Title

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)

Authors

Justine Horne, Western University
Jason A. Gilliland, Western UniversityFollow
Colleen O’Connor,, Western University
Jamie A. Seabrook, Brescia UniversityFollow
Peter Hannaberg, Western University
Janet Madill, Brescia UniversityFollow

Document Type

Article

Publication Date

2019

Journal

BMC Public Health

Volume

19

First Page

310

URL with Digital Object Identifier

https://doi.org/10.1186/s12889-019-6621-8

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.

Notes

Also available online in BMC Public Health at: https://doi.org/10.1186/s12889-019-6621-8