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

Obesity Clinical Trial

— eCMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246400
• Other study ID #: # 14-01-290
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: May 29, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Palo Alto Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
United States	Palo Alto Medical Foundation, Mills Peninsula Division	Burlingame	California

Sponsors (1)

Lead Sponsor	Collaborator
Palo Alto Medical Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in measure of Health-related quality of life from baseline to 6-months follow up.	SF-8 questionnaire	6-months	No
Secondary	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.)	6-months.	No
Secondary	Dietary Intake	Nutrition Data System for Research (NDSR).	Baseline, 3-months, and 6-months.	No
Secondary	Physical Activity	Seven-Day Physical Activity Recall (PAR).	Baseline, 3-months, and 6-months.	No
Secondary	Intervention adherence	Intervention session attendance of virtual classes and in-person physical activity classes.	3-months and 6-months.	No
Secondary	Body weight		Baseline, 3 months, and 6 months	No