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

NCT03015012 | Unknown

• 1 other identifier: 108511
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Transplant-Related Disorder; Overweight and Obesity

Keywords

Nutrigenomics; Genetics; Overweight; Obesity; Transplantation; Nutrition; Dietetics; BMI; Body Composition

Outcome Measures

Primary Outcomes (1)

• Change in Body Fat Percentage

  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

  3 months, 6 months, 12 months

Secondary Outcomes (6)

• Change in Dietary Intake

  3 months, 6 months, 12 months

• Change in Physical Activity

  3 months, 6 months, 12 months

• Change in Attitudes, Subjective Norms and Behavioural Control

  Pre- and post- lifestyle intervention (baseline), 3 months, 6 months, 12 months

• Change in Body Composition

  3 months, 6 months, 12 months

• BMI

  3 months, 6 months, 12 months

Other Outcomes (1)

• Nutrigenomics Interactions

  3 months, 6 months, 12 months

Study Arms (2)

Standard Nutrition Intervention (SNI)

ACTIVE COMPARATOR

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)

Personalized Nutrigenomics Testing (PNT)

EXPERIMENTAL

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)

Interventions

Personalized Nutrigenomics Testing (PNT) GENETIC

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.

Personalized Nutrigenomics Testing (PNT)

Standard Nutrition Intervention (SNI) OTHER

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.

Standard Nutrition Intervention (SNI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead
• Nutrigenomix Inc.: collaborator
• East Elgin Family Health Team: collaborator
• Canadian Transplant Association: collaborator

Study Sites (2)

East Elgin Family Health Team

Aylmer, Ontario, N5H1K9, Canada

COMPLETED

Brescia University College

London, Ontario, N6G 1H2, Canada

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• Horne JR, Gilliland JA, Vohl MC, Madill J. Exploring Attitudes, Subjective Norms and Perceived Behavioural Control in a Genetic-Based and a Population-Based Weight Management Intervention: A One-Year Randomized Controlled Trial. Nutrients. 2020 Dec 8;12(12):3768. doi: 10.3390/nu12123768.

  PMID: 33302460 DERIVED

• Horne J, Gilliland J, O'Connor C, Seabrook J, Madill J. Enhanced long-term dietary change and adherence in a nutrigenomics-guided lifestyle intervention compared to a population-based (GLB/DPP) lifestyle intervention for weight management: results from the NOW randomised controlled trial. BMJ Nutr Prev Health. 2020 May 21;3(1):49-59. doi: 10.1136/bmjnph-2020-000073. eCollection 2020.

  PMID: 33235971 DERIVED

• Horne JR, Gilliland J, Leckie T, O'Connor C, Seabrook JA, Madill J. Can a Lifestyle Genomics Intervention Motivate Patients to Engage in Greater Physical Activity than a Population-Based Intervention? Results from the NOW Randomized Controlled Trial. Lifestyle Genom. 2020;13(6):180-186. doi: 10.1159/000510216. Epub 2020 Oct 1.

  PMID: 33002888 DERIVED

• Horne JR, Gilliland JA, O'Connor CP, Seabrook JA, Madill J. Change in Weight, BMI, and Body Composition in a Population-Based Intervention Versus Genetic-Based Intervention: The NOW Trial. Obesity (Silver Spring). 2020 Aug;28(8):1419-1427. doi: 10.1002/oby.22880.

  PMID: 32935529 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janet Madill, PhD

  Brescia University College at Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janet Madill, PhD

CONTACT

519 432 8353; jmadill7@uwo.ca

Justine Horne, MScFN

CONTACT

519 212 0917; jhorne5@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Janet Madill

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 9, 2017
• Study Start: April 3, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)