Back to resultsCardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact (eCMP)
Primary Purpose
Obesity, Metabolic Syndrome, Pre-diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eCMP
Sponsored by
About this trial
This is an interventional health services research trial for Obesity focused on measuring eCMP, eHealth, mHealth, Lifestyle intervention, Cardiometabolic risk reduction, PAMF
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
Sites / Locations
- Palo Alto Medical Foundation, Mills Peninsula Division
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Delayed Intervention
Immediate Intervention
Arm Description
Usual care for first three months. Initiation of the eCMP after the 3-month time point.
Initiation of the eCMP immediately upon completion of baseline data collection and randomization
Outcomes
Primary Outcome Measures
Change in measure of Health-related quality of life from baseline to 6-months follow up.
SF-8 questionnaire
Secondary Outcome Measures
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.)
Dietary Intake
Nutrition Data System for Research (NDSR).
Physical Activity
Seven-Day Physical Activity Recall (PAR).
Intervention adherence
Intervention session attendance of virtual classes and in-person physical activity classes.
Body weight
Full Information
NCT ID
NCT02246400
First Posted
March 18, 2014
Last Updated
May 29, 2015
Sponsor
Palo Alto Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02246400
Brief Title
CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact
Acronym
eCMP
Official Title
CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palo Alto Medical Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome, Pre-diabetes, Type 2 Diabetes, Cardiovascular Disease
Keywords
eCMP, eHealth, mHealth, Lifestyle intervention, Cardiometabolic risk reduction, PAMF
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delayed Intervention
Arm Type
Active Comparator
Arm Description
Usual care for first three months. Initiation of the eCMP after the 3-month time point.
Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Description
Initiation of the eCMP immediately upon completion of baseline data collection and randomization
Intervention Type
Behavioral
Intervention Name(s)
eCMP
Other Intervention Name(s)
Electronically-mediated CardioMetabolic Program (eCMP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in measure of Health-related quality of life from baseline to 6-months follow up.
Description
SF-8 questionnaire
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Change in composite measure of Metabolic Syndrome
Description
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.
Title
Dietary Intake
Description
Nutrition Data System for Research (NDSR).
Time Frame
Baseline, 3-months, and 6-months.
Title
Physical Activity
Description
Seven-Day Physical Activity Recall (PAR).
Time Frame
Baseline, 3-months, and 6-months.
Title
Intervention adherence
Description
Intervention session attendance of virtual classes and in-person physical activity classes.
Time Frame
3-months and 6-months.
Title
Body weight
Time Frame
Baseline, 3 months, and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Ma, MD, PhD
Organizational Affiliation
Palo Alto Medical Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tak Poon, MD, PharmD, ABIHM, FACC
Organizational Affiliation
Palo Alto Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto Medical Foundation, Mills Peninsula Division
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27234480
Citation
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.
Results Reference
derived
Learn more about this trial
CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact
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