Skip to main content
OpenTrials
Completed

NCT Number: NCT01616563

Canadian Health Advanced By Nutrition and Graded Exercise

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Proliferative diabetic retinopathy
  • Nephropathy (Suggested parameters: serum creatinine > 160 µmol/L)
  • Clinically manifest neuropathy defined as absent ankle jerks
  • Severe fasting hyperglycemia > 11 mmol/L
  • 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

Treatment and study plan

Dietary intervention

Behavioral

Nutrition assessment, review of the basic principles of dietary intervention for metabolic syndrome with an emphasis on the clinical risk factors identified for each individual, joint goal setting to determine what dietary changes are feasible, considering intention and barriers to dietary behaviour change.

Other names: Nutrition therapy, Dietary counselling, Behavioural therapy

Exercise Prescription and Fitness Program

Behavioral

Exercise tests (aerobic fitness, muscular and flexibility tests) recommended by the Canadian Society of Exercise Physiology (CSEP), followed by an individualized exercise plan including fitness assessments.

Other names: Exercise plan, physical activity intervention

Primary outcomes

  1. Feasibility of the Diet Intervention

    Time frame: 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.

  2. Feasibility of the Exercise Intervention

    Time frame: 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.

  3. Number of Participants That Have Reversal of Metabolic Syndrome

    Time frame: 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 outcomes

  1. Percentage of Participants With Improvements in at Least One Individual Components of Metabolic Syndrome

    Time frame: 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

  2. Change From Baseline in Diet Quality-Canadian Healthy Eating Index

    Time frame: 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.

  3. Change From Baseline in Diet Quality-Mediterranean Diet Score

    Time frame: 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.

  4. Change From Baseline in Aerobic Capacity

    Time frame: Change at 12 months compared to baseline

    Estimated maximal oxygen consumption (VO2 max) standardized to age and sex

  5. Changes in Risk of Myocardial Infarction and Cardiac Events

    Time frame: 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

  6. Changes in Continuous Metabolic Syndrome Risk Score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Daren K. Heyland

Other

Collaborators

  • St. Joseph's Healthcare Hamilton

Registry information

Official study title

Canadian Health Advanced By Nutrition and Graded Exercise: CHANGE Health Paradigm

Acronym: CHANGE

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 12, 2012
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.