NCT02246400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

March 18, 2014

Last Update Submit

May 29, 2015

Conditions

ObesityMetabolic SyndromePre-diabetesType 2 DiabetesCardiovascular Disease

Keywords

eCMPeHealthmHealthLifestyle interventionCardiometabolic risk reductionPAMF

Outcome Measures

Primary Outcomes (1)

  • Change in measure of Health-related quality of life from baseline to 6-months follow up.

    SF-8 questionnaire

    6-months

Secondary Outcomes (5)

  • Change in composite measure of Metabolic Syndrome

    6-months.

  • Dietary Intake

    Baseline, 3-months, and 6-months.

  • Physical Activity

    Baseline, 3-months, and 6-months.

  • Intervention adherence

    3-months and 6-months.

  • Body weight

    Baseline, 3 months, and 6 months

Study Arms (2)

Delayed Intervention

ACTIVE COMPARATOR

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

Behavioral: eCMP

Immediate Intervention

EXPERIMENTAL

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

Behavioral: eCMP

Interventions

eCMPBEHAVIORAL

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.

Also known as: Electronically-mediated CardioMetabolic Program (eCMP)
Delayed InterventionImmediate Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palo Alto Medical Foundation, Mills Peninsula Division

Burlingame, California, 94010, United States

Location

Related Publications (1)

  • 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.

    PMID: 27234480DERIVED

MeSH Terms

Conditions

ObesityMetabolic SyndromeGlucose IntoleranceDiabetes Mellitus, Type 2Cardiovascular Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesHyperglycemiaDiabetes MellitusEndocrine System Diseases

Study Officials

  • Jun Ma, MD, PhD

    Palo Alto Medical Foundation

    PRINCIPAL INVESTIGATOR

  • Tak Poon, MD, PharmD, ABIHM, FACC

    Palo Alto Medical Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

September 22, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

June 2, 2015

Record last verified: 2015-05

Locations

US(1)