Canadian Health Advanced By Nutrition and Graded Exercise
NCT ID: NCT01616563
Last Updated: 2021-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
305 participants
INTERVENTIONAL
2012-10-31
2016-02-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Diet and exercise
A combined diet and exercise program tailored to individuals incorporating behavioural modification support
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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St. Joseph's Healthcare Hamilton
OTHER
Daren K. Heyland
OTHER
Responsible Party
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Daren K. Heyland
Director of the Clinical Evaluation research Unit
Principal Investigators
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Khush Jeejeebhoy, MD
Role: STUDY_DIRECTOR
University of Toronto
Paula Brauer
Role: STUDY_CHAIR
University of Guelph
Angelo Tremblay
Role: STUDY_CHAIR
Laval University
David Mutch, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Guelph
Doug Klein, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta, Edmonton, Alberta
Lew Pliamm, MD
Role: PRINCIPAL_INVESTIGATOR
Canadian Phase Onward
Caroline Rheaume
Role: PRINCIPAL_INVESTIGATOR
Laval University
Locations
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Edmonton Oliver Primary Care Network
Edmonton, Alberta, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, Canada
Clinique de kinésiologie de l'Université Laval
Québec, , Canada
Countries
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References
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Mensah GA, Brown DW. An overview of cardiovascular disease burden in the United States. Health Aff (Millwood). 2007 Jan-Feb;26(1):38-48. doi: 10.1377/hlthaff.26.1.38.
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
Balducci S, Zanuso S, Nicolucci A, De Feo P, Cavallo S, Cardelli P, Fallucca S, Alessi E, Fallucca F, Pugliese G; Italian Diabetes Exercise Study (IDES) Investigators. Effect of an intensive exercise intervention strategy on modifiable cardiovascular risk factors in subjects with type 2 diabetes mellitus: a randomized controlled trial: the Italian Diabetes and Exercise Study (IDES). Arch Intern Med. 2010 Nov 8;170(20):1794-803. doi: 10.1001/archinternmed.2010.380.
Gouveri ET, Tzavara C, Drakopanagiotakis F, Tsaoussoglou M, Marakomichelakis GE, Tountas Y, Diamantopoulos EJ. Mediterranean diet and metabolic syndrome in an urban population: the Athens Study. Nutr Clin Pract. 2011 Oct;26(5):598-606. doi: 10.1177/0884533611416821.
Kastorini CM, Milionis HJ, Esposito K, Giugliano D, Goudevenos JA, Panagiotakos DB. The effect of Mediterranean diet on metabolic syndrome and its components: a meta-analysis of 50 studies and 534,906 individuals. J Am Coll Cardiol. 2011 Mar 15;57(11):1299-313. doi: 10.1016/j.jacc.2010.09.073.
Engstrom G, Hedblad B, Janzon L. Hypertensive men who exercise regularly have lower rate of cardiovascular mortality. J Hypertens. 1999 Jun;17(6):737-42. doi: 10.1097/00004872-199917060-00003.
Rubenfire M, Mollo L, Krishnan S, Finkel S, Weintraub M, Gracik T, Kohn D, Oral EA. The metabolic fitness program: lifestyle modification for the metabolic syndrome using the resources of cardiac rehabilitation. J Cardiopulm Rehabil Prev. 2011 Sep-Oct;31(5):282-9. doi: 10.1097/HCR.0b013e318220a7eb.
Cardiometabolic Risk Working Group: Executive Committee; Leiter LA, Fitchett DH, Gilbert RE, Gupta M, Mancini GB, McFarlane PA, Ross R, Teoh H, Verma S, Anand S, Camelon K, Chow CM, Cox JL, Despres JP, Genest J, Harris SB, Lau DC, Lewanczuk R, Liu PP, Lonn EM, McPherson R, Poirier P, Qaadri S, Rabasa-Lhoret R, Rabkin SW, Sharma AM, Steele AW, Stone JA, Tardif JC, Tobe S, Ur E. Cardiometabolic risk in Canada: a detailed analysis and position paper by the cardiometabolic risk working group. Can J Cardiol. 2011 Mar-Apr;27(2):e1-e33. doi: 10.1016/j.cjca.2010.12.054.
Fung CS, Mercer SW. A qualitative study of patients' views on quality of primary care consultations in Hong Kong and comparison with the UK CARE Measure. BMC Fam Pract. 2009 Jan 27;10:10. doi: 10.1186/1471-2296-10-10.
Lusis AJ, Attie AD, Reue K. Metabolic syndrome: from epidemiology to systems biology. Nat Rev Genet. 2008 Nov;9(11):819-30. doi: 10.1038/nrg2468.
Imai K, Kricka LJ, Fortina P. Concordance study of 3 direct-to-consumer genetic-testing services. Clin Chem. 2011 Mar;57(3):518-21. doi: 10.1373/clinchem.2010.158220. Epub 2010 Dec 15.
Maitland SB, Brauer P, Mutch DM, Royall D, Klein D, Tremblay A, Rheaume C, Jeejeebhoy K. Exploratory analysis of the variable response to an intensive lifestyle change program for metabolic syndrome. BMC Prim Care. 2024 Oct 1;25(1):357. doi: 10.1186/s12875-024-02608-w.
Other Identifiers
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CHANGE
Identifier Type: -
Identifier Source: org_study_id
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