Clinical trial NCT05973383: Evaluation of an Individually Tailored Digital Service to Promote Healthy and Sustainable Behaviors and Well-being
Official title: Evaluation of an Individually Tailored Digital Service to Promote Healthy and Sustainable Behaviors and Well-being Among Adults
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Well-being
Keywords: primary prevention
secondary prevention
health promotion
self-management
behavior
Lead sponsor: Sophiahemmet University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Stockholm University
name: The Swedish School of Sport and Health Sciences
name: Linnaeus University
name: Södertörn University
First posted: 2023-08-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intervention:

Adults signing up for a digital service that is supporting a healthy lifestyle.

Control:

Adults in the general population.

Brief summary: The goal of this quasi-experimental observational study is to evaluate the impact of an individually tailored digital service aimed to support healthy habits on well-being, lifestyle behaviors, and mental health among the adult population. The main questions it aims to answer are:

I) Is a digital service developed to personalize support for healthy habits effective in improving well-being compared to a control group in the general population after 6 months? II) Does the digital service improve dietary and physical activity habits, mental health, and well-being among users across 24 months? III) Are sociodemographic factors associated with achieving the self-identified goals and improvements in dietary and physical activity habits, mental health, and well-being? IV) Do the intended mediators (engagement with the service, improved motivation, improved self-efficacy, and reduced barriers) mediate the effects of the digital service on achieving the self-identified goal, improved dietary and physical activity habits, mental health, and well-being? V) How is the pattern of user engagement across 24 months?

Participants are users of the mobile phone application LongLife Active®. Researchers will compare with individuals in the general population to see if the digital service is effective in improving well-being, dietary and physical activity habits, and mental health.

Detailed description: LongLife Active is an individually tailored digital service supporting healthy habits that is based on behavioral research evidence, supported by artificial intelligence and co-developed.

Eligibility criteria: Inclusion Criteria (intervention arms):

* adults ≥18 years
* siging up for the service LongLife Active using BankID for 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
* subjects scoring \>70 on well-being will be excluded from the primary analyses

Exclusion Criteria (controls):

* age ≤ 17 years.
* is currently using a digital product or any other kind of support for behavior change
* is found to be a user of LongLife Active.
* subjects scoring \>70 on well-being will be excluded from the primary analyses

Primary outcomes:
measure: Well-being
timeFrame: 6 months
measure: Well-being
timeFrame: 24 months
Secondary outcomes:
measure: Stress
timeFrame: 6 months
measure: Burnout
timeFrame: 6 months
measure: Sleep
timeFrame: 6 months
measure: Stress
timeFrame: 24 months
measure: Burnout
timeFrame: 24 months
measure: Sleep
timeFrame: 24 months
Other outcomes:
measure: Goal achievement
timeFrame: 6 months
measure: Dietary habits
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
measure: Sedentary behavior
timeFrame: 6 months
measure: Daily number of steps
timeFrame: 6 months
measure: Goal achievement
timeFrame: 24 months
measure: Dietary habits
timeFrame: 24 months
measure: Physical activity
timeFrame: 24 months
measure: Sedentary behavior
timeFrame: 24 months
measure: Daily number of steps
timeFrame: 24 months
Locations:
Study officials:
affiliation: Sophiahemmet University
name: Jenny Rossen, PhD
role: PRINCIPAL_INVESTIGATOR
References: