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

• ClinicalTrials.gov Identifier: NCT02246400
• Recruitment Status: Completed
• First Posted: September 22, 2014
• Last Update Posted: June 2, 2015
• Sponsor: Palo Alto Medical Foundation
• Information provided by (Responsible Party): Palo Alto Medical Foundation

Tracking Information

• First Submitted Date: March 18, 2014
• First Posted Date: September 22, 2014
• Last Update Posted Date: June 2, 2015
• Study Start Date: January 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 18, 2014)

Change in measure of Health-related quality of life from baseline to 6-months follow up. [ Time Frame: 6-months ]

SF-8 questionnaire

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02246400 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: September 18, 2014)

• Change in composite measure of Metabolic Syndrome [ Time Frame: 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 [ Time Frame: Baseline, 3-months, and 6-months. ]
  Nutrition Data System for Research (NDSR).
• Physical Activity [ Time Frame: Baseline, 3-months, and 6-months. ]
  Seven-Day Physical Activity Recall (PAR).
• Intervention adherence [ Time Frame: 3-months and 6-months. ]
  Intervention session attendance of virtual classes and in-person physical activity classes.
• Body weight [ Time Frame: Baseline, 3 months, and 6 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact
• Official Title: CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact
• 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).
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Health Services Research

Condition

• Obesity
• Metabolic Syndrome
• Pre-diabetes
• Type 2 Diabetes
• Cardiovascular Disease

Intervention

Behavioral: eCMP

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.

Other Name: Electronically-mediated CardioMetabolic Program (eCMP)

Study Arms

• Active Comparator: Delayed Intervention
  Usual care for first three months. Initiation of the eCMP after the 3-month time point.
  Intervention: Behavioral: eCMP
• Experimental: Immediate Intervention
  Initiation of the eCMP immediately upon completion of baseline data collection and randomization
  Intervention: Behavioral: eCMP

• Publications *: Azar KM, Koliwad S, Poon T, Xiao L, Lv N, Griggs R, Ma J. The Electronic CardioMetabolic Program (eCMP) for Patients With Cardiometabolic Risk: A Randomized Controlled Trial. J Med Internet Res. 2016 May 27;18(5):e134. doi: 10.2196/jmir.5143.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 29, 2015): 74
• Original Estimated Enrollment (submitted: September 18, 2014): 100
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02246400
• Other Study ID Numbers: # 14-01-290
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Palo Alto Medical Foundation
• Study Sponsor: Palo Alto Medical Foundation
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jun Ma, MD, PhD; Palo Alto Medical Foundation
• Principal Investigator: Tak Poon, MD, PharmD, ABIHM, FACC; Palo Alto Medical Foundation

• PRS Account: Palo Alto Medical Foundation
• Verification Date: May 2015