Clinical trial NCT03583983: The DNA-Based Lifestyle Enhancement Trial
Official title: Evaluating the Impact of Personalized Recommendations on Healthy Behaviours and Cardio-metabolic Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Genetic Information
Cardiovascular Risk Factor
Keywords: Physical Activity
Dietary Habits
Genetic Scores
Cardiovascular Health
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: GeneBlueprint Corp
name: Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
name: GoodLife Fitness
name: Southlake Regional Health Centre
First posted: 2018-07-12
Enrollment: 424
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Despite the known cardiovascular benefits of regular physical activity and having a balanced diet, it has proven challenging to change health behaviours towards favourable lifestyles. The overarching aim of the study is to test the effect of providing personalized genetic information along with diet and exercise plans on adherence to healthy lifestyle habits and cardio-metabolic risk. There is tremendous public interest in genetics and some evidence that providing genetic information can help improve health habits. However, no intervention to date has examined the effect of comprehensive genetic testing using cutting-edge polygenic score (PGS) prediction and an interactive health portal on health behaviours and cardio-metabolic risk. The investigators hypothesize that providing participants with detailed genetic information about genetic determinants of fitness and nutrition traits will help motivate people to adopt healthy lifestyle habits. The primary objective is to test the effect of providing genetic information and interactive recommendations for diet and exercise on adoption of healthy behaviours. The secondary objective is to evaluate the effects of the personalized health recommendations on cardio-metabolic risk markers, such as dyslipidemia, inflammatory markers, and fasting glucose.

Detailed description: Cardiovascular disease (CVD) is a leading cause of death and disability worldwide, accounting for 17.9 million deaths and the loss of 348 million disability-adjusted life years in 2015 alone. Diabetes and obesity are very strong risk factors for CVD. Individuals with diabetes and obesity have an 82.75% life-time risk for developing CVD. While treatments do exist for both obesity (e.g. bariatric surgery) and diabetes (e.g. pharmaceutical control of blood sugar levels), these only partially attenuate risk of adverse health outcomes and they do not address prevention and upstream causes of cardiovascular diseases, namely sedentary lifestyle and unhealthy diet. Despite the known cardiovascular benefits of regular physical activity and having a balanced diet, it has proven challenging to change health behaviours towards favourable lifestyles. Indeed, the prevalence of obesity is increasing in Canada as less than 80% of adults follow the current recommendation of 150 minutes of moderate-to-vigorous physical activity per week and approximately less than 60% of adults consume fruits and vegetables 5 or more times a day. The overarching aim of the study is to test the effect of providing personalized genetic information along with diet and exercise plans on adherence to healthy lifestyle habits and cardio-metabolic risk. There is tremendous public interest in genetics and some evidence that providing genetic information can help improve health habits. However, no intervention to date has examined the effect of comprehensive genetic testing using cutting-edge polygenic score (PGS) prediction and an interactive health portal on health behaviours and cardio-metabolic risk.

The investigators hypothesize that providing participants with detailed genetic information about genetic determinants of fitness and nutrition traits will help to motivate people to adopt healthy lifestyle habits. The primary objective is to test the effect of providing genetic information and interactive recommendations for diet and exercise on adoption of healthy behaviours. The secondary objective is to evaluate the effects of the personalized health recommendations on cardio-metabolic risk markers, such as dyslipidemia, inflammatory markers, and fasting glucose.

The investigators propose to conduct a randomized controlled trial investigating whether personalized lifestyle recommendations including genetic information motivates Hamilton Health Sciences employees to adopt healthy lifestyle changes. Study participation will be open to Hamilton Health Sciences employees. Recruitment will begin in March 2017. Eligible and consenting individuals will be enrolled. Enrollment will occur in a staggered fashion. The intervention group will receive (1) a free 3-month GoodLife Fitness gym membership providing access to any Ontario GoodLife Fitness facility, (2) professional trainer-approved workout plans, (3) dietitian-approved meal plans, and (4) genetic information pertaining to their health and fitness. The control group will also receive a GoodLife Fitness membership to ensure that all study participants are granted similar ease-of-access to perform physical activities and generic health recommendations (Canadian Food Guide / Health Canada Physical Activity Recommendations) but will not receive the personalized component of the intervention (workout plans, meal plans or genetic information) until the end of their trial period. Participants will be randomized to treatment or control groups using a minimization scheme for adaptive randomization, which will serve to balance age, gender, and ethnicity across groups as participants are enrolled. Thus, randomization will be performed in a single-blind fashion wherein the study team is unaware of whom is receiving the intervention or control. All study participants will be monitored over the course of 3 months beginning with their baseline assessment and ending with their 3-month follow-up assessment. At these two timepoints, study participants will be assessed for behavioural (physical activity levels and diet healthiness), fitness markers (blood pressure, resting heart rate, body fat %, and other anthropometric measurements) and biological markers (lipids, insulin sensitivity, and inflammation) of cardio-metabolic disease.

Eligibility criteria: Inclusion Criteria:

* Hamilton Health Science employees living in Southern Ontario who are capable and willing to follow an exercise and diet program for 3 months as well as fitness and blood assessments

Exclusion Criteria:

* Insulin-dependent diabetes
* History of cardiovascular disease (stroke, heart attack, coronary artery bypass graft (CABG) surgery, coronary angioplasty, peripheral artery disease)
* Injury or condition impeding ability to engage in physical activity (e.g. osteoarthritis, COPD)
* Pregnant or breast-feeding or planning to be pregnant
* Anyone on medication that interacts with foods
* Anyone planning to be on vacation for \> 2 weeks in the next 3 months.
* Dietary restrictions (e.g. vegetarianism, gluten sensitivity, etc.)
* History of bone marrow transplant

Primary outcomes:
measure: Change in Physical Activity Levels (Strength Training)
timeFrame: Baseline and 3 months follow-up
measure: Change in Physical Activity Levels (Aerobic Exercise)
timeFrame: Baseline and 3 months follow-up
measure: Change in Dietary Healthiness
timeFrame: Baseline and 3 months follow-up
Secondary outcomes:
measure: Change in Triglycerides
timeFrame: Baseline and 3 months follow-up
measure: Change in C-Reactive Protein
timeFrame: Baseline and 3 months follow-up
measure: Change in Fasting Glucose
timeFrame: Baseline and 3 months follow-up
measure: Change in Blood Pressure
timeFrame: Baseline and 3 months follow-up
measure: Change in Resting Heart Rate
timeFrame: Baseline and 3 months follow-up
measure: Change in Body Fat %
timeFrame: Baseline and 3 months follow-up
measure: Change in Circumference of Body Parts
timeFrame: Baseline and 3 months follow-up
measure: Change in Body Mass Index
timeFrame: Baseline and 3 months follow-up
measure: Change in Cardio-metabolic Risk Score
timeFrame: Baseline and 3 months follow-up
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences (Juravinski Hospital, General Hospital, MUMC)
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences, McMaster University
name: Guillaume Pare, MSc,MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: