<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/NCT03015012</url>
  </required_header>
  <id_info>
    <org_study_id>108511</org_study_id>
    <nct_id>NCT03015012</nct_id>
  </id_info>
  <brief_title>Nutrigenomics, Overweight/Obesity and Weight Management Trial (NOW Trial)</brief_title>
  <acronym>NOW</acronym>
  <official_title>Using Personalized Nutrigenomics Testing to Mitigate Overweight/Obesity Risk in Two Distinct Patient Populations: A Multicentre Randomized Clinical Intervention Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nutrigenomix Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>East Elgin Family Health Team</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Transplant Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Western University, Canada</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>
      The investigators hypothesize that compared to the provision of population-based lifestyle&#xD;
      advice, providing DNA-based lifestyle advice via personalized nutrigenomics testing (PNT) to&#xD;
      two distinct patient populations (Family Health Team patients receiving a lifestyle&#xD;
      counselling intervention and transplant recipients) will lead to greater reductions in&#xD;
      percent body fat. In addition, it will motivate them to adopt healthier dietary and physical&#xD;
      activity habits through changes in attitudes and/or subjective norms and/or behavioural&#xD;
      control, lead to greater fat loss (kg), increased percent lean mass and therefore improve&#xD;
      health and quality of life outcomes for both patient populations. In addition, it is&#xD;
      hypothesized that dietary strategies related to the intake of one or more dietary components&#xD;
      of interest will mitigate post-transplant weight gain associated with three SNPs of interest.&#xD;
&#xD;
      This is a randomized clinical intervention trial involving a total of four groups of patients&#xD;
      (n = 400). The two main patient groups include overweight or obese, stable transplant&#xD;
      recipients and overweight or obese patients who are attending group counselling sessions at&#xD;
      the East Elgin Family Health Team. Within these two main groups, there will be two&#xD;
      sub-groups. Patients will be randomized to receive either PNT or standard nutrition&#xD;
      intervention (SNI). Baseline data will be conducted consisting of a food frequency&#xD;
      questionnaire and three-day food records using a validated multiple pass method.&#xD;
      Bioelectrical Impedance Analysis (BIA) will be conducted to assess body composition and to&#xD;
      derive percent body fat and lean mass. Weight and height will be measured using a weigh scale&#xD;
      and stadiometer. Attitudes, subjective norms and behavioural control will be assessed using a&#xD;
      Theory of Planned Behaviour Questionnaire. Those patients randomized to the PNT group will be&#xD;
      instructed on a tailored nutrition care plan and physical activity recommendations based on&#xD;
      their individual genetic profile. At the same time, the SNI group will be instructed on&#xD;
      general nutrition and physical activity recommendations for weight loss, which include the&#xD;
      use of dietary strategies from the standard tool ('Just the Basics') used by registered&#xD;
      dietitians for transplant patients and the GLB program for patients attending the East Elgin&#xD;
      Family Health Team sessions. Monthly email reminders or phone calls (depending on patient&#xD;
      preference) will be sent to transplant recipients as a reminder of their nutrition and&#xD;
      physical activity plan. Reminders of nutrition and physical activity goals for the Family&#xD;
      Health Team participants are incorporated into the GLB program. Three months, six months and&#xD;
      twelve months after baseline data collection and individual nutrition interventions, baseline&#xD;
      data will be repeated. After the study is complete, participants in the SNI group will be&#xD;
      offered a nutrigenomics report and consultation with a registered dietitian.&#xD;
&#xD;
      A paired t-test or repeated measures ANOVA will be used to assess within group change from&#xD;
      baseline to each follow-up time point for: BMI, body fat, lean mass, and dietary intake. A&#xD;
      repeated measures ANOVA will be used to test between group differences from baseline to each&#xD;
      follow-up time point for: BMI, body fat, lean mass, and dietary intake. If significant mean&#xD;
      differences are detected, a Tukey's post hoc test will be used to compare differences by&#xD;
      group. Statistical significance will be determined by P &lt; 0.05. General linear regression&#xD;
      models will be used to assess interactions between each genotype of interest and each dietary&#xD;
      component of interest on BMI and body composition from baseline to each follow-up time point.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hypotheses: Compared to the provision of population-based lifestyle advice, providing&#xD;
      DNA-based lifestyle advice via personalized nutrigenomics testing (PNT) to two distinct&#xD;
      patient populations (patients attending group counselling sessions at the East Elgin Family&#xD;
      Health Team and transplant recipients) in which overweight and obesity are common concerns,&#xD;
      will motivate them to adopt healthier dietary and physical activity habits via changes in&#xD;
      attitudes and/or subjective norms and/or behavioural control, lead to greater fat loss,&#xD;
      increased percent lean mass and therefore improve health and quality of life outcomes for&#xD;
      both patient populations. It is also hypothesized that dietary strategies related to the&#xD;
      intake of one or more dietary components of interest (protein, monounsaturated fat,&#xD;
      polyunsaturated fat, total fat, sodium, carbohydrates, alcohol and calories) will mitigate&#xD;
      post-transplant weight gain associated with the following SNPs: ACE (rs4343), FTO (rs1558902)&#xD;
      and MC4R (rs571312).&#xD;
&#xD;
      Sample Size: No research to date has studied the aforementioned hypotheses. Previously&#xD;
      published data assessing weight loss in a SNI group compared to a PNT group using a&#xD;
      randomized clinical intervention model in a different population used a sample of n = 93 and&#xD;
      an alpha &lt; 0.05 to find statistical significance after 3-7 month follow-up. Similarly,&#xD;
      nutrigenomics research in the ACE gene (rs4343) found statistical significance using a sample&#xD;
      of n = 104 and an alpha &lt; 0.05. A sample size calculation with 80% power and an alpha of 0.05&#xD;
      indicated that 37 participants per group (n = 148 total) are needed to detect significant&#xD;
      differences between groups for changes in body fat percentage (primary outcome). Since it is&#xD;
      feasible for this research, a larger sample size goal (n = 400) will be used to increase&#xD;
      power and draw meaningful inferences from the data. There will be 100 participants in each&#xD;
      patient group (n = 200 in SNI group, n = 200 in PNT group) in this landmark study.&#xD;
&#xD;
      Design and Methods: Participants will be recruited from the Canadian Transplant Association&#xD;
      (CTA) meetings with the assistance of the Director, Sandra Holdsworth (transplant recipients;&#xD;
      n = 200) and from the Group Lifestyle Balance Program (GLB Program) through the East Elgin&#xD;
      Family Health Team (GLB; n = 200) for this randomized clinical intervention trial.&#xD;
      Word-of-mouth recruitment is also expected. This trial involves a total of four groups of&#xD;
      patients. The two main patient groups include overweight or obese (BMI ≥ 25 kg/m^2), stable&#xD;
      transplant recipients greater than or equal to one year post-transplant, and overweight or&#xD;
      obese (BMI ≥ 25 kg/m^2) patients who are attending the GLB program at the East Elgin Family&#xD;
      Health Team. Within these two main patient groups, there will be two sub-groups (n = 100 per&#xD;
      sub-group). Patients will be randomized to receive either PNT or standard nutrition&#xD;
      intervention (SNI) based on strategies from the standard teaching tool used by dietitians in&#xD;
      both patient populations: 'Just the Basics' - developed by the Canadian Diabetes Association&#xD;
      for transplant participants. Participants from the East Elgin Family Health Team, will&#xD;
      participate in the GLB Program and will either complete the standard program (SNI Group) +&#xD;
      receive population-based nutrition and physical activity recommendations or will complete a&#xD;
      modified GLB program + receive personalized nutrition and physical activity recommendations&#xD;
      based on their genetics (PNT Group). Baseline data will be conducted consisting of a food&#xD;
      frequency questionnaire and three-day food records using a validated multiple pass method.&#xD;
      Bioelectrical Impedance Analysis (BIA) will be conducted to assess body composition and to&#xD;
      derive percent and kg body fat and lean mass. Weight and height will be measured using a&#xD;
      weigh scale and stadiometer. Surveys will be completed by participants to assess several&#xD;
      demographic characteristics, as well as key components of the Theory of Planned Behaviour.&#xD;
      Those patients randomized to the PNT group will be instructed on a tailored nutrition care&#xD;
      plan and physical activity goal based on their individual genetic profile. At the same time,&#xD;
      the SNI group will be instructed on general nutrition and physical activity recommendations&#xD;
      for weight loss. A survey based on the Theory of Planned Behaviour will be administered&#xD;
      before and after participants receive their nutrition and physical activity advice. These&#xD;
      components are needed so that we can assess whether or not social and built environment&#xD;
      factors, subjective norms, attitudes and behavioural control influence change in dietary&#xD;
      intake. Monthly email or phone call reminders (depending on participant preference) will be&#xD;
      sent to participants as a reminder of their nutrition and physical activity plan for&#xD;
      transplant recipients. For East Elgin Family Health Team participants, reminders of the&#xD;
      nutrition and physical activity plan will be incorporated into the GLB Program. Three months,&#xD;
      six months and twelve months after baseline data collection and individual nutrition&#xD;
      interventions, baseline data will be repeated. After the study is complete, participants in&#xD;
      the SNI group will be offered a nutrigenomics test and consultation with a registered&#xD;
      dietitian.&#xD;
&#xD;
      Statistical Analysis: A paired t-test or repeated measures ANOVA will be used to assess&#xD;
      within group change from baseline to each of the follow-up time points for: BMI, body fat,&#xD;
      lean mass, water weight, TPB components, dietary intake (protein, total fat, saturated fat,&#xD;
      unsaturated fat, carbohydrates, alcohol, calories and sodium), and physical activity. A&#xD;
      repeated measures ANOVA will be used to test between group differences from baseline to each&#xD;
      of the follow-up time points for: BMI, body fat, lean mass, water weight, TPB components,&#xD;
      dietary intake (protein, total fat, saturated fat, unsaturated fat, carbohydrates, alcohol,&#xD;
      calories and sodium) and physical activity. If significant mean differences are detected, a&#xD;
      Tukey's post hoc test will be used to compare differences by group. Statistical significance&#xD;
      will be determined by P &lt; 0.05. General linear regression models will be used to assess the&#xD;
      effect of each genotype of interest (ACE rs4343, MC4R rs573112, FTO rs1558902) and the impact&#xD;
      of each dietary component of interest (protein, total fat, saturated fat, unsaturated fat,&#xD;
      carbohydrates, alcohol, calories and sodium) on BMI and body composition from baseline to&#xD;
      each follow-up time point. We will control for age, sex, ethnicity, immunosuppressive&#xD;
      medications (transplant recipients) and baseline body composition and BMI. IBM SPSS&#xD;
      Statistics, version 21.0 will be used for the data analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Fat Percentage</measure>
    <time_frame>3 months, 6 months, 12 months</time_frame>
    <description>Change in body composition (body fat percentage as the primary outcome) will be assessed using BIA which will provide information on fat mass, lean mass, and water weight</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Dietary Intake</measure>
    <time_frame>3 months, 6 months, 12 months</time_frame>
    <description>Change in dietary intake will be assessed using pre- and post- dietary data collected using 3-day food records, and a past-month online food frequency questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity</measure>
    <time_frame>3 months, 6 months, 12 months</time_frame>
    <description>Change in physical activity will be assessed using pre- and post- physical activity data collected using a 7-day physical activity recall. Metabolic equivalents will then be calculated from this data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Attitudes, Subjective Norms and Behavioural Control</measure>
    <time_frame>Pre- and post- lifestyle intervention (baseline), 3 months, 6 months, 12 months</time_frame>
    <description>Change in these key components of the Theory of Planned Behaviour (TPB) will be assessed using a TPB questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Composition</measure>
    <time_frame>3 months, 6 months, 12 months</time_frame>
    <description>Change in body composition will be assessed using BIA which will provide information on fat mass, lean mass, and water weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>3 months, 6 months, 12 months</time_frame>
    <description>Change in BMI will be measured using weight and height data collected using a weigh scale and stadiometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>3 months, 6 months, 12 months</time_frame>
    <description>Change in weight will be measured using a weigh scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Nutrigenomics Interactions</measure>
