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/NCT06042452</url>
    </required_header>
    <id_info>
      <org_study_id>FG-NHS-Wellbeing</org_study_id>
      <nct_id>NCT06042452</nct_id>
    </id_info>
    <brief_title>Use of Personalized Recommendations, Through Genetic and Lifestyle Data, to Improve Healthcare Staff Wellbeing</brief_title>
    <official_title>Exploring the Utility and Effectiveness of Personalised Insights and Recommendations, Using Genetic and Lifestyle Data, to Improve Employee Health and Wellbeing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>FitnessGenes Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>FitnessGenes Ltd.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        With the NHS under increasing pressure and strain, the health and wellbeing of staff is an&#xD;
        important area to prioritize, to help reduce staff stress levels and increase retention of&#xD;
        staff. This study will look to explore how efficacious personalised insights and&#xD;
        recommendations are, based on genetic and lifestyle information, at improving the health and&#xD;
        wellbeing of NHS employees. It will also explore how sustainable these recommendations are&#xD;
        for long-term change. Recruitment of NHS staff as participants will take place across&#xD;
        multiple NHS trusts including Bradford Teaching Hospital NHS Trust and Sandwell and West&#xD;
        Birmingham NHS Trust.&#xD;
  &#xD;
        Following consent to partake in the trial, participants will be asked to complete a pre-trial&#xD;
        questionnaire which will explore health and wellbeing interests and motivations, perceptions&#xD;
        of genetic testing, and a baseline measure of mental and physical wellbeing using a&#xD;
        standardised and validated questionnaire (5-item World Health Organisation Well-being Index&#xD;
        (WHO-5)). This, and all further questionnaires, will be completed online.&#xD;
  &#xD;
        Participants will undertake a DNA test provided by FitnessGenes, free of charge. This test&#xD;
        will require participants to provide a saliva sample via a spit test. This sample will then&#xD;
        be analysed at an ISO-accredited laboratory and results provided back to the participant&#xD;
        within 2-3 weeks. While awaiting the results, participants will have access to lifestyle&#xD;
        traits calculated using questionnaire data collected when creating a FitnessGenes account.&#xD;
  &#xD;
        Once their genetic data is added to a participant's FitnessGenes accounts, they will be asked&#xD;
        to spend two weeks exploring this information. A questionnaire will then be completed to&#xD;
        reassess participant's wellbeing measures and any changes in their perceptions of DNA&#xD;
        testing. At this stage, some semi-structured interviews may be conducted, to those who&#xD;
        consent to this, to gain further insight.&#xD;
  &#xD;
        A 3-month follow up will be completed to assess whether the platform has had any long-lasting&#xD;
        impacts on participants' health and wellbeing.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This will be a 6-week long study to explore the impact of FitnessGenes' platform, with a&#xD;
        follow-up after 3 months. NHS staff from multiple NHS trusts will be recruited to partake in&#xD;
        the study.&#xD;
  &#xD;
        Following consent to partake in the trial, participants will be asked to complete a pre-trial&#xD;
        questionnaire which will explore health and wellbeing interests and motivations, alongside&#xD;
        taking a baseline measure of mental and physical wellbeing using the 5-item World Health&#xD;
        Organization Well-being Index (WHO-5) which has been clinically validated. This, and all&#xD;
        further questionnaires, will be completed online.&#xD;
  &#xD;
        Participants will undertake a DNA test provided by FitnessGenes, free of charge. This test&#xD;
        will require participants to provide a saliva sample via a spit test. This sample will then&#xD;
        be analysed at an ISO-accredited laboratory and results provided back to the participant&#xD;
        within 2-3 weeks. Test result data is stored in an encrypted format and saliva samples are&#xD;
        anonymized using unique barcodes printed on the collection tubes, which do not contain any&#xD;
        Personal Information. User identity data (email, name, address, contact info etc.) is kept in&#xD;
        a separate database to user personal data (demographic, biometric, lifestyle, genetic etc.).&#xD;
        This means all personal data is already kept in an anonymised form.&#xD;
  &#xD;
        Once their genetic data is added to a participant's FitnessGenes account, they will be asked&#xD;
        to spend a week exploring this upgraded information. A feedback questionnaire will be&#xD;
        completed, 3 weeks after they have received their results, to assess participant's&#xD;
        experiences of the platform and their results. At this stage, some semi-structured interviews&#xD;
        may be conducted, to those who consent to this, to gain further insight.&#xD;
  &#xD;
        A 3-month follow up, after the baseline measures were taken, will be completed to assess&#xD;
        whether the platform has had any long-lasting impacts on participants' health and wellbeing.&#xD;
        This follow up will be completed via a short online questionnaire.&#xD;
  &#xD;
        The primary aim of the study is to assess changes in subjects' well-being, as evaluated by&#xD;
        the 5-item World Health Organisation Well-being Index (WHO-5).&#xD;
  &#xD;
        The investigators will adopt a repeated measures analysis, collecting raw WHO-5 scores from&#xD;
        the same subjects at three discrete time points: baseline (i.e. before genetic analysis), 3&#xD;
        weeks after receiving genetic results and at 3 months after baseline. The investigators will&#xD;
        also assess the internal consistency of the WHO-5 by performing a Cronbach's alpha test at&#xD;
        the three time points.&#xD;
  &#xD;
        To assess changes in well-being, raw WHO-5 scores (ranging from 0 to 25) will be multiplied&#xD;
        by 4 and transformed into final scores of 0 - 100 for each subject. Descriptive statistics&#xD;
        (mean and standard deviation) will be calculated for the 5 individual items of the WHO-5 and&#xD;
        the final WHO-5 scores (0-100).&#xD;
  &#xD;
        The main dependent variable to be evaluated will be the final WHO-5 Score (ranging from&#xD;
        0-100). The investigators will use repeated measures analysis to assess changes in mean final&#xD;
        WHO-5 score across the three different time points.&#xD;
  &#xD;
        Briefly, the investigators will assess the distributions of the WHO-5 scores and perform&#xD;
        basic tests of normality (including Q-Q plot and performing a Shapiro-Wilkes test) and&#xD;
        sphericity/equal variances (Mauchly's test). Depending on the distributions of this data, the&#xD;
        investigators will select the appropriate statistical test to assess changes in mean final&#xD;
        WHO-5 score.&#xD;
  &#xD;
        Assuming normality and sphericity of data and no outliers, the investigators will perform a&#xD;
        repeated measures (within-subjects) ANOVA to assess whether the mean final WHO-5 score is&#xD;
        statistically significantly different across the three time points. Post-hoc tests will&#xD;
        include paired T-tests to make pairwise comparisons in mean final WHO-5 score between the&#xD;
        time points, with P-values adjusted using the Bonferroni multiple testing correction method.&#xD;
        Depending on the demographic make-up of the subjects, the investigators may include other&#xD;
        moderator variables (e.g. gender) to assess for interactions with time point.&#xD;
  &#xD;
        If the assumptions behind these parametric tests are violated, a non-parametric alternative&#xD;
        (e.g. Friedmans test) will be used to assess changes in mean WHO-5 score. All statistical&#xD;
        analysis will be performed using R.&#xD;
  &#xD;
        Repeated measures analysis will be used to evaluate the secondary outcomes related to user&#xD;
        experience and perceptions of genetic testing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in physical and psychological well-being</measure>
      <time_frame>Measurements taken at baseline, 3 weeks following receiving personalized recommendations, and at a 3 month follow-up</time_frame>
      <description>5-Item World Health Organisation Well-being Index (WHO-5). This uses a Likert Scale from 0 ('At no time') to 5 ('All of the time').&#xD;
  A raw score of 0 (lowest well-being) to 25 (highest well-being) is possible on the WHO-5.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Perceptions of DNA testing</measure>
      <time_frame>Measurements taken at baseline, 3 weeks following receiving personalized recommendations, and at 3 month follow-up</time_frame>
      <description>A questionnaire using a scale from Strongly against to Strongly for.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>How sustainable are the personalized recommendations</measure>
      <time_frame>Measurements taken at 3 month follow-up</time_frame>
      <description>A questionnaire that will cover whether recommendations were followed (Yes/No), for how long (1-5 days, 1-2 weeks, 3-4 weeks, 1 month, &gt; 2 months) and how easy participants found implementing the recommendations (scale from Very hard to very easy).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Well-Being, Psychological</condition>
    <arm_group>
      <arm_group_label>Genetic</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will have their DNA tested and this data alongside lifestyle data will personalize the information they receive</description>
    </arm_group>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>Genetic</intervention_name>
      <description>A saliva sample test will be undertaken by all participants in order to analyze their DNA for personalizing their recommendations. The Global Screening Array (GSA) will be used.</description>
      <arm_group_label>Genetic</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Health care staff within the NHS (including both clinical and administrative)&#xD;
  &#xD;
            -  Able to proficiently read English (reports are only produced in English)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to proficiently read English&#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_official>
      <last_name>Stuart Grice, DPhil</last_name>
      <role>Principal Investigator</role>
      <affiliation>FitnessGenes Ltd.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Geraldine M Campbell, MSc</last_name>
      <phone>01869255770</phone>
      <email>geraldine.campbell@fitnessgenes.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Samantha Decombel, PhD</last_name>
      <phone>01869255770</phone>
      <email>sam@fitnessgenes.com</email>
    </overall_contact_backup>
    <link>
      <url>https://www.england.nhs.uk/personalisedcare/what-is-personalised-care/</url>
      <description>Advancing personalized care being a key focus in the NHS Long Term Plan</description>
    </link>
    <reference>
      <citation>Ricciardi W, Boccia S. New challenges of public health: bringing the future of personalised healthcare into focus. Eur J Public Health. 2017 Oct 1;27(suppl_4):36-39. doi: 10.1093/eurpub/ckx164.</citation>
      <PMID>29028243</PMID>
    </reference>
    <reference>
      <citation>Sauerteig SO, Wijesuriya J, Tuck M, Barham-Brown H. Doctors' health and wellbeing: at the heart of the NHS's mission or still a secondary consideration? Int Rev Psychiatry. 2019 Nov-Dec;31(7-8):548-554. doi: 10.1080/09540261.2019.1586165. Epub 2019 May 14.</citation>
      <PMID>31084440</PMID>
    </reference>
    <reference>
      <citation>Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.</citation>
      <PMID>25831962</PMID>
    </reference>
    <reference>
      <citation>Ghasemi A, Zahediasl S. Normality tests for statistical analysis: a guide for non-statisticians. Int J Endocrinol Metab. 2012 Spring;10(2):486-9. doi: 10.5812/ijem.3505. Epub 2012 Apr 20.</citation>
      <PMID>23843808</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06042452
  org study id: FG-NHS-Wellbeing
  nct id: NCT06042452
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  With the NHS under increasing pressure and strain, the health and wellbeing of staff is an
        important area to prioritize, to help reduce staff stress levels and increase retention of
        staff. This study will look to explore how efficacious personalised insights and
        recommendations are, based on genetic and lifestyle information, at improving the health and
        wellbeing of NHS employees. It will also explore how sustainable these recommendations are
        for long-term change. Recruitment of NHS staff as participants will take place across
        multiple NHS trusts including Bradford Teaching Hospital NHS Trust and Sandwell and West
        Birmingham NHS Trust.
  
        Following consent to partake in the trial, participants will be asked to complete a pre-trial
        questionnaire which will explore health and wellbeing interests and motivations, perceptions
        of genetic testing, and a baseline measure of mental and physical wellbeing using a
        standardised and validated questionnaire (5-item World Health Organisation Well-being Index
        (WHO-5)). This, and all further questionnaires, will be completed online.
  
        Participants will undertake a DNA test provided by FitnessGenes, free of charge. This test
        will require participants to provide a saliva sample via a spit test. This sample will then
        be analysed at an ISO-accredited laboratory and results provided back to the participant
        within 2-3 weeks. While awaiting the results, participants will have access to lifestyle
        traits calculated using questionnaire data collected when creating a FitnessGenes account.
  
        Once their genetic data is added to a participant's FitnessGenes accounts, they will be asked
        to spend two weeks exploring this information. A questionnaire will then be completed to
        reassess participant's wellbeing measures and any changes in their perceptions of DNA
        testing. At this stage, some semi-structured interviews may be conducted, to those who
        consent to this, to gain further insight.
  
        A 3-month follow up will be completed to assess whether the platform has had any long-lasting
        impacts on participants' health and wellbeing.
  This will be a 6-week long study to explore the impact of FitnessGenes' platform, with a
        follow-up after 3 months. NHS staff from multiple NHS trusts will be recruited to partake in
        the study.
  
        Following consent to partake in the trial, participants will be asked to complete a pre-trial
        questionnaire which will explore health and wellbeing interests and motivations, alongside
        taking a baseline measure of mental and physical wellbeing using the 5-item World Health
        Organization Well-being Index (WHO-5) which has been clinically validated. This, and all
        further questionnaires, will be completed online.
  
        Participants will undertake a DNA test provided by FitnessGenes, free of charge. This test
        will require participants to provide a saliva sample via a spit test. This sample will then
        be analysed at an ISO-accredited laboratory and results provided back to the participant
        within 2-3 weeks. Test result data is stored in an encrypted format and saliva samples are
        anonymized using unique barcodes printed on the collection tubes, which do not contain any
        Personal Information. User identity data (email, name, address, contact info etc.) is kept in
        a separate database to user personal data (demographic, biometric, lifestyle, genetic etc.).
        This means all personal data is already kept in an anonymised form.
  
        Once their genetic data is added to a participant's FitnessGenes account, they will be asked
        to spend a week exploring this upgraded information. A feedback questionnaire will be
        completed, 3 weeks after they have received their results, to assess participant's
        experiences of the platform and their results. At this stage, some semi-structured interviews
        may be conducted, to those who consent to this, to gain further insight.
  
        A 3-month follow up, after the baseline measures were taken, will be completed to assess
        whether the platform has had any long-lasting impacts on participants' health and wellbeing.
        This follow up will be completed via a short online questionnaire.
  
        The primary aim of the study is to assess changes in subjects' well-being, as evaluated by
        the 5-item World Health Organisation Well-being Index (WHO-5).
  
        The investigators will adopt a repeated measures analysis, collecting raw WHO-5 scores from
        the same subjects at three discrete time points: baseline (i.e. before genetic analysis), 3
        weeks after receiving genetic results and at 3 months after baseline. The investigators will
        also assess the internal consistency of the WHO-5 by performing a Cronbach's alpha test at
        the three time points.
  
        To assess changes in well-being, raw WHO-5 scores (ranging from 0 to 25) will be multiplied
        by 4 and transformed into final scores of 0 - 100 for each subject. Descriptive statistics
        (mean and standard deviation) will be calculated for the 5 individual items of the WHO-5 and
        the final WHO-5 scores (0-100).
  
        The main dependent variable to be evaluated will be the final WHO-5 Score (ranging from
        0-100). The investigators will use repeated measures analysis to assess changes in mean final
        WHO-5 score across the three different time points.
  
