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Background: No real-world randomised controlled trials (RCTs) have explored the effectiveness of lifestyle interventions based on multiple behaviour change theories and using combined digital and group-based face-to-face delivery to improve risk factors for type 2 diabetes (T2D). Methods: We conducted a one-year, multi-centre, unblinded, pragmatic RCT in primary healthcare using the habit formation, self-determination, and self-regulation theories among 2907 adults aged 18–74 years at increased T2D risk randomised into a digital lifestyle intervention group (DIGI, n = 967), a combined digital and group-based lifestyle intervention group (DIGI+GROUP, n = 971), and a control group receiving usual care (CONTROL, n = 969). We collected data on primary outcomes (diet quality by Healthy Diet Index [HDI], physical activity, body weight, fasting plasma glucose, 2-hour plasma glucose) and secondary outcomes (sedentary time, waist circumference, fasting plasma insulin) using digital questionnaires, clinical examinations, fasting blood tests, and 2-hour oral glucose tolerance tests. Main statistical analyses were performed using linear mixed-effects models adjusted for age, sex, and province. This RCT was registered with ClinicalTrials.gov, NCT03156478. Findings: The 2907 participants assigned were recruited between March 1st, 2017, and February 28th, 2018. Diet quality improved more (3·2 vs. 1·4 HDI points, p

Funding Information: The authors thank Sarah E Scott for her valuable contributions as the trial manager and in the user experience evaluation, and Susana Cunha for her contribution in conducting and reporting the focus groups. This project has received funding from the European Union?s Horizon 2020 research and innovation program under grant agreement number 643309. The material presented and views expressed here are the responsibility of the authors only. The European Union Commission does not take responsibility for any use made of the information set out. Background: Digital behavior change interventions (DBCIs) offer a promising channel for providing health promotion services. However, user experience largely determines whether they are used, which is a precondition for effectiveness. Objective: The primary aim of this study is to evaluate user experiences with the NoHoW Toolkit (TK)—a DBCI that targets weight loss maintenance—over a 12-month period by using a mixed methods approach and to identify the main strengths and weaknesses of the TK and the external factors affecting its adoption. The secondary aim is to objectively describe the measured use of the TK and its association with user experience. Methods: An 18-month, 2×2 factorial randomized controlled trial was conducted. The trial included 3 intervention arms receiving an 18-week active intervention and a control arm. The user experience of the TK was assessed quantitatively through electronic questionnaires after 1, 3, 6, and 12 months of use. The questionnaires also included open-ended items that were thematically analyzed. Focus group interviews were conducted after 6 months of use and thematically analyzed to gain deeper insight into the user experience. Log files of the TK were used to evaluate the number of visits to the TK, the total duration of time spent in the TK, and information on intervention completion. Results: The usability level of the TK was rated as satisfactory. User acceptance was rated as modest; this declined during the trial in all the arms, as did the objectively measured use of the TK. The most appreciated features were weekly emails, graphs, goal setting, and interactive exercises. The following 4 themes were identified in the qualitative data: engagement with features, decline in use, external factors affecting user experience, and suggestions for improvements. Conclusions: The long-term user experience of the TK highlighted the need to optimize the technical functioning, appearance, and content of the DBCI before and during the trial, similar to how a commercial app would be optimized. In a trial setting, the users should be made aware of how to use the intervention and what its requirements are, especially when there is more intensive intervention content. publishersversion published

Funding Information: This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement number 643309. The materials presented and views expressed here are the responsibility of the authors only. The European Commission takes no responsibility for any use made of the information in this study. Funding Information: 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. Publisher Copyright: © 2021 Journal of Medical Internet Research. All rights reserved. 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. publishersversion published

Additional file 1: Table 1. The main effects of recovery group for all eating behaviour and diet quality variables.

BackgroundType 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. ObjectiveThe 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). MethodsThe 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. ResultsOf 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. ConclusionsResults 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 RegistrationClinicalTrials.gov NCT03156478; https://clinicaltrials.gov/ct2/show/NCT03156478

Background: The StopDia study is based on the convincing scientific evidence that type 2 diabetes (T2D) and its comorbidities can be prevented by a healthy lifestyle. The need for additional research is based on the fact that the attempts to translate scientific evidence into actions in the real-world health care have not led to permanent and cost-effective models to prevent T2D. The specific aims of the StopDia study following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework are to 1) improve the Reach of individuals at increased risk, 2) evaluate the Effectiveness and cost-effectiveness of the digital lifestyle intervention and the digital and face-to-face group lifestyle intervention in comparison to routine care in a randomized controlled trial (RCT), and 3) evaluate the Adoption and Implementation of the StopDia model by the participants and the health care organizations at society level. Finally, we will address the Maintenance of the lifestyle changes at participant level and that of the program at organisatory level after the RCT. Methods: The StopDia study is carried out in the primary health care system as part of the routine actions of three provinces in Finland, including Northern Savo, Southern Carelia, and Päijät-Häme. We estimate that one fifth of adults aged 18-70 years living in these areas are at increased risk of T2D. We recruit the participants using the StopDia Digital Screening Tool, including questions from the Finnish Diabetes Risk Score (FINDRISC). About 3000 individuals at increased risk of T2D (FINDRISC ≥12 or a history of gestational diabetes, impaired fasting glucose, or impaired glucose tolerance) participate in the one-year randomized controlled trial. We monitor lifestyle factors using the StopDia Digital Questionnaire and metabolism using laboratory tests performed as part of routine actions in the health care system. Discussion: Sustainable and scalable models are needed to reach and identify individuals at increased risk of T2D and to deliver personalized and effective lifestyle interventions. With the StopDia study we aim to answer these challenges in a scientific project that is fully digitally integrated into the routine health care. Trial registration: ClinicalTials.gov. Identifier: NCT03156478. Date of registration 17.5.2017.

The global health and wellness sector is one of the most progressive industries in the world, and the market is being reshaped by the emergence of new technologies and changing societal, patient and consumer demands. The Finnish health and wellness industry is currently one of the most flourishing national export business areas. The country's health and wellness sector export growth has been very positive for many years. Remarkably, export growth is based on a limited number of companies. This is one of the reasons why there is urgent need to find new growth-oriented companies and new ways to boost future growth of the healthcare sector. Relevant Finnish companies have been analysed also from the IPR point of view: a clear observation is that all the largest players in the field have a strong and active IPR portfolio as the basis for significant export share of the Finnish health tech industry. To propose for the potential Kalewa ecosystem, thorough investigation is needed to investigate the state of the art of Finnish health and wellness industry. How is the actor network constructed, who and where are the key public and private organizations and stakeholders, service providers, investors, R&D&Iorganizations, accelerators, and especially the numerous technology and service companies? To summarise the analysis, the Finnish health and wellness industry ecosystem is highly complex and dynamic: it is dominated by a rather limited number of large companies responsible for a significant percentage of the total exports in the field. Further, the number of mid-size companies is very low and needs strengthening to support growth. The positive aspect is that the SMEs in the field are numerous and are very dynamically seeking new potential for product and service innovation. Due to the complex operational environment falling under the remit of several ministries, sufficient coordination of the priorities at the national level should be reached to ensure effectiveness and impact of public funding yet allowing the commercial prospects to drive the actual innovation.

eHealth studies typically suffer from high attrition rates. Objective To investigate type 2 diabetes and heart disease patients’ adherence to a self-management intervention that combined health coaching and telemonitoring. Methods Renewing Health Finland was a 12-month randomized controlled trial to improve quality of life (QoL) and/or HbA1c of 595 patients with chronic conditions. The intervention consisted of (1) weekly measurement of health parameters (2) health coaching every 4–6 weeks. Adherence to telemonitoring was defined as the percentage of weeks with at least one reported health measurement. Adherence to coaching was defined as the number of received calls. Results The median percentage of monitored weeks was 65 % without time-dependent attrition. 66 % of participants received 7–11 calls that corresponds to the predefined coaching schedule. Adherence did not correlate with QoL or HbA1c. Discussion Our results indicate that the intervention in the Renewing Health Finland trial was delivered almost with planned intensity.

