<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/NCT02264366</url>
  </required_header>
  <id_info>
    <org_study_id>ACCELERATION</org_study_id>
    <nct_id>NCT02264366</nct_id>
  </id_info>
  <brief_title>Activity ,Smoking Cessation, Healthy Eating and Alcohol Intervention Program:(ACCELERATION)</brief_title>
  <official_title>ACCELERATION: An Activity,Smoking Cessation, Healthy Eating and Alcohol Intervention Program With Motivational Supports Aimed at Chronic Disease Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Concordia University, Montreal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ACCELERATION (ACtivity, smoking Cessation, healthy Eating and aLcohol Education,&#xD;
      inteRvention, and motivATION) Program is a collaborative project in cancer and chronic&#xD;
      disease prevention that has been designed by and will be delivered amongst cardiopulmonary&#xD;
      rehabilitation and prevention programs and cancer centres in Ontario (ON), British Columbia&#xD;
      (BC), Quebec (QC) and Nova Scotia (NS). This project is being funded by the Canadian&#xD;
      Partnership Against Cancer, Health Canada and Heart and Stroke Foundation of Canada and in&#xD;
      the amount of $2.4M over a 3 year period (October 2013 - September 2016). The ACCELERATION&#xD;
      Program is a 12 week structured model of behavioural interventions and education around&#xD;
      self-management and prevention that aims to access readily available and referable people for&#xD;
      primary prevention intervention.This program aligns with current provincial, national and&#xD;
      international chronic disease prevention and management strategies. The goal of the&#xD;
      ACCELERATION program is to measurably and effectively change the risk factors and health&#xD;
      behaviours known to impact cancer and other chronic diseases. Specifically we will aim to&#xD;
      increase physical activity, reduce smoking, encourage healthy eating, and moderate alcohol&#xD;
      consumption in about 3,000 participants across Canada over 3 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic diseases including cancer, cardiovascular disease, lung conditions and diabetes are&#xD;
      the leading cause of mortality and morbidity in Canada and worldwide. These chronic&#xD;
      conditions share common modifiable risk factors including physical inactivity, suboptimal&#xD;
      nutrition, smoking and excessive alcohol intake. Cardiac rehabilitation centres in this&#xD;
      Coalition have been providing primary and secondary prevention services for many years&#xD;
      focused on these behavioural risks, and many of our participants with heart disease also have&#xD;
      co-morbidities including cancer, diabetes and lung disease. Co-morbidities are a clinical&#xD;
      reality, and we no longer deal with diseases singularly. Today, our client population is more&#xD;
      diverse than ever and fiscal constraints call for the pooling of prevention resources to&#xD;
      simultaneously address a range of chronic diseases impacted by common risk factors.&#xD;
&#xD;
      Extending our reach to populations at risk of cancer and other chronic diseases, populations&#xD;
      which are readily available and referable In Ontario, UHN/Toronto Rehab has a cancer program&#xD;
      for women who have survived breast cancer as well as women undergoing cancer treatment.&#xD;
      Discussions with Princess Margaret Hospital point to opportunities to extend programming to&#xD;
      more cancer patients and people at risk of cancer. The ELLICSR arm of Princess Margaret&#xD;
      Hospital, which focuses on helping survivors, has expressed interest in collaborating to&#xD;
      reach family and friends of cancer survivors, for primary prevention. Likewise, the Odette&#xD;
      Cancer Centre at Sunnybrook Hospital sees over 900 new women every year who are referred due&#xD;
      to a family history of breast cancer. They have expressed to us that they can identify and&#xD;
      will refer women at high risk of developing breast cancer into our proposed primary&#xD;
      prevention program. Similarly, in Quebec, L'Hôpital du Sacré-Cœur de Montréal has one of the&#xD;
      nation's highest rated lung cancer groups. Our Quebec partner, Centre de réadaptation&#xD;
      cardio-respiratoire Jean-Jacques-Gauthier (CRJJG) has strong ties to this program. With&#xD;
      funding, they will be able to reach and deliver prevention programmes to the family and&#xD;
      friends of their lung cancer clients, an opportunity that exists because family and friends&#xD;
      tend to be more engaged and open to the possibility of lifestyle change.&#xD;
&#xD;
      This is why we have partnered with these cancer centres in this Coalition: to formalize our&#xD;
      existing partnerships and focus our resources on the population at risk of cancer that is&#xD;
      readily available and referable for primary prevention.&#xD;
&#xD;
      The links that our Coalition partners have with primary care hold opportunities not yet&#xD;
      seized. In Ontario, the Department of Family and Community Medicine at Sunnybrook has many&#xD;
      patients at risk for, or with, multiple chronic diseases.&#xD;
&#xD;
      The opportunity that exists to reach pregnant women with obesity-related risks is one that&#xD;
      could be seized Canada-wide. The unfortunate reality is that obesity complicates about 50% of&#xD;
      pregnancies today.&#xD;
&#xD;
      The opportunity, and need, to impact a person's family and social circle Our program concept&#xD;
      is founded on the idea that 'you really need to get the whole family' to sustain the&#xD;
      long-term impact of prevention and change in behaviour. We know there is evidence that&#xD;
      family/social support can help. A systematic review on childhood obesity identified promising&#xD;
      strategies that included parent support and home activities that encourage children to be&#xD;
      more active, eat more nutritious foods and spend less time in screen-based activities (Waters&#xD;
      et al, 2011).&#xD;
&#xD;
      As Lead Agency, the UHN/Toronto Rehab already runs a successful Cardiac Rehab @ Home program&#xD;
      which is a six-month program that sees approximately 120 clients per year. The average client&#xD;
      lives approximately 200kms away from the urban area, is younger, and more likely to be&#xD;
      working, compared to on-site clients. An evaluation has shown that the program is effective&#xD;
      with similar outcomes as an on-site program: clients made the same gains in cardiovascular&#xD;
      fitness and were just as likely to adhere to the program. The study also showed that such&#xD;
      programs are more cost-effective than on-site programs for participants living in remote&#xD;
      areas (Scane et al, 2012).&#xD;
&#xD;
      Deepening and broadening our reach to selected at risk populations already connected to us.&#xD;
&#xD;
      Many of the core partners not only have links to their local communities but have years of&#xD;
      collaboration with the community on prevention. Notably, our BC partner, the BC&#xD;
      Cardiovascular Physiology &amp; Rehabilitation Laboratory, has extensive primary prevention&#xD;
      experience having worked with more than 300,000 participants in the past 10 years on&#xD;
      community-based programs for children (school-based and out-of-school), workplace wellness&#xD;
      (e.g. police and firefighters) and population groups at risk for chronic disease.&#xD;
&#xD;
      Additionally, they have solid partnerships with Aboriginal communities throughout BC. Formal&#xD;
      partnerships have been forged with Aboriginal communities throughout BC including extensive&#xD;
      research in rural and remote communities.&#xD;
&#xD;
      Through the Coalition's work and history with the Aboriginal communities, and because they&#xD;
      know there is evidence that there are health benefits for Aboriginal peoples in participating&#xD;
      in a community-based physical activity intervention , the ACCELERATION program could be&#xD;
      delivered with relative ease to these communities in BC.&#xD;
&#xD;
      The Centre de réadaptation cardio-respiratoire Jean-Jacques-Gauthier (CRJJG) provides&#xD;
      prevention programming for patients with cardiovascular (heart disease and heart failure) and&#xD;
      respiratory disease (chronic obstructive pulmonary disease and asthma). One very unique&#xD;
      aspect is the ongoing asthma prevention work of this coalition member. This adult asthma&#xD;
      population are, on average, younger than most classical rehabilitation groups (ca. 40 years&#xD;
      old) and, whilst not having overt cancer or cardiovascular disease, do normally display&#xD;
      several risk factors, which provides a model of engaging and adapting the ACCELERATION&#xD;
      program to these kinds of populations.&#xD;
&#xD;
      Furthermore, the CRJJG is conveniently housed within the YMCA Cartierville. There is,&#xD;
      therefore, already a strong partnership with the YMCA. The proposed program will allow our&#xD;
      Quebec partner to deliver a prevention program to YMCA users with risk factors or a family&#xD;
      history of chronic diseases. In addition, the YMCA Cartierville has a unique partnership with&#xD;
      the local council where it provides free access to non-YMCA local community members, thus&#xD;
      allowing the ACCELERATION programme to be delivered to a very diverse cultural and&#xD;
      socio-economic community base.&#xD;
&#xD;
      Finally, the CRJJG has specific expertise in motivational interviewing (MI) , which is a&#xD;
      client-centred communication tool focusing on enhancing intrinsic motivation to change a&#xD;
      particular behaviour, and exploring and resolving ambivalence about behavior change (Lavoie&#xD;
      et al, 2012).&#xD;
&#xD;
      At the Eastern end of Canada, the province of Nova Scotia has one of the highest rates of&#xD;
      cardiovascular disease in the country with a prevalence of 6.4% (Heart and Stroke Foundation,&#xD;
      2012). There is also an excess incidence and prevalence of lung, colorectal, prostate,&#xD;
      melanoma and breast cancer (Canadian Cancer Society). This is one reason we chose to partner&#xD;
      with Nova Scotia. Our partner runs the Community Cardiovascular Hearts in Motion (CCHIM)&#xD;
      program which is a community-based exercise and health education program. Referrals are&#xD;
      accepted from predominantly family doctors but also other specialists and allied health&#xD;
      professionals including physiotherapists, nurse practitioners and diabetes clinics. Patients&#xD;
      expand the complete vascular spectrum from primary care to all levels of secondary&#xD;
      prevention. There is also a Heart Health Clinic available to assist those individuals living&#xD;
      with more complicated and higher risk cardiac and pulmonary disease (tertiary). The successes&#xD;
      of this program are translatable to the ACCELERATION program that targets people at risk of&#xD;
      cancer and chronic diseases, as well as family and friends of people who have suffered an&#xD;
      acute event associated with a chronic disease.&#xD;
&#xD;
      Our Nova Scotia partner notes that there is strong representation of females in the primary&#xD;
      prevention arm of CCHIM and most of these are obese with diabetes. The planned Ontario&#xD;
      program with ante- and post-partum women at risk of obesity-related cancer is replicable for&#xD;
      the Nova Scotia female population, and we would seek to transfer knowledge and replicate the&#xD;
      program in Nova Scotia as well.&#xD;
&#xD;
      There is also an opportunity to reach the underserviced black population. Incidence rate&#xD;
      ratios for African Canadians relative to the general population of Nova Scotia were&#xD;
      significantly elevated for circulatory disease, diabetes and psychiatric disorders (Kisely et&#xD;
      al, 2008). Our Nova Scotia partner (CCHIM) sees opportunity in providing a virtual program&#xD;
      for this population. CCHIM is in present development of translational research to move beyond&#xD;
      the &quot;bricks and mortar&quot; to reach such patient populations who are in need of such a program&#xD;
      by virtue of risk or established disease but cannot, or will not, attend. This will be run&#xD;
      through the primary care physician and local health care teams (such as NP clinics, addiction&#xD;
      services, etc). It will allow for adaptation and implementation when the patient is &quot;ready&quot;&#xD;
      to engage (similar to smoking cessation as per the &quot;Ottawa Model&quot;). This approach will be&#xD;
      adapted to the present project in an effort to expand its exposure further while evaluating&#xD;
      the elements that are sustainable upon project completion.&#xD;
&#xD;
      In Ontario, the South Asian population is the largest visible minority group in Ontario, and&#xD;
      one with a higher prevalence of chronic diseases compared to other groups (Statistics Canada,&#xD;
      2010; Fraser Health, 2013). They would benefit from a targeted program like ACCELERATION that&#xD;
      is customized for them, and made culturally appropriate to their beliefs, values and customs.&#xD;
&#xD;
      Deepening prevention impact in workplaces Two of our key partners (BC and NS) have existing&#xD;
      partnerships with large employers.&#xD;
&#xD;
      In BC, our partner has a formal research relationship with the City of Richmond. They&#xD;
      evaluate the risk for chronic disease in approximately 200-300 City of Richmond workers each&#xD;
      year. The proposed program will allow the introduction of a workplace wellness program for&#xD;
      these workers. We estimate that with the awarding of this program that the current workplace&#xD;
      wellness program will expand meeting the needs of family and friends of city workers meeting&#xD;
      a direct mandate of the City of Richmond employers.&#xD;
&#xD;
      Our Nova Scotia partner will engage their Capital District Health Authority (CDHA) workplace,&#xD;
      drawing participants from a population of 10,000 employees. Having both a set program and a&#xD;
      virtualization of the program will offer a unique opportunity to address both the benefits to&#xD;
      at risk patients as well as the application of a program to the most common yet possibly the&#xD;
      most difficult workplace sector to access.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2016</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in one or more of the Four Core Health Behaviors</measure>
    <time_frame>12 weeks, and 3 month follow-up</time_frame>
    <description>Target: at least 150 min moderate to vigorous physical activity and exercise per week .Baseline assumption - 15% of population meets this goal; end of program - at least 30% will meet goal.&#xD;
Target: at least 50% reduction in number of smokers&#xD;
Reduce long-term health risks by drinking no more than:&#xD;
10 drinks a week for women, with no more than 2 drinks a day most days 15 drinks a week for men, with no more than 3 drinks a day most days Target: at least 5 fruits/vegetables per day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in Risk Factors for Chronic Disease</measure>
    <time_frame>12 weeks, and 3 month follow-up</time_frame>
    <description>Blood Pressure: Target &lt;140/90 (&lt;130/80 for persons with DM) Target: at least 10% more people reaching guideline.&#xD;
Blood Lipids:Target: at least 10% more people reaching guideline according to their baseline risk category 2nd target: 10% reduction in LDL cholesterol Blood glucose:For persons with diabetes or pre-diabetes, as per CDA guidelines. Target: at least 10% more people reaching guideline for A1C control BMI and Waist Circumference:BMI &lt;25; waist circumference Men: &lt;102 cm Women: &lt;88 cm . Target: at least 10% more people reaching guideline</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-efficacy and Behavioural Readiness</measure>
    <time_frame>12 weeks, and 3 month follow-up</time_frame>
    <description>Improvement in stage of change by at least one level for key behaviour for that individual</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>At Risk Group: ACCELERATION program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This &quot;At Risk&quot; Group will include ;People at risk of cancer referred from UHN partners and community practices. Also included in this group are; First Nations population of BC, Asians and South Asian populations from Greater Vancouver and the working population of the City of Richmond employees. At the Montreal site users of the YMCA with risk factors for, or family history of, cancer and other chronic diseases will be targeted. And finally, in Nova Scotia the &quot;At Risk&quot; Group will be identified as being at risk of cancer and other chronic diseases referred from community practices and from the workplace population of the Capital District Health Authority (CDHA).&#xD;
Intervention: Motivational Communication for Health Behavior management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Friends &amp; Family -ACCELERATION Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group includes family and friends of cancer survivors and family and friends of cardiac &amp; COPD rehab patients. The intervention includes Motivational Communication for Health Behavior management</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Communication for Health Behavior management</intervention_name>
    <description>An appropriate and evidence-informed model of motivational counselling, health coaching and chronic disease self-management will be integrated into the delivery of all aspects of the ACCELERATION program. The focus will be on 4 health behaviors that include healthy eating, exercise, smoking cessation and moderation of alcohol consumption. This will include engagement techniques such as motivational interviewing, identification of stage of change, visioning of &quot;best self&quot;, goal setting and action planning, expressing empathy, developing discrepancy, decisional balance, &quot;rolling with resistance&quot;, and supporting self-efficacy. (Rubak 2005, Knight 2006).</description>
    <arm_group_label>At Risk Group: ACCELERATION program</arm_group_label>
    <arm_group_label>Friends &amp; Family -ACCELERATION Program</arm_group_label>
    <other_name>Behavior Change</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Must have at least one behavioural risk factor&#xD;
&#xD;
          -  physical inactivity (less than 150 minutes of moderate to vigorous physical activity&#xD;
             per week)&#xD;
&#xD;
          -  suboptimal nutrition behaviour (consumption of less than 5 fruits/vegetables per day)&#xD;
&#xD;
