Clinical trial NCT02246400: CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact
Official title: CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Pre-diabetes
Type 2 Diabetes
Cardiovascular Disease
Keywords: eCMP
eHealth
mHealth
Lifestyle intervention
Cardiometabolic risk reduction
PAMF
Lead sponsor: Palo Alto Medical Foundation
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility 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

Primary outcomes:
measure: Change in measure of Health-related quality of life from baseline to 6-months follow up.
timeFrame: 6-months
Secondary outcomes:
measure: Change in composite measure of Metabolic Syndrome
timeFrame: 6-months.
measure: Dietary Intake
timeFrame: Baseline, 3-months, and 6-months.
measure: Physical Activity
timeFrame: Baseline, 3-months, and 6-months.
measure: Intervention adherence
timeFrame: 3-months and 6-months.
measure: Body weight
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Burlingame
country: United States
facility: Palo Alto Medical Foundation, Mills Peninsula Division
state: California
Study officials:
affiliation: Palo Alto Medical Foundation
name: Jun Ma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palo Alto Medical Foundation
name: Tak Poon, MD, PharmD, ABIHM, FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.