Metabolic Syndrome, Risk Factors
Conditions
Keywords
Metabolic Syndrome, Cancer Risk, Lifestyle Interventions, Primary Care, Behavioural Change
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALCHANGE Intervention
Canadian Health Advanced by Nutrition and Graded Exercise Protocol
OTHERUsual Care
Usual Care by Family Doctor
Sponsors
Canadian Institutes of Health Research (CIHR)
Alberta Innovates Health Solutions
Alberta Pulse Growers
Alberta Health services
Metabolic Syndrome Canada
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Metabolic Syndrome Outcomes | Baseline, 3 months, 12 months, 18 months | Proportion of patients achieving reversal of Metabolic Syndrome (no longer meeting 3 of 5 diagnostic criteria |
| Primary Cancer Risk Outcome - Nutrition | Baseline, 3 months. 12 months, 18 months | Proportion of patients with improved eating behaviours (Healthy Eating Index) as measured by 2-24 hour dietary recalls |
| Primary Cancer Risk Outcome - Physical Activity | Baseline, 12 months | Proportion of patients with improved physical activity levels (step counts) measured by 7-day accelerometer step count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Metabolic Syndrome Outcome - Cardiovascular Risk | Baseline, 3 months, 12 months, 18 months | Proportion of patients achieving reduction in 10-year cardiovascular risk (as calculated by the PROCAM (Prospective Cardiovascular Munster Study) risk algorithm) |
| Secondary Cancer Risk Outcome - BMI | Baseline, 3 months, 12 months, 18 months | Proportion of patients achieving reduction in BMI |
| Secondary Caner Risk Outcome - Waist Circumference | Baseline, 3 months, 12 months, 18 months | Proportion of patients achieving reduction in waist circumference |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Self Reported Health | Baseline, 3 months, 12 months, 18 months | Proportion of patients improving self-reported health (using the short-form-12 \[SF-12 (Short Form-12) Health Scale Scoring\] |
| Patient Self Reported Quality of Life | Baseline, 3 months, 12 months, 18 months | Proportion of patients improving self-reported quality of life (using EQ-5D-5L (EuroQol-5 Dimension-5 Level)) |
Outcome results
None listed