Abstract
BackgroundThe 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.MethodsPatients 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.DiscussionOverall, 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 registrationThis study was registered with clinicaltrials.gov: NCT03015012 on January 9, 2017.
Highlights
The nutrigenomics, overweight/obesity and weight management trial ( The Nutrigenomics (Trial)) is a pragmatic randomized controlled trial of community-dwelling adults recruited from the Group Lifestyle BalanceTM (GLBTM) Program
Lifestyle modification of nutrition and physical activity are often recommended to help manage overweight and obesity [1]
Given the documented success of the Diabetes Prevention Program (DPP), the Ontario Ministry of Health and Long-Term Care encouraged program expansion through broader eligibility criteria [6], and as such some clinics are offering this program for general weight management, since overweight and obesity are considered risk factors for the development of type 2 diabetes [7]
Summary
The nutrigenomics, overweight/obesity and weight management trial ( Trial) is a pragmatic randomized controlled trial of community-dwelling adults recruited from the Group Lifestyle BalanceTM (GLBTM) Program. The GLBTM 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. The Group Lifestyle BalanceTM (GLBTM) program is one of the most successful lifestyle-based weight management programs and is currently offered in over 80 primary care settings in the United States and is becoming increasingly prevalent in Canada [4]. Given the documented success of the DPP, the Ontario Ministry of Health and Long-Term Care encouraged program expansion through broader eligibility criteria [6], and as such some clinics are offering this program for general weight management (regardless of receiving a prediabetes diagnosis), since overweight and obesity are considered risk factors for the development of type 2 diabetes [7]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
