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

doi:10.1186/s12889-019-6621-8

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.

Authors

Justine Horne^{1

2

3

4}, Jason Gilliland^{5

6

7

8

9

10

11}, Colleen O'Connor^{12

5}, Jamie Seabrook^{12

5

6

9

10

11}, Peter Hannaberg¹², Janet Madill¹²

Affiliations

¹ Health and Rehabilitation Sciences, The University of Western Ontario, London, ON, Canada. jhorne5@uwo.ca.
² School of Food and Nutritional Sciences, Brescia University College at The University of Western Ontario, London, ON, Canada. jhorne5@uwo.ca.
³ The East Elgin Family Health Team, Aylmer, ON, Canada. jhorne5@uwo.ca.
⁴ Human Environments Analysis Laboratory, The University of Western Ontario, London, ON, Canada. jhorne5@uwo.ca.
⁵ Human Environments Analysis Laboratory, The University of Western Ontario, London, ON, Canada.
⁶ Department of Paediatrics, The University of Western Ontario, London, ON, Canada.
⁷ School of Health Studies, The University of Western Ontario, London, ON, Canada.
⁸ Department of Geography, The University of Western Ontario, London, ON, Canada.
⁹ Lawson Health Research Institute, London, ON, Canada.
¹⁰ Children's Health Research Institute, London, ON, Canada.
¹¹ Department of Epidemiology and Biostatistics, The University of Western Ontario, London, ON, Canada.
¹² School of Food and Nutritional Sciences, Brescia University College at The University of Western Ontario, London, ON, Canada.

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.

Publication types

Randomized Controlled Trial

MeSH terms

Adult
Genetic Counseling*
Humans
Life Style*
Nutrigenomics*
Obesity / genetics
Obesity / prevention & control
Ontario
Overweight / genetics
Overweight / prevention & control*
Program Evaluation
Research Design
Rural Population / statistics & numerical data
Weight Reduction Programs*

Associated data

ClinicalTrials.gov/NCT03015012

Grants and funding

395167/Canadian Institutes of Health Research/Canada