CHANGE Cancer Alberta: A Primary Care Program for Cancer Prevention and Screening (CHANGECaAB)

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Cancer Risk, Lifestyle Interventions, Primary Care, Behavioural Change Read More

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%.

   -

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)

    -