    <time_frame>3 months, 6 months, 12 months</time_frame>
    <description>Nutrigenomics (nutrition-genetic) interactions between ACE gene variants at rs4343, FTO gene variants at rs1558902 (in strong linkage disequilibrium with rs9939609) and MC4R (rs571312) to mitigate risk of post-transplant weight gain will be assessed for transplant recipients in the PNT group.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Transplant-Related Disorder</condition>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Standard Nutrition Intervention (SNI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transplant participants will receive standard nutrition counselling from a registered dietitian focused on strategies from the Canadian Diabetes Association's patient resource 'Just the Basics.' Nutrition counselling will focus on weight management. Individuals recruited from The East Elgin Family Health Team will complete the GLB Program. Transplant participants will receive a monthly follow-up email or phone call reviewing their nutrition and physical activity plan, until 12 months after baseline data collection. Reminders of lifestyle goals will be incorporated into the GLB Program for participants at the East Elgin Family Health Team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Personalized Nutrigenomics Testing (PNT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive nutrition counselling from a registered dietitian based on the results of their personalized nutrigenomics testing. Nutrition counselling will focus on weight management. Individuals recruited from The East Elgin Family Health Team will complete the GLB Program, but will be given personalized nutrition and physical activity advice based on the results of their nutrigenomics test. Transplant participants will receive a monthly follow-up email or phone call reviewing their nutrition and physical activity plan, until 12 months after baseline data collection. Reminders of lifestyle goals will be incorporated into the GLB Program for participants at the East Elgin Family Health Team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Personalized Nutrigenomics Testing (PNT)</intervention_name>
    <description>Participants will receive nutrition counselling from a registered dietitian based on the results of their personalized nutrigenomics testing. Nutrition and physical activity counselling will focus on weight management. Individuals recruited from The East Elgin Family Health Team will complete the GLB Program, but will be given personalized nutrition and physical activity advice based on the results of their nutrigenomics test. Transplant participants will receive a monthly follow-up email or phone call reviewing their nutrition and physical activity plan, until 12 months after baseline data collection. Reminders of lifestyle goals will be incorporated into the GLB Program for participants at the East Elgin Family Health Team.</description>
    <arm_group_label>Personalized Nutrigenomics Testing (PNT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Nutrition Intervention (SNI)</intervention_name>
    <description>Transplant participants will receive standard nutrition counselling from a registered dietitian focused on strategies from the Canadian Diabetes Association's patient resource 'Just the Basics.' Nutrition and physical activity counselling will focus on weight management. Individuals recruited from The East Elgin Family Health Team will complete the standard GLB Program. Transplant participants will receive a monthly follow-up email or phone call reviewing their nutrition and physical activity plan, until 12 months after baseline data collection. Reminders of lifestyle goals will be incorporated into the GLB Program for participants at the East Elgin Family Health Team.</description>
    <arm_group_label>Standard Nutrition Intervention (SNI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  TRANSPLANT PATIENTS: Adults greater than or equal to age 18, non-pregnant,&#xD;
             non-lactating, attending Canadian Transplant Association meetings, BMI ≥ 25kg/m2, ≥1&#xD;
             year stable (not being treated for transplant rejection or infection) post-transplant,&#xD;
             having access to a computer with email or a telephone at least one day per week and&#xD;
             English speaking.&#xD;
&#xD;
          -  LIFESTYLE INTERVENTION PROGRAM (GLB) PATIENTS: Adults greater than or equal to age 18,&#xD;
             non-pregnant, non-lactating, BMI ≥ 25kg/m2, having access to a computer with email or&#xD;
             a telephone at least one day per week and English speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  TRANSPLANT PATIENTS: Patients with BMI &lt;25 kg/m2, unwilling to undergo PNT, unable to&#xD;
