Canadian Health Advanced By Nutrition and Graded Exercise

Not Applicable

Completed

Conditions: Metabolic Syndrome

Interventions: Behavioral: Dietary Intervention
Behavioral: Exercise Prescription and Fitness Program

Registration Number: NCT01616563

Lead Sponsor: Daren K. Heyland

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 305

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diet and exercise	Dietary Intervention	A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Diet and exercise	Exercise Prescription and Fitness Program	A combined diet and exercise program tailored to individuals incorporating behavioural modification support

Primary Outcome Measures

Name	Time	Method
Feasibility of the Exercise Intervention	At 12 months	Percentage of the prescribed exercise visits attended over 12 months. Each participant was to attend a total of 21 prescribed exercise visits over 12 months.
Feasibility of the Diet Intervention	At 12 months	Percentage of the prescribed diet visits visits attended over 12 months. Each participant was to attend a total of 21 prescribed diet visits over 12 months.
Number of Participants That Have Reversal of Metabolic Syndrome	At 12 months compared to baseline measures	Metabolic syndrome is defined as having 3/5 of the following: elevated blood pressure (or on medication), elevated blood sugars (or on medication), elevated triglycerides (or on medication), low HDL-C and a large waist circumference. Reversal of metabolic syndrome is defined as having less than 3/5 criteria

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Aerobic Capacity	Change at 12 months compared to baseline	Estimated maximal oxygen consumption (VO2 max) standardized to age and sex
Changes in Risk of Myocardial Infarction and Cardiac Events	Change at 12 months compared to baseline	Changes in PROCAM score, which estimates the risk of a myocardial infarction or dying from an acute coronary event within the next 10 years. Similar to Framingham risk score but for metabolic syndrome. A lower score means a better outcome. PROCAM score varies from 0-87,0 means there are no risk factors (pt is younger than 39), while 87 means the patient is a smoker and older than 60 years and presents all risk factors
Percentage of Participants With Improvements in at Least One Individual Components of Metabolic Syndrome	At 12 months compared to baseline	Improvements in blood pressure (or elimination of medication), blood sugars (or elimination of medication), triglycerides (or elimination of medication), HDL-C and waist circumference
Change From Baseline in Diet Quality-Mediterranean Diet Score	Change at 12 months compared to baseline	Mediterranean Diet Score (MDS) is reported on a 0-14 point score with a higher score indicating a better outcome.
Changes in Continuous Metabolic Syndrome Risk Score	Change at 12 months compared to baseline	Metabolic syndrome risk score is a composite continuous score that measures the severity of metabolic syndrome as a continuous variable rather than dichotomized with arbitrary cut-points . The score is the principal component of waist circumference, glucose, systolic blood pressure, triglycerides. It has a mean of 0 and a standard deviation of 1 with higher score meaning greater risk. Reference Hillier TA, et al., Practical way to assess metabolic syndrome using a continuous score obtained from principal components analysis. Diabetologia (2006) 49:1528-1535
Change From Baseline in Diet Quality-Canadian Healthy Eating Index	Change at 12 months compared to baseline	Canadian Health Eating Index (HEI-C) is reported on a 100 point score with a higher score indicating a better outcome. A higher score means a better outcome. HEI-C is on a 100 point score.

Trial Locations

Locations (3): Clinique de kinésiologie de l'Université Laval
🇨🇦
Quebec, Canada
Edmonton Oliver Primary Care Network
🇨🇦
Edmonton, Alberta, Canada
Canadian Phase Onward Inc.
🇨🇦
Toronto, Ontario, Canada