The primary purpose of this trial will be to test the effectiveness of CHANGE intervention to increase physical activity, improve diets, reduce obesity and reverse Metabolic Syndrome among adult patients identified as at risk for cancer due to diet and physical activity behaviours when implemented in typical primary care settings within the Alberta context.
The study is a cluster randomized control trial of 16 Primary Care Networks (PCN) in Alberta. Inclusion and exclusion criteria will occur at both the cluster and the patient levels. Site criteria have been designed to ensure implementation of the intervention is possible while contamination to the control sites is minimized. Patient level criteria are designed to include as many patients with Metabolic Syndrome identified at risk for cancer due to diet and physical activity behaviours as possible, maximizing generalizability, while ensuring that patients recruited are safely able to follow the CHANGE intervention. CHANGE intervention utilizes a novel approach of embedding the expertise of Dietitians (RD) and Exercise Specialists (ES) with a patient's own Family Doctor (FD) to support a personalized nutrition and exercise intervention for patients with Metabolic Syndrome identified at risk for cancer due to diet and physical activity behaviours that is feasible to implement across diverse practice settings. There is sufficient data to support that the individual components of lifestyle interventions (diet and exercise) are efficacious. Unfortunately, primary care currently has limited capacity to implement lifestyle interventions to manage individuals who are overweight or obese. Family Doctors experience various barriers to providing diet and exercise counseling, including lack of staff and resources, limited time for effective health promotion counseling and limited specialized training. In order to provide quality of care for patients with Metabolic Syndrome identified at risk for cancer due to diet and physical activity behaviours, the investigators need to reduce these barriers and support Family Doctors with health care professionals who have the skills and time to help patients change their behaviours. Although access to interdisciplinary teams has increased in Alberta over the past few years through the development of Primary Care Networks, the optimal composition of these teams has not yet been determined. There is significant evidence to support increased diet and exercise professionals within these primary care teams. Currently, Primary Care Networks are making decisions on how to structure the health care team for their networks. This recent development and strong provincial organizational structure creates a unique time and location to conduct a trial examining the prevention activities of health care teams. Findings from the CHANGE Cancer Alberta Study will inform Primary Care Network business plans to support the implementation of the CHANGE intervention broadly across Alberta.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
750
Canadian Health Advanced by Nutrition and Graded Exercise Protocol
Usual Care by Family Doctor
Primary Cancer Risk Outcome - Physical Activity
Proportion of patients with improved physical activity levels (step counts) measured by 7-day accelerometer step count
Time frame: Baseline, 12 months
Primary Cancer Risk Outcome - Nutrition
Proportion of patients with improved eating behaviours (Healthy Eating Index) as measured by 2-24 hour dietary recalls
Time frame: Baseline, 3 months. 12 months, 18 months
Primary Metabolic Syndrome Outcomes
Proportion of patients achieving reversal of Metabolic Syndrome (no longer meeting 3 of 5 diagnostic criteria
Time frame: Baseline, 3 months, 12 months, 18 months
Secondary Cancer Risk Outcome - BMI
Proportion of patients achieving reduction in BMI
Time frame: Baseline, 3 months, 12 months, 18 months
Secondary Caner Risk Outcome - Waist Circumference
Proportion of patients achieving reduction in waist circumference
Time frame: Baseline, 3 months, 12 months, 18 months
Secondary Metabolic Syndrome Outcome - Cardiovascular Risk
Proportion of patients achieving reduction in 10-year cardiovascular risk (as calculated by the PROCAM (Prospective Cardiovascular Munster Study) risk algorithm)
Time frame: Baseline, 3 months, 12 months, 18 months
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