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The eCMP Pilot aims to study the feasibility and potential effectiveness of an electronically-mediated CardioMetabolic Program (eCMP) for therapeutic lifestyle change among adults with or at high risk for type 2 diabetes, heart disease, and/or stroke.
The eCMP is an evidence-based lifestyle intervention using a holistic, mind-body-spirit-based, and multidisciplinary approach, and it will be delivered using existing web and mobile technologies. In this pragmatic randomized controlled trial, participants will be recruited from primary care patients of an integrated ambulatory care system. They will be randomly assigned to receive the eCMP upon completion of baseline data collection (the Immediate Intervention group) or after 3 months (the Delayed Intervention group). All participants will be assessed at 0, 3 and 6 months. Outcomes include common cardiometabolic risk factors (e.g., weight, blood pressure, and fasting plasma glucose), health behaviors (e.g., dietary intake and physical activity), and indicators of eCMP engagement and adherence (e.g., attendance and self-monitoring).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Intervention | Active Comparator | Usual care for first three months. Initiation of the eCMP after the 3-month time point. |
|
| Immediate Intervention | Experimental | Initiation of the eCMP immediately upon completion of baseline data collection and randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eCMP | Behavioral | eCMP is a 6-month lifestyle intervention designed and led by a team of experienced health professionals, including physicians, researchers, dietitians, and registered nurses. The program consists of weekly home and class activities delivered through online or take-home videos, video conferencing, and/or in-person sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in measure of Health-related quality of life from baseline to 6-months follow up. | SF-8 questionnaire | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in composite measure of Metabolic Syndrome | Composite measure of Metabolic Syndrome (criterion factors: waist circumference, blood pressure, fasting plasma glucose, triglycerides, High-density lipoprotein, and body mass index.) | 6-months. |
| Dietary Intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Ma, MD, PhD | Palo Alto Medical Foundation | Principal Investigator |
| Tak Poon, MD, PharmD, ABIHM, FACC | Palo Alto Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto Medical Foundation, Mills Peninsula Division | Burlingame | California | 94010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27234480 | Derived | Azar KM, Koliwad S, Poon T, Xiao L, Lv N, Griggs R, Ma J. The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial. J Med Internet Res. 2016 May 27;18(5):e134. doi: 10.2196/jmir.5143. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D018149 | Glucose Intolerance |
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Nutrition Data System for Research (NDSR). |
| Baseline, 3-months, and 6-months. |
| Physical Activity | Seven-Day Physical Activity Recall (PAR). | Baseline, 3-months, and 6-months. |
| Intervention adherence | Intervention session attendance of virtual classes and in-person physical activity classes. | 3-months and 6-months. |
| Body weight | Baseline, 3 months, and 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D006943 | Hyperglycemia |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |