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

May 29, 2015 updated by: Palo Alto Medical Foundation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Burlingame, California, United States, 94010
        • Palo Alto Medical Foundation, Mills Peninsula Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Delayed Intervention
Usual care for first three months. Initiation of the eCMP after the 3-month time point.
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 Names:
  • Electronically-mediated CardioMetabolic Program (eCMP)
Experimental: Immediate Intervention
Initiation of the eCMP immediately upon completion of baseline data collection and randomization
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 Names:
  • Electronically-mediated CardioMetabolic Program (eCMP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in measure of Health-related quality of life from baseline to 6-months follow up.
Time Frame: 6-months
SF-8 questionnaire
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
6-months.
Dietary Intake
Time Frame: Baseline, 3-months, and 6-months.
Nutrition Data System for Research (NDSR).
Baseline, 3-months, and 6-months.
Physical Activity
Time Frame: Baseline, 3-months, and 6-months.
Seven-Day Physical Activity Recall (PAR).
Baseline, 3-months, and 6-months.
Intervention adherence
Time Frame: 3-months and 6-months.
Intervention session attendance of virtual classes and in-person physical activity classes.
3-months and 6-months.
Body weight
Time Frame: Baseline, 3 months, and 6 months
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Medical Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • # 14-01-290

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe