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NCT Number: NCT05973383

Evaluation of a Personalised Digital Intervention (EviBody) for Healthy and Sustained Lifestyle Behaviors and Well-being Among Adults: a Real-world Quasi-experimental Study

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.

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Key information

Conditions

Well-Being Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sophiahemmet University

Stockholm, Sweden

Location status: Recruiting

Location contact

Jenny Rossen, Associate professor

CONTACT

[email protected]

+4684062985

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(intervention arms):

  • adults ≥18 years
  • signing up for the app EviBody using electronic identification
  • consent to the research study

Inclusion criteria

(controls):

  • adults ≥18 years
  • consent to the research study

Exclusion criteria

(intervention arms):

  • 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.

Exclusion criteria

(controls):

  • 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.

Treatment and study plan

EviBody- Basic

Behavioral

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- Standard

Behavioral

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- Premium

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Stress

    Time frame: 6 months

    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.

  2. Burnout

    Time frame: 6 months

    Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.

  3. Sleep

    Time frame: 6 months

    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.

  4. Stress

    Time frame: 24 months

    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.

  5. Burnout

    Time frame: 24 months

    Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.

  6. Sleep

    Time frame: 24 months

    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.

Other outcomes

  1. Goal achievement

    Time frame: 6 months

    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.

  2. Dietary habits

    Time frame: 6 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.

  3. Physical activity

    Time frame: 6 months

    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.

  4. Sedentary behavior

    Time frame: 6 months

    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.

  5. Daily number of steps

    Time frame: 6 months

    Daily number of steps will be obtained from app analytics.

  6. Goal achievement

    Time frame: 24 months

    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.

  7. Dietary habits

    Time frame: 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.

  8. Physical activity

    Time frame: 24 months

    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.

  9. Sedentary behavior

    Time frame: 24 months

    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.

  10. Daily number of steps

    Time frame: 24 months

    Daily number of steps will be obtained from app analytics.

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Rossen, PhD

CONTACT

[email protected]

+4684062985

Unn-Britt Johansson, Professor

CONTACT

[email protected]

+464062902

Sponsors and collaborators

Lead sponsor

Sophiahemmet University

Other

Collaborators

  • Karolinska Institutet
  • Linnaeus University
  • Stockholm University
  • The Swedish School of Sport and Health Sciences

Registry information

Official study title

Effectiveness and Theory-based Evaluation of a Personalised Digital Intervention (EviBody) for Healthy and Sustained Lifestyle Behaviours and Well-being Among Adults

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Aug 2, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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