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Canadian Health Advanced By Nutrition and Graded Exercise (CHANGE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier:
NCT01616563
First received: June 7, 2012
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Behavioral: Dietary Intervention
Behavioral: Exercise Prescription and Fitness Program

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Canadian Health Advanced By Nutrition and Graded Exercise: CHANGE Health Paradigm

Resource links provided by NLM:


Further study details as provided by Clinical Evaluation Research Unit at Kingston General Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet and exercise
A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Behavioral: Dietary Intervention
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
Behavioral: Exercise Prescription and Fitness Program
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616563

Locations
Canada, Alberta
Edmonton Oliver Primary Care Network Recruiting
Edmonton, Alberta, Canada
Contact: Douglas Klein, MD       doug.klein@ualberta.ca   
Canada, Ontario
Athletic Edge Sports Medicine Recruiting
Toronto, Ontario, Canada, M5H 3T9
Contact: Grant Lum       grant@aesm.ca   
Canadian Phase Onward Inc. Recruiting
Toronto, Ontario, Canada, M3H 5S4
Contact: Lew Pliam, MD       lew.pliamm@phaseonward.com   
Canada
Clinique de kinésiologie de l'Université Laval Recruiting
Quebec, Canada, G1K 7P4
Contact: Gilles Lortie, MD    418-656-2131 ext 11336    gilleslortie@videotron.ca   
Sponsors and Collaborators
Daren K. Heyland
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Khursheed Jeejeebhoy, MD Polyclinic
Principal Investigator: Paula Brauer University of Guelph
Principal Investigator: Angelo Tremblay Laval University
Principal Investigator: David Mutch, PhD University of Guelph, Deptartment of Human Health and Nutritional Sciences
Principal Investigator: Leah Gramlich, MD Royal Alexandra Hospital, Edmonton, Alberta
  More Information

Publications:

Responsible Party: Daren K. Heyland, Director of the Clinical Evaluation research Unit, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier: NCT01616563     History of Changes
Other Study ID Numbers: CHANGE
Study First Received: June 7, 2012
Last Updated: July 3, 2014
Health Authority: Canada: Health Canada

Keywords provided by Clinical Evaluation Research Unit at Kingston General Hospital:
central obesity
abdominal obesity
hypertension
cardiovascular disease
high cholesterol
high triglycerides
insulin resistance
diabetes mellitus

Additional relevant MeSH terms:
Metabolic Syndrome X
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014