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Cardiovascular Health Program Registry

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ClinicalTrials.gov Identifier: NCT01975181
Recruitment Status : Enrolling by invitation
First Posted : November 4, 2013
Last Update Posted : May 18, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The Cardiovascular Health Program (CHP) Registry seeks to improve the cardiovascular disease (CVD) risk profile of subjects through therapeutic lifestyle change using an integrative model of medicine.

Condition or disease Intervention/treatment
Cardiovascular Disease Behavioral: Diet Behavioral: Exercise Behavioral: Stress Management Behavioral: Sleep Improvement

Detailed Description:

Through improvements in lifestyle choices regarding diet, exercise, sleep and stress management, the CHP Registry expects to find improvements in calculated risk for heart disease and stroke.

Upon entry to the CHP Registry, subjects are given a detailed assessment of CVD risk through their reported past medical history, family history, review of systems, physical examination, laboratory data including lipid profile and glucose metabolism, electrocardiogram and/or exercise stress test, and carotid ultrasound for intima-medial thickness. Framingham risk score is calculated and in combination with other factors, a global score for CVD risk is appraised.

Subjects then attend a half-day workshop on heart healthy behaviors including a cooking demonstration that promulgates a Mediterranean Diet. At approximately monthly intervals over a 6-month timeframe, subjects consult in 20 minute onsite appointments with a dietician, exercise physiologist, and stress management coach to work on behavioral improvements to encourage heart health. These onsite visits are then followed by 6 months of telephonic lifestyle coaching.

At program's end, typically 12 months after enrollment in the Registry, subjects repeat their CVD risk assessment to receive a personal report card detailing the results of their therapeutic lifestyle changes.

Study Design

Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Cardiovascular Health Program Registry
Study Start Date : September 2013
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020
Groups and Cohorts

Group/Cohort Intervention/treatment
Therapeutic Lifestyle Change Arm
All subjects entering the Registry will receive therapeutic lifestyle change interventions for diet, exercise, stress management and sleep improvement.
Behavioral: Diet
In receiving recommendations for a Mediterranean-style diet, subjects are encouraged to get protein predominantly from fish and legumes, fat from olive oil or other sources high in omega-3 oils, to eat whole grains and complex carbohydrates while avoiding highly processed foods. Subjects are also coached on portion control, stress-eating and snacking, aiming for adequate water intake, and eating meals including breakfast with regularity.
Other Name: Mediterranean-style diet
Behavioral: Exercise
After assessing safety of exercise with a supervised, graded exercise tolerance test, subjects are given a prescription for exercise with activities tailored to their preferences and physical limitations aiming for at least 150 minutes of continuous aerobic exercise per week.
Behavioral: Stress Management
In supervised coaching sessions and with assigned homework behaviors, subjects learn to use a "tension tamer" with visualized imagery, deep breathing, and progressive muscle relaxation to live with lower levels of stress.
Other Name: Stress Reduction
Behavioral: Sleep Improvement
After evaluation of treatment of sleep pathologies such as obstructive sleep apnea and periodic limb movement disorder, subjects are taught to employ "tension tamer" techniques and pursue daily exercise to improve sleep latency and sleep continuity.

Outcome Measures

Primary Outcome Measures :
  1. Improvement in Cardiovascular Disease Risk Score [ Time Frame: 8 months ]
    A cardiovascular disease risk score is calculated using the Framingham Risk Score PLUS other factors including family history, body mass index, diastolic blood pressure, high sensitivity C-reactive protein, low-density lipoprotein, triglyceride and lipoprotein(a).

Secondary Outcome Measures :
  1. Improvement in Dietary Score using the Rate-Your-Plate Dietary Assessment Tool [ Time Frame: 8 months ]
    Specific dietary behaviors are surveyed using the Rate-Your-Plate Dietary Assessment Tool with scores for each behavior ranging from 0 to 3. A high score indicates a healthy dietary behavior. All individual scores are added to calculate an overall score for healthful eating.

  2. Improvement in International Physical Activity Questionnaire (IPAQ) score [ Time Frame: 8 months ]
    Using the International Physical Activity Questionnaire (IPAQ), subjects report how much continuous exertional activity they accomplish each week.

  3. Improvement in Perceived Stress Scale [ Time Frame: 8 months ]
    Using the Perceived Stress Scale, subjects report on subjectively experienced stress levels over the several weeks prior to the measurement date.

  4. Improvement in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 months ]
    Subjects complete the questionnaire (PSQI) to have a global assessment of their sleep quality for the time period including a month before the questionnaire completion.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult Military Health-Care Beneficiaries

Inclusion Criteria: The CHP Registry is a clinical program available to any adult (age 18 years or older) military health care beneficiary. Subjects who present to the CHP for evaluation and participation may be self-referred or be referred by a provider. A majority of participants are free of cardiovascular disease symptoms. Participants elect to enroll in order to learn about healthy lifestyle choices that can help prevent the development of cardiovascular disease.

Exclusion Criteria:

  1. Less than 18 years of age.
  2. Individuals unable or unwilling to participate or give informed consent.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975181

United States, Maryland
Integrative Cardiac Health Project, Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Walter Reed National Military Medical Center
Henry M. Jackson Foundation for the Advancement of Military Medicine
Principal Investigator: Todd C Villines, MD Walter Reed National Military Medical Center
More Information

Responsible Party: Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01975181     History of Changes
Other Study ID Numbers: 372910-6
First Posted: November 4, 2013    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Walter Reed National Military Medical Center:
cardiovascular disease risk factors
cardiovascular disease prevention

Additional relevant MeSH terms:
Cardiovascular Diseases