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Clinical Trials/NCT05973383
NCT05973383
Not yet recruiting
Not Applicable

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

Sophiahemmet University0 sites1,500 target enrollmentJanuary 1, 2026
ConditionsWell-being

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Well-being
Sponsor
Sophiahemmet University
Enrollment
1500
Primary Endpoint
Well-being
Status
Not yet recruiting
Last Updated
4 months ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2026
End Date
December 31, 2028
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sophiahemmet University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Sleep(24 months)
  • Stress(24 months)
  • Burnout(24 months)

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