Obesity, Hypertension, Cardiovascular Disease Circulatory System
Conditions
Interventions
Our project has two arms, the Shared Decisions Making (SDM) and Usual Decision Making (UDM).
Shared Decision Making combines subject preferences with evidence-based medicine in a coll
Sponsors
New York State Department of Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At baseline, 3-months, 6-months, 9-months, 12-months: 1. Salt intake measured using Salt questioner (adapted from WHO STEPwise approach to chronic disease risk factor surveillance of Dietary salt module) 2. Diet measured using Rate Your Plate (adapted from 2000 Brown University Center for Primary Care and Prevention, Pawtucket, RI 02860) 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) 4. Physical activity measured using IPAQ 7-days tool | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Medical Knowledge measured using Questioner on High-Blood Pressure (1) and Obesity (2) to gauge knowledge of the disease awareness and disease process at baseline, 6-months, 12-months 2. Mental and emotional health measured using PHQ-9 at baseline, 6-months, 12-months. 3. Commitment to outcome measured using stage of change scale at baseline, 3-months, 6-months, 9-months, 12-months 4. Self-efficacy measured using the General Self-Efficacy Scale (GSES) at baseline, 3-months, 6-months, 9-months, 12-months 5. Environmental factors measured using a home and work environment questionnaire at baseline, 6-months, 12-months 6. Medication Adherence measured using a modified medication adherence assessment adapted from Morisky Medication Adherence Scale at baseline, 6-months, 12-months 7. Alcohol use measured using AUDIT questionnaire at baseline, 6-months, 12-months 8. Smoking behavior measured using smoking questions at baseline, 6-months, 12-months 9. Sleep measured using a modified version of the Pittsburgh Sleep Quality Index (PSQI) at baseline, 6-months, 12-months 10. Major Stressful Life Events measured using a novel questionnaire at baseline, 6-months, 12-months 11. Social Support and Relationship measured using a novel questionnaire at baseline, 6-months, 12-months | — |
Countries
United States of America
Outcome results
None listed