Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number and Percentage of Men Achieving 5% Weight Loss or More |
Number and Percentage of men who achieve 5% or more of weight loss compared to their baseline weight |
Baseline, 18 months |
|
Secondary |
Trajectory of Weight Change From Baseline Through 18 Months |
Slope of changes in weights abstracted from EHR from baseline through 18 months |
18 months |
|
Secondary |
Changes in Weight From Baseline |
Weight measurements were abstracted from EHR. |
6 months |
|
Secondary |
Changes in Weight From Baseline |
Weight measurements were abstracted from EHR. |
12 months |
|
Secondary |
Changes in Weight From Baseline |
Weight measurements were abstracted from EHR. |
18 months |
|
Secondary |
Change in Waist Circumference From Baseline |
Waist circumference at 18 months - waist circumference at baseline |
Baseline, 18 months |
|
Secondary |
Change in Systolic Blood Pressure From Baseline |
Systolic blood pressure at 18 months - systolic blood pressure at baseline |
Baseline, 18 months |
|
Secondary |
Change in Diastolic Blood Pressure From Baseline |
Diastolic blood pressure at 18 months - diastolic blood pressure at baseline |
Baseline, 18 months |
|
Secondary |
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 |
Baseline, 18 months |
|
Secondary |
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. |
Baseline, 18 months |
|
Secondary |
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 |
Baseline, 18 months |
|
Secondary |
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. |
Baseline, 18 months |
|
Secondary |
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. |
Baseline, 18 months |
|
Secondary |
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. |
Baseline, 18 months |
|
Secondary |
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. |
Baseline, 18 months |
|
Secondary |
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. |
Baseline, 18 months |
|
Secondary |
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. |
Baseline, 18 months |
|
Secondary |
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. |
Baseline, 18 months |
|
Secondary |
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. |
Baseline, 18 months |
|
Secondary |
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. |
Baseline, 18 months |
|
Secondary |
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. |
18 months |
|
Secondary |
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. |
18 months |
|
Secondary |
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). |
18 months |
|
Secondary |
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. |
18 months |
|
Secondary |
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. |
18 months |
|