CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact

Conditions
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Obesity, Metabolic Syndrome, Pre-diabetes, Type 2 Diabetes, Cardiovascular Disease

Intervention / Treatment
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* Behavioral: eCMP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking adults aged 18+ years High-risk primary prevention: BMI 35+ and prediabetes (including hx of gestational diabetes) and/or metabolic syndrome Secondary prevention: BMI 30+ and type 2 diabetes and/or cardiovascular disease Able and willing to provide written informed consent Exclusion Criteria: Medical determination that the study is inappropriate or unsafe for the patient Type 1 diabetes Safety concerns related to significant physical or mental health issues or life expectancy of less than 12 months Currently pregnant or lactating No regular telephone or broadband Internet access or otherwise unable to participate in the intervention

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Delayed Intervention<br>Usual care for first three months. Initiation of the eCMP after the 3-month time point. | Behavioral: eCMP<br>* 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.<br>* Other names: Electronically-mediated CardioMetabolic Program (eCMP);|
| Experimental: Immediate Intervention<br>Initiation of the eCMP immediately upon completion of baseline data collection and randomization | Behavioral: eCMP<br>* 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.<br>* Other names: Electronically-mediated CardioMetabolic Program (eCMP);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eCMP, eHealth, mHealth, Lifestyle intervention, Cardiometabolic risk reduction, PAMF