Evaluation of an Individually Tailored Digital Service to Promote Healthy and Sustainable Behaviors and Well-being

Well-being Clinical Trial

Official title:

Evaluation of an Individually Tailored Digital Service to Promote Healthy and Sustainable Behaviors and Well-being Among Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05973383
• Other study ID #: CIV-23-07-043416
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: Sophiahemmet University
• Contact: Jenny Rossen, PhD
• Phone: +4684062985
• Email: jenny.rossen[@]shh.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Well-being

Intervention

Behavioral:
• LongLife Active- Basic
The digital service LongLife Active 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.
• LongLife Active- Standard
The digital service LongLife Active 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.
• LongLife Active- Premium
The digital service LongLife Active 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 private health consultations is 3 for a 3 months subscription, 4 for a 6 months subscription, and 6 for a 12 months subscription.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Sophiahemmet University	Karolinska Institutet, Linnaeus University, Södertörn University, Stockholm University, The Swedish School of Sport and Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Goal achievement	Reaching the self-identified goal will be evaluated by collecting information on number of days/week the self-identified goal was met during the past month. Confidence for reaching the goal will also be asked for on a scale 1 low confidence to 6 high confidence.	6 months
Other	Dietary habits	Dietary behaviours will be assessed by questions from the Social Board of Health and Welfare in Sweden, with the addition of some study specific questions on plant based diet.	6 months
Other	Physical activity	Physical activity will be collected by questions from the Social Board of Health and Welfare with additional questions on active transport and physical activity at work. In a randomized sample of individuals having increased physical activity as a goal (n=300) physical activity will also be measured objectively by the use of the three-axial accelerometer-based device.	6 months
Other	Sedentary behavior	Sedentary behavior will be collected by questions from the Social Board of Health and Welfare with additional questions on active transport and physical activity at work. In a randomized sample of individuals having increased physical activity as a goal (n=300) physical activity will also be measured objectively by the use of the three-axial accelerometer-based device.	6 months
Other	Daily number of steps	Daily number of steps will be obtained from app analytics.	6 months
Other	Goal achievement	Reaching the self-identified goal will be evaluated by collecting information on number of days/week the self-identified goal was met during the past month. Confidence for reaching the goal will also be asked for on a scale 1 low confidence to 6 high confidence.	24 months
Other	Dietary habits	Dietary behaviours will be assessed by questions from the Social Board of Health and Welfare in Sweden, with the addition of some study specific questions on plant based diet.	24 months
Other	Physical activity	Physical activity will be collected by questions from the Social Board of Health and Welfare with additional questions on active transport and physical activity at work. In a randomized sample of individuals having increased physical activity as a goal (n=300) physical activity will also be measured objectively by the use of the three-axial accelerometer-based device.	24 months
Other	Sedentary behavior	Sedentary behavior will be collected by questions from the Social Board of Health and Welfare with additional questions on active transport and physical activity at work. In a randomized sample of individuals having increased physical activity as a goal (n=300) physical activity will also be measured objectively by the use of the three-axial accelerometer-based device.	24 months
Other	Daily number of steps	Daily number of steps will be obtained from app analytics.	24 months
Primary	Well-being	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.	6 months
Primary	Well-being	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.	24 months
Secondary	Stress	Stress will be assessed by the Karolinska Exhaustion Disorder Scale (KEDS), a self-rating scale for stress-induced exhaustion disorder. 9 items are scored 1-6, a higher total score indicates more exhaustion.	6 months
Secondary	Burnout	Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.	6 months
Secondary	Sleep	Sleep will be assessed by the self-reported number of hours of sleep per night and by Insomnia Severity Index (ISI). In ISI 7 items are scored 1-4 and a higher total score indicates more sleeping problems.	6 months
Secondary	Stress	Stress will be assessed by the Karolinska Exhaustion Disorder Scale (KEDS), a self-rating scale for stress-induced exhaustion disorder. 9 items are scored 1-6, a higher total score indicates more exhaustion.	24 months
Secondary	Burnout	Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.	24 months
Secondary	Sleep	Sleep will be assessed by the self-reported number of hours of sleep per night and by Insomnia Severity Index (ISI). In ISI 7 items are scored 1-4 and a higher total score indicates more sleeping problems.	24 months