Canadian Health Advanced By Nutrition and Graded Exercise (CHANGE)

• The proportion of patients that have a reversal of the features of the metabolic syndrome present in individual patients (return to the normal range) or elimination of drug therapy based on normalization of the features of the metabolic syndrome [ Time Frame: At 12 months, serum glucose, lipid, and cholesterol levels and medication profiles will be compared to baseline measures ] [ Designated as safety issue: No ]
  

• The decreased medical need for pharmacotherapy for metabolic syndrome since baseline [ Time Frame: At 3 months, pharmacotherapy and changes in blood pressure, renal insufficiency or diabetes, & concomitant medications taken including vitamin/mineral supplements will be compared to baseline status ] [ Designated as safety issue: No ]
  
• The decreased medical need for pharmacotherapy for metabolic syndrome since baseline [ Time Frame: At 6 months, pharmacotherapy and changes in blood pressure, renal insufficiency or diabetes, & concomitant medications taken including vitamin/mineral supplements will be compared to baseline status ] [ Designated as safety issue: No ]
  
• The decreased medical need for pharmacotherapy for metabolic syndrome since baseline [ Time Frame: At 9 months, pharmacotherapy and changes in blood pressure, renal insufficiency or diabetes, & concomitant medications taken including vitamin/mineral supplements will be compared to baseline status ] [ Designated as safety issue: No ]
  
• The decreased medical need for pharmacotherapy for metabolic syndrome since baseline [ Time Frame: At 12 months, pharmacotherapy and changes in blood pressure, renal insufficiency or diabetes, & concomitant medications taken including vitamin/mineral supplements will be compared to baseline status ] [ Designated as safety issue: No ]
  
• Each individual's compliance to diet and exercise interventions [ Time Frame: At 3 months, readiness to change, barriers and facilitators, and compliance to diet and exercise interventions will be recorded will be compared to baseline ] [ Designated as safety issue: No ]

  Compliance to diet will be assessed by a nutritional assessment including 3 day food records, macronutrient intake, health eating index, weight changes, waist circumference, hip circumference and barriers to change.

  Compliance to exercise intervention will be assessed by a fitness assessment whereas the type of exercise, duration, frequency, # repetitions, heart rate and unsupervised exercise will also be documented.

  
  
• Each individual's compliance to diet and exercise interventions [ Time Frame: At 6 months, readiness to change, barriers and facilitators, and compliance to diet and exercise interventions will be recorded will be compared to baseline. ] [ Designated as safety issue: No ]

  Compliance to diet will be assessed by a nutritional assessment including 3 day food records, macronutrient intake, health eating index, weight changes, waist circumference, hip circumference and barriers to change.

  Compliance to exercise intervention will be assessed by a fitness assessment whereas the type of exercise, duration, frequency, # repetitions, heart rate and unsupervised exercise will also be documented.

  
  
• Each individual's compliance to diet and exercise interventions [ Time Frame: At 9 months, readiness to change, barriers and facilitators, and compliance to diet and exercise interventions will be recorded will be compared to baseline. ] [ Designated as safety issue: No ]

  Compliance to diet will be assessed by a nutritional assessment including 3 day food records, macronutrient intake, health eating index, weight changes, waist circumference, hip circumference and barriers to change.

  Compliance to exercise intervention will be assessed by a fitness assessment whereas the type of exercise, duration, frequency, # repetitions, heart rate and unsupervised exercise will also be documented.

  
  
• Each individual's compliance to diet and exercise interventions [ Time Frame: At 12 months, readiness to change, barriers and facilitators, and compliance to diet and exercise interventions will be recorded will be compared to baseline. ] [ Designated as safety issue: No ]

  Compliance to diet will be assessed by a nutritional assessment including 3 day food records, macronutrient intake, health eating index, weight changes, waist circumference, hip circumference and barriers to change.

  Compliance to exercise intervention will be assessed by a fitness assessment whereas the type of exercise, duration, frequency, # repetitions, heart rate and unsupervised exercise will also be documented.

  
  
• The proportion of patients that have a reversal of the features of the metabolic syndrome present in individual patients (return to the normal range) or elimination of drug therapy based on normalization of the features of the metabolic syndrome [ Time Frame: At 3 months, serum glucose, lipid, and cholesterol levels and medication profiles will be compared to baseline measures ] [ Designated as safety issue: No ]
  
• The proportion of patients that have a reversal of the features of the metabolic syndrome present in individual patients (return to the normal range) or elimination of drug therapy based on normalization of the features of the metabolic syndrome [ Time Frame: At 6 months, serum glucose, lipid, and cholesterol levels and medication profiles will be compared to baseline measures ] [ Designated as safety issue: No ]
  
• The proportion of patients that have a reversal of the features of the metabolic syndrome present in individual patients (return to the normal range) or elimination of drug therapy based on normalization of the features of the metabolic syndrome [ Time Frame: At 12 months, serum glucose, lipid, and cholesterol levels and medication profiles will be compared to baseline measures ] [ Designated as safety issue: No ]
  

Hypertension, cardiovascular disease, strokes, diabetes and their complications including renal failure and neuropathy are major contributors to healthcare costs1. Metabolic Syndrome, a widespread genetic trait refers to a group of factors that increase risk for these diseases. Progression of the components of the metabolic syndrome can be significantly reduced by dietary manipulation and exercise.

The aging population, with both metabolic syndrome and muscular weakness, is going to result in an enormous social and financial burden not only for medical care but also for families caring for such patients. Existing knowledge would suggest that dietary modification and exercise training would substantially reduce the costs and complications of these medical conditions.

The Canadian Guidelines for the diagnosis and management of cardiometabolic risk identify patients with metabolic syndrome who have an increased risk of cardiac and vascular disease and diabetes but the application of these results to prevent disease has been a dismal failure in general and in particular, in our country.

The current model of advice about preventive care is through family doctors (FD) in the primary care setting. FDs tend not to advise their patients about diet and exercise for a variety of reasons including a lack of education about these modalities, a lack of support from professionals qualified to assess and advise about diet and exercise, the belief that drugs are better, lack of time and a lack of reimbursement in addition to patient barriers to adoption. Although other factors, such has smoking, hypercoagulability and increased expression of proinflammatory cytokines increase cardiometabolic risk, these changes are closely related to the metabolic syndrome. "Health behavior interventions" are identified as critical to preventing the occurrence of cardiovascular disease and diabetes. These interventions can be associated with appropriate pharmacotherapy where required. The guidelines recommend a multidisciplinary team to manage these interventions. In addition it is also recommended that ethnicity be considered in these interventions.

The various traits associated with the metabolic syndrome are strongly influenced by genetic factors, i.e. the heritability of abdominal obesity and insulin resistance are estimated to be as high as 70%. Accordingly, the investigators propose to implement a 'program' of nutrition and exercise interventions imbedded into the primary care setting that are tailored to reduce the risk of metabolic syndrome and overcome these barriers. Numerous genetic polymorphisms (also referred to as markers) have been linked to the various traits associated with metabolic syndrome. It is hypothesized that these markers can be used as a means to better predict the variable responses observed in individuals following a lifestyle intervention. Several companies have begun to commercialize direct-to-consumer genetic-testing to provide nutritional counseling to individuals based on the analysis of a small subset of polymorphisms11; however, there is an absence of scientific research to either support or refute the value of genetic markers for predicting an individual's response. Considering common genetic markers in a lifestyle intervention study will enable us to assess their value for predicting response.