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 |
Trial Parameters
Eligibility Fast-Check
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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