receiving only standard care.