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

NCT ID: NCT05973383

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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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

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Well-being

Keywords

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primary prevention secondary prevention health promotion self-management behavior

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention group- Basic

Subjects with behavioral support from the app EviBody

EviBody- Basic

Intervention Type 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.

Intervention group- Standard

Subjects with behavioral support from the app EviBody + social support

EviBody- Standard

Intervention Type 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.

Intervention group- Premium

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

EviBody- Premium

Intervention Type 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.

Control group

No exposure

No interventions assigned to this group

Interventions

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EviBody- Basic

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 Type BEHAVIORAL

EviBody- 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 Standard are also offered a community with social support.

Intervention Type BEHAVIORAL

EviBody- Premium

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Stockholm University

OTHER

Sponsor Role collaborator

The Swedish School of Sport and Health Sciences

OTHER

Sponsor Role collaborator

Linnaeus University

OTHER

Sponsor Role collaborator

Sophiahemmet University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jenny Rossen, PhD

Role: PRINCIPAL_INVESTIGATOR

Sophiahemmet University

Central Contacts

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Jenny Rossen, PhD

Role: CONTACT

Phone: +4684062985

Email: [email protected]

Unn-Britt Johansson, Professor

Role: CONTACT

Phone: +464062902

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 41056320 (View on PubMed)

Related Links

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Other Identifiers

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CIV-23-07-043416

Identifier Type: -

Identifier Source: org_study_id