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

NCT ID: NCT02246400

Last Updated: 2015-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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).

Conditions

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Obesity Metabolic Syndrome Pre-diabetes Type 2 Diabetes Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Delayed Intervention

Usual care for first three months. Initiation of the eCMP after the 3-month time point.

Group Type ACTIVE_COMPARATOR

eCMP

Intervention Type BEHAVIORAL

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.

Immediate Intervention

Initiation of the eCMP immediately upon completion of baseline data collection and randomization

Group Type EXPERIMENTAL

eCMP

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Electronically-mediated CardioMetabolic Program (eCMP)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Palo Alto Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Ma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Palo Alto Medical Foundation

Tak Poon, MD, PharmD, ABIHM, FACC

Role: PRINCIPAL_INVESTIGATOR

Palo Alto Medical Foundation

Locations

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Palo Alto Medical Foundation, Mills Peninsula Division

Burlingame, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27234480 (View on PubMed)

Other Identifiers

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# 14-01-290

Identifier Type: -

Identifier Source: org_study_id

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