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

Sponsor
Sophiahemmet University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05973383
Collaborator
Karolinska Institutet (Other), Stockholm University (Other), The Swedish School of Sport and Health Sciences (Other), Linnaeus University (Other), Södertörn University (Other)
5,000
48

Study Details

Study Description

Brief Summary

The goal of this quasi-experimental study 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:

  1. 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?
  2. 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 Phase
  • 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

Study Type:
Observational
Anticipated Enrollment :
5000 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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2027
Anticipated Study Completion Date :
Aug 31, 2027

Arms and Interventions

Arm 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, 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, a database with food recipes, a database with exercises, inspiration, and skills training webinars. Users with the membership Standard are also offered of 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, a database with food recipes, a database with exercises, inspiration, and skills training webinars. Users with the membership Premium are also offered of 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

Primary Outcome Measures

  1. Well-being [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [6 months]

    Daily number of steps will be obtained from app analytics.

  6. Goal achievement [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 [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 [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 [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 [24 months]

    Daily number of steps will be obtained from app analytics.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

No locations specified.

Sponsors and Collaborators

  • Sophiahemmet University
  • Karolinska Institutet
  • Stockholm University
  • The Swedish School of Sport and Health Sciences
  • Linnaeus University
  • Södertörn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sophiahemmet University
ClinicalTrials.gov Identifier:
NCT05973383
Other Study ID Numbers:
  • CIV-23-07-043416
First Posted:
Aug 2, 2023
Last Update Posted:
Aug 2, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sophiahemmet University

Study Results

No Results Posted as of Aug 2, 2023