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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

Tracking Information
First Submitted Date  ICMJE March 18, 2014
First Posted Date  ICMJE September 22, 2014
Last Update Posted Date June 2, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT02246400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Obesity
  • Metabolic Syndrome
  • Pre-diabetes
  • Type 2 Diabetes
  • Cardiovascular Disease
Intervention  ICMJE 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2015)
74
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2014)
100
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02246400
Other Study ID Numbers  ICMJE # 14-01-290
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Palo Alto Medical Foundation
Study Sponsor  ICMJE Palo Alto Medical Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP