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)

Justine Horne, Jason Gilliland, Colleen O'Connor, Jamie Seabrook, Peter Hannaberg, Janet Madill, Justine Horne, Jason Gilliland, Colleen O'Connor, Jamie Seabrook, Peter Hannaberg, Janet Madill

Abstract

Background: The nutrigenomics, overweight/obesity and weight management trial (NOW Trial) is a pragmatic randomized controlled trial of community-dwelling adults recruited from the Group Lifestyle Balance™ (GLB™) Program. The GLB™ Program (formerly referred to as the Diabetes Prevention Program) is an evidence-based, intensive weight management program, which was offered to overweight/obese patients (BMI ≥ 25.0 kg/m2) in a rural Ontario community.

Methods: Patients enrolled in the GLB™ Program were invited to participate in this study. GLB™ groups were randomized 1:1 to receive either the standard GLB™ program + population-based lifestyle advice for weight management, or a modified GLB™ program + personalized, genetic-based lifestyle advice for weight management. The purpose of this study is to determine if the provision of genetic-based lifestyle guidelines is superior to the provision of population-based guidelines in a pragmatic clinical setting to promote changes in: body composition, weight, body mass index, dietary and physical activity habits, as well as attitudes, subjective norms, and behavioural control. The 12-month intervention protocol consists of 23 group-based sessions and 4 one-on-one sessions. Data collection time points include baseline in addition to 3, 6, and 12-month follow up. The comprehensive study design is described in the present manuscript, using both the extended CONSORT checklist for reporting pragmatic trials and the SPIRIT checklist as guidance during manuscript development.

Discussion: Overall, this study seeks to pragmatically determine if the provision of DNA-based lifestyle advice leads to improved health and lifestyle outcomes compared to the provision of standard, population-based lifestyle advice. The results of this trial can be used to inform clinical and community nutrition practice guidelines.

Trial registration: This study was registered with clinicaltrials.gov : NCT03015012 on January 9, 2017.

Keywords: Genetics; Lifestyle genomics; Nutrigenetics; Nutrigenomics; Nutrition; Obesity; Overweight; Physical activity.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the Western University Research Ethics Board (#108511) and all participants completed an informed consenting process with a member of the research team. Personal information about participants collected during the consent/data collection processes are stored securely in a locked cabinet, in a locked office. Saliva samples are analyzed and securely stored at the Nutrigenomix, Inc. Laboratory. Each sample is coded with a 14-digit barcode; no personal identifying information are included on the samples. Any reported adverse events and unintended effects will be discussed amongst the research team and dealt with on a case-by-case basis. A data monitoring committee is not needed for the purposes of this study given that one author is not blinded, and that the overall risk for harm is low.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow of Study Protocol
Fig. 2
Fig. 2
CONSORT 2010 Flow Diagram (Clinical Trial Registration Number: NCT03015012)
Fig. 3
Fig. 3
SPIRIT Flow Diagram of The NOW Trial Study Protocol at the EEFHT. SE: study entry; Mo: month

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