The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial

BACKGROUND: Effective lifestyle interventions targeting high-risk adults that are both practical for use in ambulatory care settings and scalable at a population management level are needed. OBJECTIVE: Our aim was to examine the potential effectiveness, feasibility, and acceptability of delivering an evidence-based Electronic Cardio-Metabolic Program (eCMP) for improving health-related quality of life, improving health behaviors, and reducing cardiometabolic risk factors in ambulatory care high-risk adults. METHODS: We conducted a randomized, wait-list controlled trial with 74 adults aged ≥18 years recruited from a large multispecialty health care organization. Inclusion criteria were (1) BMI ≥35 kg/m(2) and prediabetes, previous gestational diabetes and/or metabolic syndrome, or (2) BMI ≥30 kg/m(2) and type 2 diabetes and/or cardiovascular disease. Participants had a mean age of 59.7 years (SD 11.2), BMI 37.1 kg/m(2) (SD 5.4) and were 59.5% female, 82.4% white. Participants were randomized to participate in eCMP immediately (n=37) or 3 months later (n=37). eCMP is a 6-month program utilizing video conferencing, online tools, and pre-recorded didactic videos to deliver evidence-based curricula. Blinded outcome assessments were conducted at 3 and 6 months postbaseline. Data were collected and analyzed between 2014 and 2015. The primary outcome was health-related quality of life. Secondary outcomes included biometric cardiometabolic risk factors (eg, body weight), self-reported diet and physical activity, mental health status, retention, session attendance, and participant satisfaction. RESULTS: Change in quality of life was not significant in both immediate and delayed participants. Both groups significantly lost weight and reduced waist circumference at 6 months, with some cardiometabolic factors trending accordingly. Significant reduction in self-reported anxiety and perceived stress was seen in the immediate intervention group at 6 months. Retention rate was 93% at 3 months and 86% at 6 months post-baseline. Overall eCMP attendance was high with 59.5-83.8% of immediate and delayed intervention participants attending 50% of the virtual stress management and behavioral lifestyle sessions and 37.8-62.2% attending at least 4 out of 7 in-person physical activity sessions. The intervention received high ratings for satisfaction. CONCLUSIONS: The technology-assisted eCMP is a feasible and well-accepted intervention and may significantly decrease cardiometabolic risk among high-risk individuals. TRIAL REGISTRATION: Clinicaltrials.gov NCT02246400; https://clinicaltrials.gov/ct2/show/NCT02246400 (Archived by WebCite at http://www.webcitation.org/6h6mWWokP)