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

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

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.

Condition or disease Intervention/treatment Phase
Obesity Metabolic Syndrome Pre-diabetes Type 2 Diabetes Cardiovascular Disease Behavioral: eCMP Not Applicable

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  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact
Study Start Date : January 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Electronically-mediated CardioMetabolic Program (eCMP)




Primary Outcome Measures :
  1. Change in measure of Health-related quality of life from baseline to 6-months follow up. [ Time Frame: 6-months ]
    SF-8 questionnaire


Secondary Outcome Measures :
  1. 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.)

  2. Dietary Intake [ Time Frame: Baseline, 3-months, and 6-months. ]
    Nutrition Data System for Research (NDSR).

  3. Physical Activity [ Time Frame: Baseline, 3-months, and 6-months. ]
    Seven-Day Physical Activity Recall (PAR).

  4. Intervention adherence [ Time Frame: 3-months and 6-months. ]
    Intervention session attendance of virtual classes and in-person physical activity classes.

  5. Body weight [ Time Frame: Baseline, 3 months, and 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246400


Locations
United States, California
Palo Alto Medical Foundation, Mills Peninsula Division
Burlingame, California, United States, 94010
Sponsors and Collaborators
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Palo Alto Medical Foundation
ClinicalTrials.gov Identifier: NCT02246400     History of Changes
Other Study ID Numbers: # 14-01-290
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015

Keywords provided by Palo Alto Medical Foundation:
eCMP
eHealth
mHealth
Lifestyle intervention
Cardiometabolic risk reduction
PAMF

Additional relevant MeSH terms:
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetes Mellitus
Metabolic Syndrome X
Prediabetic State
Glucose Intolerance
Insulin Resistance
Hyperinsulinism
Hyperglycemia