          -  smoking (any amount of personal smoking by self-report)&#xD;
&#xD;
          -  alcohol intake in excess of Canada's Low-Risk Alcohol Drinking Guidelines (low risk is&#xD;
             defined by less than 10 drinks a week for women, with no more than 2 drinks a day most&#xD;
             days; or less than 15 drinks a week for men, with no more than 3 drinks a day most&#xD;
             days)&#xD;
&#xD;
          -  over the age of 18&#xD;
&#xD;
          -  family history of cancer or cardiovascular disease&#xD;
&#xD;
          -  in addition, subjects may have stable medical co-morbidities such as hypertension,&#xD;
             dyslipidemia, diabetes, obesity and respiratory conditions, and persons with a&#xD;
             diagnosis of cancer or cardiovascular event more than 5 years previously will also be&#xD;
             included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  new cancer diagnosis or cardiovascular event within 5 years&#xD;
&#xD;
          -  alcoholism and alcohol abuse (mild, moderate or severe)&#xD;
&#xD;
          -  Unable to participate fully in the program due to mental health or physical&#xD;
             limitations&#xD;
&#xD;
          -  participating concurrently in other studies of intensive health behaviour&#xD;
             modification.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Oh, MD FRCPC</last_name>
    <role>Study Director</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>paul Oh, MD FRCPC</last_name>
    <phone>(416) 597-3422</phone>
    <phone_ext>5267</phone_ext>
    <email>paul.oh@uhn.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4G 1R7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paul Oh, FRCPC</last_name>
      <phone>(416) 597-3422</phone>
      <phone_ext>5267</phone_ext>
      <email>paul.oh@uhn.ca</email>
    </contact>
    <contact_backup>
      <last_name>Karolina Perraud, MA</last_name>
      <phone>416-597-3422</phone>
      <phone_ext>5225</phone_ext>
      <email>karolina.perraud@uhn.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Civljak M, Sheikh A, Stead LF, Car J. Internet-based interventions for smoking cessation. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007078. doi: 10.1002/14651858.CD007078.pub3.</citation>
    <PMID>20824856</PMID>
  </reference>
  <reference>
    <citation>Fraser Health (2013) 'South Asian Health Institute' [Online] Available from: http://www.fraserhealth.ca/about_us/media_centre/news_releases/2013-news-releases/south-asian-health-institute [Accessed March 10, 2013.]</citation>
  </reference>
  <reference>
    <citation>Gaikwad R, Warren J. The role of home-based information and communications technology interventions in chronic disease management: a systematic literature review. Health Informatics J. 2009 Jun;15(2):122-46. doi: 10.1177/1460458209102973.</citation>
    <PMID>19474225</PMID>
  </reference>
  <reference>
    <citation>Kisely S, Terashima M, Langille D. A population-based analysis of the health experience of African Nova Scotians. CMAJ. 2008 Sep 23;179(7):653-8. doi: 10.1503/cmaj.071279.</citation>
    <PMID>18809896</PMID>
  </reference>
  <reference>
    <citation>Murray E, Burns J, See Tai S, Lai R, Nazareth I. Interactive Health Communication Applications for people with chronic disease. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD004274. DOI: 10.1002/14651858.CD004274.pub4 [Online] Available from: http://summaries.cochrane.org/CD004274/computer-based-programmes-interactive-health-communication-applications-for-people-with-chronic-disease [Accessed March 3, 2013.]</citation>
  </reference>
  <reference>
    <citation>Waters E, de Silva-Sanigorski A, Hall BJ, Brown T, Campbell KJ, Gao Y, Armstrong R, Prosser L, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD001871. doi: 10.1002/14651858.CD001871.pub3.</citation>
    <PMID>22161367</PMID>
  </reference>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT02264366
org study id: ACCELERATION
nct id: NCT02264366
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The ACCELERATION (ACtivity, smoking Cessation, healthy Eating and aLcohol Education,
      inteRvention, and motivATION) Program is a collaborative project in cancer and chronic
      disease prevention that has been designed by and will be delivered amongst cardiopulmonary
      rehabilitation and prevention programs and cancer centres in Ontario (ON), British Columbia
      (BC), Quebec (QC) and Nova Scotia (NS). This project is being funded by the Canadian
      Partnership Against Cancer, Health Canada and Heart and Stroke Foundation of Canada and in
      the amount of $2.4M over a 3 year period (October 2013 - September 2016). The ACCELERATION
      Program is a 12 week structured model of behavioural interventions and education around
      self-management and prevention that aims to access readily available and referable people for
      primary prevention intervention.This program aligns with current provincial, national and
      international chronic disease prevention and management strategies. The goal of the
      ACCELERATION program is to measurably and effectively change the risk factors and health
      behaviours known to impact cancer and other chronic diseases. Specifically we will aim to
      increase physical activity, reduce smoking, encourage healthy eating, and moderate alcohol
      consumption in about 3,000 participants across Canada over 3 years.
Chronic diseases including cancer, cardiovascular disease, lung conditions and diabetes are
      the leading cause of mortality and morbidity in Canada and worldwide. These chronic
      conditions share common modifiable risk factors including physical inactivity, suboptimal
      nutrition, smoking and excessive alcohol intake. Cardiac rehabilitation centres in this
      Coalition have been providing primary and secondary prevention services for many years
      focused on these behavioural risks, and many of our participants with heart disease also have
      co-morbidities including cancer, diabetes and lung disease. Co-morbidities are a clinical
      reality, and we no longer deal with diseases singularly. Today, our client population is more
      diverse than ever and fiscal constraints call for the pooling of prevention resources to
      simultaneously address a range of chronic diseases impacted by common risk factors.

      Extending our reach to populations at risk of cancer and other chronic diseases, populations
      which are readily available and referable In Ontario, UHN/Toronto Rehab has a cancer program
      for women who have survived breast cancer as well as women undergoing cancer treatment.
      Discussions with Princess Margaret Hospital point to opportunities to extend programming to
      more cancer patients and people at risk of cancer. The ELLICSR arm of Princess Margaret
      Hospital, which focuses on helping survivors, has expressed interest in collaborating to
      reach family and friends of cancer survivors, for primary prevention. Likewise, the Odette
      Cancer Centre at Sunnybrook Hospital sees over 900 new women every year who are referred due
      to a family history of breast cancer. They have expressed to us that they can identify and
      will refer women at high risk of developing breast cancer into our proposed primary
      prevention program. Similarly, in Quebec, L'Hôpital du Sacré-Cœur de Montréal has one of the
      nation's highest rated lung cancer groups. Our Quebec partner, Centre de réadaptation
      cardio-respiratoire Jean-Jacques-Gauthier (CRJJG) has strong ties to this program. With
      funding, they will be able to reach and deliver prevention programmes to the family and
      friends of their lung cancer clients, an opportunity that exists because family and friends
      tend to be more engaged and open to the possibility of lifestyle change.

      This is why we have partnered with these cancer centres in this Coalition: to formalize our
      existing partnerships and focus our resources on the population at risk of cancer that is
      readily available and referable for primary prevention.

      The links that our Coalition partners have with primary care hold opportunities not yet
      seized. In Ontario, the Department of Family and Community Medicine at Sunnybrook has many
      patients at risk for, or with, multiple chronic diseases.

      The opportunity that exists to reach pregnant women with obesity-related risks is one that
      could be seized Canada-wide. The unfortunate reality is that obesity complicates about 50% of
      pregnancies today.

      The opportunity, and need, to impact a person's family and social circle Our program concept
      is founded on the idea that 'you really need to get the whole family' to sustain the
      long-term impact of prevention and change in behaviour. We know there is evidence that
      family/social support can help. A systematic review on childhood obesity identified promising
      strategies that included parent support and home activities that encourage children to be
      more active, eat more nutritious foods and spend less time in screen-based activities (Waters
      et al, 2011).

      As Lead Agency, the UHN/Toronto Rehab already runs a successful Cardiac Rehab @ Home program
      which is a six-month program that sees approximately 120 clients per year. The average client
      lives approximately 200kms away from the urban area, is younger, and more likely to be
      working, compared to on-site clients. An evaluation has shown that the program is effective
      with similar outcomes as an on-site program: clients made the same gains in cardiovascular
      fitness and were just as likely to adhere to the program. The study also showed that such
      programs are more cost-effective than on-site programs for participants living in remote
      areas (Scane et al, 2012).

      Deepening and broadening our reach to selected at risk populations already connected to us.

      Many of the core partners not only have links to their local communities but have years of
      collaboration with the community on prevention. Notably, our BC partner, the BC
      Cardiovascular Physiology & Rehabilitation Laboratory, has extensive primary prevention
      experience having worked with more than 300,000 participants in the past 10 years on
      community-based programs for children (school-based and out-of-school), workplace wellness
      (e.g. police and firefighters) and population groups at risk for chronic disease.

      Additionally, they have solid partnerships with Aboriginal communities throughout BC. Formal
      partnerships have been forged with Aboriginal communities throughout BC including extensive
      research in rural and remote communities.

      Through the Coalition's work and history with the Aboriginal communities, and because they
      know there is evidence that there are health benefits for Aboriginal peoples in participating
      in a community-based physical activity intervention , the ACCELERATION program could be
      delivered with relative ease to these communities in BC.

      The Centre de réadaptation cardio-respiratoire Jean-Jacques-Gauthier (CRJJG) provides
      prevention programming for patients with cardiovascular (heart disease and heart failure) and
      respiratory disease (chronic obstructive pulmonary disease and asthma). One very unique
      aspect is the ongoing asthma prevention work of this coalition member. This adult asthma
      population are, on average, younger than most classical rehabilitation groups (ca. 40 years
      old) and, whilst not having overt cancer or cardiovascular disease, do normally display
      several risk factors, which provides a model of engaging and adapting the ACCELERATION
      program to these kinds of populations.

      Furthermore, the CRJJG is conveniently housed within the YMCA Cartierville. There is,
      therefore, already a strong partnership with the YMCA. The proposed program will allow our
      Quebec partner to deliver a prevention program to YMCA users with risk factors or a family
      history of chronic diseases. In addition, the YMCA Cartierville has a unique partnership with
      the local council where it provides free access to non-YMCA local community members, thus
      allowing the ACCELERATION programme to be delivered to a very diverse cultural and
      socio-economic community base.

      Finally, the CRJJG has specific expertise in motivational interviewing (MI) , which is a
      client-centred communication tool focusing on enhancing intrinsic motivation to change a
      particular behaviour, and exploring and resolving ambivalence about behavior change (Lavoie
      et al, 2012).

      At the Eastern end of Canada, the province of Nova Scotia has one of the highest rates of
      cardiovascular disease in the country with a prevalence of 6.4% (Heart and Stroke Foundation,
      2012). There is also an excess incidence and prevalence of lung, colorectal, prostate,
      melanoma and breast cancer (Canadian Cancer Society). This is one reason we chose to partner
      with Nova Scotia. Our partner runs the Community Cardiovascular Hearts in Motion (CCHIM)
      program which is a community-based exercise and health education program. Referrals are
      accepted from predominantly family doctors but also other specialists and allied health
      professionals including physiotherapists, nurse practitioners and diabetes clinics. Patients
      expand the complete vascular spectrum from primary care to all levels of secondary
      prevention. There is also a Heart Health Clinic available to assist those individuals living
      with more complicated and higher risk cardiac and pulmonary disease (tertiary). The successes
      of this program are translatable to the ACCELERATION program that targets people at risk of
      cancer and chronic diseases, as well as family and friends of people who have suffered an
      acute event associated with a chronic disease.

      Our Nova Scotia partner notes that there is strong representation of females in the primary
      prevention arm of CCHIM and most of these are obese with diabetes. The planned Ontario
      program with ante- and post-partum women at risk of obesity-related cancer is replicable for
      the Nova Scotia female population, and we would seek to transfer knowledge and replicate the
      program in Nova Scotia as well.

      There is also an opportunity to reach the underserviced black population. Incidence rate
      ratios for African Canadians relative to the general population of Nova Scotia were
      significantly elevated for circulatory disease, diabetes and psychiatric disorders (Kisely et
      al, 2008). Our Nova Scotia partner (CCHIM) sees opportunity in providing a virtual program
      for this population. CCHIM is in present development of translational research to move beyond
      the "bricks and mortar" to reach such patient populations who are in need of such a program
      by virtue of risk or established disease but cannot, or will not, attend. This will be run
      through the primary care physician and local health care teams (such as NP clinics, addiction
      services, etc). It will allow for adaptation and implementation when the patient is "ready"
      to engage (similar to smoking cessation as per the "Ottawa Model"). This approach will be
      adapted to the present project in an effort to expand its exposure further while evaluating
      the elements that are sustainable upon project completion.

      In Ontario, the South Asian population is the largest visible minority group in Ontario, and
      one with a higher prevalence of chronic diseases compared to other groups (Statistics Canada,
      2010; Fraser Health, 2013). They would benefit from a targeted program like ACCELERATION that
      is customized for them, and made culturally appropriate to their beliefs, values and customs.

      Deepening prevention impact in workplaces Two of our key partners (BC and NS) have existing
      partnerships with large employers.

      In BC, our partner has a formal research relationship with the City of Richmond. They
      evaluate the risk for chronic disease in approximately 200-300 City of Richmond workers each
      year. The proposed program will allow the introduction of a workplace wellness program for
      these workers. We estimate that with the awarding of this program that the current workplace
      wellness program will expand meeting the needs of family and friends of city workers meeting
      a direct mandate of the City of Richmond employers.

      Our Nova Scotia partner will engage their Capital District Health Authority (CDHA) workplace,
      drawing participants from a population of 10,000 employees. Having both a set program and a
      virtualization of the program will offer a unique opportunity to address both the benefits to
      at risk patients as well as the application of a program to the most common yet possibly the
      most difficult workplace sector to access.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Improvement in one or more of the Four Core Health Behaviors
time frame: 12 weeks, and 3 month follow-up
description: Target: at least 150 min moderate to vigorous physical activity and exercise per week .Baseline assumption - 15% of population meets this goal; end of program - at least 30% will meet goal.
Target: at least 50% reduction in number of smokers
Reduce long-term health risks by drinking no more than:
10 drinks a week for women, with no more than 2 drinks a day most days 15 drinks a week for men, with no more than 3 drinks a day most days Target: at least 5 fruits/vegetables per day
measure: Improvement in Risk Factors for Chronic Disease
time frame: 12 weeks, and 3 month follow-up
description: Blood Pressure: Target <140/90 (<130/80 for persons with DM) Target: at least 10% more people reaching guideline.
Blood Lipids:Target: at least 10% more people reaching guideline according to their baseline risk category 2nd target: 10% reduction in LDL cholesterol Blood glucose:For persons with diabetes or pre-diabetes, as per CDA guidelines. Target: at least 10% more people reaching guideline for A1C control BMI and Waist Circumference:BMI <25; waist circumference Men: <102 cm Women: <88 cm . Target: at least 10% more people reaching guideline
measure: Self-efficacy and Behavioural Readiness
time frame: 12 weeks, and 3 month follow-up
description: Improvement in stage of change by at least one level for key behaviour for that individual
arm group label: At Risk Group: ACCELERATION program
arm group type: Experimental
description: This "At Risk" Group will include ;People at risk of cancer referred from UHN partners and community practices. Also included in this group are; First Nations population of BC, Asians and South Asian populations from Greater Vancouver and the working population of the City of Richmond employees. At the Montreal site users of the YMCA with risk factors for, or family history of, cancer and other chronic diseases will be targeted. And finally, in Nova Scotia the "At Risk" Group will be identified as being at risk of cancer and other chronic diseases referred from community practices and from the workplace population of the Capital District Health Authority (CDHA).
Intervention: Motivational Communication for Health Behavior management
arm group label: Friends & Family -ACCELERATION Program
arm group type: Experimental
description: This group includes family and friends of cancer survivors and family and friends of cardiac & COPD rehab patients. The intervention includes Motivational Communication for Health Behavior management
intervention type: Behavioral
intervention name: Motivational Communication for Health Behavior management
description: An appropriate and evidence-informed model of motivational counselling, health coaching and chronic disease self-management will be integrated into the delivery of all aspects of the ACCELERATION program. The focus will be on 4 health behaviors that include healthy eating, exercise, smoking cessation and moderation of alcohol consumption. This will include engagement techniques such as motivational interviewing, identification of stage of change, visioning of "best self", goal setting and action planning, expressing empathy, developing discrepancy, decisional balance, "rolling with resistance", and supporting self-efficacy. (Rubak 2005, Knight 2006).
arm group label: At Risk Group: ACCELERATION program
arm group label: Friends & Family -ACCELERATION Program
other name: Behavior Change
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Oh, MD FRCPC
role: Study Director
affiliation: University Health Network, Toronto
last name: paul Oh, MD FRCPC
phone: (416) 597-3422
phone ext: 5267
email: paul.oh@uhn.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
citation: Civljak M, Sheikh A, Stead LF, Car J. Internet-based interventions for smoking cessation. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007078. doi: 10.1002/14651858.CD007078.pub3.
PMID: 20824856
citation: Fraser Health (2013) 'South Asian Health Institute' [Online] Available from: http://www.fraserhealth.ca/about_us/media_centre/news_releases/2013-news-releases/south-asian-health-institute [Accessed March 10, 2013.]
citation: Gaikwad R, Warren J. The role of home-based information and communications technology interventions in chronic disease management: a systematic literature review. Health Informatics J. 2009 Jun;15(2):122-46. doi: 10.1177/1460458209102973.
PMID: 19474225
citation: Kisely S, Terashima M, Langille D. A population-based analysis of the health experience of African Nova Scotians. CMAJ. 2008 Sep 23;179(7):653-8. doi: 10.1503/cmaj.071279.
PMID: 18809896
citation: Murray E, Burns J, See Tai S, Lai R, Nazareth I. Interactive Health Communication Applications for people with chronic disease. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD004274. DOI: 10.1002/14651858.CD004274.pub4 [Online] Available from: http://summaries.cochrane.org/CD004274/computer-based-programmes-interactive-health-communication-applications-for-people-with-chronic-disease [Accessed March 3, 2013.]
citation: Waters E, de Silva-Sanigorski A, Hall BJ, Brown T, Campbell KJ, Gao Y, Armstrong R, Prosser L, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD001871. doi: 10.1002/14651858.CD001871.pub3.
PMID: 22161367
responsible party type: Sponsor
mesh term: Chronic Disease