A Theory- and Evidence-Based Digital Intervention Tool for Weight Loss Maintenance (NoHoW Toolkit): Systematic Development and Refinement Study.

BACKGROUND: Many weight loss programs show short-term effectiveness, but subsequent weight loss maintenance is difficult to achieve. Digital technologies offer a promising means of delivering behavior change approaches at low costs and on a wide scale. The Navigating to a Healthy Weight (NoHoW) project, which was funded by the European Union's Horizon 2020 research and innovation program, aimed to develop, test, and evaluate a digital toolkit designed to promote successful long-term weight management. The toolkit was tested in an 18-month, large-scale, international, 2×2 factorial (motivation and self-regulation vs emotion regulation) randomized controlled trial that was conducted on adults with overweight or obesity who lost ≥5% of their body weight in the preceding 12 months before enrollment into the intervention. OBJECTIVE: This paper aims to describe the development of the NoHoW Toolkit, focusing on the logic models, content, and specifications, as well as the results from user testing. METHODS: The toolkit was developed by using a systematic approach, which included the development of the theory-based logic models, the selection of behavior change techniques, the translation of these techniques into a web-based app (NoHoW Toolkit components), technical development, and the user evaluation and refinement of the toolkit. RESULTS: The toolkit included a set of web-based tools and inputs from digital tracking devices (smart scales and activity trackers) and modules that targeted weight, physical activity, and dietary behaviors. The final toolkit comprised 34 sessions that were distributed through 15 modules and provided active content over a 4-month period. The motivation and self-regulation arm consisted of 8 modules (17 sessions), the emotion regulation arm was presented with 7 modules (17 sessions), and the combined arm received the full toolkit (15 modules; 34 sessions). The sessions included a range of implementations, such as videos, testimonies, and questionnaires. Furthermore, the toolkit contained 5 specific data tiles for monitoring weight, steps, healthy eating, mood, and sleep. CONCLUSIONS: A systematic approach to the development of digital solutions based on theory, evidence, and user testing may significantly contribute to the advancement of the science of behavior change and improve current solutions for sustained weight management. Testing the toolkit by using a 2×2 design provided a unique opportunity to examine the effect of motivation and self-regulation and emotion regulation separately, as well as the effect of their interaction in weight loss maintenance.

Use of home telemonitoring to support multidisciplinary care of heart failure patients in Finland: randomized controlled trial.

BACKGROUND: Heart failure (HF) patients suffer from frequent and repeated hospitalizations, causing a substantial economic burden on society. Hospitalizations can be reduced considerably by better compliance with self-care. Home telemonitoring has the potential to boost patients' compliance with self-care, although the results are still contradictory. OBJECTIVE: A randomized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization. METHODS: HF patients were eligible whose left ventricular ejection fraction was lower than 35%, NYHA functional class ≥2, and who needed regular follow-up. Patients in the telemonitoring group (n=47) measured their body weight, blood pressure, and pulse and answered symptom-related questions on a weekly basis, reporting their values to the heart failure nurse using a mobile phone app. The heart failure nurse followed the status of patients weekly and if necessary contacted the patient. The primary outcome was the number of HF-related hospital days. Control patients (n=47) received multidisciplinary treatment according to standard practices. Patients' clinical status, use of health care resources, adherence, and user experience from the patients' and the health care professionals' perspective were studied. RESULTS: Adherence, calculated as a proportion of weekly submitted self-measurements, was close to 90%. No difference was found in the number of HF-related hospital days (incidence rate ratio [IRR]=0.812, P=.351), which was the primary outcome. The intervention group used more health care resources: they paid an increased number of visits to the nurse (IRR=1.73, P<.001), spent more time at the nurse reception (mean difference of 48.7 minutes, P<.001), and there was a greater number of telephone contacts between the nurse and intervention patients (IRR=3.82, P<.001 for nurse-induced contacts and IRR=1.63, P=.049 for patient-induced contacts). There were no statistically significant differences in patients' clinical health status or in their self-care behavior. The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the study. CONCLUSIONS: Home telemonitoring did not reduce the number of patients' HF-related hospital days and did not improve the patients' clinical condition. Patients in the telemonitoring group contacted the Cardiology Outpatient Clinic more frequently, and on this way increased the use of health care resources. TRIAL REGISTRATION: Clinicaltrials.gov NCT01759368; http://clinicaltrials.gov/show/NCT01759368 (Archived by WebCite at http://www.webcitation.org/6UFxiCk8Z).

