Well-beingNCT05973383
Evaluation of a Personalised Digital Intervention (EviBody) for Healthy and Sustained Lifestyle Behaviors and Well-being Among Adults: a Real-world Quasi-experimental Study
An observational study of Well-being, run by Sophiahemmet University at 1 site in Sweden.
Trial summary
The goal of this quasi-experimental observational study is to evaluate the impact of a personally tailored digital intervention aimed to support a healthy lifestyle on well-being, lifestyle behaviors, and mental health among the adult population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-being
- What is being tested?
- EviBody- Basic, EviBody- Standard and EviBody- Premium
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Intervention: Adults signing up for a digital intervention that is supporting a healthy lifestyle. Control: Adults of the general population.
Who may be able to join
- adults ≥18 years
- signing up for the app EviBody using electronic identification
- consent to the research study
- adults ≥18 years
- consent to the research study
Who cannot join
- individuals who are discharged from the app due to refracting the terms of the service,
- is currently using a digital product that is explicitly designed to support behaviour change,
- subjects scoring >70 on well-being will be excluded from the primary analyses,
- subjects who appear as friends, colleagues, or family with anyone in the research or owner group will be excluded.
- is currently using a digital product that is explicitly designed to support behaviour change,
- is found to be a user of EviBody,
- subjects scoring >70 on well-being will be excluded from the primary analyses,
- subjects who appear as friends, colleagues, or family with anyone in the research or owner group will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sophiahemmet University
Stockholm
Jenny Rossen, Associate professor, +4684062985, jenny.rossen@shh.se
About this study
Official title: Effectiveness and Theory-based Evaluation of a Personalised Digital Intervention (EviBody) for Healthy and Sustained Lifestyle Behaviours and Well-being Among Adults
The goal of this quasi-experimental observational study is to evaluate the impact of a personally tailored digital intervention aimed to support a healthy lifestyle on well-being, lifestyle behaviors, and mental health among the adult population.
The main questions it aims to answer are:
Read more
- Is a digital intervention developed to offer personalised digital support for healthy habits effective in improving well-being compared to a control group from the general population after 6 months? II) Is the effectiveness dose-dependent (better effect with higher membership level)? III) Does the digital intervention assist in maintaining healthy eating and physical activity habits, mental health, and well-being across 24 months? IV) Are sociodemographic factors associated with achieving the self-identified goals and improvements in eating and physical activity habits, mental health, and well-being? VI) Do engagement, motivation, self-efficacy, and perceived barriers mediate the associations between sociodemographic characteristics and changes in self-identified goals, eating and physical activity habits, mental health, and well-being over a 24-month period? V) How is the pattern of user engagement across 24 months?
Participants are users of the mobile phone application EviBody. The group will be compared with individuals from the general population to evaluate if the digital intervention is effective in improving well-being, eating and physical activity habits, and mental health.
Read the detailed description
EviBody is a personally tailored digital intervention promoting healthy habits that is co-developed, based on behavioural research evidence, and supported by artificial intelligence.
The primary study is a quasi-experimental study with a non-randomised control group. A four-armed design will allow for comparison between three levels of intervention (basic, standard and premium) and a control group. The digital intervention (the app EviBody) will be marketed and managed by its owner LongLife Active AB (Limited Company), Sweden. Allocation to intervention arm is by preference (chosen membership level of the app) and takes place at enrolment. Being a research participant includes answering seven questionnaires during two years and allowing researchers to extract data from app analytics. Ethical approval was obtained from the Swedish Ethical Review Authority, Dnr 2023-06246-01 on January 30 2024.
- Conditions
- Well-being
- Being tested
- EviBody- Basic, EviBody- Standard, EviBody- Premium
- Keywords
- primary prevention, secondary prevention, health promotion, self-management, behavior
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EviBody- BasicBehavioural
The app EviBody with three core subjects:
- a Healthy eating, 2) Physical activity, and 3) Mental balance. The intervention includes tracking and self-monitoring of behaviors, goal setting, action planning, feedback and digital rewards, an AI chat, a database with food recipes, a database with exercises, inspiration, and skills training webinars.
EviBody- StandardBehavioural
The digital service EviBody with three core subjects:
- a Healthy diet, 2) Physical activity, and 3) Mental balance. The service includes tracking and self-monitoring of behaviors, goal setting, action planning, feedback and digital rewards, an AI chat, a database with food recipes, a database with exercises, inspiration, and skills training webinars.
Users with the membership Standard are also offered a community with social support.
EviBody- PremiumBehavioural
The digital service EviBody with three core subjects:
- a Healthy diet, 2) Physical activity, and 3) Mental balance. The service includes tracking and self-monitoring of behaviors, goal setting, action planning, feedback and digital rewards, an AI chat, a database with food recipes, a database with exercises, inspiration, and skills training webinars.
Users with the membership Premium are also offered a community with social support plus private on-line health consultations. The number of private health consultations is 3 for a 3 months subscription, 4 for a 6 months subscription, and 6 for a 12 months subscription.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group- Basic | Subjects with behavioral support from the app EviBody Receives: Behavioral: EviBody- Basic | |
| Intervention group- Standard | Subjects with behavioral support from the app EviBody + social support Receives: Behavioral: EviBody- Standard | |
| Intervention group- Premium | Subjects with behavioral support from the app EviBody + social support + individual coaching Receives: Behavioral: EviBody- Premium | |
| Control group | No exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being
Well-being will be assessed by the WHO-5 Well-Being Index. The WHO-5 comprises the following five items: being cheerful and in good spirits; being calm and relaxed; feeling active and vigorous; feeling fresh and rested when waking up in the morning; and having an interest in day-to-day activities. Six response alternatives are scored from 5 (All of the time) to 0 (At no time). The total raw score which ranges from 0 to 25 is multiplied by 4 to calculate the final score. The final score range goes from 0 = worst imaginable well-being to 100 = the best imaginable well-being.
Measured: 6 months
Well-being
Well-being will be assessed by the WHO-5 Well-Being Index. The WHO-5 comprises the following five items: being cheerful and in good spirits; being calm and relaxed; feeling active and vigorous; feeling fresh and rested when waking up in the morning; and having an interest in day-to-day activities. Six response alternatives are scored from 5 (All of the time) to 0 (At no time). The total raw score which ranges from 0 to 25 is multiplied by 4 to calculate the final score. The final score range goes from 0 = worst imaginable well-being to 100 = the best imaginable well-being.
Measured: 24 months
Secondary outcomes (6)
Stress
Stress will be assessed by the Karolinska Exhaustion Disorder Scale (KEDS), a self-rating scale for stress-induced exhaustion disorder. 9 items are scored 1-6, a higher total score indicates more exhaustion.
Measured: 6 months
Burnout
Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.
Measured: 6 months
Sleep
Sleep will be assessed by the self-reported number of hours of sleep per night and by Insomnia Severity Index (ISI). In ISI 7 items are scored 1-4 and a higher total score indicates more sleeping problems.
Measured: 6 months
Stress
Stress will be assessed by the Karolinska Exhaustion Disorder Scale (KEDS), a self-rating scale for stress-induced exhaustion disorder. 9 items are scored 1-6, a higher total score indicates more exhaustion.
Measured: 24 months
Burnout
Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.
Measured: 24 months
Sleep
Sleep will be assessed by the self-reported number of hours of sleep per night and by Insomnia Severity Index (ISI). In ISI 7 items are scored 1-4 and a higher total score indicates more sleeping problems.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Well-beingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sophiahemmet University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Stockholm University, The Swedish School of Sport and Health Sciences, Linnaeus University
- Responsible party
- Sponsor
- Investigators
- Jenny Rossen, PhD, Principal investigator, Sophiahemmet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973383
- Sponsor's protocol ID
- CIV-23-07-043416
- Status last verified
- Apr 2026
- First submitted
- 8 Jul 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rossen J, Anderbro T, Andermo S, Bergman P, Hagstromer M, Jacobsson M, Johansson UB, Kallings L, Lonn A, Regan C, von Rosen P. Effectiveness and theory-based evaluation of a personalised digital intervention (EviBody(R)) for healthy and sustained lifestyle behaviours and well-being among adults: Study protocol for a real-world quasi-experimental study. PLoS One. 2025 Oct 7;20(10):e0333201. doi: 10.1371/journal.pone.0333201. eCollection 2025.
PubMed 41056320
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Theory-based Evaluation of a Personalised Digital Intervention (EviBody) for Healthy and Sustained Lifestyle Behaviours and Well-being Among Adults
- ClinicalTrials.gov ID
- NCT05973383
- Acronym / sponsor ID
- CIV-23-07-043416
- Conditions
- Well-being
- Keywords
- primary prevention, secondary prevention, health promotion, self-management, behavior
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Sophiahemmet UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Stockholm University, The Swedish School of Sport and Health Sciences, Linnaeus University
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this quasi-experimental observational study is to evaluate the impact of a personally tailored digital intervention aimed to support a healthy lifestyle on well-being, lifestyle behaviors, and mental health among the adult population.
The main questions it aims to answer are:
- Is a digital intervention developed to offer personalised digital support for healthy habits effective in improving well-being compared to a control group from the general population after 6 months? II) Is the effectiveness dose-dependent (better effect with higher membership level)? III) Does the digital intervention assist in maintaining healthy eating and physical activity habits, mental health, and well-being across 24 months? IV) Are sociodemographic factors associated with achieving the self-identified goals and improvements in eating and physical activity habits, mental health, and well-being? VI) Do engagement, motivation, self-efficacy, and perceived barriers mediate the associations between sociodemographic characteristics and changes in self-identified goals, eating and physical activity habits, mental health, and well-being over a 24-month period? V) How is the pattern of user engagement across 24 months?
Participants are users of the mobile phone application EviBody. The group will be compared with individuals from the general population to evaluate if the digital intervention is effective in improving well-being, eating and physical activity habits, and mental health.
Detailed description
EviBody is a personally tailored digital intervention promoting healthy habits that is co-developed, based on behavioural research evidence, and supported by artificial intelligence.