             provide consent, undergoing treatment for transplant rejection or infection, not&#xD;
             English speaking, without access to a computer with email or a telephone at least one&#xD;
             day per week and/or &lt;1 year post-transplant, seeing another healthcare provider for&#xD;
             weight loss advice outside of this study&#xD;
&#xD;
          -  LIFESTYLE INTERVENTION PROGRAM (GLB) PATIENTS: Patients with BMI &lt;25 kg/m2, unwilling&#xD;
             to undergo PNT, unable to provide consent, not English speaking, without access to a&#xD;
             computer with email or a telephone at least one day per week, seeing another&#xD;
             healthcare provider for weight loss advice outside of this study&#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>Janet Madill, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brescia University College at Western University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Janet Madill, PhD</last_name>
    <phone>519 432 8353</phone>
    <phone_ext>28240</phone_ext>
    <email>jmadill7@uwo.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Justine Horne, MScFN</last_name>
    <phone>519 212 0917</phone>
    <email>jhorne5@uwo.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>East Elgin Family Health Team</name>
      <address>
        <city>Aylmer</city>
        <state>Ontario</state>
        <zip>N5H1K9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Brescia University College</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6G 1H2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janet Madill, PhD</last_name>
      <phone>519 432 8353</phone>
      <phone_ext>28240</phone_ext>
      <email>jmadill7@uwo.ca</email>
    </contact>
    <contact_backup>
      <last_name>Justine Horne, MScFN</last_name>
      <phone>519 212 0917</phone>
      <email>jhorne5@uwo.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Horne J, Gilliland J, O'Connor C, Seabrook J, Hannaberg P, Madill J. Study protocol of a pragmatic randomized controlled trial incorporated into the Group Lifestyle Balance program: the nutrigenomics, overweight/obesity and weight management trial (the NOW trial). BMC Public Health. 2019 Mar 15;19(1):310. doi: 10.1186/s12889-019-6621-8.</citation>
    <PMID>30876469</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>March 5, 2020</last_update_submitted>
  <last_update_submitted_qc>March 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western University, Canada</investigator_affiliation>
    <investigator_full_name>Janet Madill</investigator_full_name>
    <investigator_title>Dr. Janet Madill</investigator_title>
  </responsible_party>
  <keyword>Nutrigenomics</keyword>
  <keyword>Genetics</keyword>
  <keyword>Overweight</keyword>
  <keyword>Obesity</keyword>
  <keyword>Transplantation</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Dietetics</keyword>
  <keyword>BMI</keyword>
  <keyword>Body Composition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will only be available to the current research team.</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/NCT03015012
org study id: 108511
nct id: NCT03015012
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators hypothesize that compared to the provision of population-based lifestyle
      advice, providing DNA-based lifestyle advice via personalized nutrigenomics testing (PNT) to
      two distinct patient populations (Family Health Team patients receiving a lifestyle
      counselling intervention and transplant recipients) will lead to greater reductions in
      percent body fat. In addition, it will motivate them to adopt healthier dietary and physical
      activity habits through changes in attitudes and/or subjective norms and/or behavioural
      control, lead to greater fat loss (kg), increased percent lean mass and therefore improve
      health and quality of life outcomes for both patient populations. In addition, it is
      hypothesized that dietary strategies related to the intake of one or more dietary components
      of interest will mitigate post-transplant weight gain associated with three SNPs of interest.

      This is a randomized clinical intervention trial involving a total of four groups of patients
      (n = 400). The two main patient groups include overweight or obese, stable transplant
      recipients and overweight or obese patients who are attending group counselling sessions at
      the East Elgin Family Health Team. Within these two main groups, there will be two
      sub-groups. Patients will be randomized to receive either PNT or standard nutrition
      intervention (SNI). Baseline data will be conducted consisting of a food frequency
      questionnaire and three-day food records using a validated multiple pass method.
