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

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

Tracking Information

• First Submitted Date: July 8, 2023
• First Posted Date: August 2, 2023
• Last Update Posted Date: April 26, 2024
• Estimated Study Start Date: June 1, 2024
• Estimated Primary Completion Date: December 31, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 1, 2023)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 1, 2023)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: August 1, 2023)

• 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.
• 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.
• 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.
• 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.
• Daily number of steps [ Time Frame: 6 months ]
  Daily number of steps will be obtained from app analytics.
• 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.
• 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.
• 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.
• 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.
• Daily number of steps [ Time Frame: 24 months ]
  Daily number of steps will be obtained from app analytics.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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

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.
• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

• Condition: 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.

• 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.

• 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.

Study Groups/Cohorts

• Intervention group- Basic
  Subjects with behavioral support from the app LongLife Active®
  Intervention: Behavioral: LongLife Active- Basic
• Intervention group- Standard
  Subjects with behavioral support from the app LongLife Active® + social support
  Intervention: Behavioral: LongLife Active- Standard
• Intervention group- Premium
  Subjects with behavioral support from the app LongLife Active® + social support + individual coaching
  Intervention: Behavioral: LongLife Active- Premium
• Control group
  No exposure

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 25, 2024): 1500
• Original Estimated Enrollment (submitted: August 1, 2023): 5000
• Estimated Study Completion Date: December 31, 2027
• Estimated Primary Completion Date: December 31, 2027 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Jenny Rossen, PhD; +4684062985; jenny.rossen@shh.se

Contact: Unn-Britt Johansson, Professor; +464062902; Unn-Britt.Johansson@shh.se

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05973383
• Other Study ID Numbers: CIV-23-07-043416
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sophiahemmet University
• Original Responsible Party: Same as current
• Current Study Sponsor: Sophiahemmet University
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Jenny Rossen, PhD; Sophiahemmet University

• PRS Account: Sophiahemmet University
• Verification Date: April 2024