Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: More alternatives are needed for recording people's normal diet in different populations, especially adults or the elderly, as part of the investigation into the effects of nutrition on health. Objective: To compare the estimated values of energy intake, macro and micronutrient and alcohol consumption gathered using the EVIDENT II Smartphone application against the data estimated with a food intake frequency questionnaire in an adult population aged 18-70. Methods: We included 362 individuals (52 ± 12 years, 59.1% women) who were part of the EVIDENT II study. The participants registered their food intake using the EVIDENT application during a period of 3 months and through a food intake frequency questionnaire (FFQ). Both methods estimate the average nutritional composition including energy intake, macro and micronutrients and alcohol. Through the application, the values of the first week of food recording, the first month and the entire 3-month period were estimated. The FFQ gathers data regarding the food intake of the year prior to the moment of interview. Results: The intraclass correlation for the estimation of energy intake with the FFQ and the application shows significant results, with the highest values returned when analyzing the application's data for the full 3-month period (0.304 (95% CI 0.144 to 0.434), p <.001). For this period, the correlation coefficient regarding energy intake is 0.233 (p <.001). The highest value corresponds to alcohol consumption and the lowest to the intake of polyunsaturated fatty acids (r = 0.676 and r = 0.155, p <.001), respectively. The estimation of daily intake of energy, macronutrients and alcohol presents higher values in the FFQ compared to the EVIDENT application data. Taking the values recorded during the 3-month period, the FFQ for energy intake estimation (Kcal) was higher than that of the application (a difference of 408.7 (95% CI 322.7 to 494.8), p <.001). The same is true for the other macronutrients, with the exception g/day of saturated fatty acids (0.4 (95% CI -1.2 to 2.0), p = .62). Conclusions: The EVIDENT application is significantly correlated to the food intake frequency questionnaire in the estimation of energy intake, macro and micronutrients and alcohol consumption. This correlation increases with longer application recording periods. The EVIDENT application can be a good alternative for recording food intake intake in the context of longitudinal or intervention studies. Clinical Trial: ClinicalTrials.gov Identifier:NCT02016014

The increasing use of smartphones by older adults also increases their potential for improving different aspects of health in this population. Some studies have shown promising results in the improvement of cognitive performance through lifestyle modification. All this may have a broad impact on the quality of life and carrying out daily living activities. The objective of this study is to evaluate the effectiveness of combining the use of smartphone and smartband technology for 3 months with brief counseling on life habits, as opposed to providing counseling only, in increasing physical activity and improving adherence to the Mediterranean diet. Secondary objectives are to assess the effect of the intervention on body composition, quality of life, independence in daily living activities and cognitive performance. This study is a two-arm cluster-randomized trial that will be carried out in urban health centers in Spain. We will recruit 160 people aged between 65 and 80 without cardiovascular disease or cognitive impairment (score in the Mini-mental State Examination ≥24). On a visit to their center, intervention group participants will be instructed to use a smartphone application for a period of 3 months. This application integrates information on physical activity received from a fitness bracelet and self-reported information on the patient’s daily nutritional composition. The primary outcome will be the change in the number of steps measured by accelerometer. Secondary variables will be adherence to the Mediterranean diet, sitting time, body composition, quality of life, independence in daily living activities and cognitive performance. All variables will be measured at baseline and on the assessment visit after 3 months. A telephone follow-up will be carried out at 6 months to collect self-reported data regarding physical activity and adherence to the Mediterranean diet. Preventive healthy aging programs should include health education with training in nutrition and lifestyles, while stressing the importance of and enhancing physical activity; the inclusion of new technologies can facilitate these goals. The EVIDENT-AGE study will incorporate a simple, accessible intervention with potential implementation in the care of older adults. ClinicalTrials.gov Identifier: NCT03574480 . Date of trial Registration July 2, 2018.

The increase in life expectancy and survival time implies an increase in the possible side-effects of pharmacological treatments in patients. Cancer-related fatigue is one of these side-effects. The main objective of this study was to evaluate the effects of a multimodal program of physical exercise and functional rehabilitation on asthenia, pain, functional capacity, and quality of life in cancer patients with cancer-related fatigue. Methods: This was a randomized, parallel-controlled clinical trial, with two arms (experimental and control group), and it was conducted over the course of a year in the Oncology Hospitalization Unit at the University Hospital of Salamanca, Spain. Participants (n = 48) were assessed at three points during the study. The first assessment was prior to hospital discharge, the second assessment was after 15 days, and the final assessment was at one month post-hospital follow-up. The intervention lasted one month. The main variables studied were the dependency levels (Barthel), cancer-related fatigue (FACT-An), health-related quality of life (EuroQoL-5D), functional capacity (SPPB), and kinesiophobia (TSK-F). Results: Sample size (n = 44). Mean age 63.46 ± 12.36 years. Significant differences between control and experimental group participants in Barthel, FACT-An, TSK-F, and SPPB scores at follow-up and final assessment. Conclusions: There are beneficial effects of a multimodal physical exercise and functional rehabilitation program in improving the autonomy of cancer-related fatigue patients.

This study aimed to evaluate the effects of the intake of 10 g of cocoa-rich chocolate on blood pressure, other cardiovascular risk factors, and vascular structure and function in postmenopausal women. A total of 140 postmenopausal women participated in this randomized and controlled parallel clinical trial. For six months, the intervention group (IG; n = 73) consumed daily 10 g of chocolate (99% cocoa) added to their usual food intake, whereas the control group (CG; n = 67) did not receive any intervention. Blood pressure, pulse pressure (PP), cardio-ankle vascular index (CAVI), ankle-brachial index (ABI), brachial-ankle pulse wave velocity (baPWV), augmentation index, and laboratory variables were measured at baseline and six months. ANCOVA analyses adjusted for baseline values revealed no significant differences for systolic blood pressure (−1.45 mm Hg; 95% confidence interval (CI): −4.79, 1.88; p = 0.391) or baPWV (0.18 m/s; 95% CI: −0.14, 0.50; p = 0.263) between groups. A decrease in PP was observed in the IG compared to the CG (−2.05 mm Hg; 95% CI: −4.08, −0.02; p = 0.048). The rest of the vascular structure and function parameters and other measured variables remained unchanged. The daily intake of 10 g of cocoa-rich chocolate seems to provide little improvement to cardiovascular health, but neither does it cause any adverse effects on the parameters evaluated in postmenopausal women in the long term.

Introduction: Mobile technology, when included within multicomponent interventions, could contribute to more effective weight loss. The objective of this project is to assess the impact of adding the use of the EVIDENT 3 application, designed to promote healthy living habits, to traditional modification strategies employed for weight loss. Other targeted behaviors (walking, caloric-intake, sitting time) and outcomes (quality of life, inflammatory markers, measurements of arterial aging) will also be evaluated. Methods: Randomized, multicentre clinical trial with 2 parallel groups. The study will be conducted in the primary care setting and will include 700 subjects 20 to 65 years, with a body mass index (27.5-40kg/m(2)), who are clinically classified as sedentary. The primary outcome will be weight loss. Secondary outcomes will include change in walking (steps/d), sitting time (min/wk), caloric intake (kcal/d), quality of life, arterial aging (augmentation index), and pro-inflammatory marker levels. Outcomes will be measured at baseline, after 3 months, and after 1 year. Participants will be randomly assigned to either the intervention group (IG) or the control group (CG). Both groups will receive the traditional primary care lifestyle counseling prior to randomization. The subjects in the IG will be lent a smartphone and a smartband for a 3-month period, corresponding to the length of the intervention. The EVIDENT 3 application integrates the information collected by the smartband on physical activity and the self-reported information by participants on daily food intake. Using this information, the application generates recommendations and personalized goals for weight loss. Discussion: There is a great diversity in the applications used obtaining different results on lifestyle improvement and weight loss. The populations studied are not homogeneous and generate different results. The results of this study will help our understanding of the efficacy of new technologies, combined with traditional counseling, towards reducing obesity and enabling healthier lifestyles. Ethicsanddissemination: The study was approved by the Clinical Research Ethics Committee of the Health Area of Salamanca ("CREC of Health Area of Salamanca") on April 2016. A SPIRIT checklist is available for this protocol.