      Bioelectrical Impedance Analysis (BIA) will be conducted to assess body composition and to
      derive percent body fat and lean mass. Weight and height will be measured using a weigh scale
      and stadiometer. Attitudes, subjective norms and behavioural control will be assessed using a
      Theory of Planned Behaviour Questionnaire. Those patients randomized to the PNT group will be
      instructed on a tailored nutrition care plan and physical activity recommendations based on
      their individual genetic profile. At the same time, the SNI group will be instructed on
      general nutrition and physical activity recommendations for weight loss, which include the
      use of dietary strategies from the standard tool ('Just the Basics') used by registered
      dietitians for transplant patients and the GLB program for patients attending the East Elgin
      Family Health Team sessions. Monthly email reminders or phone calls (depending on patient
      preference) will be sent to transplant recipients as a reminder of their nutrition and
      physical activity plan. Reminders of nutrition and physical activity goals for the Family
      Health Team participants are incorporated into the GLB program. Three months, six months and
      twelve months after baseline data collection and individual nutrition interventions, baseline
      data will be repeated. After the study is complete, participants in the SNI group will be
      offered a nutrigenomics report and consultation with a registered dietitian.

      A paired t-test or repeated measures ANOVA will be used to assess within group change from
      baseline to each follow-up time point for: BMI, body fat, lean mass, and dietary intake. A
      repeated measures ANOVA will be used to test between group differences from baseline to each
      follow-up time point for: BMI, body fat, lean mass, and dietary intake. If significant mean
      differences are detected, a Tukey's post hoc test will be used to compare differences by
      group. Statistical significance will be determined by P < 0.05. General linear regression
      models will be used to assess interactions between each genotype of interest and each dietary
      component of interest on BMI and body composition from baseline to each follow-up time point.
Hypotheses: Compared to the provision of population-based lifestyle advice, providing
      DNA-based lifestyle advice via personalized nutrigenomics testing (PNT) to two distinct
      patient populations (patients attending group counselling sessions at the East Elgin Family
      Health Team and transplant recipients) in which overweight and obesity are common concerns,
      will motivate them to adopt healthier dietary and physical activity habits via changes in
      attitudes and/or subjective norms and/or behavioural control, lead to greater fat loss,
      increased percent lean mass and therefore improve health and quality of life outcomes for
      both patient populations. It is also hypothesized that dietary strategies related to the
      intake of one or more dietary components of interest (protein, monounsaturated fat,
      polyunsaturated fat, total fat, sodium, carbohydrates, alcohol and calories) will mitigate
      post-transplant weight gain associated with the following SNPs: ACE (rs4343), FTO (rs1558902)
      and MC4R (rs571312).

      Sample Size: No research to date has studied the aforementioned hypotheses. Previously
      published data assessing weight loss in a SNI group compared to a PNT group using a
      randomized clinical intervention model in a different population used a sample of n = 93 and
      an alpha < 0.05 to find statistical significance after 3-7 month follow-up. Similarly,
      nutrigenomics research in the ACE gene (rs4343) found statistical significance using a sample
      of n = 104 and an alpha < 0.05. A sample size calculation with 80% power and an alpha of 0.05
      indicated that 37 participants per group (n = 148 total) are needed to detect significant
      differences between groups for changes in body fat percentage (primary outcome). Since it is
      feasible for this research, a larger sample size goal (n = 400) will be used to increase
      power and draw meaningful inferences from the data. There will be 100 participants in each
      patient group (n = 200 in SNI group, n = 200 in PNT group) in this landmark study.

      Design and Methods: Participants will be recruited from the Canadian Transplant Association
      (CTA) meetings with the assistance of the Director, Sandra Holdsworth (transplant recipients;
      n = 200) and from the Group Lifestyle Balance Program (GLB Program) through the East Elgin
      Family Health Team (GLB; n = 200) for this randomized clinical intervention trial.
      Word-of-mouth recruitment is also expected. This trial involves a total of four groups of
      patients. The two main patient groups include overweight or obese (BMI ≥ 25 kg/m^2), stable
      transplant recipients greater than or equal to one year post-transplant, and overweight or
      obese (BMI ≥ 25 kg/m^2) patients who are attending the GLB program at the East Elgin Family
      Health Team. Within these two main patient groups, there will be two sub-groups (n = 100 per
      sub-group). Patients will be randomized to receive either PNT or standard nutrition
      intervention (SNI) based on strategies from the standard teaching tool used by dietitians in
      both patient populations: 'Just the Basics' - developed by the Canadian Diabetes Association
      for transplant participants. Participants from the East Elgin Family Health Team, will
      participate in the GLB Program and will either complete the standard program (SNI Group) +
      receive population-based nutrition and physical activity recommendations or will complete a
      modified GLB program + receive personalized nutrition and physical activity recommendations
      based on their genetics (PNT Group). Baseline data will be conducted consisting of a food
      frequency questionnaire and three-day food records using a validated multiple pass method.
      Bioelectrical Impedance Analysis (BIA) will be conducted to assess body composition and to
      derive percent and kg body fat and lean mass. Weight and height will be measured using a
      weigh scale and stadiometer. Surveys will be completed by participants to assess several
      demographic characteristics, as well as key components of the Theory of Planned Behaviour.
      Those patients randomized to the PNT group will be instructed on a tailored nutrition care
      plan and physical activity goal based on their individual genetic profile. At the same time,
      the SNI group will be instructed on general nutrition and physical activity recommendations
      for weight loss. A survey based on the Theory of Planned Behaviour will be administered
      before and after participants receive their nutrition and physical activity advice. These
      components are needed so that we can assess whether or not social and built environment
      factors, subjective norms, attitudes and behavioural control influence change in dietary
      intake. Monthly email or phone call reminders (depending on participant preference) will be
      sent to participants as a reminder of their nutrition and physical activity plan for
      transplant recipients. For East Elgin Family Health Team participants, reminders of the
      nutrition and physical activity plan will be incorporated into the GLB Program. Three months,
      six months and twelve months after baseline data collection and individual nutrition
      interventions, baseline data will be repeated. After the study is complete, participants in
      the SNI group will be offered a nutrigenomics test and consultation with a registered
      dietitian.

      Statistical Analysis: A paired t-test or repeated measures ANOVA will be used to assess
      within group change from baseline to each of the follow-up time points for: BMI, body fat,
      lean mass, water weight, TPB components, dietary intake (protein, total fat, saturated fat,
      unsaturated fat, carbohydrates, alcohol, calories and sodium), and physical activity. A
      repeated measures ANOVA will be used to test between group differences from baseline to each
      of the follow-up time points for: BMI, body fat, lean mass, water weight, TPB components,
      dietary intake (protein, total fat, saturated fat, unsaturated fat, carbohydrates, alcohol,
      calories and sodium) and physical activity. If significant mean differences are detected, a
      Tukey's post hoc test will be used to compare differences by group. Statistical significance
      will be determined by P < 0.05. General linear regression models will be used to assess the
      effect of each genotype of interest (ACE rs4343, MC4R rs573112, FTO rs1558902) and the impact
      of each dietary component of interest (protein, total fat, saturated fat, unsaturated fat,
      carbohydrates, alcohol, calories and sodium) on BMI and body composition from baseline to
      each follow-up time point. We will control for age, sex, ethnicity, immunosuppressive
      medications (transplant recipients) and baseline body composition and BMI. IBM SPSS
      Statistics, version 21.0 will be used for the data analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Body Fat Percentage
time frame: 3 months, 6 months, 12 months
description: Change in body composition (body fat percentage as the primary outcome) will be assessed using BIA which will provide information on fat mass, lean mass, and water weight
measure: Change in Dietary Intake
time frame: 3 months, 6 months, 12 months
description: Change in dietary intake will be assessed using pre- and post- dietary data collected using 3-day food records, and a past-month online food frequency questionnaire.
measure: Change in Physical Activity
time frame: 3 months, 6 months, 12 months
description: Change in physical activity will be assessed using pre- and post- physical activity data collected using a 7-day physical activity recall. Metabolic equivalents will then be calculated from this data.
measure: Change in Attitudes, Subjective Norms and Behavioural Control
time frame: Pre- and post- lifestyle intervention (baseline), 3 months, 6 months, 12 months
description: Change in these key components of the Theory of Planned Behaviour (TPB) will be assessed using a TPB questionnaire.
