Cardiovascular Prevention Program Registry
Behavioral: Stress Management
Behavioral: Sleep Improvement
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||3 Years|
|Official Title:||Cardiovascular Prevention Program Registry|
- Improvement in Cardiovascular Disease Risk Score [ Time Frame: 8 months ] [ Designated as safety issue: No ]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).
- Improvement in Dietary Score using the Rate-Your-Plate Dietary Assessment Tool [ Time Frame: 8 months ] [ Designated as safety issue: No ]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.
- Improvement in International Physical Activity Questionnaire (IPAQ) score [ Time Frame: 8 months ] [ Designated as safety issue: No ]Using the International Physical Activity Questionnaire (IPAQ), subjects report how much continuous exertional activity they accomplish each week.
- Improvement in Perceived Stress Scale [ Time Frame: 8 months ] [ Designated as safety issue: No ]Using the Perceived Stress Scale, subjects report on subjectively experienced stress levels over the several weeks prior to the measurement date.
- Improvement in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||October 2020|
|Estimated Primary Completion Date:||October 2019 (Final data collection date for primary outcome measure)|
Therapeutic Lifestyle Change Arm
All subjects entering the Registry will receive therapeutic lifestyle change interventions for diet, exercise, stress management and sleep improvement.
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 dietBehavioral: 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 ReductionBehavioral: 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.
Through improvements in lifestyle choices regarding diet, exercise, sleep and stress management, the CPP Registry expects to find improvements in calculated risk for heart disease and stroke.
Upon entry to the CPP 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, subjects consult in 20 minute appointments with a dietician, exercise physiologist, and stress management coach to work on behavioral improvements to encourage heart health.
At program's end, typically 6 to 8 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01975181
|Contact: Marina N Vernalis, DOemail@example.com|
|United States, Maryland|
|Integrative Cardiac Health Project, Walter Reed National Military Medical Center||Recruiting|
|Bethesda, Maryland, United States, 20889|
|Contact: Elaine Walizer, MSN 301-400-1107 firstname.lastname@example.org|
|Contact: Claire E Fuller 301-400-1111 email@example.com|
|Principal Investigator: Marina N Vernalis, DO|
|Sub-Investigator: Mariam D Kashani, DNP|
|Sub-Investigator: Arn H Eliasson, MD|
|Sub-Investigator: Renata J Engler, MD|
|Principal Investigator:||Todd C Villines, MD||Walter Reed National Military Medical Center|