BackgroundInformation and communication technologies are currently among the supporting elements that may contribute to improving health and changing lifestyles.ObjectiveThe aim of this study was to evaluate the long-term effectiveness of adding an app to standardized counseling in order to increase physical activity (PA) and adherence to the Mediterranean diet and to analyze the effects of app adherence in lifestyle changes.MethodsA randomized, multicenter clinical trial with a 12 month-follow up was conducted, involving 833 participants recruited by random sampling in 6 primary Spanish care centers (415 vs 418). Counseling on PA and the Mediterranean diet was given to both groups by a research nurse; however, the counseling + app group (intervention group) received additional training in the use of an app that was designed to promote the Mediterranean diet and PA over a 3-month period. Main outcomes and measures included PA by accelerometer and the 7-day Physical Activity Recall (PAR) questionnaire and adherence to the Mediterranean diet by an adherence screener questionnaire. We considered adherence to the app to be high when it was used for more than 60 days.ResultsThe mean age was 51 years (SD 12) in the intervention group and 52.3 years (SD 12.0) in the counseling-only group; females predominated in both groups (60.0%, 249/415 and 64.1%, 268/418, respectively). PA by accelerometer declined in both groups at 12 months (P value for tendency in moderate to vigorous PA, [MVPA]=.15). The intervention subgroup with high app adherence had better behavior than the low adherence subgroup (P value for tendency in MVPA=.001). PA analyzed by 7-day PAR did not show changes at 12 months in any of the groups (P value for tendency=.25). In the Mediterranean diet, an increase in adherence was observed in both groups at 12 months with no differences between them (P value for tendency=.46). In these two cases, the group with high app adherence also had better behavior, although without reaching significance for the tendency (P>.05).ConclusionsThe participants with strongest app adherence showed better outcomes in terms of maintenance of healthy lifestyles at 12 months than those with weaker adherence. Overall, however, we found no differences between intervention group and counseling-only group in PA increase and adherence to the Mediterranean diet in the long term.Trial RegistrationClinicaltrials.gov NCT02016014; https://clinicaltrials.gov/ct2/show/NCT02016014 (Archived by WebCite at http://www.webcitation.org/6ymEXH6W4)
Background Promotion of physical activity, healthy eating, adequate sleep, and reduced sedentary behavior in adolescents is a major priority globally given the current increase in population health challenges of noncommunicable diseases and risk factors such as obesity. Adolescents are highly engaged with mobile technology, but the challenge is to engage them with mobile health (mHealth) technology. Recent innovations in mobile technology provide opportunities to promote a healthy lifestyle in adolescents. An increasingly utilized approach to facilitate increased engagement with mHealth technology is to involve potential users in the creation of the technology. Objective This study aimed to describe the process of and findings from co-designing and prototyping components of the PEGASO Fit for Future (F4F) mHealth intervention for adolescents from different cultural backgrounds. Methods A total of 74 adolescents aged 13 to 16 years from Spain, Italy, and the United Kingdom participated in the co-design of the PEGASO F4F technology. In 3 iterative cycles over 12 months, participants were involved in the co-design, refinement, and feasibility testing of a system consisting of diverse mobile apps with a variety of functions and facilities to encourage healthy weight–promoting behaviors. In the first iteration, participants attended a single workshop session and were presented with mock-ups or early-version prototypes of different apps for user requirements assessment and review. During the second iteration, prototypes of all apps were tested by participants for 1 week at home or school. In the third iteration, further developed prototypes were tested for 2 weeks. Participants’ user experience feedback and development ideas were collected through focus groups and completion of questionnaires. Results For the PEGASO F4F technology to be motivating and engaging, participants suggested that it should (1) allow personalization of the interface, (2) have age-appropriate and easy-to-understand language (of icons, labels, instructions, and notifications), (3) provide easily accessible tutorials on how to use the app or navigate through a game, (4) present a clear purpose and end goal, (5) have an appealing and self-explanatory reward system, (6) offer variation in gamified activities within apps and the serious game, and (7) allow to seek peer support and connect with peers for competitive activities within the technology. Conclusions Incorporating adolescents’ preferences, the PEGASO F4F technology combines the functions of a self-monitoring, entertainment, advisory, and social support tool. This was the first study demonstrating that it is possible to develop a complex mobile phone-based technological system applying the principles of co-design to mHealth technology with adolescents across 3 countries. The findings from this study informed the development of an mHealth system for healthy weight promotion to be tested in a controlled multinational pilot trial.
Background The use of apps for weight management has increased over recent years; however, there is a lack of evidence regarding the efficacy and safety of these apps. The EVALAPPS project will develop and validate an assessment instrument to specifically assess the safety and efficacy of weight management apps. Objective The aim of this study was to reach a consensus among stakeholders on a comprehensive set of criteria to guide development of the EVALAPPS assessment instrument. A modified Delphi process was used in order to verify the robustness of the criteria that had been identified through a literature review and to prioritize a set of the identified criteria. Methods Stakeholders (n=31) were invited to participate in a 2-round Delphi process with 114 initial criteria that had been identified from the literature. In round 1, participants rated criteria according to relevance on a scale from 0 (“I suggest this criterion is excluded”) to 5 (“This criterion is extremely relevant”). A criterion was accepted if the median rating was 4 or higher and if the relative intraquartile range was equal to 0.67 or lower. In round 2, participants were asked about criteria that had been discarded in round 1. A prioritization strategy was used to identify crucial criteria according to (1) the importance attributed by participants (criteria with a mean rating of 4.00 or higher), (2) the level of consensus (criteria with a score of 4 or 5 by at least 80% of the participants). Results The response rate was 83.9% (26/31) in round 1 and 90.3% (28/31) in round 2. A total of 107 out of 114 criteria (93.9%) were accepted by consensus—105 criteria in round 1 and 2 criteria in round 2. After prioritization, 53 criteria were deemed crucial. These related mainly to the dimensions of security and privacy (13/53, 24.5%) and usability (9/53, 17.0%), followed by activity data (5/53, 9.4%), clinical effectiveness (5/53, 9.4%), and reliability (5/53, 9.4%). Conclusions Results confirmed the robustness of the criteria that were identified, with those relating to security and privacy being deemed most relevant by stakeholders. Additionally, a specific set of criteria based on health indicators (activity data, physical state data, and personal data) was also prioritized.
BackgroundThe use of information and communication technologies (ICTs) in the health service is increasing. In spite of limitations, such as lack of time and experience, the deployment of ICTs in the healthcare system has advantages which include patient satisfaction with secure messaging, and time saving benefits and utility for patients and health professionals. ICTs may be helpful as either interventions on their own or as complementary tools to help patients stop smoking.ObjectivesTo gather opinions from both medical professionals and smokers about an email-based application that had been designed by our research group to help smoking cessation, and identify the advantages and disadvantages associated with interventions based on the utilization of ICTs for this purpose.MethodsA qualitative, descriptive–interpretative study with a phenomenological perspective was performed to identify and interpret the discourses of the participating smokers and primary healthcare professionals. Data were obtained through two techniques: semi-structured individual interviews and discussion groups, which were recorded and later systematically and literally transcribed together with the interviewer’s notes. Data were analyzed with the ATLAS TI 6.0 programme.ResultsSeven individual interviews and four focal groups were conducted. The advantages of the application based on the email intervention designed by our research group were said to be the saving of time in consultations and ease of access for patients who found work timetables and following a programme for smoking cessation incompatible. The disadvantages were thought to be a lack of personal contact with the healthcare professional, and the possibility of cheating/ self-deception, and a greater probability of relapse on the part of the smokers.ConclusionsBoth patients and healthcare professionals viewed the email-based application to help patients stop smoking as a complementary aid to face-to-face consultations. Nevertheless, ICTs could not substitute personal contact in the smoking cessation programme.
Background The use of apps to tackle overweight and obesity by tracking physical and dietary patterns and providing recommendations and motivation strategies to achieve personalized goals has increased over recent years. However, evidence of the efficacy, effectiveness, and safety of these apps is severely lacking. Objective The aim of this study was to identify efficacy, safety, and effectiveness criteria used to assess weight control, overweight, and obesity management in mobile health (mHealth) interventions through a systematic review. Methods PubMed, PsycINFO, Scopus, UK Trial Database, ClinicalTrials.gov, and the Cochrane Library were surveyed up to May 2018. All types of clinical studies were considered. A total of 2 independent reviewers assessed quality using Scottish Intercollegiate Guidelines Network (SIGN) criteria. Ratings were used to provide an overall score for each study (low, moderate, or high). Data were synthesized in evidence tables. Results From 233 potentially relevant publications, only 28 studies were included. Of these, 13 (46%) were randomized control trials, 11 were single-arm studies (39%), 3 were nonrandomized controlled trials (11%), and 1 study was a cluster randomized trial (4%). The studies were classified as low (15), high (7), and moderate (6) quality according to SIGN criteria. All studies focused on efficacy, with only 1 trial mentioning safety and another 1 effectiveness. In 11 studies, the apps were used as stand-alone interventions, the others were multicomponent studies that included other tools for support such as sensors or websites. The main management tool included in the apps was feedback messaging (24), followed by goal-setting mechanisms (20) and self-monitoring (19). The majority of studies took weight or body mass index loss as the main outcome (22) followed by changes in physical activity (14) and diet (12). Regarding outputs, usability, adherence, and engagement (17) were the most reported, followed by satisfaction (7) and acceptability (4). Conclusions There is a remarkable heterogeneity among these studies and the majority have methodological limitations that leave considerable room for improvement. Further research is required to identify all relevant criteria for assessing the efficacy of mHealth interventions in the management of overweight and obesity. Trial Registration PROSPERO CRD42017056761; https://tinyurl.com/y2zhxtjx
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