measure: Change in Body Composition
time frame: 3 months, 6 months, 12 months
description: Change in body composition will be assessed using BIA which will provide information on fat mass, lean mass, and water weight
measure: BMI
time frame: 3 months, 6 months, 12 months
description: Change in BMI will be measured using weight and height data collected using a weigh scale and stadiometer
measure: Weight
time frame: 3 months, 6 months, 12 months
description: Change in weight will be measured using a weigh scale
measure: Nutrigenomics Interactions
time frame: 3 months, 6 months, 12 months
description: Nutrigenomics (nutrition-genetic) interactions between ACE gene variants at rs4343, FTO gene variants at rs1558902 (in strong linkage disequilibrium with rs9939609) and MC4R (rs571312) to mitigate risk of post-transplant weight gain will be assessed for transplant recipients in the PNT group.
arm group label: Standard Nutrition Intervention (SNI)
arm group type: Active Comparator
description: Transplant participants will receive standard nutrition counselling from a registered dietitian focused on strategies from the Canadian Diabetes Association's patient resource 'Just the Basics.' Nutrition counselling will focus on weight management. Individuals recruited from The East Elgin Family Health Team will complete the GLB Program. Transplant participants will receive a monthly follow-up email or phone call reviewing their nutrition and physical activity plan, until 12 months after baseline data collection. Reminders of lifestyle goals will be incorporated into the GLB Program for participants at the East Elgin Family Health Team.
arm group label: Personalized Nutrigenomics Testing (PNT)
arm group type: Experimental
description: Participants will receive nutrition counselling from a registered dietitian based on the results of their personalized nutrigenomics testing. Nutrition counselling will focus on weight management. Individuals recruited from The East Elgin Family Health Team will complete the GLB Program, but will be given personalized nutrition and physical activity advice based on the results of their nutrigenomics test. Transplant participants will receive a monthly follow-up email or phone call reviewing their nutrition and physical activity plan, until 12 months after baseline data collection. Reminders of lifestyle goals will be incorporated into the GLB Program for participants at the East Elgin Family Health Team.
intervention type: Genetic
intervention name: Personalized Nutrigenomics Testing (PNT)
description: Participants will receive nutrition counselling from a registered dietitian based on the results of their personalized nutrigenomics testing. Nutrition and physical activity counselling will focus on weight management. Individuals recruited from The East Elgin Family Health Team will complete the GLB Program, but will be given personalized nutrition and physical activity advice based on the results of their nutrigenomics test. Transplant participants will receive a monthly follow-up email or phone call reviewing their nutrition and physical activity plan, until 12 months after baseline data collection. Reminders of lifestyle goals will be incorporated into the GLB Program for participants at the East Elgin Family Health Team.
arm group label: Personalized Nutrigenomics Testing (PNT)
intervention type: Other
intervention name: Standard Nutrition Intervention (SNI)
description: Transplant participants will receive standard nutrition counselling from a registered dietitian focused on strategies from the Canadian Diabetes Association's patient resource 'Just the Basics.' Nutrition and physical activity counselling will focus on weight management. Individuals recruited from The East Elgin Family Health Team will complete the standard GLB Program. Transplant participants will receive a monthly follow-up email or phone call reviewing their nutrition and physical activity plan, until 12 months after baseline data collection. Reminders of lifestyle goals will be incorporated into the GLB Program for participants at the East Elgin Family Health Team.
arm group label: Standard Nutrition Intervention (SNI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janet Madill, PhD
role: Principal Investigator
affiliation: Brescia University College at Western University
last name: Janet Madill, PhD
phone: 519 432 8353
phone ext: 28240
email: jmadill7@uwo.ca
last name: Justine Horne, MScFN
phone: 519 212 0917
email: jhorne5@uwo.ca
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
citation: Horne J, Gilliland J, O'Connor C, Seabrook J, Hannaberg P, Madill J. Study protocol of a pragmatic randomized controlled trial incorporated into the Group Lifestyle Balance program: the nutrigenomics, overweight/obesity and weight management trial (the NOW trial). BMC Public Health. 2019 Mar 15;19(1):310. doi: 10.1186/s12889-019-6621-8.
PMID: 30876469
responsible party type: Principal Investigator
investigator affiliation: Western University, Canada
investigator full name: Janet Madill
investigator title: Dr. Janet Madill
mesh term: Obesity
mesh term: Overweight
sharing ipd: No
ipd description: IPD will only be available to the current research team.