<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/NCT03258138</url>
  </required_header>
  <id_info>
    <org_study_id>Healthy lifestyles pilot</org_study_id>
    <nct_id>NCT03258138</nct_id>
  </id_info>
  <brief_title>Feasibility and Implementation of a Healthy Lifestyles Program</brief_title>
  <official_title>Feasibility and Implementation of a Healthy Lifestyles Program: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</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>
      Chronic conditions, such as obesity and diabetes, are increasing worldwide. Lifestyle changes&#xD;
      (e.g., physical activity, healthy diet, sufficient sleep, managing stress, smoking cessation)&#xD;
      are often recommended to prevent or manage these conditions, but changing habits is&#xD;
      difficult. Mental health can play a role in the ability to seek out and follow through on the&#xD;
      changes necessary to achieve or maintain a healthy lifestyle, yet this aspect is rarely&#xD;
      addressed, and access to mental health services is often limited. Furthermore, individuals&#xD;
      are influenced by factors at the individual, interpersonal, community and policy levels&#xD;
      (e.g., lack of socialization, unsafe neighborhoods). These factors can act as barriers and&#xD;
      need to be addressed in order for individuals to make sustainable lifestyle changes.&#xD;
&#xD;
      A new year-long person-centered healthy lifestyles program is proposed to address the &quot;how&#xD;
      to&quot; gap in making lifestyle changes through a combination of individual and group sessions.&#xD;
      The feasibility and implementation of this new program will be evaluated through a pilot&#xD;
      study looking at the full healthy lifestyles program compared to a less intensive version of&#xD;
      the program. The study's hypothesis is that the full program will be feasible, acceptable and&#xD;
      more effective for helping participants move across stages of change and for meeting their&#xD;
      goals than the less intensive program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A pragmatic mixed methods design including a randomized controlled trial and qualitative&#xD;
      components will be used for this pilot study. The randomized controlled trial will include a&#xD;
      1:1 allocation comparing a more intensive program (MIP - usual care plus healthy lifestyles&#xD;
      program) with a less intensive program (LIP - usual care plus development of health goals).&#xD;
&#xD;
      The qualitative components include semi-structured interviews of participants (exit&#xD;
      interviews at 12 months), MIP staff and participants' healthcare providers (at 6 months and&#xD;
      12 months). In addition, focus groups will be conducted with family members of MIP&#xD;
      participants at 9 months. These elements will provide perspectives from multiple stakeholders&#xD;
      for improving the healthy lifestyles program and on their roles in creating and maintaining&#xD;
      healthy lifestyles.&#xD;
&#xD;
      The primary aim of this study is to assess the feasibility and implementation of the healthy&#xD;
      lifestyles program. Impact on participant experiences and outcomes will also be measured.&#xD;
      Findings from this study will help inform a larger randomized trial to further look at&#xD;
      effectiveness of the program and to determine health system implications. A 2-year extension&#xD;
      was approved in order to determine sustainability of findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2018</start_date>
  <completion_date type="Actual">September 22, 2021</completion_date>
  <primary_completion_date type="Actual">October 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Enrolled participants will be allocated to one of the two intervention groups for the duration of the study. One group will be assigned to the more intensive program (MIP= usual care plus healthy lifestyles program) and the other group will be assigned to the less intensive program (LIP= usual care plus health goal development).</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The amount of exposure to the programs will be known to participants and providers.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Retention rates</measure>
    <time_frame>Baseline to 12 months</time_frame>
    <description>Number of participants recruited and number of participants completing the program</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in health goals - Stage of change over time</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months</time_frame>
    <description>For each health goal, stage of change will be determined with a 7-point Likert scale. Comparisons will be made with baseline but also with other time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health goals - Self-efficacy over time</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months</time_frame>
    <description>For each health goal, self-efficacy will be determined with a 7-point Likert scale. Comparisons will be made with baseline but also with other time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health goals - Goal achievement over time</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months</time_frame>
    <description>For each health goal, goal achievement will be determined with a 7-point Likert scale. Comparisons will be made with baseline but also with other time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health-related quality of life on the SF-36</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months</time_frame>
    <description>Using a validated scale, health-related quality of life will be measured over time. Comparisons will be made with baseline but also with other time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health-related quality of life on the Health Utilities Index (HUI) 2/3</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months</time_frame>
    <description>Using a validated scale, health-related quality of life will be measured over time. Comparisons will be made with baseline but also with other time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Patient Health Questionnaire (PHQ)</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months</time_frame>
    <description>Using a validated scale, five common mental health conditions (depression, anxiety, alcohol misuse, somatoform disorder and bulimia) will be measured over time. Comparisons will be made with baseline but also with other time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Insomnia Severity Index (ISI)</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months</time_frame>
    <description>Using a validated scale, signs and symptoms of insomnia will be measured over time. Comparisons will be made with baseline but also with other time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the Perceived Stress Scale</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months</time_frame>
    <description>Using a validated scale, signs and symptoms of perceived stress will be measured over time. Comparisons will be made with baseline but also with other time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in the DeJong Gierveld 6-item Loneliness Scale</measure>
    <time_frame>Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months</time_frame>
    <description>Using a validated scale, emotional and social loneliness will be measured over time. Comparisons will be made with baseline but also with other time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure</measure>
    <time_frame>Baseline and 12 months, 24 months, 36 months</time_frame>
    <description>Both systolic and diastolic blood pressure will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weight</measure>
    <time_frame>Baseline and 12 months, 24 months, 36 months</time_frame>
    <description>Weight will be measured in kilograms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body mass index (BMI)</measure>
    <time_frame>Baseline and 12 months, 24 months, 36 months</time_frame>
    <description>Weight and height will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in waist circumference</measure>
    <time_frame>Baseline and 12 months, 24 months, 36 months</time_frame>
    <description>Measured around waist with a tape measure in inches</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in waist:hip ratio</measure>
    <time_frame>Baseline and 12 months, 24 months, 36 months</time_frame>
    <description>Measured around waist and hips with a tape measure in inches</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Health Behavior</condition>
  <condition>Quality of Life</condition>
  <condition>Chronic Disease</condition>
  <condition>Health Promotion</condition>
  <condition>Stress</condition>
  <condition>Mental Health Wellness 1</condition>
  <arm_group>
    <arm_group_label>More Intensive Program (MIP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the more intensive program, which combines usual care with the full version of the healthy lifestyles program. Participants in this arm will meet weekly for group health and wellness learning sessions or brainstorming group sessions. In addition, they will meet monthly for individual sessions with a multidisciplinary health team, including a family physician, physical therapist and dietician to tailor their health goal development and action plans to their particular needs and situations. They will be asked to maintain physical activity and nutrition journals for a week each every three months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Less Intensive Program (LIP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the less intensive program, which combines usual care along with health goal development. Participants in this arm will meet at baseline to set health goals with the support of a research assistant trained in theories of health behaviour and goal setting. They will also meet every three months to measure progress in achieving their goals. They will be asked to maintain physical activity and nutrition journals for a week each every three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health and wellness learning sessions</intervention_name>
    <description>The health and wellness learning sessions provide a platform for concepts from a variety of health behaviour theories and CBT to be combined with evidence- and practice-based recommendations for healthy lifestyles. They provide the basis for participants' development of an individualized action plan. The sessions will last one hour and participants will receive them in a group setting, 18 times throughout the duration of the program. Specifically, the sessions will be delivered during weeks: 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48.</description>
    <arm_group_label>More Intensive Program (MIP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brainstorming group sessions</intervention_name>
