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
| NCT ID | NCT05973383 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sophiahemmet University |
| Condition | Well-being |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2026-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Jenny Rossen, PhD
PRINCIPAL INVESTIGATOR
Sophiahemmet University
Frequently Asked Questions
Who can join the NCT05973383 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Well-being. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05973383 currently recruiting?
Yes, NCT05973383 is actively recruiting participants. Contact the research team at jenny.rossen@shh.se for enrollment information.
Where is the NCT05973383 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05973383 clinical trial?
NCT05973383 is sponsored by Sophiahemmet University. The principal investigator is Jenny Rossen, PhD at Sophiahemmet University. The trial plans to enroll 1,500 participants.