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

Palo Alto Medical Foundation74 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Obesity Metabolic Syndrome Pre-diabetes Type 2 Diabetes Cardiovascular Disease

Interventions

eCMPBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Palo Alto Medical Foundation, Mills Peninsula Division

Burlingame, California, United States

Outcomes

Primary Outcomes

Change in measure of Health-related quality of life from baseline to 6-months follow up.

SF-8 questionnaire

Time frame: 6-months

Secondary Outcomes

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.)

Time frame: 6-months.

Dietary Intake

Nutrition Data System for Research (NDSR).

Time frame: Baseline, 3-months, and 6-months.

Physical Activity

Seven-Day Physical Activity Recall (PAR).

Time frame: Baseline, 3-months, and 6-months.

Intervention adherence

Intervention session attendance of virtual classes and in-person physical activity classes.

Time frame: 3-months and 6-months.

Body weight

Time frame: Baseline, 3 months, and 6 months

Data from ClinicalTrials.gov

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