ObesityeCMPNCT02246400
CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact
A study testing eCMP in people with Obesity and Metabolic Syndrome, run by Palo Alto Medical Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Metabolic Syndrome, Pre-diabetes
- What is being tested?
- eCMP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto Medical Foundation, Mills Peninsula Division
Burlingame, California, 94010
About this study
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.
Read the 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).
- Being tested
- eCMP
- Keywords
- eCMP, eHealth, mHealth, Lifestyle intervention, Cardiometabolic risk reduction, PAMF
- Medical subject headings
- Obesity, Metabolic Syndrome, Glucose Intolerance, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCMPBehavioural
Also called Electronically-mediated CardioMetabolic Program (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.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Intervention | Active comparator | Usual care for first three months. Initiation of the eCMP after the 3-month time point. Receives: Behavioral: eCMP |
| Immediate Intervention | Experimental | Initiation of the eCMP immediately upon completion of baseline data collection and randomization Receives: Behavioral: eCMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in measure of Health-related quality of life from baseline to 6-months follow up.
SF-8 questionnaire
Measured: 6-months
Secondary outcomes (5)
Change in composite measure of Metabolic Syndrome
Composite measure of Metabolic Syndrome (criterion factors: waist circumference, blood pressure, fasting plasma glucose, triglycerides, High-density lipoprotein, and body mass index.)
Measured: 6-months.
Dietary Intake
Nutrition Data System for Research (NDSR).
Measured: Baseline, 3-months, and 6-months.
Physical Activity
Seven-Day Physical Activity Recall (PAR).
Measured: Baseline, 3-months, and 6-months.
Intervention adherence
Intervention session attendance of virtual classes and in-person physical activity classes.
Measured: 3-months and 6-months.
Body weight
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Ma, MD, PhD, Principal investigator, Palo Alto Medical FoundationTak Poon, MD, PharmD, ABIHM, FACC, Principal investigator, Palo Alto Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246400
- Sponsor's protocol ID
- # 14-01-290
- Acronym
- eCMP
- Status last verified
- May 2015
- First submitted
- 18 Mar 2014
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27234480
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact
- ClinicalTrials.gov ID
- NCT02246400
- Acronym / sponsor ID
- eCMP / # 14-01-290
- Keywords
- eCMP, eHealth, mHealth, Lifestyle intervention, Cardiometabolic risk reduction, PAMF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Palo Alto Medical FoundationUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Intervention | Active comparator | Behavioral: eCMPUsual care for first three months. Initiation of the eCMP after the 3-month time point. |
| Immediate Intervention | Experimental | Behavioral: eCMPInitiation of the eCMP immediately upon completion of baseline data collection and randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eCMPAlso: Electronically-mediated CardioMetabolic Program (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. | Behavioural | Delayed Intervention, Immediate Intervention |
Primary outcome
Change in measure of Health-related quality of life from baseline to 6-months follow up.
Time frame: 6-months
SF-8 questionnaire
5 secondary outcomes
Change in composite measure of Metabolic Syndrome
Time frame: 6-months.
Dietary Intake
Time frame: Baseline, 3-months, and 6-months.
Physical Activity
Time frame: Baseline, 3-months, and 6-months.
Intervention adherence
Time frame: 3-months and 6-months.
Body weight
Time frame: Baseline, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Derived from this study: PubMed 27234480Azar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Ma, MD, PhD principal investigator
Palo Alto Medical Foundation
Tak Poon, MD, PharmD, ABIHM, FACC principal investigator
Palo Alto Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCMP in people with Obesity and Metabolic Syndrome, run by Palo Alto Medical Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in measure of Health-related quality of life from baseline to 6-months follow up. (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02246400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015; AzTrials last refreshed its copy on 31 Oct 2026.