Clinical Trial Radar

Mean change from Baseline, Systolic Blood Pressure

Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor. Reporting will compare participants in the present study with propensity-score-matched controls.

Baseline, 6 Months

Mean change from Baseline, Diastolic Blood Pressure

Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor. Reporting will compare participants in the present study with propensity-score-matched controls.

Baseline, 6 Months

Number of Participants with Personal History of Cardiovascular Disease

Personal history of cardiovascular disease is measured via self-report at baseline using an adapted item from My Personal Health Record (MyPHR). Personal history of cardiovascular disease is defined as history of diabetes, heart surgery, high blood cholesterol, high blood pressure, pain or pressure in chest, palpitations, stroke, or other heart condition (including heart attack).

Baseline

Number of Participants with Family History of Cardiovascular Disease

Family history of cardiovascular disease is measured via self-report using an adapted item from the Women's Health Initiative. Family history of cardiovascular disease is defined as having a parent, full-blooded sibling, or child who has ever had a heart condition, such as heart attack, high blood pressure, or stroke.

Baseline

Mean Systolic Blood Pressure in mmHg

Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor.

Baseline, 6 Months, 12 Months

Mean Diastolic Blood Pressure in mmHg

Blood pressure is measured as the average of three readings, taken in a seated position using an Omron BP6100 digital blood pressure monitor.

Baseline, 6 Months, 12 Months

Mean Body-mass Index

Body-mass index (BMI) will be calculated as weight (pounds) \* 703 / height\^2 (inches).

Baseline, 6 Months, 12 Months

Mean Weight in Pounds

Weight will be measured via a digital scale.

Baseline, 6 Months, 12 Months

Mean Waist Circumference in Centimeters

Waist circumference will be measured using inelastic tape.

Baseline, 6 Months, 12 Months

Mean Total Cholesterol in mg/dL

Total cholesterol is measured via blood sample using a Cholestech LDX analyzer.

Baseline, 6 Months, 12 Months

Mean High-density Lipoprotein (HDL) Cholesterol in mg/dL

HDL cholesterol is measured via blood sample using a Cholestech LDX analyzer.

Baseline, 6 Months, 12 Months

Mean Low-density Lipoprotein (LDL) Cholesterol in mg/dL

LDL cholesterol is measured via blood sample using a Cholestech LDX analyzer.

Baseline, 6 Months, 12 Months

Mean Blood Triglycerides in mg/dL

Blood triglycerides are measured via blood sample using a Cholestech LDX analyzer.

Baseline, 6 Months, 12 Months

Mean Glycated Hemoglobin (A1C) Score

A1C is measured via blood sample using A1CNow+ test kits.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Smoking Status

Smoking status is measured via self-report using excerpted items from wave 1 of the Population Assessment of Tobacco and Health Study. Reporting will include number of participants endorsing ever having smoked a cigarette and (among participants who have endorse ever having smoked) numbers of participants endorsing now smoking every day, some days, or not at all.

Baseline, 6 Months, 12 Months

Mean Healthy Days

Healthy Days measured via self report using the Center for Disease Control (CDC)'s 4-item Healthy Days Core Module (HRQOL-4) with a look-back period of 30 days. HRQOL-4 scores can range from 0 to 30, with 30 indicating maximum number of healthy days.

Baseline, 6 Months, 12 Months

Mean Heart Disease Fact Questionnaire Score

Heart disease knowledge is measured via self-report using the 25-item Heart Disease Fact Questionnaire (HDFQ). HDFQ scores can range from 0 to 25, with higher scores indicating greater knowledge of heart disease.

Baseline, 6 Months, 12 Months

Mean University of Rhode Island Change Assessment Score

Readiness for behavioral change is measured via self-report using the 32-item University of Rhode Island Change Assessment (URICA). URICA scores can range from -2 to +14, with higher scores indicating greater levels of readiness to change.

Baseline, 6 Months, 12 Months

Mean Perceived Stress Scale Score

Perceived stress is measured via self-report using the 10-item Perceived Stress Scale (PSS). PSS scores can range from 0 to 40, with higher scores indicating higher levels of perceived stress.

Baseline, 6 Months, 12 Months

Mean Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) Score

Alcohol use is measured via self-report using the 3-item Alcohol Use Disorders Identification Test - Consumption (AUDIT-C). AUDIT-C scores can range from 0 to 12, with higher scores indicating greater of drinking quantity and/or frequency.

Baseline, 6 Months, 12 Months

Mean Minutes of Light, Moderate, and Vigorous Leisure-Time Physical Activity

Minutes of light, moderate, and vigorous leisure-time physical activity is measured via self-report using an English-language version of Registre Gironí del Cor (REGICOR) with a look-back period of one month.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Sweetened Fruit Drinks

Dietary intake of sweetened fruit drinks is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of 100% Pure Fruit Juice

Dietary intake of 100% pure fruit juice is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Soda

Dietary intake of soda is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Water

Dietary intake of water is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Fruit

Dietary intake of fruit is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Vegetables (Excluding Potatoes)

Dietary intake of vegetables (excluding potatoes) is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Frozen and Fast Food

Dietary intake of frozen and fast food is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Processed Meat

Dietary intake of processed meat is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Whole Grains

Dietary intake of whole grains is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Candy, Desserts, and Chocolate

Dietary intake of candy, desserts, and chocolate is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Chips

Dietary intake of chips is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Sugary Cereals

Dietary intake of sugary cereals is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Fish

Dietary intake of fish is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Nuts and Seeds

Dietary intake of nuts and seeds is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months

Number of Participants by Categorical Frequency of Dietary Intake of Eggs

Dietary intake of eggs is measured via an adapted self-report item from Family Life, Activity, Sun, Health, and Eating (FLASHE) with a look-back period of 7 days. Reporting will include categorical number of participants endorsing non-consumption, 1-3 times weekly consumption, 4-6 times weekly consumption, once-daily consumption, twice-daily consumption, or three-or-more times daily consumption.

Baseline, 6 Months, 12 Months