About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
adults ≥18 years
signing up for the app EviBody using electronic identification
consent to the research study
adults ≥18 years
Disqualifiers
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.
Trial population
Intervention: Adults signing up for a digital intervention that is supporting a healthy lifestyle. Control: Adults of the general population.
Trial design
Other
Prospective
Treatments tested in this trial
EviBody- Basic
BehavioralThe 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.
EviBody- Standard
BehavioralThe 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
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
Burnout
Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.
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.
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.
Other outcomes
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.
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.
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.
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.
Sponsors and contacts
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Sophiahemmet University
Lead sponsor
Karolinska Institutet
Collaborator
Stockholm University
Collaborator
The Swedish School of Sport and Health Sciences
Collaborator
Linnaeus University
Collaborator