Cardiovascular Disease, Metabolic Syndrome, Obesity, Pre-diabetes, Type 2 Diabetes
Conditions
Keywords
eCMP, eHealth, mHealth, Lifestyle intervention, Cardiometabolic risk reduction, PAMF
Brief summary
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
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).
Interventions
BEHAVIORALeCMP
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.
Sponsors
Palo Alto Medical Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in measure of Health-related quality of life from baseline to 6-months follow up. | 6-months | SF-8 questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in composite measure of Metabolic Syndrome | 6-months. | Composite measure of Metabolic Syndrome (criterion factors: waist circumference, blood pressure, fasting plasma glucose, triglycerides, High-density lipoprotein, and body mass index.) |
| Dietary Intake | Baseline, 3-months, and 6-months. | Nutrition Data System for Research (NDSR). |
| Physical Activity | Baseline, 3-months, and 6-months. | Seven-Day Physical Activity Recall (PAR). |
| Intervention adherence | 3-months and 6-months. | Intervention session attendance of virtual classes and in-person physical activity classes. |
| Body weight | Baseline, 3 months, and 6 months | — |
Countries
United States
Outcome results
None listed