Terveysriskien ja sairauksien hallinta vaatii usein monien elämäntapatekijöiden ja käyttäytymisen muuttamista. Muutosten tekeminen ja erityisesti niiden ylläpitäminen on haastavaa ja vaatii pitkäaikaista sitoutumista ja motivaatiota. Terveydenhuollon resurssit mahdollistavat vain rajallisen tuen tarjoamisen elämäntapojen muuttamiseen ja yleensä vasta siinä vaiheessa, kun huonoista elämäntavoista johtuvat sairaudet ovat jo puhjenneet. Teknologiset menetelmät tarjoavat uusia, kustannustehokkaita mahdollisuuksia yksilöllisen elämäntapamuutoksen tukemiseen. Monet tietokone- ja internetpohjaiset palvelut on todistettu tehokkaiksi erilaisten fyysisten ja psykologisten ongelmien hallinnassa. Mobiiliteknologiat tarjoavat erityisen houkuttelevan kanavan uusille terveyden edistämiseen tähtääville palveluille. Matkapuhelimet ovat henkilökohtaisia laitteita ja kulkevat käyttäjänsä mukana kaikkialle, joten niiden kautta tarjottava tuki on aina saatavilla. Mobiililaitteita käytetään hyvin vaihtelevissa tilanteissa ja käyttöön liittyy usein keskeytyksiä. Siksi onkin tärkeää tarjota interventio pieninä annoksina päivittäisen arjen keskelle. Oiva-sovellus on Hyväksymis- ja omistautumisterapiaan perustuva mobiilisovellus, jonka tavoitteena on lisätä mielen joustavuutta lyhyiden harjoitusten avulla. Harjoitukset ovat pääosin vain 2-3 minuutin mittaisia ja ne voi suorittaa audio- tai tekstiohjeistuksen avulla. Sovellus opastaa käyttäjää suorittamaan ohjelman, antaa muistutuksia sovelluksen käytöstä ja opituista taidoista sekä näyttää käyttäjän edistymisen ohjelmassa. Käyttäjä voi myös tallentaa sovellukseen omia päiväkirjamerkintöjä harjoituksiin liittyen. Alustavissa tutkimuksissa saadut sovelluksen käyttäjäkokemus- ja hyväksyttävyystulokset ovat olleet lupaavia. Sovelluksen vaikuttavuutta tutkitaan syksyllä 2012 stressin ja metabolisen oireyhtymän piirteistä kärsivillä henkilöillä. Jatkossa selvitetään myös sitä, miten puhelimen automaattisesti keräämää tietoa voidaan hyödyntää käyttäytymisen ja arjen tilanteiden ymmärtämisessä ja miten tämän tiedon avulla interventioita voidaan räätälöidä paremmin käyttäjien arkeen ja tarpeisiin sopivaksi.

This report presents a VTT roadmap on ICT for environmental sustainability, based on the assessments and evaluations made by VTT technology experts. We adopt a broad and systemic view to the issue; in other words, we believe that ICT's effectiveness depends on mutual understanding and changing the system level activities, i.e. the complex web of behaviour of people, institutions, organisations and political jurisdictions, like nation-states. We use the term ICT for environmental sustainability or environmentally sustainable ICT, instead of green ICT, and defined it as: The optimal use of ICT for managing the environmental sustainability of societal activities. The roadmap is divided into three themes. Empowering people means using ICT to raise people's awareness of the environmental impact of their actions and to channel their behaviour in a more environmentally-friendly direction. Extending natural resources involves reducing the use of diverse environmentally unsustainable resources through ICT-based solutions. Optimising systems refers to minimising the environmental load of diverse systems by optimising their operation. As a synthesis, we identified four focal topics within the roadmap themes that are most promising for further investigation. These are: 1) environmentally sustainable consumption, 2) smart energy and buildings, 3) lifecycle efficient production, and 4) optimised and adaptive networks.