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Open Access 01-12-2019 | Obesity | Study protocol

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, Jason Gilliland, Colleen O’Connor, Jamie Seabrook, Peter Hannaberg, Janet Madill

Published in: BMC Public Health | Issue 1/2019

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.

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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
Jason Gilliland
Colleen O’Connor
Jamie Seabrook
Peter Hannaberg
Janet Madill
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Obesity
Obesity
Nutrition
Overweight
Published in: BMC Public Health / Issue 1/2019
Electronic ISSN: 1471-2458
DOI: https://doi.org/10.1186/s12889-019-6621-8

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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)

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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