The primary study is a quasi-experimental study with a non-randomised control group. A four-armed design will allow for comparison between three levels of intervention (basic, standard and premium) and a control group. The digital intervention (the app EviBody) will be marketed and managed by its owner LongLife Active AB (Limited Company), Sweden. Allocation to intervention arm is by preference (chosen membership level of the app) and takes place at enrolment. Being a research participant includes answering seven questionnaires during two years and allowing researchers to extract data from app analytics. Ethical approval was obtained from the Swedish Ethical Review Authority, Dnr 2023-06246-01 on January 30 2024.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention group- Basic | – | Behavioral: EviBody- BasicSubjects with behavioral support from the app EviBody |
| Intervention group- Standard | – | Behavioral: EviBody- StandardSubjects with behavioral support from the app EviBody + social support |
| Intervention group- Premium | – | Behavioral: EviBody- PremiumSubjects with behavioral support from the app EviBody + social support + individual coaching |
| Control group | – | –No exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Intervention: Adults signing up for a digital intervention that is supporting a healthy lifestyle. Control: Adults of the general population.
Key inclusion criteria (5 listed)
- adults ≥18 years
- signing up for the app EviBody using electronic identification
- consent to the research study
- adults ≥18 years
- consent to the research study
Key exclusion criteria (8 listed)
- individuals who are discharged from the app due to refracting the terms of the service,
- is currently using a digital product that is explicitly designed to support behaviour change,
- subjects scoring >70 on well-being will be excluded from the primary analyses,
- subjects who appear as friends, colleagues, or family with anyone in the research or owner group will be excluded.
- is currently using a digital product that is explicitly designed to support behaviour change,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EviBody- BasicThe app EviBody with three core subjects: 1) a Healthy eating, 2) Physical activity, and 3) Mental balance. The intervention includes tracking and self-monitoring of behaviors, goal setting, action planning, feedback and digital rewards, an AI chat, a database with food recipes, a database with exercises, inspiration, and skills training webinars. | Behavioural | Intervention group- Basic |
| EviBody- StandardThe digital service EviBody with three core subjects: 1) a Healthy diet, 2) Physical activity, and 3) Mental balance. The service includes tracking and self-monitoring of behaviors, goal setting, action planning, feedback and digital rewards, an AI chat, a database with food recipes, a database with exercises, inspiration, and skills training webinars. Users with the membership Standard are also offered a community with social support. | Behavioural | Intervention group- Standard |
| EviBody- PremiumThe digital service EviBody with three core subjects: 1) a Healthy diet, 2) Physical activity, and 3) Mental balance. The service includes tracking and self-monitoring of behaviors, goal setting, action planning, feedback and digital rewards, an AI chat, a database with food recipes, a database with exercises, inspiration, and skills training webinars. Users with the membership Premium are also offered a community with social support plus private on-line health consultations. The number of private health consultations is 3 for a 3 months subscription, 4 for a 6 months subscription, and 6 for a 12 months subscription. | Behavioural | Intervention group- Premium |
Primary outcome
Well-being
Time frame: 6 months
Well-being will be assessed by the WHO-5 Well-Being Index. The WHO-5 comprises the following five items: being cheerful and in good spirits; being calm and relaxed; feeling active and vigorous; feeling fresh and rested when waking up in the morning; and having an interest in day-to-day activities. Six response alternatives are scored from 5 (All of the time) to 0 (At no time). The total raw score which ranges from 0 to 25 is multiplied by 4 to calculate the final score. The final score range goes from 0 = worst imaginable well-being to 100 = the best imaginable well-being.
Well-being
Time frame: 24 months
Well-being will be assessed by the WHO-5 Well-Being Index. The WHO-5 comprises the following five items: being cheerful and in good spirits; being calm and relaxed; feeling active and vigorous; feeling fresh and rested when waking up in the morning; and having an interest in day-to-day activities. Six response alternatives are scored from 5 (All of the time) to 0 (At no time). The total raw score which ranges from 0 to 25 is multiplied by 4 to calculate the final score. The final score range goes from 0 = worst imaginable well-being to 100 = the best imaginable well-being.
6 secondary outcomes
Stress
Time frame: 6 months
Burnout
Time frame: 6 months
Sleep
Time frame: 6 months
Stress
Time frame: 24 months
Burnout
Time frame: 24 months
Sleep
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 41056320Rossen J, Anderbro T, Andermo S, Bergman P, Hagstromer M, Jacobsson M, Johansson UB, Kallings L, Lonn A, Regan C, von Rosen P. Effectiveness and theory-based evaluation of a personalised digital intervention (EviBody(R)) for healthy and sustained lifestyle behaviours and well-being among adults: Study protocol for a real-world quasi-experimental study. PLoS One. 2025 Oct 7;20(10):e0333201. doi: 10.1371/journal.pone.0333201. eCollection 2025.
- Research project websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jenny Rossen, PhD principal investigator
Sophiahemmet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Well-being, run by Sophiahemmet University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jenny Rossen, PhD (+4684062985, jenny.rossen@shh.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05973383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.