<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/NCT03809871</url>
  </required_header>
  <id_info>
    <org_study_id>LMS</org_study_id>
    <nct_id>NCT03809871</nct_id>
  </id_info>
  <brief_title>Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course</brief_title>
  <official_title>Biomarker Feedback on Health and Wellbeing and Exercise Adherence Following a 6 Month Weight Management Course: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Hertfordshire</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medichecks</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Watford FC Community Sports and Education Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Hertfordshire</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>
      Participants who have signed up to the Watford Football Club Community and Education Trust&#xD;
      Weight management programme called Shape Up will be approached to see if they would like to&#xD;
      take part in this research study. Their participation in the Shape Up programme will not be&#xD;
      affected if they do not choose to opt in to the research component. Fifty participants will&#xD;
      be recruited and randomised in to one of two groups. One group will be the control group and&#xD;
      they will undertake the Shape Up programme as normal and will be asked to complete some&#xD;
      questionnaires in week 1, week 12 and then at 12 weeks follow up. The intervention group will&#xD;
      be asked to complete the same questionnaires and will also have a venous blood sample taken&#xD;
      at week 1, 12 and then at 12 weeks follow up. This is for measures of cholesterol, sugar,&#xD;
      vitamin D, vitamin B12 and iron. The participants will receive a report from a medical doctor&#xD;
      in layman terms on these results a week later and will have access to their data on an online&#xD;
      portal set up by Medichecks.&#xD;
&#xD;
      The weight management programme is based on a behaviour change programme where the&#xD;
      participants attend a 90-minute session for 12 weeks, and they are then supported for another&#xD;
      12 weeks following the end of the supervision. The participants have weight and BMI measured&#xD;
      at week 1, 12 and 12 weeks follow up. Each session consists of an education component&#xD;
      followed by an exercise component. Initially, the education part is longer and the exercise&#xD;
      is shorter, but as the programme progresses the education part becomes shorter and the&#xD;
      exercise longer. The education programme includes topics such as healthy eating, increased&#xD;
      physical activity and stress. The exercise programme includes whole body activities such as&#xD;
      circuit training as well as other group exercise such as football.&#xD;
&#xD;
      The questionnaires will include The Treatment Self-Regulation Questionnaire which will&#xD;
      identify the motivation behind the participants' health. A general health questionnaire which&#xD;
      is a subjective measure of health (Euro qol EQ-5). The Mental Component Summary of the 12-&#xD;
      item Short Form (SF12) which measures emotional quality of life. Physical activity will be&#xD;
      measured through the short Active Lives Questionnaire. All these questionnaires have been&#xD;
      attached as appendices.&#xD;
&#xD;
      All participants will complete an exit telephone interview from the study to determine&#xD;
      qualitative feedback on their experience of the study and to explore whether the biomarkers&#xD;
      influenced their motivation to change their lifestyle. Some example questions have been&#xD;
      attached.&#xD;
&#xD;
      This is just a feasibility study, therefore no hypothesis testing will be undertaken.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">September 24, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Behaviour regulation</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the behaviour regulation by measuring autonmoic regulation versus controlled regulation through the use of the Treatment Self-Regulation Questionnaire.&#xD;
An average of the scores on the subscale for autoregulation and also for the controlled regulation questions will be calculated. Scores will be from 1-7 for both sub scales.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective health measure</measure>
    <time_frame>12 months</time_frame>
    <description>A standardised measure of health status will be calculated using the Euro qol EQ-5 questionnaire. There are 5 dimensions to the questionnaire (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each is rated from 1-5. An average of the 5 is calculated as a general health score. A visual analogue scale is also presented for a self related health measure and this is from 0-100. 100 being the best health you can imagine and 0 being the worst health you can imagine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>12 months</time_frame>
    <description>Amount of physical activity measured through the short Active Lives questionnaire. The amount of minutes where breathing is increased will be calculated per week.&#xD;
For each activity that respondents indicate was sufficient to raise their breathing rate, the total number of days is multiplied by the usual minutes spent undertaking the activity to give a measure of total minutes over the 7-day period for that activity.&#xD;
The respondent's final score is calculated by summing all activities which were sufficient to raise breathing rate, as follows:&#xD;
(Days of walking * usual minutes of walking IF sufficient to raise breathing rate) + (Days of cycling * usual munities of cycling IF sufficient to raise breathing rate) + (days of sport, fitness or dance * usual minutes of sport, fitness or dance IF sufficient to raise breathing rate).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost savings to health care service</measure>
    <time_frame>12 months</time_frame>
    <description>Extrapolating the potential cost savings to the health care service of the community programme by analysing the biomarker trend information</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Exercise Training</condition>
  <condition>Biomarkers</condition>
  <arm_group>
    <arm_group_label>Biomarker group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These participants will receive information about cardiometabolic biomarkers pre and post weight management course</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>They will receive the same weight management programme as the experimental group, but they will not have biomarker information.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Cardiometabolic biomarkers</intervention_name>
    <description>This is for measures of cholesterol (HDL, LDL and total cholesterol), blood glucose and HbA1c, vitamin D, vitamin B12 and iron levels.</description>
    <arm_group_label>Biomarker group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;28&#xD;
&#xD;
          -  No injuries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Injury preventing from participating in exercise&#xD;
&#xD;
          -  fear of needles&#xD;
&#xD;
          -  does not pass a physical activity readiness questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lindsay Bottoms, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Hertfordshire</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Grant, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medichecks</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Hertforshire</name>
      <address>
        <city>Hatfield</city>
        <zip>AL10 9AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Hertfordshire</investigator_affiliation>
    <investigator_full_name>Lindsay Bottoms</investigator_full_name>
    <investigator_title>Research Lead for Sport, Health and Exercise</investigator_title>
  </responsible_party>
  <keyword>exercise training</keyword>
  <keyword>weight management</keyword>
  <keyword>biomarkers</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Anonymised group data will be available.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03809871/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03809871
org study id: LMS
nct id: NCT03809871
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Participants who have signed up to the Watford Football Club Community and Education Trust
      Weight management programme called Shape Up will be approached to see if they would like to
      take part in this research study. Their participation in the Shape Up programme will not be
      affected if they do not choose to opt in to the research component. Fifty participants will
      be recruited and randomised in to one of two groups. One group will be the control group and
      they will undertake the Shape Up programme as normal and will be asked to complete some
      questionnaires in week 1, week 12 and then at 12 weeks follow up. The intervention group will
      be asked to complete the same questionnaires and will also have a venous blood sample taken
      at week 1, 12 and then at 12 weeks follow up. This is for measures of cholesterol, sugar,
      vitamin D, vitamin B12 and iron. The participants will receive a report from a medical doctor
      in layman terms on these results a week later and will have access to their data on an online
      portal set up by Medichecks.

      The weight management programme is based on a behaviour change programme where the
      participants attend a 90-minute session for 12 weeks, and they are then supported for another
      12 weeks following the end of the supervision. The participants have weight and BMI measured
      at week 1, 12 and 12 weeks follow up. Each session consists of an education component
      followed by an exercise component. Initially, the education part is longer and the exercise
      is shorter, but as the programme progresses the education part becomes shorter and the
      exercise longer. The education programme includes topics such as healthy eating, increased
      physical activity and stress. The exercise programme includes whole body activities such as
      circuit training as well as other group exercise such as football.

      The questionnaires will include The Treatment Self-Regulation Questionnaire which will
      identify the motivation behind the participants' health. A general health questionnaire which
      is a subjective measure of health (Euro qol EQ-5). The Mental Component Summary of the 12-
      item Short Form (SF12) which measures emotional quality of life. Physical activity will be
      measured through the short Active Lives Questionnaire. All these questionnaires have been
      attached as appendices.

      All participants will complete an exit telephone interview from the study to determine
      qualitative feedback on their experience of the study and to explore whether the biomarkers
      influenced their motivation to change their lifestyle. Some example questions have been
      attached.

      This is just a feasibility study, therefore no hypothesis testing will be undertaken.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Behaviour regulation
time frame: 12 months
description: To determine the behaviour regulation by measuring autonmoic regulation versus controlled regulation through the use of the Treatment Self-Regulation Questionnaire.
An average of the scores on the subscale for autoregulation and also for the controlled regulation questions will be calculated. Scores will be from 1-7 for both sub scales.
measure: Subjective health measure
time frame: 12 months
description: A standardised measure of health status will be calculated using the Euro qol EQ-5 questionnaire. There are 5 dimensions to the questionnaire (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each is rated from 1-5. An average of the 5 is calculated as a general health score. A visual analogue scale is also presented for a self related health measure and this is from 0-100. 100 being the best health you can imagine and 0 being the worst health you can imagine.
measure: Physical Activity
time frame: 12 months
description: Amount of physical activity measured through the short Active Lives questionnaire. The amount of minutes where breathing is increased will be calculated per week.
For each activity that respondents indicate was sufficient to raise their breathing rate, the total number of days is multiplied by the usual minutes spent undertaking the activity to give a measure of total minutes over the 7-day period for that activity.
The respondent's final score is calculated by summing all activities which were sufficient to raise breathing rate, as follows:
(Days of walking * usual minutes of walking IF sufficient to raise breathing rate) + (Days of cycling * usual munities of cycling IF sufficient to raise breathing rate) + (days of sport, fitness or dance * usual minutes of sport, fitness or dance IF sufficient to raise breathing rate).
measure: Cost savings to health care service
time frame: 12 months
description: Extrapolating the potential cost savings to the health care service of the community programme by analysing the biomarker trend information
arm group label: Biomarker group
arm group type: Experimental
description: These participants will receive information about cardiometabolic biomarkers pre and post weight management course
arm group label: Control group
arm group type: No Intervention
description: They will receive the same weight management programme as the experimental group, but they will not have biomarker information.
intervention type: Biological
intervention name: Cardiometabolic biomarkers
description: This is for measures of cholesterol (HDL, LDL and total cholesterol), blood glucose and HbA1c, vitamin D, vitamin B12 and iron levels.
arm group label: Biomarker group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lindsay Bottoms, PhD
role: Principal Investigator
affiliation: University of Hertfordshire
last name: Daniel Grant, MBBS
role: Principal Investigator
affiliation: Medichecks
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Hertfordshire
investigator full name: Lindsay Bottoms
investigator title: Research Lead for Sport, Health and Exercise
sharing ipd: No
ipd description: Anonymised group data will be available.
provided document: 