    <description>The brainstorming group sessions allow for facilitated discussions where individuals explore barriers and facilitators to achieving their goals and provide an interpersonal component to the program through the building of social interactions. Participants will also receive help in finding community programs to support healthy lifestyles. These sessions will last one hour and participants will receive them in a group setting, 30 times throughout the duration of the program. Specifically, these sessions will be delivered during weeks: 9-11, 13-15, 17-19, 21-23, 25-27, 29-31, 33-35, 37-39, 41-43, 45-47.</description>
    <arm_group_label>More Intensive Program (MIP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individual sessions with a multidisciplinary health team</intervention_name>
    <description>Monthly individual sessions with a family physician trained in medical CBT, a dietician and a physical therapist help individuals tailor their action plans and recommendations to their particular circumstances and provide supports based on their needs. The initial session will last 3 hours and occur at baseline. The follow-up sessions will last 1 hour.</description>
    <arm_group_label>More Intensive Program (MIP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health goal development</intervention_name>
    <description>Participants in both arms will develop health goals. Several components of these goals will be measured throughout the study, including the stage of change, self-efficacy and actual goal achievement. In the more intensive program arm, participants will develop health goals and learn about how to meet those goals through the group and individual sessions. In the less intensive program arm, participants will receive support in developing health goals from a research assistant trained in theories of health behaviour and in goal setting at baseline, 3 months, 6 months, 9 months and 12 months. The initial goal setting session will be provided within a time period of 2 hours, and the follow-up sessions will be provided within one hour time periods.</description>
    <arm_group_label>Less Intensive Program (LIP)</arm_group_label>
    <arm_group_label>More Intensive Program (MIP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical activity and nutrition journals</intervention_name>
    <description>Participants in both arm will be asked to maintain a physical activity journal and a nutrition journal for a week each every three months. These journals help participants reflect on current behaviours and areas for change.</description>
    <arm_group_label>Less Intensive Program (LIP)</arm_group_label>
    <arm_group_label>More Intensive Program (MIP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for randomized controlled trial:&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
        Inclusion criteria for qualitative components (family focus groups):&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  16 years of age or older&#xD;
&#xD;
          -  related to participants in randomized controlled trial&#xD;
&#xD;
        Inclusion criteria for qualitative components (program staff):&#xD;
&#xD;
          -  Provide services within the more intensive program&#xD;
&#xD;
        Inclusion criteria for qualitative components (healthcare providers):&#xD;
&#xD;
          -  Provide health care outside of the healthy lifestyles program for participants in&#xD;
             randomized controlled trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NA&#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>Elizabeth Alvarez, MD, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McMaster University</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.who.int/mediacentre/factsheets/fs311/en/</url>
    <description>Obesity and overweight</description>
  </link>
  <link>
    <url>http://www.obesitynetwork.ca/obesity-in-canada</url>
    <description>Obesity in Canada</description>
  </link>
  <link>
    <url>http://www.webmd.com/children/news/20110916/obesity-puts-young-kids-at-risk-of-social-isolation</url>
    <description>Obesity Puts Young Kids at Risk of Social Isolation</description>
  </link>
  <link>
    <url>http://www.cbc.ca/news/health/socializing-key-to-successful-aging-1.1260922</url>
    <description>Socializing key to &quot;successful aging&quot;</description>
  </link>
  <link>
    <url>http://www.metronews.ca/news/toronto/2016/06/21/mental-health-wait-times-not-just-a-problem-in-small-communities.html</url>
    <description>Mental health wait times a serious problem across Ontario, say advocates</description>
  </link>
  <link>
    <url>https://www.thestar.com/life/health_wellness/2015/05/05/ontario-youth-wait-a-year-or-more-for-mental-health-care-report.html</url>
    <description>Ontario youth wait a year or more for mental health care: report</description>
  </link>
  <link>
    <url>https://www.theglobeandmail.com/life/health-and-fitness/health/taking-patient-centred-care-from-rhetoric-to-reality/article31077949/</url>
    <description>Taking patient-centred health care from rhetoric to reality</description>
  </link>
  <link>
    <url>https://www.simplypsychology.org/maslow.html</url>
    <description>Maslow's Hierarchy of Needs</description>
  </link>
  <link>
    <url>https://www.google.ca/search?q=prochaska+and+diclemente%27s+stages+of+change+model&amp;ie=utf-8&amp;oe=utf-8&amp;gws_rd=cr&amp;ei=U__kWM3gDsrqjwTq1ZT4Dg</url>
    <description>Prochaska and diclemente's stages of change model - Google Search</description>
  </link>
  <link>
    <url>http://digitalcommons.unl.edu/dissertations/AAI3487306</url>
    <description>Mixed methods embedded design in medical education, mental health and health services research: A methodological analysis</description>
  </link>
  <link>
    <url>http://guidelines.diabetes.ca/browse/chapter4</url>
    <description>Chapter 4: Screening for Type 1 and Type 2 Diabetes</description>
  </link>
  <link>
    <url>https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html</url>
    <description>36-Item Short Form Survey (SF-36)</description>
  </link>
  <link>
    <url>https://hqlo.biomedcentral.com/articles/10.1186/1477-7525-1-54</url>
    <description>HUI Update</description>
  </link>
  <link>
    <url>https://www.sheffield.ac.uk/scharr/sections/heds/mvh/hui2</url>
    <description>Measuring and Valuing Health</description>
  </link>
  <link>
    <url>http://www.phqscreeners.com/</url>
    <description>Patient Healthcare Questionnaire</description>
  </link>
  <link>
    <url>https://doi.org/10.1016/S1389-9457(00)00065-4</url>
    <description>Validation of the Insomnia Severity Index as an outcome measure for insomnia research</description>
  </link>
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  </reference>
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    <citation>Kohrt BA, Luitel NP, Acharya P, Jordans MJ. Detection of depression in low resource settings: validation of the Patient Health Questionnaire (PHQ-9) and cultural concepts of distress in Nepal. BMC Psychiatry. 2016 Mar 8;16:58. doi: 10.1186/s12888-016-0768-y.</citation>
    <PMID>26951403</PMID>
  </reference>
  <reference>
    <citation>Seo JG, Park SP. Validation of the Generalized Anxiety Disorder-7 (GAD-7) and GAD-2 in patients with migraine. J Headache Pain. 2015;16:97. doi: 10.1186/s10194-015-0583-8. Epub 2015 Nov 23.</citation>
    <PMID>26596588</PMID>
  </reference>
  <reference>
    <citation>Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.</citation>
    <PMID>15550799</PMID>
  </reference>
  <reference>
    <citation>Lynch DJ, McGrady A, Alvarez E, Forman J. Recent life changes and medical utilization in an academic family practice. J Nerv Ment Dis. 2005 Sep;193(9):633-5. doi: 10.1097/01.nmd.0000177778.27069.77.</citation>
    <PMID>16131948</PMID>
  </reference>
  <reference>
    <citation>Reis RS, Hino AA, Anez CR. Perceived stress scale: reliability and validity study in Brazil. J Health Psychol. 2010 Jan;15(1):107-14. doi: 10.1177/1359105309346343.</citation>
    <PMID>20064889</PMID>
  </reference>
  <reference>
    <citation>Leung DY, Lam TH, Chan SS. Three versions of Perceived Stress Scale: validation in a sample of Chinese cardiac patients who smoke. BMC Public Health. 2010 Aug 25;10:513. doi: 10.1186/1471-2458-10-513.</citation>
    <PMID>20735860</PMID>
  </reference>
  <reference>
    <citation>Grygiel P, Humenny G, Rebisz S. Using the De Jong Gierveld Loneliness Scale With Early Adolescents: Factor Structure, Reliability, Stability, and External Validity. Assessment. 2019 Mar;26(2):151-165. doi: 10.1177/1073191116682298. Epub 2016 Dec 8.</citation>
    <PMID>27932403</PMID>
  </reference>
  <reference>
    <citation>Horowitz CR, Robinson M, Seifer S. Community-based participatory research from the margin to the mainstream: are researchers prepared? Circulation. 2009 May 19;119(19):2633-42. doi: 10.1161/CIRCULATIONAHA.107.729863.</citation>
    <PMID>19451365</PMID>
  </reference>
  <reference>
    <citation>Anderson JB. Unraveling health disparities: examining the dimensions of hypertension and diabetes through community engagement. J Health Care Poor Underserved. 2005 Nov;16(4 Suppl A):91-117. doi: 10.1353/hpu.2005.0121.</citation>
    <PMID>16327099</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>Elizabeth Alvarez</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Pragmatic</keyword>
  <keyword>Pilot study</keyword>
  <keyword>Mixed methods</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Implementation research</keyword>
  <keyword>Person-centered care</keyword>
  <keyword>Multidisciplinary</keyword>
  <keyword>Ecological approach</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03258138/Prot_SAP_005.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Participants</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>October 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03258138/ICF_006.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Healthcare providers</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>October 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03258138/ICF_007.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Program staff</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>October 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03258138/ICF_008.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Family members</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>October 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03258138/ICF_009.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/NCT03258138
org study id: Healthy lifestyles pilot
nct id: NCT03258138
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic conditions, such as obesity and diabetes, are increasing worldwide. Lifestyle changes
      (e.g., physical activity, healthy diet, sufficient sleep, managing stress, smoking cessation)
      are often recommended to prevent or manage these conditions, but changing habits is
      difficult. Mental health can play a role in the ability to seek out and follow through on the
      changes necessary to achieve or maintain a healthy lifestyle, yet this aspect is rarely
      addressed, and access to mental health services is often limited. Furthermore, individuals
      are influenced by factors at the individual, interpersonal, community and policy levels
      (e.g., lack of socialization, unsafe neighborhoods). These factors can act as barriers and
      need to be addressed in order for individuals to make sustainable lifestyle changes.

