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

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ClinicalTrials.gov Identifier: NCT05973383
Recruitment Status : Not yet recruiting
First Posted : August 2, 2023
Last Update Posted : April 26, 2024
Sponsor:
Collaborators:
Karolinska Institutet
Stockholm University
The Swedish School of Sport and Health Sciences
Linnaeus University
Södertörn University
Information provided by (Responsible Party):
Sophiahemmet University

Study Description
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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.


Condition or disease Intervention/treatment
Well-being Behavioral: LongLife Active- Basic Behavioral: LongLife Active- Standard Behavioral: LongLife Active- Premium

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of an Individually Tailored Digital Service to Promote Healthy and Sustainable Behaviors and Well-being Among Adults
Estimated Study Start Date : June 1, 2024
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027
Groups and Cohorts
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Group/Cohort Intervention/treatment
Intervention group- Basic
Subjects with behavioral support from the app LongLife Active®
 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.
Intervention group- Standard
Subjects with behavioral support from the app LongLife Active® + social support
 Behavioral: 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.
Intervention group- Premium
Subjects with behavioral support from the app LongLife Active® + social support + individual coaching
 Behavioral: 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.
Control group
No exposure


Outcome Measures
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Primary Outcome Measures :
  1. Well-being [ Time Frame: 6 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.

  2. 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 Outcome Measures :
  1. Stress [ Time Frame: 6 months ]
    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.

  2. Burnout [ Time Frame: 6 months ]
    Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.

  3. Sleep [ Time Frame: 6 months ]
    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.

  4. Stress [ Time Frame: 24 months ]
    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.

  5. Burnout [ Time Frame: 24 months ]
    Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.

  6. Sleep [ Time Frame: 24 months ]
    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.


Other Outcome Measures:
  1. Goal achievement [ Time Frame: 6 months ]
    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.

  2. Dietary habits [ Time Frame: 6 months ]
    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.

  3. Physical activity [ Time Frame: 6 months ]
    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.

  4. Sedentary behavior [ Time Frame: 6 months ]
    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.

  5. Daily number of steps [ Time Frame: 6 months ]
    Daily number of steps will be obtained from app analytics.

  6. Goal achievement [ Time Frame: 24 months ]
    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.

  7. Dietary habits [ Time Frame: 24 months ]
    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.

  8. Physical activity [ Time Frame: 24 months ]
    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.

  9. Sedentary behavior [ Time Frame: 24 months ]
    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.

  10. Daily number of steps [ Time Frame: 24 months ]
    Daily number of steps will be obtained from app analytics.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05973383


Contacts
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Contact: Jenny Rossen, PhD +4684062985 jenny.rossen@shh.se
Contact: Unn-Britt Johansson, Professor +464062902 Unn-Britt.Johansson@shh.se

Sponsors and Collaborators
Sophiahemmet University
Karolinska Institutet
Stockholm University
The Swedish School of Sport and Health Sciences
Linnaeus University
Södertörn University
Investigators
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Principal Investigator: Jenny Rossen, PhD Sophiahemmet University
More Information
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Responsible Party: Sophiahemmet University
ClinicalTrials.gov Identifier: NCT05973383    
Other Study ID Numbers: CIV-23-07-043416
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sophiahemmet University:
primary prevention
secondary prevention
health promotion
self-management
behavior