The DNA-Based Lifestyle Enhancement Trial
Condition: Health Behavior; Genetic Information; Cardiovascular Risk Factor
Study type: Interventional

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.
    

Intervention name(s): Personalized Health Recommendations; Generic Health Recommendations
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Includes 3-month gym membership, personalized exercise and meal plans, and genetic information related to health and wellness traits. The genetic information provided to study participants will consist of scores ranging from 0 to 100 based on the population percentile of the combined effects of many genetic variants, herein referred to as polygenic scores (PGS). PGS for approximately twenty traits related to health, fitness and nutrition will be provided to study participants. These traits are chosen for their relevance to healthy lifestyle habits (e.g. genetic predisposition to adiposity or muscle strength), entertainment value (e.g. preference for mornings) or both (e.g. bitterness taste perception, which while entertaining can also help guide vegetable choices).; Includes 3-month gym membership and generic recommendations (Canada Food Guide / Health Canada Physical Activity guidelines)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Physical Activity; Dietary Habits; Genetic Scores; Cardiovascular Health