xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05973383</url>
    </required_header>
    <id_info>
      <org_study_id>CIV-23-07-043416</org_study_id>
      <nct_id>NCT05973383</nct_id>
    </id_info>
    <brief_title>Evaluation of an Individually Tailored Digital Service to Promote Healthy and Sustainable Behaviors and Well-being</brief_title>
    <official_title>Evaluation of an Individually Tailored Digital Service to Promote Healthy and Sustainable Behaviors and Well-being Among Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sophiahemmet University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Karolinska Institutet</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Stockholm University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Swedish School of Sport and Health Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Linnaeus University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Södertörn University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Sophiahemmet University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this quasi-experimental study observational study is to evaluate the impact of an&#xD;
        individually tailored digital service aimed to support healthy habits on well-being,&#xD;
        lifestyle behaviors, and mental health among the adult population. The main questions it aims&#xD;
        to answer are:&#xD;
  &#xD;
        I) Is a digital service developed to personalize support for healthy habits effective in&#xD;
        improving well-being compared to a control group in the general population after 6 months?&#xD;
        II) Does the digital service improve dietary and physical activity habits, mental health, and&#xD;
        well-being among users across 24 months? III) Are sociodemographic factors associated with&#xD;
        achieving the self-identified goals and improvements in dietary and physical activity habits,&#xD;
        mental health, and well-being? IV) Do the intended mediators (engagement with the service,&#xD;
        improved motivation, improved self-efficacy, and reduced barriers) mediate the effects of the&#xD;
        digital service on achieving the self-identified goal, improved dietary and physical activity&#xD;
        habits, mental health, and well-being? V) How is the pattern of user engagement across 24&#xD;
        months?&#xD;
  &#xD;
        Participants are users of the mobile phone application LongLife Active®. Researchers will&#xD;
        compare with individuals in the general population to see if the digital service is effective&#xD;
        in improving well-being, dietary and physical activity habits, and mental health.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        LongLife Active is an individually tailored digital service supporting healthy habits that is&#xD;
        based on behavioral research evidence, supported by artificial intelligence and co-developed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Well-being</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Well-being</measure>
      <time_frame>24 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Stress</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Burnout</measure>
      <time_frame>6 months</time_frame>
      <description>Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stress</measure>
      <time_frame>24 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Burnout</measure>
      <time_frame>24 months</time_frame>
      <description>Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep</measure>
      <time_frame>24 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Goal achievement</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Dietary habits</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Physical activity</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Sedentary behavior</measure>
      <time_frame>6 months</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily number of steps</measure>
      <time_frame>6 months</time_frame>
      <description>Daily number of steps will be obtained from app analytics.</description>
    </other_outcome>
    <other_outcome>
      <measure>Goal achievement</measure>
      <time_frame>24 months</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Dietary habits</measure>
      <time_frame>24 months</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Physical activity</measure>
      <time_frame>24 months</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Sedentary behavior</measure>
      <time_frame>24 months</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily number of steps</measure>
      <time_frame>24 months</time_frame>
      <description>Daily number of steps will be obtained from app analytics.</description>
    </other_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>Well-being</condition>
    <arm_group>
      <arm_group_label>Intervention group- Basic</arm_group_label>
      <description>Subjects with behavioral support from the app LongLife Active®</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention group- Standard</arm_group_label>
      <description>Subjects with behavioral support from the app LongLife Active® + social support</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention group- Premium</arm_group_label>
      <description>Subjects with behavioral support from the app LongLife Active® + social support + individual coaching</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>No exposure</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>LongLife Active- Basic</intervention_name>
      <description>The digital service LongLife Active with three core subjects:&#xD;
  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.</description>
      <arm_group_label>Intervention group- Basic</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>LongLife Active- Standard</intervention_name>
      <description>The digital service LongLife Active with three core subjects:&#xD;
  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.&#xD;
  Users with the membership Standard are also offered of a community with social support.</description>
      <arm_group_label>Intervention group- Standard</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>LongLife Active- Premium</intervention_name>
      <description>The digital service LongLife Active with three core subjects:&#xD;
  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.&#xD;
  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.</description>
      <arm_group_label>Intervention group- Premium</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Intervention:&#xD;
  &#xD;
          Adults signing up for a digital service that is supporting a healthy lifestyle.&#xD;
  &#xD;
          Control:&#xD;
  &#xD;
          Adults in the general population.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria (intervention arms):&#xD;
  &#xD;
            -  adults ≥18 years&#xD;
  &#xD;
            -  siging up for the service LongLife Active using BankID for identification&#xD;
  &#xD;
            -  consent to the research study&#xD;
  &#xD;
          Inclusion Criteria (controls):&#xD;
  &#xD;
            -  adults ≥18 years&#xD;
  &#xD;
            -  consent to the research study&#xD;
  &#xD;
          Exclusion Criteria (intervention arms):&#xD;
  &#xD;
            -  individuals who are discharged from the app due to refracting the terms of the service&#xD;
  &#xD;
            -  subjects scoring &gt;70 on well-being will be excluded from the primary analyses&#xD;
  &#xD;
          Exclusion Criteria (controls):&#xD;
  &#xD;
            -  age ≤ 17 years.&#xD;
  &#xD;
            -  is currently using a digital product or any other kind of support for behavior change&#xD;
  &#xD;
            -  is found to be a user of LongLife Active.&#xD;
  &#xD;
            -  subjects scoring &gt;70 on well-being will be excluded from the primary analyses&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jenny Rossen, PhD</last_name>
      <phone>+4684062985</phone>
      <email>jenny.rossen@shh.se</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Unn-Britt Johansson, Professor</last_name>
      <phone>+464062902</phone>
      <email>Unn-Britt.Johansson@shh.se</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>primary prevention</keyword>
    <keyword>secondary prevention</keyword>
    <keyword>health promotion</keyword>
    <keyword>self-management</keyword>
    <keyword>behavior</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05973383
  org study id: CIV-23-07-043416
  nct id: NCT05973383
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  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:
  
        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.
  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.
  observational model: Other
  time perspective: Prospective
  measure: Well-being
  time frame: 6 months
  description: 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.
  measure: Well-being
  time frame: 24 months
  description: 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.
  measure: Stress
  time frame: 6 months
  description: 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.
  measure: Burnout
  time frame: 6 months
  description: Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.
  measure: Sleep
  time frame: 6 months
  description: 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.
  measure: Stress
  time frame: 24 months
  description: 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.
  measure: Burnout
  time frame: 24 months
  description: Burnout will be assessed by the Oldenburg Burnout Inventory (OLBI). 16 items are scored 1-4, a higher total score indicates more burnout.
  measure: Sleep
  time frame: 24 months
  description: 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.
  measure: Goal achievement
  time frame: 6 months
  description: 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.
  measure: Dietary habits
  time frame: 6 months
  description: 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.
  measure: Physical activity
  time frame: 6 months
  description: 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.
  measure: Sedentary behavior
  time frame: 6 months
  description: 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.
  measure: Daily number of steps
  time frame: 6 months
  description: Daily number of steps will be obtained from app analytics.
  measure: Goal achievement
  time frame: 24 months
  description: 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.
  measure: Dietary habits
  time frame: 24 months
  description: 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.
  measure: Physical activity
  time frame: 24 months
  description: 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.
  measure: Sedentary behavior
  time frame: 24 months
  description: 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.
  measure: Daily number of steps
  time frame: 24 months
  description: Daily number of steps will be obtained from app analytics.
  arm group label: Intervention group- Basic
  description: Subjects with behavioral support from the app LongLife Active®
  arm group label: Intervention group- Standard
  description: Subjects with behavioral support from the app LongLife Active® + social support
  arm group label: Intervention group- Premium
  description: Subjects with behavioral support from the app LongLife Active® + social support + individual coaching
  arm group label: Control group
  description: No exposure
  intervention type: Behavioral
  intervention name: LongLife Active- Basic
  description: 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.
  arm group label: Intervention group- Basic
  intervention type: Behavioral
  intervention name: LongLife Active- Standard
  description: 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.
  arm group label: Intervention group- Standard
  intervention type: Behavioral
  intervention name: LongLife Active- Premium
  description: 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.
  arm group label: Intervention group- Premium
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jenny Rossen, PhD
  phone: +4684062985
  email: jenny.rossen@shh.se
  last name: Unn-Britt Johansson, Professor
  phone: +464062902
  email: Unn-Britt.Johansson@shh.se
  responsible party type: Sponsor