N/A N=293 Treatment

Canadian Health Advanced By Nutrition and Graded Exercise

Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT01616563 ↗

Enrolled (actual)

293

Serious AEs

—

Results posted

Feb 2021

Primary outcome: Primary: Feasibility of the Diet Intervention — 4782 prescribed diet visits

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dietary Intervention (Behavioral); Exercise Prescription and Fitness Program (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Daren K. Heyland
Primary completion: Feb 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of the Diet Intervention	4782	—
PRIMARY Feasibility of the Exercise Intervention	4038	—
PRIMARY Number of Participants That Have Reversal of Metabolic Syndrome	48	—
SECONDARY Percentage of Participants With Improvements in at Least One Individual Components of Metabolic Syndrome	106	—
SECONDARY Change From Baseline in Diet Quality-Canadian Healthy Eating Index	9.6	—
SECONDARY Change From Baseline in Diet Quality-Mediterranean Diet Score	1.4	—
SECONDARY Change From Baseline in Aerobic Capacity	15.6	—
SECONDARY Changes in Risk of Myocardial Infarction and Cardiac Events	1.4	—
SECONDARY Changes in Continuous Metabolic Syndrome Risk Score	0.4	—

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.

Eligibility 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 /= 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
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
Investigator discretion for clinical safety or protocol adherence reasons
Chronic inflammatory diseases
Body Mass Index > 35

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01616563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.