<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/NCT01708824</url>
  </required_header>
  <id_info>
    <org_study_id>WCRF 2012/595</org_study_id>
    <nct_id>NCT01708824</nct_id>
  </id_info>
  <brief_title>Diet and Physical Activity Intervention in CRC Survivors</brief_title>
  <official_title>The Acceptability and Feasibility of a Diet and Physical Activity Intervention to Prevent Recurrence in Colorectal Cancer Survivors: a Phase 2 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Cancer Research Fund International</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong&#xD;
      Kong. A recent report concluded physical activity (PA) protects against colon cancer and&#xD;
      foods low in dietary fibre, red meat and processed meat cause CRC. Yet, the influence of&#xD;
      lifestyle factors on cancer outcome (i.e. recurrence and survival rates) in CRC survivors is&#xD;
      largely unknown.&#xD;
&#xD;
      Objectives &amp; hypothesis - Our study aims to evaluate the acceptability of two behavioural&#xD;
      interventions for CRC survivors intended to improve cancer outcome and designed to (1)&#xD;
      increase PA levels and (2) reduce consumption of a Western diet.&#xD;
&#xD;
      The investigators hypothesize that the proposed interventions are (1) efficacious in changing&#xD;
      the two targeted behaviours; and (2) acceptable to CRC survivors.&#xD;
&#xD;
      Settings and methods - Phase 2 feasibility trial. Two hundred and twenty-four CRC survivors&#xD;
      within 12 months of completion of cancer treatment and without evidence of&#xD;
      persistent/recurrent disease will be recruited from four public hospitals in Hong Kong after&#xD;
      informed consent. Subjects will be randomized in a 2x2 factorial design for the two targeted&#xD;
      behaviours prescribed over 12 months. Primary outcome measure is whether the target levels of&#xD;
      PA and dietary intake could be met at the end of intervention. Secondary outcome measures&#xD;
      include: (1) magnitude of changes in PA level and dietary intakes; (2) rates and determinants&#xD;
      of compliance; (3) facilitators and barriers to behavioural change; (4) measurement of&#xD;
      theoretical constructs underlying PA and dietary interventions; (5) possible health benefits&#xD;
      and side effects (PA-associated injury and nutritional deficiency) arising from the&#xD;
      interventions. Outcome will be assessed at baseline, 6 months into intervention and then at&#xD;
      0, 6 and 12 months post-intervention.&#xD;
&#xD;
      Impact - If proven feasible, our intervention programme would pave way for a large randomized&#xD;
      controlled trial testing the effect of PA and diet on the treatment outcome of CRC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong&#xD;
      Kong. A recent World Cancer Research Fund (WCRF) report concluded physical activity (PA)&#xD;
      protects against colon cancer and foods low in dietary fibre, red meat and processed meat&#xD;
      cause CRC. Yet, the influence of lifestyle factors on cancer outcome (i.e. recurrence and&#xD;
      survival rates) in CRC survivors is largely unknown. Our literature review showed a paucity&#xD;
      of published studies on lifestyle intervention in CRC survivors; none had investigated the&#xD;
      effect of such intervention on cancer outcomes.&#xD;
&#xD;
      With advances in treatment, CRC survivors live longer. Many of them are motivated to make&#xD;
      lifestyle changes. However, our qualitative research has shown a huge service gap in the&#xD;
      provision of appropriate PA and dietary advice to CRC survivors. Many patients were unaware&#xD;
      of the link between PA and diet with CRC outcome but most demonstrated acceptance of&#xD;
      lifestyle intervention. Yet, there is currently no scientifically-based evidence to allow&#xD;
      firm recommendations to be made.&#xD;
&#xD;
      Objectives &amp; hypothesis - Our study aims to evaluate the acceptability of two behavioural&#xD;
      interventions for CRC survivors intended to improve cancer outcome and designed to (1)&#xD;
      increase PA levels (to 60 minutes of moderate PA 5 days/week) and (2) reduce consumption of a&#xD;
      Western diet (&lt;5 servings of red/processed meat weekly and 2 servings of refined grain&#xD;
      daily).&#xD;
&#xD;
      We hypothesize that the proposed interventions are (1) efficacious in changing the two&#xD;
      targeted behaviours; and (2) acceptable to CRC survivors with compliance rates of about 80%.&#xD;
&#xD;
      Settings and methods - The study follows the Medical Research Council Framework for the&#xD;
      design and evaluation of complex interventions. Phases 0 and 1 (funded by WCRF) have been&#xD;
      completed.&#xD;
&#xD;
      This application seeks funding for a Phase 2 feasibility trial. Two hundred and twenty-four&#xD;
      CRC survivors within 12 months of completion of cancer treatment and without evidence of&#xD;
      persistent/recurrent disease will be recruited from four public hospitals in Hong Kong after&#xD;
      informed consent. Subjects will be randomized in a 2x2 factorial design for the two targeted&#xD;
      behaviours prescribed over 12 months. Primary outcome measure is whether the target levels of&#xD;
      PA and dietary intake could be met at the end of intervention. Secondary outcome measures&#xD;
      include: (1) magnitude of changes in PA level and dietary intakes; (2) rates and determinants&#xD;
      of compliance by questionnaire; (3) facilitators and barriers to behavioural change by&#xD;
      questionnaire; (4) measurement of theoretical constructs underlying PA and dietary&#xD;
      interventions by questionnaire; (5) possible health benefits (body composition, physical&#xD;
      fitness, quality of life and mood) and side effects (PA-associated injury and nutritional&#xD;
      deficiency) arising from the interventions. Outcome will be assessed at baseline, 6 months&#xD;
      into intervention and then at 0, 6 and 12 months post-intervention (i.e. at baseline, 6, 12,&#xD;
      18 and 24 months after the start of intervention).&#xD;
&#xD;
      Impact - To the best of our knowledge, this is the first behavioural intervention model&#xD;
      targeting PA and reduced consumption of a Western diet in CRC survivors. If proven feasible,&#xD;
      our intervention programme would pave way for a large randomized controlled trial testing the&#xD;
      effect of PA and diet on the treatment outcome of CRC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Whether the PA and dietary intake targets are met at the end of intervention;</measure>
    <time_frame>at the end of 12 months of intervention</time_frame>
    <description>Whether the PA and dietary intake targets are met at the end of intervention; i.e.&#xD;
PA group: achieve PA targets or not&#xD;
Dietary group: achieve dietary target or not&#xD;
PA + dietary group: achieve both PA and dietary targets or not&#xD;
Control group: achieve PA or dietary target or not</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Magnitude of change in PA level using objective accelerometry</measure>
    <time_frame>6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnitude of change in each component of dietary target using validated food frequency questionnaire (FFQ);</measure>
    <time_frame>6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate and determinants of compliance with intervention;</measure>
    <time_frame>at the end of 12 months of intervention</time_frame>
    <description>Rates of compliance - measured by rate of completion of assignment; determinants of compliance measured by a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Facilitators and barriers to intervention</measure>
    <time_frame>at the end of intervention</time_frame>
    <description>Measured by (a) qualitatively during the last group meeting and (b) quantitatively by questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of theoretical constructs underlying PA and dietary interventions</measure>
    <time_frame>6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)</time_frame>
    <description>Using questionnaire specifically desinged to measure these theoretical constructs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other possible health benefits arising from the intervention</measure>
    <time_frame>at 12 and 24 months after start of intervention (i.e. at 0 and 12 months post-intervention)</time_frame>
    <description>including&#xD;
Changes in body composition via body mass index (BMI)&#xD;
Changes in body fat and/or visceral fat via waist-hip ratio (WHR) and bioelectrical impedance analysis&#xD;
Physical fitness in the form of submaximal oxygen uptake as predicted by 6-minute ergometry&#xD;
Quality-of-life/mood via validated tools (SF12, FACT, HADS and PSS);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Possible side effects arising from the intervention</measure>
    <time_frame>at 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)</time_frame>
    <description>including&#xD;
PA-associated injury&#xD;
Dietary deficiency - (i) anaemia (haemoglobin level); (ii) energy and protein deficiency</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">224</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>dietary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary intervention to meet the target of&#xD;
1.&lt;5 servings of red/processed meat weekly; &lt;2 servings would be processed meat 2.2 servings of refined grains daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>physical activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physical activity intervention with the following targets:&#xD;
General health target - 30 minutes of moderate-to-vigorous physical activity (MVPA) 5 days per week (i.e. 10 MET-hours/week);&#xD;
Cancer outcome target - 60 minutes of MVPA 5 days per week (i.e. 18-20 MET-hours/week)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dietary and physical activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Meeting both the dietary and physical activity targets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Follow the general lifestyle advice in accordance with the recommendations of the Department of Health in Hong Kong available in the public domain</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary</intervention_name>
    <description>Dietary intervention to meet the target of&#xD;
&lt;5 servings of red/processed meat weekly; &lt;2 servings would be processed meat&#xD;
2 servings of refined grains daily</description>
    <arm_group_label>dietary</arm_group_label>
    <arm_group_label>dietary and physical activity</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical activity</intervention_name>
    <description>Physical activity intervention with the following targets:&#xD;
General health target - 30 minutes of moderate-to-vigorous physical activity (MVPA) 5 days per week (i.e. 10 MET-hours/week);&#xD;
Cancer outcome target - 60 minutes of MVPA 5 days per week (i.e. 18-20 MET-hours/week)</description>
    <arm_group_label>dietary and physical activity</arm_group_label>
    <arm_group_label>physical activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically proven colorectal adenocarcinoma;&#xD;
&#xD;
          2. Within one year of completion of main cancer treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Persistent/recurrent disease upon recruitment;&#xD;
&#xD;
          2. Current cancer treatment;&#xD;
&#xD;
          3. Hereditary CRC syndromes;&#xD;
&#xD;
          4. Known contraindication to PA;&#xD;
&#xD;
          5. Illiteracy;&#xD;
&#xD;
          6. Weekly red/processed meat &lt; 5 servings and daily refined grains &lt; 2 servings&#xD;
&#xD;
          7. Weekly MPA &gt; 300 minutes&#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>Judy WC Ho, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Mary Hospital, University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Judy WC Ho, MBBS</last_name>
    <phone>852 2255 4762</phone>
    <email>judyho@hku.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pamela Youde Nethersole Eastern Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hester Cheung, MBBS</last_name>
      <email>cheuys@ha.org.hk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>SM Hui, MBBS</last_name>
      <email>huism@ha.org.hk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Judy WC Ho, MBBS</last_name>
      <phone>852 2255 4762</phone>
      <email>judyho@hku.hk</email>
    </contact>
    <investigator>
      <last_name>Judy WC Ho, MBBS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yan Chai Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CK Kong, MBBS</last_name>
      <email>kck326@ha.org.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>May 11, 2016</last_update_submitted>
  <last_update_submitted_qc>May 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Judy Wai-Chu Ho</investigator_full_name>
    <investigator_title>Consultant, Honorary Clinical Associate Professor</investigator_title>
  </responsible_party>
  <keyword>colorectal cancer</keyword>
  <keyword>cancer survivor</keyword>
  <keyword>western pattern diet</keyword>
  <keyword>physical activity</keyword>
  <keyword>behavioral intervention</keyword>
  <keyword>acceptability</keyword>
  <keyword>feasibility</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>compliance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no consent has been obtained to make individual participant data available</ipd_description>
  </patient_data>
  <!-- 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/NCT01708824
org study id: WCRF 2012/595
nct id: NCT01708824
lead sponsor: 
collaborator: 
has dmc: No
Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong
      Kong. A recent report concluded physical activity (PA) protects against colon cancer and
      foods low in dietary fibre, red meat and processed meat cause CRC. Yet, the influence of
      lifestyle factors on cancer outcome (i.e. recurrence and survival rates) in CRC survivors is
      largely unknown.

      Objectives & hypothesis - Our study aims to evaluate the acceptability of two behavioural
      interventions for CRC survivors intended to improve cancer outcome and designed to (1)
      increase PA levels and (2) reduce consumption of a Western diet.

      The investigators hypothesize that the proposed interventions are (1) efficacious in changing
      the two targeted behaviours; and (2) acceptable to CRC survivors.

      Settings and methods - Phase 2 feasibility trial. Two hundred and twenty-four CRC survivors
      within 12 months of completion of cancer treatment and without evidence of
      persistent/recurrent disease will be recruited from four public hospitals in Hong Kong after
      informed consent. Subjects will be randomized in a 2x2 factorial design for the two targeted
      behaviours prescribed over 12 months. Primary outcome measure is whether the target levels of
      PA and dietary intake could be met at the end of intervention. Secondary outcome measures
      include: (1) magnitude of changes in PA level and dietary intakes; (2) rates and determinants
      of compliance; (3) facilitators and barriers to behavioural change; (4) measurement of
      theoretical constructs underlying PA and dietary interventions; (5) possible health benefits
      and side effects (PA-associated injury and nutritional deficiency) arising from the
      interventions. Outcome will be assessed at baseline, 6 months into intervention and then at
      0, 6 and 12 months post-intervention.

      Impact - If proven feasible, our intervention programme would pave way for a large randomized
      controlled trial testing the effect of PA and diet on the treatment outcome of CRC.
Background - Colorectal cancer (CRC) incidence is increasing at an alarming rate in Hong
      Kong. A recent World Cancer Research Fund (WCRF) report concluded physical activity (PA)
      protects against colon cancer and foods low in dietary fibre, red meat and processed meat
      cause CRC. Yet, the influence of lifestyle factors on cancer outcome (i.e. recurrence and
      survival rates) in CRC survivors is largely unknown. Our literature review showed a paucity
      of published studies on lifestyle intervention in CRC survivors; none had investigated the
      effect of such intervention on cancer outcomes.

      With advances in treatment, CRC survivors live longer. Many of them are motivated to make
      lifestyle changes. However, our qualitative research has shown a huge service gap in the
      provision of appropriate PA and dietary advice to CRC survivors. Many patients were unaware
      of the link between PA and diet with CRC outcome but most demonstrated acceptance of
      lifestyle intervention. Yet, there is currently no scientifically-based evidence to allow
      firm recommendations to be made.

      Objectives & hypothesis - Our study aims to evaluate the acceptability of two behavioural
      interventions for CRC survivors intended to improve cancer outcome and designed to (1)
      increase PA levels (to 60 minutes of moderate PA 5 days/week) and (2) reduce consumption of a
      Western diet (<5 servings of red/processed meat weekly and 2 servings of refined grain
      daily).

      We hypothesize that the proposed interventions are (1) efficacious in changing the two
      targeted behaviours; and (2) acceptable to CRC survivors with compliance rates of about 80%.

      Settings and methods - The study follows the Medical Research Council Framework for the
      design and evaluation of complex interventions. Phases 0 and 1 (funded by WCRF) have been
      completed.

      This application seeks funding for a Phase 2 feasibility trial. Two hundred and twenty-four
      CRC survivors within 12 months of completion of cancer treatment and without evidence of
      persistent/recurrent disease will be recruited from four public hospitals in Hong Kong after
      informed consent. Subjects will be randomized in a 2x2 factorial design for the two targeted
      behaviours prescribed over 12 months. Primary outcome measure is whether the target levels of
      PA and dietary intake could be met at the end of intervention. Secondary outcome measures
      include: (1) magnitude of changes in PA level and dietary intakes; (2) rates and determinants
      of compliance by questionnaire; (3) facilitators and barriers to behavioural change by
      questionnaire; (4) measurement of theoretical constructs underlying PA and dietary
      interventions by questionnaire; (5) possible health benefits (body composition, physical
      fitness, quality of life and mood) and side effects (PA-associated injury and nutritional
      deficiency) arising from the interventions. Outcome will be assessed at baseline, 6 months
      into intervention and then at 0, 6 and 12 months post-intervention (i.e. at baseline, 6, 12,
      18 and 24 months after the start of intervention).

      Impact - To the best of our knowledge, this is the first behavioural intervention model
      targeting PA and reduced consumption of a Western diet in CRC survivors. If proven feasible,
      our intervention programme would pave way for a large randomized controlled trial testing the
      effect of PA and diet on the treatment outcome of CRC.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Whether the PA and dietary intake targets are met at the end of intervention;
time frame: at the end of 12 months of intervention
description: Whether the PA and dietary intake targets are met at the end of intervention; i.e.
PA group: achieve PA targets or not
Dietary group: achieve dietary target or not
PA + dietary group: achieve both PA and dietary targets or not
Control group: achieve PA or dietary target or not
measure: Magnitude of change in PA level using objective accelerometry
time frame: 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)
measure: Magnitude of change in each component of dietary target using validated food frequency questionnaire (FFQ);
time frame: 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)
measure: Rate and determinants of compliance with intervention;
time frame: at the end of 12 months of intervention
description: Rates of compliance - measured by rate of completion of assignment; determinants of compliance measured by a questionnaire
measure: Facilitators and barriers to intervention
time frame: at the end of intervention
description: Measured by (a) qualitatively during the last group meeting and (b) quantitatively by questionnaire
measure: Measurement of theoretical constructs underlying PA and dietary interventions
time frame: 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)
description: Using questionnaire specifically desinged to measure these theoretical constructs
measure: Other possible health benefits arising from the intervention
time frame: at 12 and 24 months after start of intervention (i.e. at 0 and 12 months post-intervention)
description: including
Changes in body composition via body mass index (BMI)
Changes in body fat and/or visceral fat via waist-hip ratio (WHR) and bioelectrical impedance analysis
Physical fitness in the form of submaximal oxygen uptake as predicted by 6-minute ergometry
Quality-of-life/mood via validated tools (SF12, FACT, HADS and PSS);
measure: Possible side effects arising from the intervention
time frame: at 6, 12, 18 and 24 months after start of intervention (i.e. interim, 0, 6 and 12 months post-intervention)
description: including
PA-associated injury
Dietary deficiency - (i) anaemia (haemoglobin level); (ii) energy and protein deficiency
arm group label: dietary
arm group type: Experimental
description: Dietary intervention to meet the target of
1.<5 servings of red/processed meat weekly; <2 servings would be processed meat 2.2 servings of refined grains daily
arm group label: physical activity
arm group type: Experimental
description: Physical activity intervention with the following targets:
General health target - 30 minutes of moderate-to-vigorous physical activity (MVPA) 5 days per week (i.e. 10 MET-hours/week);
Cancer outcome target - 60 minutes of MVPA 5 days per week (i.e. 18-20 MET-hours/week)
arm group label: dietary and physical activity
arm group type: Experimental
description: Meeting both the dietary and physical activity targets
arm group label: usual care
arm group type: No Intervention
description: Follow the general lifestyle advice in accordance with the recommendations of the Department of Health in Hong Kong available in the public domain
intervention type: Behavioral
intervention name: Dietary
description: Dietary intervention to meet the target of
<5 servings of red/processed meat weekly; <2 servings would be processed meat
2 servings of refined grains daily
arm group label: dietary
arm group label: dietary and physical activity
intervention type: Behavioral
intervention name: Physical activity
description: Physical activity intervention with the following targets:
General health target - 30 minutes of moderate-to-vigorous physical activity (MVPA) 5 days per week (i.e. 10 MET-hours/week);
Cancer outcome target - 60 minutes of MVPA 5 days per week (i.e. 18-20 MET-hours/week)
arm group label: dietary and physical activity
arm group label: physical activity
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Judy WC Ho, MBBS
role: Principal Investigator
affiliation: Queen Mary Hospital, University of Hong Kong
last name: Judy WC Ho, MBBS
phone: 852 2255 4762
email: judyho@hku.hk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Judy Wai-Chu Ho
investigator title: Consultant, Honorary Clinical Associate Professor
mesh term: Colorectal Neoplasms
sharing ipd: No
ipd description: no consent has been obtained to make individual participant data available