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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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 pr

Первичные конечные точки

• Well-being [Срок оценки: 6 months]
• Well-being [Срок оценки: 24 months]

Вторичные конечные точки (6)

• Stress [Срок оценки: 6 months]
• Burnout [Срок оценки: 6 months]
• Sleep [Срок оценки: 6 months]
• Stress [Срок оценки: 24 months]
• Burnout [Срок оценки: 24 months]
• Sleep [Срок оценки: 24 months]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Швеция · 1 центр

• Sophiahemmet University — Stockholm

Публикации

• 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 PMID 41056320

Идентификаторы

NCT: NCT05973383 · CIV-23-07-043416

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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