Onnikka® lifestyle intervention application for weight management

Onnikka Health offers a lifestyle intervention application designed to support weight management. Onnikka® is intended for persons aged 18 to 65 with a body mass index (BMI) of 27 to 40 kg/m2. Contraindications for using the app include a previously diagnosed eating disorder, alcohol or medication dependence, or severe psychiatric illness. [1] The application is based on the weight management method developed at the University of Oulu, which makes use of a cognitive behavioural therapy framework (Health Behaviour Change Support Systems, HBCSS) and persuasive programming (Persuasive Systems Design, PSD) [2,3,4,5].  

Onnikka® includes various functionalities for users, including self-monitoring, virtual exercise, positive feedback, reminders, and tips. The Onnikka® lifestyle intervention application helps users to independently observe and possibly change their thoughts, feelings, and behavioural models related to their lifestyles. The application aims to support health-promoting changes in diet while improving health literacy. [1] 

Evidence of the methodology on which the product under assessment is based 

PrevMetSyn study 

The Onnikka® application is based on a web-based weight management method, which has been studied as part of the PrevMetSyn study from 2012 to 2019 [6,7]. The study examined how well group counselling based on cognitive behavioural therapy in conjunction with the web-based weight management method promoted weight loss, as well as the web-based weight management method alone.  

The study had 532 participants with the following enrolment criteria: their body mass index (BMI) had to be 27-35 kg/m2 and age between 20 and 60 years; people with health barriers such as pregnancy were not enrolled; no other obesity treatment methods were allowed at the same time; the participants needed to have access to the Internet.  

The subjects were randomly divided into three main groups. The main groups were divided into two further subgroups, one using the web-based weight management method and the other not. The main groups were as follows: 

• The subjects participated in eight face-to-face nutritional counselling sessions based on cognitive behavioural therapy.   
• The subjects participated in two face-to-face nutritional counselling sessions based on face-to-face cognitive behavioural therapy.  
• The subjects did not receive face-to-face nutritional counselling. 

PrevMetSyn was a two-year follow-up study. The web-based weight management method was used for 52 weeks from the beginning of the study. Of the subjects started the study, 80% attended the one-year intervention follow-up and 70% the two-year follow-up. The results of the study have been published in two peer-reviewed articles. [6,7]  

Studies based on the PrevMetSyn data 

An article by Teeriniemi et al. studied the impact of the web-based weight management method on the body weight of the subjects based on the PrevMetSyn data. The main outcome of the study was a change in body weight compared to baseline at the 1-year and 2-year follow-ups. The largest weight loss was achieved in the group that participated in eight face-to-face nutritional guidance sessions along with using the web-based weight management method. The subjects achieved a 4.1% (95% CI [-5.4 ─ -2.8], P < 0.001) weight loss at 12 months and a 3.4% (95% CI [-4.8 ─ -2.0], P < 0.001) loss at 24 months. The web-based weight management method, even without nutritional guidance, reduced the average weight by 1.6% in 24 months (95% CI [-2.9 ─ -0.3], P = 0.015).  

In all groups using web-based weight management, the highest weight loss was achieved by individuals with a BMI of 30-35 kg/m2. Similarly, all of those using the web-based weight management method had still had a reduced waist circumference even at 24 months. [6] According to the Current Care Guidelines, a weight loss of at least 5% appears to result in beneficial metabolic changes [8].  

The goal of the peer-reviewed study, Seon et al., published in 2020, was to investigate the impact of the web-based weight management method on the incidence of metabolic syndrome based on the PrevMetSyn data. The study compared the incidence of metabolic syndrome among the users of a web-based weight management method and other subjects. After two years of follow-up, results showed that the proportion of metabolic syndrome in the group using web-based weight management was significantly lower than in the group not using web-based weight management (33.7% vs. 45,3%, p = .022). The group using web-based weight management had a lower incidence of metabolic syndrome after intervention than the non-using group by 0.50 (OR [0.27–0.90]).  In addition, the study suggested that more active use of web-based weight management is associated with a larger reduction in the incidence of metabolic syndrome. [7] 

Other studies 

A peer-reviewed study published in 2023 evaluated the impact of a weight management method used on a mobile device in the treatment of obesity as a standalone treatment.  200 subjects with an average BMI of 34.3 kg/m2 and aged between 18 and 65 years participated in the study. The study measured the anthropometric (body composition measurement) and metabolic characteristics of the participants. The subjects were randomized to two groups. At the beginning of the study, one group immediately adopted the weight management method used on a mobile device, while the other group waited six months before the introduction of the weight management method used a mobile device. Retention rates were 98.5% at the six-month (6) follow-up and 89.0% at the twelve-month (12) follow-up. At the six-month follow-up it was observed that those receiving immediate access to the application achieved a significantly higher weight loss of -2.3% (95% CI [-3.4 ─ 1.6], p < 0.001) than those who had to wait for the application to be introduced by 0.2%, (95% CI [-0.4 ─ 0.9], p = 0.466; inter-group p < 0.001). Weight loss remained at -2.1% (95% CI [-3.3 ─ 0.9], p = 0.001) in the application user group at 12 months. [9] 

Literature reviews 

The National Institute for Health and Care Excellence (NICE) has issued recommendations on the use of digital weight management technologies in the UK health care sector. The recommendations evaluate the clinical effectiveness of weight management technologies. [10] 

Digital weight management technologies are an integral part of the recommendations, offering an alternative to traditional face-to-face weight management services. Preliminary evidence suggests that the weight loss achieved through the technologies is comparable to traditional services over a two-year period. [10] 

The recommendations also noted that diverse weight management programmes covering dietary habits, physical activity and behavioural change techniques can help adults lose weight and maintain weight management for at least 12-18 months. This will increase understanding of how diverse technologies can complement the health care weight management strategy effectively. [11] 

Recommendations and previous assessments 

The Finnish Food Authority refers to Onnikka as an example of low-threshold lifestyle intervention in conjunction with service chains and operating models. The web-based weight management software has proven to be an effective method in primary health care and has impacts on both weight and cardiovascular health. In particular, the use of Onnikka has been shown to reduce the incidence of metabolic syndrome by up to 71% in the one-third who made most use of the software. [12] 

In 2020, the Council for Choices in Health Care in Finland (COHERE Finland) certified Onnikka as an effective lifestyle guidance method. The practices observed in the design of the weight management software, such as information exchange, setting objectives, planning, monitoring and feedback, have proven to be effective. [13] The Current Care Guidelines for the treatment of obesity refer to Onnikka as a potential internet-based treatment of obesity that supports weight loss and weight management in a cost-effective manner [14].

The Onnikka® application has been extensively studied. To date, the app has had more than 1,000 end users.  One adverse event has been reported and was related to the onset of a client’s eating disorder. This has now been taken into account in the exclusion criteria for the use of the service. [1]  

The company has prepared a risk analysis and a risk management plan for the service. Any adverse reactions will be evaluated and processed at a weekly meeting at the company. New risks will be recorded in a risk analysis and what can be done to mitigate them will be investigated. The company has designated a person responsible for handling incident reports. [1] 

The service needs an Internet connection to function correctly. [1]

Onnikka Health will invoice the costs of setting up and training, depending on the scope and configuration of the service specific to each client. The primary cost of the service consists of user-specific licence fees, which are invoiced to the health care service provider. The monthly licence fee shall be determined on the basis of the number of new users and shall be charged per user for the entire 12-month period of use. [1] 

The costs of using the service appear to be reasonable compared to providing a similar service in other ways.  

The assessment was carried out using the list of data security and data protection requirements for social welfare and health care procurement and the response material provided by Onnikka Health Ltd [1,15] 

Risk management and data security testing 

Potential risks are thoroughly mapped and evaluated and plans for improvements are made on the basis of the findings. Data security testing is carried out on Onnikka, for example, through scanning. Regression testing is carried out on the in-production system. Security guidelines and policies have been defined. The software requires an encrypted TLS connection to function. User information will be stored in the application in an encrypted form. 

Log management 

Onnikka Health manages the log data collected from the application. Logs are collected on the activities of both Onnikka Health technical personnel and the users. 

User management 

The service does not support two-step authentication or federation of user data to an external service. The professionals and the customers use the same app. Professionals can invite customers to use the app. At the time of writing of this assessment (29 January 2024), there are no roles in the application that would be able to view the data of others. 

Equipment 

The product is a SaaS service implemented through a cloud computing solution provided by DigitalOcean. Administrators must use two-step authentication to access third-party cloud services. The Matomo cloud service is utilised for web analytics. The end user application is browser-based. 

Data protection 

Personal data are processed in the EU/EEA or in countries for which an adequate level of data protection with regard to the GDPR has been established by the EU Commission. Such countries include New Zealand, where the offices of the Onnikka analytics subcontractor InnoCraft are located. However, InnoCraft’s Matomo servers are sited in Europe. All personal data will be deleted six (6) months after the user account is deleted. The product has been subject to a data protection impact assessment (DPIA). 

General guidance on procurement

During the purchase phase it is always important to contact the IT management, data security specialist and data protection specialist of the organisation. Please discuss with them whether the product in question fulfils your requirements. In addition, we recommend that wellbeing services counties utilise the European Union Agency for Cybersecurity’s (ENISA) data security procurement guidelines [16].

Onnikka® is a SaaS service that can be used either through a Progressive Web App (PWA) app or a web browser. The service works best with the Chrome, Edge, Samsung, and Safari browsers. The service offers a separate user interface for professionals and for end users. [1] 

Professionals use the same Onnikka® application as end users, but the professional user interface has an integrated feature for sending registration links to end users [1].  

According to the manufacturer, ease of use has been a key goal of the product design and the end user does not need separate instructions for use. The Onnikka® application is based on a browser-based version developed 10 years ago and used over a long term in clinical trials. In 2020, design started on a version for mobile devices. In the end user usability tests carried out at that time, the application has generally been found to be easy to use. Feedback from professional users is collected through various questionnaires and feedback meetings. Any major deficiencies have been remedied before the final product version. The application includes a feedback questionnaire, which will be filled out twice during the use guidance. In addition, there is a feedback mailbox for users. [1] 

The service does not yet meet the A and AA level requirements of the WCAG 2.1 criteria. These deficiencies are described in the accessibility statement, which is the same for both professionals and end users. The accessibility statement can be found on the Onnikka website. A client may report accessibility problems to the company through the electronic feedback channel and the company promises to respond within 14 days. [17] The company aims to address accessibility issues by 2025. Customer feedback is constantly analysed and taken into account in the development of both usability and accessibility. [1] 

The text content of the application is written with clarity, ease of reading, and learnability in mind. The application does not take into account visually impaired or partially sighted people or people using screen readers. However, the application has been designed to ensure that red-green colour blindness does not affect usability. The use of the app does not require a sense of hearing or knowledge of sign language, so people with hearing impairment and sign language speakers can use the app. There are no flashing elements in the application and people with epilepsy can use the service. [1]  

General guidance on procurement

The purchasing organisation shall take into account the accessibility requirements set out in the legislation in force at the time [18,19,20]. 

Interoperability 

The company has launched a project to explore the possibilities of integration into electronic patient records [1]. 

Technical stability 

Onnikka® is not a medical device, but the company complies with IEC 62304 as applicable [1].  

The user interface applications for professional users and end users will automatically update to a newer version when available. Service updates do not require any action from the client. Any significant updates that impact the user experience will be notified to each user and the main users designated by the user organisation, either by e-mail or on the service once the update has been made. If an update causes a downtime, the update will be notified also in advance. [1] 

If necessary, it is possible to revert to an earlier version of the application [1]. 

In the last six months, the service has never been out of use [1].  

Training and product support 

Onnikka Health trains the professionals of client organisations, i.e., the administrators, in the use of the service. No organised training will be provided to end users. Client organization administrators will send a registration link to end users and ensure that the application is registered and installed successfully. [1] 

End users will be provided with a feedback mailbox through which they can report any technical problems. Communication with the end users will take place by e-mail after the feedback has been received. Only a few requests for support have been received from users, having to do with technical issues or application functionality. [1] 

Product support is provided to organizations during office hours by telephone and by e-mail [1]. 

Distribution of the product 

In Finland, the Onnikka® application is in clinical use in one wellbeing services county. 

The Onnikka® application has been piloted in one wellbeing services county between May 2022 and September 2023. Further pilots are in progress or are to be launched in four different wellbeing services counties at the time of evaluation in February 2024. [1] 

1. The Digi-HTA questionnaire filled out by the company, not public information. 
2. Karppinen, Pasi & Oinas-Kukkonen, Harri. (2013). Three Approaches to Ethical Considerations in the Design of Behavior Change Support Systems. 87-98. 10.1007/978-3–642-37157-8_12 
3. Karppinen P, Oinas-Kukkonen H, Alahäivälä T, Jokelainen T, Teeriniemi AM, Salonurmi T, Savolainen MJ. Opportunities and challenges of behavior change support systems for enhancing habit formation: A qualitative study. J Biomed Inform. 2018 Aug;84:82-92. doi: 10.1016/j.jbi.2018.06.012. Epub 2018 Jun 21. PMID: 29936091. 
4. Oinas-Kukkonen, Harri & Harjumaa, Marja. (2009). Persuasive Systems Design: Key Issues, Process Model, and System Features. Communications of the Association for Information Systems. 24. 10.17705/1CAIS.02428. 
5. Alahäivälä, Tuomas & Oinas-Kukkonen, Harri & Jokelainen, Terhi. (2013). Software Architecture Design for Health BCSS: Case Onnikka. 7822. 3-14. 10.1007/978-3–642-37157-8_3. 
6. Teeriniemi AM, Salonurmi T, Jokelainen T, Vähänikkilä H, Alahäivälä T, Karppinen P, Enwald H, Huotari ML, Laitinen J, Oinas-Kukkonen H, Savolainen MJ. A randomized clinical trial of the effectiveness of a Web-based health behaviour change support system and group lifestyle counselling on body weight loss in overweight and obese subjects: 2-year outcomes. J Intern Med. 2018 Nov;284(5):534-545. doi: 10.1111/joim.12802. Epub 2018 Jul 4. PMID: 29974563. 
7. Seo YG, Salonurmi T, Jokelainen T, Karppinen P, Teeriniemi AM, Han J, Park KH, Oinas-Kukkonen H, Savolainen MJ. Lifestyle counselling by persuasive information and communications technology reduces prevalence of metabolic syndrome in a dose-response manner: a randomized clinical trial (PrevMetSyn). Ann Med. 2020 Sep;52(6):321-330. doi:  10.1080/07853890.2020.1783455. PMID: 32727302; PMCID: PMC7877935. 
8. Duodecim käypähoito. 5 % laihtumistavoitteen terveyshyödyt. Available at: https://www.kaypahoito.fi/nak09343. Accessed on 30.1.2024 
9. Markkanen, J.O., Oikarinen, N., Savolainen, M.J. et al. Mobile health behaviour change support system as independent treatment tool for obesity: a randomized controlled trial. Int J Obes (2023). https://doi.org/10.1038/s41366-023-01426-x 
10. National Institute for Health and Care Excellence. 2023. Digital technologies for delivering specialist weight-management services to manage weight-management medicine: early value assessment. https://www.nice.org.uk/guidance/hte14/resources/digital-technologies-for-delivering-specialist-weightmanagement-services-to-manage-weightmanagement-medicine-early-value-assessment-pdf-50261971277509 Accessed on 25.1.2024. 
11. National Institute for Health and Care Excellence. 2014. Weight management: lifestyle services for overweight or obese adults. https://www.nice.org.uk/guidance/ph53/resources/weight-management-lifestyle-services-for-overweight-or-obese-adults-pdf-1996416726469 Accessed on 25.1.2024. 
12. Esimerkkejä palveluketjuista ja toimintamalleista. Available at: http://www.ruokavirasto.fi. Accessed on 25.1.2024. 
13. Palveluvalikoimaneuvosto. Available at: https://palveluvalikoima.fi/-/elintapamuutosta-tukevat-tekijat-elintapaohjauksen-ja-omahoidon-tuen-menetelmissa-epaterveellisen-ravitsemuksen-ja-vahaisen-liikunnan-aiheuttaman-sairastumisriskin-pienentamiseksi-koskeva-suositus-on-hyvaksytty Accessed on 25.1.2024. 
14. Käypähoitosuositukset: Lihavuus (lapset, nuoret ja aikuiset). Available at: https://kaypahoito.fi/hoi50124#s13. Accessed on 16.2.2024. 
15. National Cyber Security Centre: Information security and data protection requirements for social welfare and healthcare procurements. Available at: https://www.kyberturvallisuuskeskus.fi/en/ncsc-news/instructions-and-guides/information-security-and-data-protection-requirements-social Accessed on 16.2.2024. 
16. The European Union Agency for Cybersecurity Procurement Guidelines for Cybersecurity in Hospitals. Available at: https://www.enisa.europa.eu/publications/good-practices-for-the-security-of-healthcare-services Accessed on 16.2.2024. 
17. Onnikka Health saavutettavuusseloste. Available at: https://www.onnikkahealth.fi/wp-content/uploads/2023/11/Saavutettavuusseloste_Onnikka-sovellus-2023-11-30-1.pdf Accessed on 25.1.2024. 
18. Act on the Provision of Digital Services 306/2019 (Available only in Finnish). Available at: https://www.finlex.fi/fi/laki/alkup/2019/20190306  Accessed on 16.2.2024. 
19. Regional State Administrative Agency of Southern Finland, Accessibility supervision unit. The requirements of the Act on Provision of Digital Services. Available at: https://www.webaccessibility.fi/requirements-of-the-act-on-the-provision-of-digital-services/ Accessed on 16.2.2024. 
20. Act on public Procurement and concession contracts 1397/2016 (Available only in Finnish). Available at: https://www.finlex.fi/fi/laki/alkup/2016/20161397 Accessed on 16.2.2024. 

Petra Falkenbach, Head of Assessment, FinCCHTA 

Jari Haverinen, Special Planning Officer, FinCCHTA 

Raija Järvinen, Special Planning Officer, FinCCHTA 

Teemu Mustola, Special Planning Officer, FinCCHTA 

Tommi Hanhela, Information Security Expert, University of Oulu 

Jere Kinnunen, Information Security Expert, University of Oulu 

Antti Koskela, Information Security Expert, University of Oulu