The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men

Trajectory of Weight Change From Baseline Through 18 Months

Slope of changes in weights abstracted from EHR from baseline through 18 months

Time frame: 18 months

Changes in Weight From Baseline

Weight measurements were abstracted from EHR.

Time frame: 6 months

Changes in Weight From Baseline

Weight measurements were abstracted from EHR.

Time frame: 12 months

Changes in Weight From Baseline

Weight measurements were abstracted from EHR.

Time frame: 18 months

Change in Waist Circumference From Baseline

Waist circumference at 18 months - waist circumference at baseline

Time frame: Baseline, 18 months

Change in Systolic Blood Pressure From Baseline

Systolic blood pressure at 18 months - systolic blood pressure at baseline

Time frame: Baseline, 18 months

Change in Diastolic Blood Pressure From Baseline

Diastolic blood pressure at 18 months - diastolic blood pressure at baseline

Time frame: Baseline, 18 months

Change in Health Behavior: Leisure Time Physical Activity

Physical activity measured at 18 months minus physical activity measured at baseline using Stanford 7-day physical activity recall

Time frame: Baseline, 18 months

Change in Health Behavior: Energy Expenditure

The Stanford 7-day Physical Activity Recall data also provided estimates of total daily energy expenditures. Total energy expenditure = sleep hours × 1 MET + light activity hours × 1.5 METs + moderate activity hours × 4 METs + hard activity hours × 6 METs + very hard activity hours × 10 METs. Total daily energy expenditure at 18 months - Total daily energy expenditure at baseline.

Time frame: Baseline, 18 months

Change in Health Behavior: Sedentary Behavior

Weekly hours of sedentary behavior measured at 18 months minus weekly hours of sedentary behavior at baseline using the Sedentary behavior Questionnaire

Time frame: Baseline, 18 months

Change in Health Behavior: Diet Quality

Dietary intake was measured using the gold-standard approach of multiple pass 24-hour recalls in Spanish or English using Nutrition Data System for Research (NDSR). Diet quality was assessed by the Dietary Approaches to Stop Hypertension (DASH) score. DASH scores were calculated based on combining nine nutrient targets (i.e. total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium). A higher score reflects higher diet quality. The minimum score is 8 and the maximum is 40. DASH score at 18 months - DASH score at baseline.

Time frame: Baseline, 18 months

Change in Health Behavior: Fruit and Vegetable Intake

Fruit and vegetable intake measured at 18 months minus fruit and vegetable intake measured at baseline using 24-hour multiple pass recalls. Fruit and vegetable intake is measured in servings per day.

Time frame: Baseline, 18 months

Change in Health Behavior: Total Calorie Intake

Total calorie intake per day measured at 18 months minus total calorie intake per day measured at baseline using 24-hour multiple pass dietary recalls.

Time frame: Baseline, 18 months

Change in Health Behavior: Total Fat

Total fat consumption per day measured at 18 months minus total fat consumption per day measured at baseline using 24-hour multiple pass dietary recalls.

Time frame: Baseline, 18 months

Change in Psychosocial Well-being: Obesity-specific Quality of Life

Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems. Obesity-related quality of life measured at 18 months - obesity-related quality of life measured at baseline.

Time frame: Baseline, 18 months

Change in Psychosocial Well-being: Depressive Symptoms

The Patient Health Questionnaire PHQ-9 is a self-report questionnaire with 9 items. Respondents answered questions regarding how often a symptom has bothered them over the last two weeks. Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). PHQ-9 total score is the sum of the nine items, ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score at 18 months - PHQ-9 score at baseline.

Time frame: Baseline, 18 months

Change in Perceived Stress

Perceived stress scale with a range of 0 to 40 with higher scores indicating higher stress. Perceived stress at 18 months - Perceived stress at baseline.

Time frame: Baseline, 18 months

Change in Psychosocial Well-being: Sleep Disturbance T-score

Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. Sleep disturbance score at 18 months - sleep disturbance score at baseline.

Time frame: Baseline, 18 months

Change in Psychosocial Well-being: Sleep Impairment T-score

Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. Sleep impairment score at 18 months - sleep impairment at baseline.

Time frame: Baseline, 18 months

Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Mobility Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D

Utility-based quality of life was measured by EuroQol EQ-5D. Number and percentage of participants who had no problems with mobility.

Time frame: 18 months

Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Self Care Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D

Number and percentage of participants who had no problems with self care was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100.

Time frame: 18 months

Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Usual Activities Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D

Number and percentage of participants who had no problems with usual activities (e.g. work, study, housework, family or leisure activities).

Time frame: 18 months

Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Pain/Discomfort Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D

Number and percentage of participants who had no problems with pain was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100.

Time frame: 18 months

Change in Psychosocial Well-being: Number and Percentage of Participants Who Had no Problems With Anxiety and Depression Domain in Utility-based Quality of Life Measured by EuroQol EQ-5D

Number and percentage of participants who had no problems with anxiety and depression was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100.

Time frame: 18 months