      A new year-long person-centered healthy lifestyles program is proposed to address the "how
      to" gap in making lifestyle changes through a combination of individual and group sessions.
      The feasibility and implementation of this new program will be evaluated through a pilot
      study looking at the full healthy lifestyles program compared to a less intensive version of
      the program. The study's hypothesis is that the full program will be feasible, acceptable and
      more effective for helping participants move across stages of change and for meeting their
      goals than the less intensive program.
A pragmatic mixed methods design including a randomized controlled trial and qualitative
      components will be used for this pilot study. The randomized controlled trial will include a
      1:1 allocation comparing a more intensive program (MIP - usual care plus healthy lifestyles
      program) with a less intensive program (LIP - usual care plus development of health goals).

      The qualitative components include semi-structured interviews of participants (exit
      interviews at 12 months), MIP staff and participants' healthcare providers (at 6 months and
      12 months). In addition, focus groups will be conducted with family members of MIP
      participants at 9 months. These elements will provide perspectives from multiple stakeholders
      for improving the healthy lifestyles program and on their roles in creating and maintaining
      healthy lifestyles.

      The primary aim of this study is to assess the feasibility and implementation of the healthy
      lifestyles program. Impact on participant experiences and outcomes will also be measured.
      Findings from this study will help inform a larger randomized trial to further look at
      effectiveness of the program and to determine health system implications. A 2-year extension
      was approved in order to determine sustainability of findings.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Enrolled participants will be allocated to one of the two intervention groups for the duration of the study. One group will be assigned to the more intensive program (MIP= usual care plus healthy lifestyles program) and the other group will be assigned to the less intensive program (LIP= usual care plus health goal development).
primary purpose: Health Services Research
masking: None (Open Label)
masking description: The amount of exposure to the programs will be known to participants and providers.
measure: Retention rates
time frame: Baseline to 12 months
description: Number of participants recruited and number of participants completing the program
measure: Changes in health goals - Stage of change over time
time frame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
description: For each health goal, stage of change will be determined with a 7-point Likert scale. Comparisons will be made with baseline but also with other time points.
measure: Changes in health goals - Self-efficacy over time
time frame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
description: For each health goal, self-efficacy will be determined with a 7-point Likert scale. Comparisons will be made with baseline but also with other time points.
measure: Changes in health goals - Goal achievement over time
time frame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
description: For each health goal, goal achievement will be determined with a 7-point Likert scale. Comparisons will be made with baseline but also with other time points.
measure: Changes in health-related quality of life on the SF-36
time frame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
description: Using a validated scale, health-related quality of life will be measured over time. Comparisons will be made with baseline but also with other time points.
measure: Changes in health-related quality of life on the Health Utilities Index (HUI) 2/3
time frame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
description: Using a validated scale, health-related quality of life will be measured over time. Comparisons will be made with baseline but also with other time points.
measure: Changes in the Patient Health Questionnaire (PHQ)
time frame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
description: Using a validated scale, five common mental health conditions (depression, anxiety, alcohol misuse, somatoform disorder and bulimia) will be measured over time. Comparisons will be made with baseline but also with other time points.
measure: Changes in the Insomnia Severity Index (ISI)
time frame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
description: Using a validated scale, signs and symptoms of insomnia will be measured over time. Comparisons will be made with baseline but also with other time points.
measure: Changes in the Perceived Stress Scale
time frame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
description: Using a validated scale, signs and symptoms of perceived stress will be measured over time. Comparisons will be made with baseline but also with other time points.
measure: Changes in the DeJong Gierveld 6-item Loneliness Scale
time frame: Baseline, 3 months, 6 months, 9 months and 12 months, 18 months, 24 months, 30 months, 36 months
description: Using a validated scale, emotional and social loneliness will be measured over time. Comparisons will be made with baseline but also with other time points.
measure: Changes in blood pressure
time frame: Baseline and 12 months, 24 months, 36 months
description: Both systolic and diastolic blood pressure will be measured
measure: Changes in weight
time frame: Baseline and 12 months, 24 months, 36 months
description: Weight will be measured in kilograms
measure: Changes in body mass index (BMI)
time frame: Baseline and 12 months, 24 months, 36 months
description: Weight and height will be combined to report BMI in kg/m^2
measure: Changes in waist circumference
time frame: Baseline and 12 months, 24 months, 36 months
description: Measured around waist with a tape measure in inches
measure: Changes in waist:hip ratio
time frame: Baseline and 12 months, 24 months, 36 months
description: Measured around waist and hips with a tape measure in inches
arm group label: More Intensive Program (MIP)
arm group type: Experimental
description: Participants will receive the more intensive program, which combines usual care with the full version of the healthy lifestyles program. Participants in this arm will meet weekly for group health and wellness learning sessions or brainstorming group sessions. In addition, they will meet monthly for individual sessions with a multidisciplinary health team, including a family physician, physical therapist and dietician to tailor their health goal development and action plans to their particular needs and situations. They will be asked to maintain physical activity and nutrition journals for a week each every three months.
