Skip to content

Canadian Health Advanced By Nutrition and Graded Exercise

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01616563
Acronym
CHANGE
Enrollment
305
Registered
2012-06-12
Start date
2012-10-31
Completion date
2016-02-29
Last updated
2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

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

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.

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.

Interventions

BEHAVIORALDietary 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.

BEHAVIORALExercise 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.

Sponsors

St. Joseph's Healthcare Hamilton
CollaboratorOTHER
Daren K. Heyland
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of the Diet InterventionAt 12 monthsPercentage 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.
Feasibility of the Exercise InterventionAt 12 monthsPercentage of the prescribed exercise visits attended over 12 months. Each participant was to attend a total of 21 prescribed exercise visits over 12 months.
Number of Participants That Have Reversal of Metabolic SyndromeAt 12 months compared to baseline measuresMetabolic 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

MeasureTime frameDescription
Change From Baseline in Aerobic CapacityChange at 12 months compared to baselineEstimated maximal oxygen consumption (VO2 max) standardized to age and sex
Percentage of Participants With Improvements in at Least One Individual Components of Metabolic SyndromeAt 12 months compared to baselineImprovements in blood pressure (or elimination of medication), blood sugars (or elimination of medication), triglycerides (or elimination of medication), HDL-C and waist circumference
Changes in Continuous Metabolic Syndrome Risk ScoreChange at 12 months compared to baselineMetabolic 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
Changes in Risk of Myocardial Infarction and Cardiac EventsChange at 12 months compared to baselineChanges 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
Change From Baseline in Diet Quality-Canadian Healthy Eating IndexChange at 12 months compared to baselineCanadian 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.
Change From Baseline in Diet Quality-Mediterranean Diet ScoreChange at 12 months compared to baselineMediterranean Diet Score (MDS) is reported on a 0-14 point score with a higher score indicating a better outcome.

Countries

Canada

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.

Participants by arm

ArmCount
Diet and Exercise Intervention
A combined diet and exercise program tailored to individuals incorporating behavioural modification support
293
Total293

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up40

Baseline characteristics

CharacteristicDiet and Exercise Intervention
Age, Continuous59.1 years
STANDARD_DEVIATION 9.7
Body Mass Index31.9 kg/m^2
STANDARD_DEVIATION 3.3
Estimated V02 Max percentile46.8 %
STANDARD_DEVIATION 24
Healthy Eating Index-Canadian57.9 units on a scale
STANDARD_DEVIATION 14.2
Mediterranean Diet Score4.7 units on a scale
STANDARD_DEVIATION 1.6
PROCAM risk %8.2 %
STANDARD_DEVIATION 6.4
Region of Enrollment
Canada
293 participants
Sex: Female, Male
Female
152 Participants
Sex: Female, Male
Male
141 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

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.

Time frame: At 12 months

ArmMeasureValue (COUNT_OF_UNITS)
Diet and Exercise InterventionFeasibility of the Diet Intervention4782 prescribed diet visits
Primary

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.

Time frame: At 12 months

ArmMeasureValue (COUNT_OF_UNITS)
Diet and Exercise InterventionFeasibility of the Exercise Intervention4038 prescribed exercise visits
Primary

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

Time frame: At 12 months compared to baseline measures

Population: Combined diet and exercise program

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Diet and Exercise InterventionNumber of Participants That Have Reversal of Metabolic Syndrome48 Participants
Secondary

Change From Baseline in Aerobic Capacity

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

Time frame: Change at 12 months compared to baseline

ArmMeasureValue (MEAN)
Diet and Exercise InterventionChange From Baseline in Aerobic Capacity15.6 percentile
Secondary

Change From Baseline in Diet Quality-Canadian Healthy Eating Index

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

ArmMeasureValue (MEAN)
Diet and Exercise InterventionChange From Baseline in Diet Quality-Canadian Healthy Eating Index9.6 score on a scale out of 100
Secondary

Change From Baseline in Diet Quality-Mediterranean Diet Score

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

ArmMeasureValue (MEAN)
Diet and Exercise InterventionChange From Baseline in Diet Quality-Mediterranean Diet Score1.4 score on a scale out of 14
Secondary

Changes in Continuous Metabolic Syndrome Risk Score

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

ArmMeasureValue (MEAN)
Diet and Exercise InterventionChanges in Continuous Metabolic Syndrome Risk Score0.4 z-score
Secondary

Changes in Risk of Myocardial Infarction and Cardiac Events

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

ArmMeasureValue (MEAN)
Diet and Exercise InterventionChanges in Risk of Myocardial Infarction and Cardiac Events1.4 percentage
Secondary

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

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

Population: % participants that had improvement in metabolic syndrome components

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Diet and Exercise InterventionPercentage of Participants With Improvements in at Least One Individual Components of Metabolic Syndrome106 Participants

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026