Canadian Health Advanced By Nutrition and Graded Exercise

NCT01616563 | Completed Results

• 1 other identifier: CHANGE
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 3

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.

Conditions

Metabolic Syndrome

Keywords

central obesity; abdominal obesity; hypertension; cardiovascular disease; high cholesterol; high triglycerides; insulin resistance; diabetes mellitus

Outcome Measures

Primary Outcomes (3)

• Feasibility of the Diet Intervention

  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.

  At 12 months

• Feasibility of the Exercise Intervention

  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.

  At 12 months

• Number of Participants That Have Reversal of Metabolic Syndrome

  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

  At 12 months compared to baseline measures

Secondary Outcomes (6)

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

  At 12 months compared to baseline

• Change From Baseline in Diet Quality-Canadian Healthy Eating Index

  Change at 12 months compared to baseline

• Change From Baseline in Diet Quality-Mediterranean Diet Score

  Change at 12 months compared to baseline

• Change From Baseline in Aerobic Capacity

  Change at 12 months compared to baseline

• Changes in Risk of Myocardial Infarction and Cardiac Events

  Change at 12 months compared to baseline

Study Arms (1)

Diet and exercise

EXPERIMENTAL

A combined diet and exercise program tailored to individuals incorporating behavioural modification support

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

Interventions

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.

Also known as: Nutrition therapy, Dietary counselling, Behavioural therapy

Diet and exercise

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.

Also known as: Exercise plan, physical activity intervention

Diet and exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daren K. Heyland: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (3)

Edmonton Oliver Primary Care Network

Edmonton, Alberta, Canada

Location

Canadian Phase Onward Inc.

Toronto, Ontario, M3H 5S4, Canada

Location

Clinique de kinésiologie de l'Université Laval

Québec, G1K 7P4, Canada

Location

Related Publications (12)

• 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.

  PMID: 17211012 BACKGROUND

• 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.

  PMID: 11832527 BACKGROUND

• 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.

  PMID: 21059972 BACKGROUND

• 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.

  PMID: 21947643 BACKGROUND

• 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.

  PMID: 21392646 BACKGROUND

• 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.

  PMID: 10459869 BACKGROUND

• 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.

  PMID: 21734589 BACKGROUND

• 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.

  PMID: 21459257 BACKGROUND

• 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.

  PMID: 19173724 BACKGROUND

• 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.

  PMID: 18852695 BACKGROUND

• 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.

  PMID: 21159896 BACKGROUND

• 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.

  PMID: 39354341 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Obesity, Abdominal; Hypertension; Cardiovascular Diseases; Hypercholesterolemia; Hypertriglyceridemia; Insulin Resistance; Diabetes Mellitus

Interventions

Diet Therapy; Nutrition Therapy; Behavior Therapy

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Lack of a control group however the intent of this study was to show feasibility in real life settings. Generalization of the findings as only 3 centers and selection bias when enrolling participants.

Results Point of Contact

• Title: Rupinder Dhaliwal
• Organization: Metabolic Syndrome Canada

rupinder.dhaliwal@metsc.ca

613 484 3830

Study Officials

• Khush Jeejeebhoy, MD

  University of Toronto

  STUDY DIRECTOR

• Paula Brauer

  University of Guelph

  STUDY CHAIR

• Angelo Tremblay

  Laval University

  STUDY CHAIR

• David Mutch, PhD

  University of Guelph

  PRINCIPAL INVESTIGATOR

• Doug Klein, MD

  University of Alberta, Edmonton, Alberta

  PRINCIPAL INVESTIGATOR

• Lew Pliamm, MD

  Canadian Phase Onward

  PRINCIPAL INVESTIGATOR

• Caroline Rheaume

  Laval University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Clinical Evaluation research Unit

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 12, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)