CHANGE Cancer Alberta: A Primary Care Program for Cancer Prevention and Screening
CHANGE Cancer Alberta: A Primary Care Program for Cancer Prevention and Screening
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.
Inclusion Criteria:

 Cluster level: Inclusion criteria: These include: 1) PCN within Alberta, 2) ability to
 incorporate RDs and ESs into the health care team.

 Patient level: Inclusion criteria:

 1. Adult patients (18+);

 2. Adjusted BMI 26-40. This is a BMI calculated with the measured body weight minus 5 kg
 to reflect potential shifts in fluid balance;

 3. Edmonton Obesity Stage 1 or 2(62). • Stage 1 patients have obesity-related subclinical
 risk factor(s) (e.g., borderline hypertension, impaired fasting glucose, elevated
 liver enzymes, Etc.), mild physical symptoms (e.g., dyspnea on moderate exertion,
 occasional aches and pains, fatigue, etc.), mild psychopathology, mild functional
 limitations and/or mild impairment of well being.

 • Stage 2 patients have established obesity-related chronic disease(s) (e.g.,
 hypertension, type 2 diabetes, sleep apnea, osteoarthritis, reflux disease, polycystic
 ovary syndrome, anxiety disorder, etc.), moderate limitations in activities of daily
 living and/or well being.

 4. Have Metabolic Syndrome (MetS is defined as having 3 of the 5 following criteria):

 1. Fasting Blood Glucose > 5.6 mmol/L or receiving pharmacotherapy;

 2. Blood Pressure of > 130/85 mm Hg or receiving pharmacotherapy;

 3. Triglyceride of > 1.7 mmol/L or receiving pharmacotherapy;

 4. HDL-C < 1.0 mmol/L Males and <1.3 mmol/L females;

 5. Increased Abdominal Circumference as per protocol.

 5. Patients identified at risk for cancer due to diet and physical activity behaviours:

 a. Physical inactivity measured by: i. less than 150 minutes of moderate activity
 (i.e., brisk walking, bike riding, jogging) per week and/or strength trains less than
 2 times weekly] OR ii. high sedentary time (>11 hours per day 1,2 ) AND b. Dietary
 behaviour risk measured by: i. Diabetes risk score of high or very high or fasting
 glucose or Hgb A1c above normal OR ii. Abnormal fasting plasma lipid profile AND c.
 10-Year cardiovascular risk score >10%.

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 Exclusion Criteria:

 Cluster level: Exclusion criteria: Previous involvement of the CHANGE intervention.

 Patient Level: Exclusion criteria: These include:

 1. Edmonton Obesity Stage 0, 3, or 4(62).

 • Stage 0 patients have no apparent obesity-related risk factors, no physical
 symptoms, no psychopathology, no functional limitations and/or impairment of well
 being. They do not require intensive lifestyle interventions.

 • Stage 3 patients have established end-organ damage such as myocardial infarction,
 heart failure, diabetic complications, incapacitating osteoarthritis, significant
 psychopathology, significant functional limitation(s) and/or impairment of well being.
 This person requires intensive obesity treatment including pharmacological and
 surgical treatment options.

 • Stage 4 patients have severe (potentially end-stage) disability/ies from
 obesity-related chronic diseases, severe disabling psychopathology, severe functional
 limitation(s) and/or severe impairment of well being. Aggressive obesity management is
 required if feasible that includes palliative measures such as pain management,
 occupational therapy and psychosocial support.

 2. Unable to speak, read or understand English.

 3. Have a medical or physical condition that makes moderate intensity activity difficult
 or unsafe.

 4. Diagnosis of Type 1 diabetes mellitus.

 5. Type 2 diabetes only if any of the following are present

 o Proliferative diabetic retinopathy

 o Nephropathy (serum creatinine > 160 μmol/L)

 -  Clinically manifest neuropathy defined as absent ankle jerks

 -  Severe fasting hyperglycemia > 11 mmol/L

 -  Peripheral vascular disease

 6. Significant medical comorbidities, including uncontrolled metabolic disorders (e.g.,
 thyroid, renal, liver), heart disease, stroke and ongoing substance abuse.

 7. Clinically significant renal failure.

 8. Diagnosis of cancer (other than non-melanoma skin cancer) that is currently being
 treated with radiation or chemotherapy.

 9. Diagnosis of psychiatric disorders (cognitive impairment) that would limit adequate
 informed consent or ability to comply with study protocol.

 10. Diagnosis of a terminal illness and/or in hospice care.

 11. Pregnancy, lactating or planning to become pregnant during the study period.

 12. Investigator discretion for clinical safety or protocol adherence reasons. This is
 based on the doctor's judgement. Patients whom the doctor believes will not be
 responsive to the intervention should be excluded.

 13. Chronic inflammatory diseases. This includes clinically active inflammatory diseases
 such as clinically active ulcerative colitis, Crohn's disease or collagen vascular
 disease.

 14. Patients currently attending an intensive lifestyle intervention (i.e. diabetes
 program, hypertension lipid clinic)

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