NCT05973383

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

July 8, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
2.4 years until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

July 8, 2023

Last Update Submit

April 23, 2026

Conditions

Keywords

primary preventionsecondary preventionhealth promotionself-managementbehavior

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (6)

  • Stress

    6 months

  • Burnout

    6 months

  • Sleep

    6 months

  • Stress

    24 months

  • Burnout

    24 months

  • +1 more secondary outcomes

Other Outcomes (10)

  • Goal achievement

    6 months

  • Dietary habits

    6 months

  • Physical activity

    6 months

  • +7 more other outcomes

Study Arms (4)

Intervention group- Basic

Subjects with behavioral support from the app EviBody

Behavioral: EviBody- Basic

Intervention group- Standard

Subjects with behavioral support from the app EviBody + social support

Behavioral: EviBody- Standard

Intervention group- Premium

Subjects with behavioral support from the app EviBody + social support + individual coaching

Behavioral: EviBody- Premium

Control group

No exposure

Interventions

EviBody- BasicBEHAVIORAL

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.

Intervention group- Basic

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.

Intervention group- Standard

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.

Intervention group- Premium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intervention: Adults signing up for a digital intervention that is supporting a healthy lifestyle. Control: Adults of the general population.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sophiahemmet University

Stockholm, Sweden

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Behavior

Study Officials

  • Jenny Rossen, PhD

    Sophiahemmet University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Rossen, PhD

CONTACT

Unn-Britt Johansson, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2023

First Posted

August 2, 2023

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations