A novel approach to clinical practice by using a shared decision-making model to target cardiovascular risk: The YANKEES study
- Conditions
- Obesity, Hypertension, Cardiovascular DiseaseCirculatory System
- Registration Number
- ISRCTN61164781
- Lead Sponsor
- ew York State Department of Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 600
1. Ambulatory clinic patients that have an established record with a history of two appointments and follow-ups
2. Age 18 years and above
3. Hypertension, medical diagnosis with no more than three anti-hypertensive medications
4. Medical diagnosis of Diabetes Mellitus with hemoglobin A1c less than or equal to 8.0%
5. Calculated Body Mass Index between 25 kg/m2 and 40 kg/m2
1. Unable to provide informed consent in either English or Spanish for any reason, including cognitive impairment, psychiatric illness, drug or alcohol intoxication
2. Pregnant or are planning to become pregnant within the year
3. Participating in other trials, e.g. weight loss study
4. Prior history or present medical condition and/or surgical procedure related to the primary gastrointestinal tracts and/or accessory digestive organs affecting the transit or absorption of ingested nutrients, including but not limited to bariatric, pancreatic disease and multiple bowel surgeries
5. Severe comorbid diseases that can lead to unintentional weight change including cancer, HIV/AIDS, autoimmune disease, including and not limited to inflammatory bowel disease, in addition to chronic kidney disease, chronic liver disease and chronic heart disease
6. Severe disease, a terminal illness, be incapacitated (including stroke, myocardial infarction, coronary artery disease) with an expected limited life-span of less than a year
7. Living in an institutional setting (including nursing home, prison or group home)
8. Lab value abnormalities that preclude from participation in study interventions (i.e. significant anemia; derangement in electrolytes; elevation in liver function test; etc.) determined by the Investigator
9. Abnormalities in electrocardiogram studies, unless reviewed and cleared by a physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> At baseline, 3-months, 6-months, 9-months, 12-months:<br> 1. Salt intake measured using Salt questioner (adapted from WHO STEPwise approach to chronic disease risk factor surveillance of Dietary salt module)<br> 2. Diet measured using Rate Your Plate (adapted from 2000 Brown University Center for Primary Care and Prevention, Pawtucket, RI 02860)<br> 3. Nutrition measured using Automated Self-Administered 24-Hour (ASA-24Hrs; 24-Hour Dietary Intake Caloric Assessment from NIH Automated Self-Administered 24-Hour Dietary Assessment Tool)<br> 4. Physical activity measured using IPAQ 7-days tool<br>
- Secondary Outcome Measures
Name Time Method