arm group label: Less Intensive Program (LIP)
arm group type: Experimental
description: Participants will receive the less intensive program, which combines usual care along with health goal development. Participants in this arm will meet at baseline to set health goals with the support of a research assistant trained in theories of health behaviour and goal setting. They will also meet every three months to measure progress in achieving their goals. They will be asked to maintain physical activity and nutrition journals for a week each every three months.
intervention type: Behavioral
intervention name: Health and wellness learning sessions
description: The health and wellness learning sessions provide a platform for concepts from a variety of health behaviour theories and CBT to be combined with evidence- and practice-based recommendations for healthy lifestyles. They provide the basis for participants' development of an individualized action plan. The sessions will last one hour and participants will receive them in a group setting, 18 times throughout the duration of the program. Specifically, the sessions will be delivered during weeks: 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48.
arm group label: More Intensive Program (MIP)
intervention type: Behavioral
intervention name: Brainstorming group sessions
description: The brainstorming group sessions allow for facilitated discussions where individuals explore barriers and facilitators to achieving their goals and provide an interpersonal component to the program through the building of social interactions. Participants will also receive help in finding community programs to support healthy lifestyles. These sessions will last one hour and participants will receive them in a group setting, 30 times throughout the duration of the program. Specifically, these sessions will be delivered during weeks: 9-11, 13-15, 17-19, 21-23, 25-27, 29-31, 33-35, 37-39, 41-43, 45-47.
arm group label: More Intensive Program (MIP)
intervention type: Behavioral
intervention name: Individual sessions with a multidisciplinary health team
description: Monthly individual sessions with a family physician trained in medical CBT, a dietician and a physical therapist help individuals tailor their action plans and recommendations to their particular circumstances and provide supports based on their needs. The initial session will last 3 hours and occur at baseline. The follow-up sessions will last 1 hour.
arm group label: More Intensive Program (MIP)
intervention type: Behavioral
intervention name: Health goal development
description: Participants in both arms will develop health goals. Several components of these goals will be measured throughout the study, including the stage of change, self-efficacy and actual goal achievement. In the more intensive program arm, participants will develop health goals and learn about how to meet those goals through the group and individual sessions. In the less intensive program arm, participants will receive support in developing health goals from a research assistant trained in theories of health behaviour and in goal setting at baseline, 3 months, 6 months, 9 months and 12 months. The initial goal setting session will be provided within a time period of 2 hours, and the follow-up sessions will be provided within one hour time periods.
arm group label: Less Intensive Program (LIP)
arm group label: More Intensive Program (MIP)
intervention type: Behavioral
intervention name: Physical activity and nutrition journals
description: Participants in both arm will be asked to maintain a physical activity journal and a nutrition journal for a week each every three months. These journals help participants reflect on current behaviours and areas for change.
arm group label: Less Intensive Program (LIP)
arm group label: More Intensive Program (MIP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elizabeth Alvarez, MD, MPH, PhD
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
url: http://www.who.int/mediacentre/factsheets/fs311/en/
description: Obesity and overweight
url: http://www.obesitynetwork.ca/obesity-in-canada
description: Obesity in Canada
url: http://www.webmd.com/children/news/20110916/obesity-puts-young-kids-at-risk-of-social-isolation
description: Obesity Puts Young Kids at Risk of Social Isolation
url: http://www.cbc.ca/news/health/socializing-key-to-successful-aging-1.1260922
description: Socializing key to "successful aging"
url: http://www.metronews.ca/news/toronto/2016/06/21/mental-health-wait-times-not-just-a-problem-in-small-communities.html
description: Mental health wait times a serious problem across Ontario, say advocates
url: https://www.thestar.com/life/health_wellness/2015/05/05/ontario-youth-wait-a-year-or-more-for-mental-health-care-report.html
description: Ontario youth wait a year or more for mental health care: report
url: https://www.theglobeandmail.com/life/health-and-fitness/health/taking-patient-centred-care-from-rhetoric-to-reality/article31077949/
description: Taking patient-centred health care from rhetoric to reality
url: https://www.simplypsychology.org/maslow.html
description: Maslow's Hierarchy of Needs
url: https://www.google.ca/search?q=prochaska+and+diclemente%27s+stages+of+change+model&ie=utf-8&oe=utf-8&gws_rd=cr&ei=U__kWM3gDsrqjwTq1ZT4Dg
description: Prochaska and diclemente's stages of change model - Google Search
url: http://digitalcommons.unl.edu/dissertations/AAI3487306
description: Mixed methods embedded design in medical education, mental health and health services research: A methodological analysis
url: http://guidelines.diabetes.ca/browse/chapter4
description: Chapter 4: Screening for Type 1 and Type 2 Diabetes
url: https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html
description: 36-Item Short Form Survey (SF-36)
url: https://hqlo.biomedcentral.com/articles/10.1186/1477-7525-1-54
description: HUI Update
url: https://www.sheffield.ac.uk/scharr/sections/heds/mvh/hui2
description: Measuring and Valuing Health
url: http://www.phqscreeners.com/
description: Patient Healthcare Questionnaire
url: https://doi.org/10.1016/S1389-9457(00)00065-4
description: Validation of the Insomnia Severity Index as an outcome measure for insomnia research
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citation: Marshall D, Pericak D, Grootendorst P, Gooch K, Faris P, Frank C, Bellamy N, Torrance G, Feeny D. Validation of a prediction model to estimate health utilities index Mark 3 utility scores from WOMAC index scores in patients with osteoarthritis of the hip. Value Health. 2008 May-Jun;11(3):470-7. doi: 10.1111/j.1524-4733.2007.00258.x.
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citation: Kohrt BA, Luitel NP, Acharya P, Jordans MJ. Detection of depression in low resource settings: validation of the Patient Health Questionnaire (PHQ-9) and cultural concepts of distress in Nepal. BMC Psychiatry. 2016 Mar 8;16:58. doi: 10.1186/s12888-016-0768-y.
PMID: 26951403
citation: Seo JG, Park SP. Validation of the Generalized Anxiety Disorder-7 (GAD-7) and GAD-2 in patients with migraine. J Headache Pain. 2015;16:97. doi: 10.1186/s10194-015-0583-8. Epub 2015 Nov 23.
PMID: 26596588
citation: Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.
PMID: 15550799
citation: Lynch DJ, McGrady A, Alvarez E, Forman J. Recent life changes and medical utilization in an academic family practice. J Nerv Ment Dis. 2005 Sep;193(9):633-5. doi: 10.1097/01.nmd.0000177778.27069.77.
PMID: 16131948
citation: Reis RS, Hino AA, Anez CR. Perceived stress scale: reliability and validity study in Brazil. J Health Psychol. 2010 Jan;15(1):107-14. doi: 10.1177/1359105309346343.
PMID: 20064889
citation: Leung DY, Lam TH, Chan SS. Three versions of Perceived Stress Scale: validation in a sample of Chinese cardiac patients who smoke. BMC Public Health. 2010 Aug 25;10:513. doi: 10.1186/1471-2458-10-513.
PMID: 20735860
citation: Grygiel P, Humenny G, Rebisz S. Using the De Jong Gierveld Loneliness Scale With Early Adolescents: Factor Structure, Reliability, Stability, and External Validity. Assessment. 2019 Mar;26(2):151-165. doi: 10.1177/1073191116682298. Epub 2016 Dec 8.
PMID: 27932403
citation: Horowitz CR, Robinson M, Seifer S. Community-based participatory research from the margin to the mainstream: are researchers prepared? Circulation. 2009 May 19;119(19):2633-42. doi: 10.1161/CIRCULATIONAHA.107.729863.
PMID: 19451365
citation: Anderson JB. Unraveling health disparities: examining the dimensions of hypertension and diabetes through community engagement. J Health Care Poor Underserved. 2005 Nov;16(4 Suppl A):91-117. doi: 10.1353/hpu.2005.0121.
PMID: 16327099
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: Elizabeth Alvarez
investigator title: Assistant Professor
mesh term: Chronic Disease
sharing ipd: No
provided document: 
provided document: 
provided document: 
provided document: 
provided document: 