Clinical trial · Interventional
CHANGE Cancer Alberta: A Primary Care Program for Cancer Prevention and Screening
CHANGE (Canadian Health Advanced by Nutrition and Graded Exercise) Cancer Alberta: A Primary Care Program for Cancer Prevention and Screening
NCT02893163CI-TRIAL-00067484CHANGECaABcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metabolic Syndrome | — | UNRESOLVED | — |
| Risk Factors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CHANGE Intervention | Behavioral | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CHANGE Intervention
- description
- The CHANGE intervention is a personalized approach to nutrition and exercise modification supported by a interdisciplinary team. The FD will recruit patients, complete baseline measurements and stabilize medication. The RD will create a diet plan tailored to the individual patient based on the intervention protocol. The ES will create an exercise plan tailored to the individual patient based on the intervention protocol. At the start, patients will meet weekly with the RD and ES in order to monitor progress, ascertain barriers and facilitators to change, and ensure adherence for the first 12 weeks of the intervention. Meetings will then occur monthly for the remaining 9 months of the intervention. Visits with the FD will occur every 3 months for the 12 month intervention to monitor progress, encourage behaviour change. A follow-up visit with the Research Coordinator will take place at 18 months.
- interventionNames
- Behavioral: CHANGE Intervention
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- The usual care arm of the study will involve regular care from the patients' FD. This may involve discussions regarding nutrition and exercise. The FD will still recruit patients, complete baseline measurements and stabilize medication. Visits to the FD will occur as usual care dictates. Participating PCNs randomized to usual care will still have interdisciplinary team members available but the referral arrangements are and will continue to be ad hoc. For the study, we will mandate that control patients have follow-up with the Research Coordinator at 3, 12 and 18 months for the purpose of assessing outcomes. At these time points, appointments will not be scheduled with the FD to manage their disease; rather, the purpose of the visit is to just conduct the outcome assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
\-References
Publications (13)
- BACKGROUNDBrauer P, Gorber SC, Shaw E, Singh H, Bell N, Shane ARE, Jaramillo A, Tonelli M; Canadian Task Force on Preventive Health Care. Recommendations for prevention of weight gain and use of behavioural and pharmacologic interventions to manage overweight and obesity in adults in primary care. CMAJ. 2015 Feb 17;187(3):184-195. doi: 10.1503/cmaj.140887. Epub 2015 Jan 26. No abstract available. PMID 25623643
- BACKGROUNDPetrella RJ, Lattanzio CN, Overend TJ. Physical activity counseling and prescription among canadian primary care physicians. Arch Intern Med. 2007 Sep 10;167(16):1774-81. doi: 10.1001/archinte.167.16.1774. PMID 17846397
- BACKGROUNDPetrella RJ, Koval JJ, Cunningham DA, Paterson DH. Can primary care doctors prescribe exercise to improve fitness? The Step Test Exercise Prescription (STEP) project. Am J Prev Med. 2003 May;24(4):316-22. doi: 10.1016/s0749-3797(03)00022-9. PMID 12726869
- BACKGROUNDBrown JB, Harris SB, Webster-Bogaert S, Wetmore S, Faulds C, Stewart M. The role of patient, physician and systemic factors in the management of type 2 diabetes mellitus. Fam Pract. 2002 Aug;19(4):344-9. doi: 10.1093/fampra/19.4.344. PMID 12110552
- BACKGROUNDKirk SF, Tytus R, Tsuyuki RT, Sharma AM. Weight management experiences of overweight and obese Canadian adults: findings from a national survey. Chronic Dis Inj Can. 2012 Mar;32(2):63-9. PMID 22414302
- BACKGROUNDDahrouge S, Dinh T. The economic impact of improvements in primary healthcare performance. [electronic resource]: Ottawa, Ont.] : Canadian Health Services Research Foundation, 2012 (Saint-Lazare, Quebec : Canadian Electronic Library, 2012); 2012.
- BACKGROUNDTsai AG, Wadden TA. Treatment of obesity in primary care practice in the United States: a systematic review. J Gen Intern Med. 2009 Sep;24(9):1073-9. doi: 10.1007/s11606-009-1042-5. Epub 2009 Jun 27.