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

Sutter Health

Status: Completed

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

Treatments: Behavioral: eCMP

Study type: Interventional

Funder types: Other

Identifiers

NCT02246400

# 14-01-290

Details and patient eligibility

About

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.

Full 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).

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Delayed Intervention

Active Comparator group

Description:

Usual care for first three months. Initiation of the eCMP after the 3-month time point.

Treatment:

Behavioral: eCMP

Immediate Intervention

Experimental group

Description:

Initiation of the eCMP immediately upon completion of baseline data collection and randomization

Treatment:

Behavioral: eCMP