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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02246400
Other study ID # # 14-01-290
Secondary ID
Status Completed
Phase N/A
First received March 18, 2014
Last updated May 29, 2015
Start date January 2014
Est. completion date December 2014

Study information

Verified date May 2015
Source Palo Alto Medical Foundation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Intervention

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.

Locations

Country Name City State
United States Palo Alto Medical Foundation, Mills Peninsula Division Burlingame California

Sponsors (1)

Lead Sponsor Collaborator
Palo Alto Medical Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in measure of Health-related quality of life from baseline to 6-months follow up. SF-8 questionnaire 6-months No
Secondary 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.) 6-months. No
Secondary Dietary Intake Nutrition Data System for Research (NDSR). Baseline, 3-months, and 6-months. No
Secondary Physical Activity Seven-Day Physical Activity Recall (PAR). Baseline, 3-months, and 6-months. No
Secondary Intervention adherence Intervention session attendance of virtual classes and in-person physical activity classes. 3-months and 6-months. No
Secondary Body weight Baseline, 3 months, and 6 months No
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