CHANGE: Canadian Health Advanced By Nutrition and Graded Exercise

• Sponsor: Daren K. Heyland (Other)
• Overall Status: Completed
• CT.gov ID: NCT01616563
• Collaborator: St. Joseph's Healthcare Hamilton (Other)
• Enrollment: 305
• Locations: 3
• Arm: 1
• Actual Duration (Months): 40
• Patients Per Site: 101.7
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	Behavioral: Dietary Intervention; Behavioral: Exercise Prescription and Fitness Program	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 305 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Canadian Health Advanced By Nutrition and Graded Exercise: CHANGE Health Paradigm
• Actual Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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

1. 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

2. 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.

3. 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.

4. Change From Baseline in Aerobic Capacity [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Edmonton Oliver Primary Care Network	Edmonton	Alberta	Canada
2	Canadian Phase Onward Inc.	Toronto	Ontario	Canada	M3H 5S4
3	Clinique de kinésiologie de l'Université Laval	Quebec		Canada	G1K 7P4

Sponsors and Collaborators

• Daren K. Heyland
• St. Joseph's Healthcare Hamilton

Investigators

• Study Director: Khush Jeejeebhoy, MD, University of Toronto
• Study Chair: Paula Brauer, University of Guelph
• Study Chair: Angelo Tremblay, Laval University
• Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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, Després 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. Review.
• Engström G, Hedblad B, Janzon L. Hypertensive men who exercise regularly have lower rate of cardiovascular mortality. J Hypertens. 1999 Jun;17(6):737-42.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Review.
• Mensah GA, Brown DW. An overview of cardiovascular disease burden in the United States. Health Aff (Millwood). 2007 Jan-Feb;26(1):38-48.
• 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. Erratum in: J Cardiopulm Rehabil Prev. 2011 Nov;31(6):E1.

• Responsible Party: Daren K. Heyland, Director of the Clinical Evaluation research Unit, Clinical Evaluation Research Unit at Kingston General Hospital
• ClinicalTrials.gov Identifier: NCT01616563
• Other Study ID Numbers: CHANGE
• First Posted: Jun 12, 2012
• Last Update Posted: Feb 21, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Daren K. Heyland, Director of the Clinical Evaluation research Unit, 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

Study Results

Participant Flow

Recruitment Details	A total of 305 patients were recruited from 3 participating primary care clinics from Oct 2012 to December 2014. Of these, 12 patients were excluded, 10 that no longer met the inclusion criteria and 2 that met an exclusion criteria by the time the study started. A total of 293 patients were included in the analysis.

Arm/Group Title	Diet and Exercise Intervention
Arm/Group Description	A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Period Title: Overall Study
STARTED	293
COMPLETED	253
NOT COMPLETED	40

Baseline Characteristics

Arm/Group Title	Diet and Exercise Intervention
Arm/Group Description	A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Overall Participants	293
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.1 (9.7)
Sex: Female, Male (Count of Participants)
Female	152 51.9%
Male	141 48.1%
Region of Enrollment (participants) [Number]
Canada	293 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	31.9 (3.3)
PROCAM risk % (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	8.2 (6.4)
Estimated V02 Max percentile (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	46.8 (24)
Healthy Eating Index-Canadian (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	57.9 (14.2)
Mediterranean Diet Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.7 (1.6)

Outcome Measures

1. Primary Outcome

Title	Feasibility of the Diet Intervention
Description	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.
Time Frame	At 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diet and Exercise Intervention
Arm/Group Description	A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Measure Participants	253
Measure prescribed diet visits	5313
Count of Units [prescribed diet visits]	4782

2. Primary Outcome

Title	Feasibility of the Exercise Intervention
Description	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.
Time Frame	At 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diet and Exercise Intervention
Arm/Group Description	A combined diet and exercise program tailored to individuals incorporating behavioural modification support.
Measure Participants	253
Measure prescribed exercise visits	5313
Count of Units [prescribed exercise visits]	4038

3. Primary Outcome

Title	Number of Participants That Have Reversal of Metabolic Syndrome
Description	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
Time Frame	At 12 months compared to baseline measures

Outcome Measure Data

Analysis Population Description

Combined diet and exercise program

Arm/Group Title	Diet and Exercise Intervention
Arm/Group Description	A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Measure Participants	253
Count of Participants [Participants]	48 16.4%

4. Secondary Outcome

Title	Percentage of Participants With Improvements in at Least One Individual Components of Metabolic Syndrome
Description	Improvements in blood pressure (or elimination of medication), blood sugars (or elimination of medication), triglycerides (or elimination of medication), HDL-C and waist circumference
Time Frame	At 12 months compared to baseline

Outcome Measure Data

Analysis Population Description

% participants that had improvement in metabolic syndrome components

Arm/Group Title	Diet and Exercise Intervention
Arm/Group Description	A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Measure Participants	253
Count of Participants [Participants]	106 36.2%

5. Secondary Outcome

Title	Change From Baseline in Diet Quality-Canadian Healthy Eating Index
Description	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.
Time Frame	Change at 12 months compared to baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diet and Exercise Intervention
Arm/Group Description	A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Measure Participants	209
Mean (95% Confidence Interval) [score on a scale out of 100]	9.6

6. Secondary Outcome

Title	Change From Baseline in Diet Quality-Mediterranean Diet Score
Description	Mediterranean Diet Score (MDS) is reported on a 0-14 point score with a higher score indicating a better outcome.
Time Frame	Change at 12 months compared to baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diet and Exercise Intervention
Arm/Group Description	A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Measure Participants	209
Mean (95% Confidence Interval) [score on a scale out of 14]	1.4

7. Secondary Outcome

Title	Change From Baseline in Aerobic Capacity
Description	Estimated maximal oxygen consumption (VO2 max) standardized to age and sex
Time Frame	Change at 12 months compared to baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diet and Exercise Intervention
Arm/Group Description	A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Measure Participants	182
Mean (95% Confidence Interval) [percentile]	15.6

8. Secondary Outcome

Title	Changes in Risk of Myocardial Infarction and Cardiac Events
Description	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
Time Frame	Change at 12 months compared to baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diet and Exercise Intervention
Arm/Group Description	A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Measure Participants	206
Mean (95% Confidence Interval) [percentage]	1.4

9. Secondary Outcome

Title	Changes in Continuous Metabolic Syndrome Risk Score
Description	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
Time Frame	Change at 12 months compared to baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diet and Exercise Intervention
Arm/Group Description	A combined diet and exercise program tailored to individuals incorporating behavioural modification support
Measure Participants	206
Mean (95% Confidence Interval) [z-score]	0.4

Adverse Events

Time Frame	Adverse events were not monitored/assessed
Adverse Event Reporting Description	Adverse events were not monitored/assessed as the intervention was tailored to meet patient's abilities and needs. Hence the number of participants at risk is none.
Arm/Group Title	Diet and Exercise Intervention
Arm/Group Description	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.
All Cause Mortality
	Diet and Exercise Intervention
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Diet and Exercise Intervention
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Diet and Exercise Intervention
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.