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Completed

NCT Number: NCT02246400

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

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pre-diabetes Signs and Symptoms Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palo Alto Medical Foundation, Mills Peninsula Division

Burlingame, California, 94010, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eCMP

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.

Other names: Electronically-mediated CardioMetabolic Program (eCMP)

Primary outcomes

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

    Time frame: 6-months

    SF-8 questionnaire

Secondary outcomes

  1. Change in composite measure of Metabolic Syndrome

    Time frame: 6-months.

    Composite measure of Metabolic Syndrome (criterion factors: waist circumference, blood pressure, fasting plasma glucose, triglycerides, High-density lipoprotein, and body mass index.)

  2. Dietary Intake

    Time frame: Baseline, 3-months, and 6-months.

    Nutrition Data System for Research (NDSR).

  3. Physical Activity

    Time frame: Baseline, 3-months, and 6-months.

    Seven-Day Physical Activity Recall (PAR).

  4. Intervention adherence

    Time frame: 3-months and 6-months.

    Intervention session attendance of virtual classes and in-person physical activity classes.

  5. Body weight

    Time frame: Baseline, 3 months, and 6 months

Sponsors and collaborators

Lead sponsor

Palo Alto Medical Foundation

Other

Registry information

Acronym: eCMP

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2014
Registry last updated
Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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