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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Stockholm University | OTHER |
| The Swedish School of Sport and Health Sciences | OTHER |
| Linnaeus University |
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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:
I) 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group- Basic | Subjects with behavioral support from the app EviBody |
| |
| Intervention group- Standard | Subjects with behavioral support from the app EviBody + social support |
| |
| Intervention group- Premium | Subjects with behavioral support from the app EviBody + social support + individual coaching |
| |
| Control group | No exposure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EviBody- Basic | Behavioral | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Burnout |
| Measure | Description | Time Frame |
|---|---|---|
| Goal achievement | Reaching the self-identified goal will be evaluated by collecting information on number of days/week the self-identified goal was met during the past month. Confidence for reaching the goal will also be asked for on a scale 1 low confidence to 6 high confidence. | 6 months |
| Dietary habits |
Inclusion Criteria (intervention arms):
Inclusion Criteria (controls):
Exclusion Criteria (intervention arms):
Exclusion Criteria (controls):
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Intervention:
Adults signing up for a digital intervention that is supporting a healthy lifestyle.
Control:
Adults of the general population.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenny Rossen, PhD | Contact | +4684062985 | jenny.rossen@shh.se | |
| Unn-Britt Johansson, Professor | Contact | +464062902 | Unn-Britt.Johansson@shh.se |
| Name | Affiliation | Role |
|---|---|---|
| Jenny Rossen, PhD | Sophiahemmet University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sophiahemmet University | Recruiting | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41056320 | Derived | 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. |
| Label | URL |
|---|---|
| Research project website | View source |
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| OTHER |
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| EviBody- Standard | Behavioral | The 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. |
|
| EviBody- Premium | Behavioral | The 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. |
|
Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.
| 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. | 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. | 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. | 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. | 24 months |
Dietary behaviours will be assessed by questions from the Social Board of Health and Welfare in Sweden, with the addition of some study specific questions on plant based diet. |
| 6 months |
| Physical activity | Physical activity will be collected by questions from the Social Board of Health and Welfare with additional questions on active transport and physical activity at work. In a randomized sample of individuals having increased physical activity as a goal (n=300) physical activity will also be measured objectively by the use of the three-axial accelerometer-based device. | 6 months |
| Sedentary behavior | Sedentary behavior will be collected by questions from the Social Board of Health and Welfare with additional questions on active transport and physical activity at work. In a randomized sample of individuals having increased physical activity as a goal (n=300) physical activity will also be measured objectively by the use of the three-axial accelerometer-based device. | 6 months |
| Daily number of steps | Daily number of steps will be obtained from app analytics. | 6 months |
| Goal achievement | Reaching the self-identified goal will be evaluated by collecting information on number of days/week the self-identified goal was met during the past month. Confidence for reaching the goal will also be asked for on a scale 1 low confidence to 6 high confidence. | 24 months |
| Dietary habits | Dietary behaviours will be assessed by questions from the Social Board of Health and Welfare in Sweden, with the addition of some study specific questions on plant based diet. | 24 months |
| Physical activity | Physical activity will be collected by questions from the Social Board of Health and Welfare with additional questions on active transport and physical activity at work. In a randomized sample of individuals having increased physical activity as a goal (n=300) physical activity will also be measured objectively by the use of the three-axial accelerometer-based device. | 24 months |
| Sedentary behavior | Sedentary behavior will be collected by questions from the Social Board of Health and Welfare with additional questions on active transport and physical activity at work. In a randomized sample of individuals having increased physical activity as a goal (n=300) physical activity will also be measured objectively by the use of the three-axial accelerometer-based device. | 24 months |
| Daily number of steps | Daily number of steps will be obtained from app analytics. | 24 months |
| ID | Term |
|---|---|
| D001519 | Behavior |
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