Clinical trial NCT01616563: Canadian Health Advanced By Nutrition and Graded Exercise
Official title: Canadian Health Advanced By Nutrition and Graded Exercise: CHANGE Health Paradigm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: central obesity
abdominal obesity
hypertension
cardiovascular disease
high cholesterol
high triglycerides
insulin resistance
diabetes mellitus
Lead sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
First posted: 2012-06-12
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of the CHANGE initiative is to change the delivery of care in primary care clinics to treat disease by reducing reliance on drugs and hospitals through the promotion of scientifically validated nutritional concepts and exercise. Specifically, the objective is to identify patients from primary care clinics with metabolic syndrome who are not morbidly obese and use diet and exercise interventions to reverse the changes, reduce reliance on pharmacotherapy and prevent progression to diabetes and cardiovascular disease.

Detailed description: 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 examine numerous genetic polymorphisms (also referred to as markers) that have been linked to the various traits associated with metabolic syndrome in a sub study. 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.

Eligibility criteria: Inclusion Criteria:

* Age \>/= 18 years old
* Fasting Blood Glucose \>/= 5.6 mmol/L or receiving pharmacotherapy
* Blood Pressure of \>/= 130/85 mm Hg or receiving pharmacotherapy
* Triglyceride of \>/= 1.7 mmol/L or receiving pharmacotherapy
* HDL-C \< 1.0 mmol/L Males and \< 1.3 mmol/L females
* Abdominal circumference as determined by a pre-specified technique:
* Europids/Whites/sub-Saharan Africans/Mediterranean/middle east \>/= 94 cm Males, \>/= 80 cm Female.
* Asian and South Central Americans \>/= 90 cm males and \>/=80 cm females
* US and Canadian Whites \>/= 102 cm males, \>/=88 cm females.

Exclusion Criteria:

* Inability to speak, read or understand English and/or French for the Laval University participants.
* Having a medical or physical condition that makes moderate intensity physical activity difficult or unsafe.
* Diagnosis of Type 1 Diabetes Mellitus
* Type 2 diabetes mellitus only if any one of the following are present

  1. Proliferative diabetic retinopathy
  2. Nephropathy (Suggested parameters: serum creatinine \> 160 µmol/L)
  3. Clinically manifest neuropathy defined as absent ankle jerks
  4. Severe fasting hyperglycemia \> 11 mmol/L
  5. Peripheral vascular disease
* Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal , liver), heart disease, stroke and ongoing substance abuse
* Clinically significant renal failure
* Diagnosis of psychiatric disorders (cognitive impairment) that would limit adequate informed consent or ability to comply with study protocol
* Diagnosis of cancer (other than non-melanoma skin cancer) that was active or treated with radiation or chemotherapy within the past 2 years
* Diagnosis of a terminal illness and/or in hospice care
* Pregnant, lactating or planning to become pregnant during the study period
* Investigator discretion for clinical safety or protocol adherence reasons
* Chronic inflammatory diseases
* Body Mass Index \> 35

Primary outcomes:
measure: Feasibility of the Diet Intervention
timeFrame: At 12 months
measure: Feasibility of the Exercise Intervention
timeFrame: At 12 months
measure: Number of Participants That Have Reversal of Metabolic Syndrome
timeFrame: At 12 months compared to baseline measures
Secondary outcomes:
measure: Percentage of Participants With Improvements in at Least One Individual Components of Metabolic Syndrome
timeFrame: At 12 months compared to baseline
measure: Change From Baseline in Diet Quality-Canadian Healthy Eating Index
timeFrame: Change at 12 months compared to baseline
measure: Change From Baseline in Diet Quality-Mediterranean Diet Score
timeFrame: Change at 12 months compared to baseline
measure: Change From Baseline in Aerobic Capacity
timeFrame: Change at 12 months compared to baseline
measure: Changes in Risk of Myocardial Infarction and Cardiac Events
timeFrame: Change at 12 months compared to baseline
measure: Changes in Continuous Metabolic Syndrome Risk Score
timeFrame: Change at 12 months compared to baseline
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Edmonton Oliver Primary Care Network
state: Alberta
city: Toronto
country: Canada
facility: Canadian Phase Onward Inc.
state: Ontario
city: Quebec
country: Canada
facility: Clinique de kinésiologie de l'Université Laval
Study officials:
affiliation: University of Toronto
name: Khush Jeejeebhoy, MD
role: STUDY_DIRECTOR
affiliation: University of Guelph
name: Paula Brauer
role: STUDY_CHAIR
affiliation: Laval University
name: Angelo Tremblay
role: STUDY_CHAIR
affiliation: University of Guelph
name: David Mutch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta, Edmonton, Alberta
name: Doug Klein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadian Phase Onward
name: Lew Pliamm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Caroline Rheaume
role: PRINCIPAL_INVESTIGATOR
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