Internet-Based Lifestyle Intervention to Prevent Type 2 Diabetes Through Healthy Habits: Design and 6-Month Usage Results of Randomized Controlled Trial.

BACKGROUND: Type 2 diabetes can be prevented through lifestyle changes, but sustainable and scalable lifestyle interventions are still lacking. Habit-based approaches offer an opportunity to induce long-term behavior changes. OBJECTIVE: The purposes of this study were to describe an internet-based lifestyle intervention for people at risk for type 2 diabetes targeted to support formation of healthy habits and explore its user engagement during the first 6 months of a randomized controlled trial (RCT). METHODS: The app provides an online store that offers more than 400 simple and contextualized habit-forming behavioral suggestions triggered by daily life activities. Users can browse, inspect, and select them; report their performances; and reflect on their own activities. Users can also get reminders, information on other users' activities, and information on the prevention of type 2 diabetes. An unblended parallel RCT was carried out to evaluate the effectiveness of the app in comparison with routine care. User engagement is reported for the first 6 months of the trial based on the use log data of the participants, who were 18- to 70-year-old community-dwelling adults at an increased risk of type 2 diabetes. RESULTS: Of 3271 participants recruited online, 2909 were eligible to participate in the RCT. Participants were randomized using a computerized randomization system to the control group (n=971), internet-based intervention (digital, n=967), and internet-based intervention with face-to-face group coaching (F2F+digital, n=971). Mean age of control group participants was 55.0 years, digital group 55.2 years, and F2F+digital 55.2 years. The majority of participants were female, 81.1% (787/971) in the control group, 78.3% (757/967) in the digital group, and 80.7% (784/971) in the F2F+digital group. Of the participants allocated to the digital and F2F+digital groups, 99.53% (1929/1938) logged in to the app at least once, 98.55% (1901/1938) selected at least one habit, and 95.13% (1835/1938) reported at least one habit performance. The app was mostly used on a weekly basis. During the first 6 months, the number of active users on a weekly level varied from 93.05% (1795/1929) on week 1 to 51.79% (999/1929) on week 26. The daily use activity was not as high. The digital and F2F+digital groups used the app on a median of 23.0 and 24.5 days and for 79.4 and 85.1 minutes total duration, respectively. A total of 1,089,555 habit performances were reported during the first 6 months. There were no significant differences in the use metrics between the groups with regard to cumulative use metrics. CONCLUSIONS: Results demonstrate that internet-based lifestyle interventions can be delivered to large groups including community-dwelling middle-aged and older adults, many with limited experience in digital app use, without additional user training. This intermediate analysis of use behavior showed relatively good engagement, with the percentage of active weekly users remaining over 50% at 6 months. However, we do not yet know if the weekly engagement was enough to change the lifestyles of the participants. TRIAL REGISTRATION: ClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478.

Citizen-Centric Web-Based Health Profiling Service: A Service Concept and a Profiling Method.

Personalization of health interventions has been shown to increase their effectiveness. In digital services, user profiles enable this personalization. We introduce a web-based user profiling service, where citizens can 1) create various personal profiles, specific to certain health topics, by providing their personal data, 2) get summarized feedback on their health and behavioral determinants regarding each profile, and 3) share their profiles with health service providers. As part of the service, we define a profiling method that identifies the health needs and behavioral determinants of citizens, and highlights their most potential behavior change targets. The novelty in the service arises from allowing citizens to govern their health data, quantifying automatically various behavioral determinants, and summarizing aggregated knowledge efficiently via simple visualizations. The service aims to evoke personal awareness about behavior change needs and the factors influencing behavior, enable health service providers to develop and offer highly personalized, automated interventions, and facilitate time-efficient and transparent decision-making of health professionals. According to a preliminary concept evaluation with citizens (N=29), the presented profile feedback was perceived as interesting and intuitive.

Active assistance technology reduces glycosylated hemoglobin and weight in individuals with type 2 diabetes: results of a theory-based randomized trial.

BACKGROUND: Type 2 diabetes is an individual health challenge requiring ongoing self-management. Remote patient reporting of relevant health parameters and linked automated feedback via mobile telephone have potential to strengthen self-management and improve outcomes. This research involved development and evaluation of a mobile telephone-based remote patient reporting and automated telephone feedback system, guided by health behavior change theory, aimed at improving self-management and health status in individuals with type 2 diabetes. SUBJECTS AND METHODS: This research comprised a randomized controlled trial. Inclusion criteria were diagnosis of type 2 diabetes, elevated glycosylated hemoglobin (HbA1c) levels (range, 6.5-11%) or use of oral diabetes medication, and 30-70 years of age. Intervention subjects (n=24) participated in remote patient reporting of health status parameters and linked health behavior change feedback. Control participants (n=24) received standard of care including diabetes education and healthcare provider counseling. Patients were followed for approximately 10 months. RESULTS: Intervention participants achieved, compared with controls and controlling for baseline, a significantly greater mean reduction in HbA1c of -0.40% (95% confidence interval [CI] -0.67% to -0.14%) versus 0.036% (95% CI -0.23% to 0.30%) (P<0.03) and significantly greater weight reduction of -2.1 kg (95% CI -3.6 to -0.6 kg) versus 0.4 kg (95% CI -1.1 to 1.9 kg). Nonsignificant trends for greater intervention compared with control improvement in systolic and diastolic blood pressure were observed. CONCLUSIONS: Sophisticated information technology platforms for remote patient reporting linked with theory-based health behavior change automated feedback have potential to improve patient outcomes in type 2 diabetes and merit scaled-up research efforts.

HELCOM Baltic Sea Action Plan--a regional programme of measures for the marine environment based on the Ecosystem Approach.

The Helsinki Commission (HELCOM) Baltic Sea Action Plan, adopted by the coastal countries of the Baltic Sea and the European Community in November 2007, is a regional intergovernmental programme of measures for the protection and management of the marine environment explicitly based on the Ecosystem Approach. The Action Plan is structured around a set of Ecological Objectives used to define indicators and targets, including effect-based nutrient input ceilings, and to monitor implementation. The Action Plan strongly links Baltic marine environmental concerns to important socio-economic fields such as agriculture and fisheries and promotes cross-sectoral tools including marine spatial planning. Due to complementarities with the European Union (EU) Marine Strategy Framework Directive, the Action Plan is in essence a pilot for this process without neglecting the important role of the Russian Federation - the only Baltic coastal country not a member of the EU.

Interoperability of personal health records.

Personal Health Records (PHR's) and related services are emerging rapidly. Currently, most PHR's are isolated and do not communicate with other systems. Standards for interoperability exist, but they are oriented towards clinical applications. However, a substantial part of a typical PHR consists of non-clinical information such as a health diary. The present paper highlights the requirements related to exchanging non-clinical PHR information between services and shows how this information exchange can be accomplished. The approach utilizes a SOAP message for carrying the actual PHR content in a structure referred as Health Diary Entry (HDE) document. The HDE document provides mechanisms to bind the contents to external vocabularies and ontologies to achieve semantic interoperability. The approach was successfully tested in the context of an occupational health pilot, in which data contents from several health and wellness applications were merged into a common database.

Ontology-based approach for managing personal health and wellness information.

This paper describes a new approach for collecting and sharing personal health and wellness information. The approach is based on a Personal Health Record (PHR) including both clinical and non-clinical data. The PHR is located on a network server referred as Common Server. The overall service architecture for providing anonymous and private access to the PHR is described. Semantic interoperability is based on an ontology collection and usage of OID (Object Identifier) codes. The formal (upper) ontology combines a set of domain ontologies representing different aspects of personal health and wellness. The ontology collection emphasizes wellness aspects while clinical data is modelled by using OID references to existing vocabularies. Modular ontology approach enables distributed management and expansion of the data model.