        Briefly, the investigators will assess the distributions of the WHO-5 scores and perform
        basic tests of normality (including Q-Q plot and performing a Shapiro-Wilkes test) and
        sphericity/equal variances (Mauchly's test). Depending on the distributions of this data, the
        investigators will select the appropriate statistical test to assess changes in mean final
        WHO-5 score.
  
        Assuming normality and sphericity of data and no outliers, the investigators will perform a
        repeated measures (within-subjects) ANOVA to assess whether the mean final WHO-5 score is
        statistically significantly different across the three time points. Post-hoc tests will
        include paired T-tests to make pairwise comparisons in mean final WHO-5 score between the
        time points, with P-values adjusted using the Bonferroni multiple testing correction method.
        Depending on the demographic make-up of the subjects, the investigators may include other
        moderator variables (e.g. gender) to assess for interactions with time point.
  
        If the assumptions behind these parametric tests are violated, a non-parametric alternative
        (e.g. Friedmans test) will be used to assess changes in mean WHO-5 score. All statistical
        analysis will be performed using R.
  
        Repeated measures analysis will be used to evaluate the secondary outcomes related to user
        experience and perceptions of genetic testing.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in physical and psychological well-being
  time frame: Measurements taken at baseline, 3 weeks following receiving personalized recommendations, and at a 3 month follow-up
  description: 5-Item World Health Organisation Well-being Index (WHO-5). This uses a Likert Scale from 0 ('At no time') to 5 ('All of the time').
  A raw score of 0 (lowest well-being) to 25 (highest well-being) is possible on the WHO-5.
  measure: Perceptions of DNA testing
  time frame: Measurements taken at baseline, 3 weeks following receiving personalized recommendations, and at 3 month follow-up
  description: A questionnaire using a scale from Strongly against to Strongly for.
  measure: How sustainable are the personalized recommendations
  time frame: Measurements taken at 3 month follow-up
  description: A questionnaire that will cover whether recommendations were followed (Yes/No), for how long (1-5 days, 1-2 weeks, 3-4 weeks, 1 month, > 2 months) and how easy participants found implementing the recommendations (scale from Very hard to very easy).
  arm group label: Genetic
  arm group type: Experimental
  description: Participants will have their DNA tested and this data alongside lifestyle data will personalize the information they receive
  intervention type: Genetic
  intervention name: Genetic
  description: A saliva sample test will be undertaken by all participants in order to analyze their DNA for personalizing their recommendations. The Global Screening Array (GSA) will be used.
  arm group label: Genetic
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Stuart Grice, DPhil
  role: Principal Investigator
  affiliation: FitnessGenes Ltd.
  last name: Geraldine M Campbell, MSc
  phone: 01869255770
  email: geraldine.campbell@fitnessgenes.com
  last name: Samantha Decombel, PhD
  phone: 01869255770
  email: sam@fitnessgenes.com
  url: https://www.england.nhs.uk/personalisedcare/what-is-personalised-care/
  description: Advancing personalized care being a key focus in the NHS Long Term Plan
  citation: Ricciardi W, Boccia S. New challenges of public health: bringing the future of personalised healthcare into focus. Eur J Public Health. 2017 Oct 1;27(suppl_4):36-39. doi: 10.1093/eurpub/ckx164.
  PMID: 29028243
  citation: Sauerteig SO, Wijesuriya J, Tuck M, Barham-Brown H. Doctors' health and wellbeing: at the heart of the NHS's mission or still a secondary consideration? Int Rev Psychiatry. 2019 Nov-Dec;31(7-8):548-554. doi: 10.1080/09540261.2019.1586165. Epub 2019 May 14.
  PMID: 31084440
  citation: Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
  PMID: 25831962
  citation: Ghasemi A, Zahediasl S. Normality tests for statistical analysis: a guide for non-statisticians. Int J Endocrinol Metab. 2012 Spring;10(2):486-9. doi: 10.5812/ijem.3505. Epub 2012 Apr 20.
  PMID: 23843808
  responsible party type: Sponsor
  sharing ipd: No