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Nutrigenomics, Overweight/Obesity and Weight Management Trial (NOW Trial) (NOW)

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ClinicalTrials.gov Identifier: NCT03015012
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : March 8, 2018
Sponsor:
Collaborators:
Nutrigenomix Inc.
East Elgin Family Health Team
Canadian Transplant Association
Information provided by (Responsible Party):
Janet Madill, Western University, Canada

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Transplant-Related Disorder Overweight and Obesity Genetic: Personalized Nutrigenomics Testing (PNT) Other: Standard Nutrition Intervention (SNI) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using Personalized Nutrigenomics Testing to Mitigate Overweight/Obesity Risk in Two Distinct Patient Populations: A Multicentre Randomized Clinical Intervention Trial
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Active Comparator: Standard Nutrition Intervention (SNI)
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.
Other: Standard Nutrition Intervention (SNI)
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.
Experimental: Personalized Nutrigenomics Testing (PNT)
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.
Genetic: Personalized Nutrigenomics Testing (PNT)
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.



Primary Outcome Measures :
  1. Change in Body Fat Percentage [ Time Frame: 3 months, 6 months, 12 months ]
    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


Secondary Outcome Measures :
  1. Change in Dietary Intake [ Time Frame: 3 months, 6 months, 12 months ]
    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.

  2. Change in Physical Activity [ Time Frame: 3 months, 6 months, 12 months ]
    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.

  3. Change in Attitudes, Subjective Norms and Behavioural Control [ Time Frame: Pre- and post- lifestyle intervention (baseline), 3 months, 6 months, 12 months ]
    Change in these key components of the Theory of Planned Behaviour (TPB) will be assessed using a TPB questionnaire.

  4. Change in Body Composition [ Time Frame: 3 months, 6 months, 12 months ]
    Change in body composition will be assessed using BIA which will provide information on fat mass, lean mass, and water weight

  5. BMI [ Time Frame: 3 months, 6 months, 12 months ]
    Change in BMI will be measured using weight and height data collected using a weigh scale and stadiometer

  6. Weight [ Time Frame: 3 months, 6 months, 12 months ]
    Change in weight will be measured using a weigh scale


Other Outcome Measures:
  1. Nutrigenomics Interactions [ Time Frame: 3 months, 6 months, 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • TRANSPLANT PATIENTS: Adults greater than or equal to age 18, non-pregnant, non-lactating, attending Canadian Transplant Association meetings, BMI ≥ 25kg/m2, ≥1 year stable (not being treated for transplant rejection or infection) post-transplant, having access to a computer with email or a telephone at least one day per week and English speaking.
  • LIFESTYLE INTERVENTION PROGRAM (GLB) PATIENTS: Adults greater than or equal to age 18, non-pregnant, non-lactating, BMI ≥ 25kg/m2, having access to a computer with email or a telephone at least one day per week and English speaking.

Exclusion Criteria:

  • TRANSPLANT PATIENTS: Patients with BMI <25 kg/m2, unwilling to undergo PNT, unable to provide consent, undergoing treatment for transplant rejection or infection, not English speaking, without access to a computer with email or a telephone at least one day per week and/or <1 year post-transplant, seeing another healthcare provider for weight loss advice outside of this study
  • LIFESTYLE INTERVENTION PROGRAM (GLB) PATIENTS: Patients with BMI <25 kg/m2, unwilling to undergo PNT, unable to provide consent, not English speaking, without access to a computer with email or a telephone at least one day per week, seeing another healthcare provider for weight loss advice outside of this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015012


Contacts
Contact: Janet Madill, PhD 519 432 8353 ext 28240 jmadill7@uwo.ca
Contact: Justine Horne, MScFN 519 212 0917 jhorne5@uwo.ca

Locations
Canada, Ontario
East Elgin Family Health Team Recruiting
Aylmer, Ontario, Canada, N5H1K9
Contact: Justine Horne, MScFN    519-773-3715 ext 136    jhorne@eefht.ca   
Brescia University College Recruiting
London, Ontario, Canada, N6G 1H2
Contact: Janet Madill, PhD    519 432 8353 ext 28240    jmadill7@uwo.ca   
Contact: Justine Horne, MScFN    519 212 0917    jhorne5@uwo.ca   
Sponsors and Collaborators
Western University, Canada
Nutrigenomix Inc.
East Elgin Family Health Team
Canadian Transplant Association
Investigators
Principal Investigator: Janet Madill, PhD Brescia University College at Western University

Responsible Party: Janet Madill, Dr. Janet Madill, Western University, Canada
ClinicalTrials.gov Identifier: NCT03015012     History of Changes
Other Study ID Numbers: 108511
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will only be available to the current research team.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janet Madill, Western University, Canada:
Nutrigenomics
Genetics
Overweight
Obesity
Transplantation
Nutrition
Dietetics
BMI
Body Composition

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms