Trial Outcomes & Findings for The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men (NCT NCT03092960)
NCT ID: NCT03092960
Last Updated: 2021-11-17
Results Overview
Number and Percentage of men who achieve 5% or more of weight loss compared to their baseline weight
COMPLETED
NA
424 participants
Baseline, 18 months
2021-11-17
Participant Flow
Participant milestones
| Measure |
Minimal Intensity Intervention
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Overall Study
STARTED
|
212
|
212
|
|
Overall Study
COMPLETED
|
180
|
186
|
|
Overall Study
NOT COMPLETED
|
32
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
Baseline characteristics by cohort
| Measure |
Minimal Intensity Intervention
n=212 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=212 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
Total
n=424 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
47.0 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
424 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
212 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
424 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
212 participants
n=5 Participants
|
212 participants
n=7 Participants
|
424 participants
n=5 Participants
|
|
Weight, kg
|
99.2 kg
STANDARD_DEVIATION 17.9 • n=5 Participants
|
101.5 kg
STANDARD_DEVIATION 33.0 • n=7 Participants
|
100.4 kg
STANDARD_DEVIATION 26.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 18 monthsNumber and Percentage of men who achieve 5% or more of weight loss compared to their baseline weight
Outcome measures
| Measure |
Minimal Intensity Intervention
n=180 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=186 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Number and Percentage of Men Achieving 5% Weight Loss or More
|
37 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. For examining weight loss trajectory over time, we abstracted weight measurements from the EHR from 3 months prior to randomization to 24 months post randomization. 209 in HOMBRE and 209 in Minimal Intensity intervention had EHR-abstracted weight during this 27-month period.
Slope of changes in weights abstracted from EHR from baseline through 18 months
Outcome measures
| Measure |
Minimal Intensity Intervention
n=209 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=209 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Trajectory of Weight Change From Baseline Through 18 Months
|
-0.11 kg/month
Standard Deviation 0.04
|
-0.13 kg/month
Standard Deviation 0.04
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. We used same model as first secondary outcome to examine changes in EHR weight at 6 months. We abstracted weight from the EHR from 3 months prior to randomization to 24 months post randomization. 209 in HOMBRE and 209 in Minimal Intensity had EHR-abstracted weight during this 27-month period.
Weight measurements were abstracted from EHR.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=209 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=209 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
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|---|---|---|
|
Changes in Weight From Baseline
|
-1.79 kg
Standard Deviation 6.10
|
-2.78 kg
Standard Deviation 5.45
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity had either study-measured, EHR-abstracted, or self-reported weight, therefore were counted in retention in the Participant Flow module. We used same model as first secondary outcome to examine changes in EHR weight at 12 months. We abstracted weight from the EHR from 3 months prior to randomization to 24 months post randomization. 209 in HOMBRE and 209 in Minimal Intensity had EHR-abstracted weight during this 27-month period.
Weight measurements were abstracted from EHR.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=209 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=209 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Changes in Weight From Baseline
|
-1.56 kg
Standard Deviation 7.00
|
-2.77 kg
Standard Deviation 6.47
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity had either study-measured, EHR-abstracted, or self-reported weight, therefore were counted in retention in the Participant Flow module. We used same model as first secondary outcome to examine changes in EHR weight at 18 months. We abstracted weight from the EHR from 3 months prior to randomization to 24 months post randomization. 209 in HOMBRE and 209 in Minimal Intensity had EHR-abstracted weight during this 27-month period.
Weight measurements were abstracted from EHR.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=209 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=209 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Changes in Weight From Baseline
|
-1.67 kg
Standard Deviation 6.16
|
-2.46 kg
Standard Deviation 6.60
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 83 in the HOMBRE intervention and 88 in the Minimal Intensity intervention had waist circumference data at 18 months.
Waist circumference at 18 months - waist circumference at baseline
Outcome measures
| Measure |
Minimal Intensity Intervention
n=88 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=83 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Waist Circumference From Baseline
|
-0.0 cm
Standard Deviation 6.7
|
-0.8 cm
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 147 in the HOMBRE intervention and 145 in the Minimal Intensity intervention had blood pressure data at 18 months.
Systolic blood pressure at 18 months - systolic blood pressure at baseline
Outcome measures
| Measure |
Minimal Intensity Intervention
n=145 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=147 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
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|---|---|---|
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Change in Systolic Blood Pressure From Baseline
|
0.4 mm Hg
Standard Deviation 12.5
|
0.8 mm Hg
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 147 in the HOMBRE intervention and 145 in the Minimal Intensity intervention had blood pressure data at 18 months.
Diastolic blood pressure at 18 months - diastolic blood pressure at baseline
Outcome measures
| Measure |
Minimal Intensity Intervention
n=145 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=147 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline
|
-2.7 mm Hg
Standard Deviation 9.4
|
-2.3 mm Hg
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 174 in the HOMBRE intervention and 177 in the Minimal Intensity intervention had physical activity data at 18 months.
Physical activity measured at 18 months minus physical activity measured at baseline using Stanford 7-day physical activity recall
Outcome measures
| Measure |
Minimal Intensity Intervention
n=177 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=174 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
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Change in Health Behavior: Leisure Time Physical Activity
|
-113 MET minutes/week
Standard Deviation 1410
|
-369 MET minutes/week
Standard Deviation 1436
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 174 in the HOMBRE intervention and 177 in the Minimal Intensity intervention had physical activity data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=177 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=174 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Health Behavior: Energy Expenditure
|
-1.1 kcal/kg/day
Standard Deviation 5.3
|
-2.1 kcal/kg/day
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 136 in the HOMBRE intervention and 137 in the Minimal Intensity intervention had sedentary behavior data at 18 months.
Weekly hours of sedentary behavior measured at 18 months minus weekly hours of sedentary behavior at baseline using the Sedentary behavior Questionnaire
Outcome measures
| Measure |
Minimal Intensity Intervention
n=137 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=136 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Health Behavior: Sedentary Behavior
|
-1.5 hours/week
Standard Deviation 31.5
|
-2.4 hours/week
Standard Deviation 47.5
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 80 in the HOMBRE intervention and 90 in the Minimal Intensity intervention had diet data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=90 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=80 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Health Behavior: Diet Quality
|
0.2 score on a scale
Standard Deviation 1.9
|
0.3 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 80 in the HOMBRE intervention and 90 in the Minimal Intensity intervention had diet data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=90 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=80 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Health Behavior: Fruit and Vegetable Intake
|
0.3 servings/day
Standard Deviation 4.1
|
-0.4 servings/day
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 80 in the HOMBRE intervention and 90 in the Minimal Intensity intervention had diet data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=90 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=80 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Health Behavior: Total Calorie Intake
|
4.0 kilocalories/day
Standard Deviation 3.8
|
4.1 kilocalories/day
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 80 in the HOMBRE intervention and 90 in the Minimal Intensity intervention had diet data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=90 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=80 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Health Behavior: Total Fat
|
-23.2 g/day
Standard Deviation 121
|
-14.8 g/day
Standard Deviation 44.9
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 105 in the HOMBRE intervention and 101 in the Minimal Intensity intervention had obesity-related quality of life data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=101 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=105 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Psychosocial Well-being: Obesity-specific Quality of Life
|
-6.3 units on a scale
Standard Deviation 21.4
|
-7.4 units on a scale
Standard Deviation 19.9
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 104 in the HOMBRE intervention and 101 in the Minimal Intensity intervention had depression symptom data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=101 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=104 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Psychosocial Well-being: Depressive Symptoms
|
-0.8 score on a scale
Standard Deviation 3.9
|
-0.6 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 105 in the HOMBRE intervention and 101 in the Minimal Intensity intervention had perceived stress data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=101 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=105 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Perceived Stress
|
0.0 score on a scale
Standard Deviation 5.6
|
-1.1 score on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 103 in the HOMBRE intervention and 100 in the Minimal Intensity intervention had sleep disturbance data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=100 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=103 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Psychosocial Well-being: Sleep Disturbance T-score
|
-0.7 score on a scale
Standard Deviation 8.2
|
-0.2 score on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: Baseline, 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 103 in the HOMBRE intervention and 100 in the Minimal Intensity intervention had sleep impairment data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=100 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=103 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Change in Psychosocial Well-being: Sleep Impairment T-score
|
-0.1 score on a scale
Standard Deviation 9.3
|
-2.9 score on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 107 in the HOMBRE intervention and 104 in the Minimal Intensity intervention had utility-based quality of life mobility data at 18 months.
Utility-based quality of life was measured by EuroQol EQ-5D. Number and percentage of participants who had no problems with mobility.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=104 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=107 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
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
|
91 Participants
|
96 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 108 in the HOMBRE intervention and 104 in the Minimal Intensity intervention had utility-based quality of life - self care data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=104 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=108 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
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
|
101 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 108 in the HOMBRE intervention and 104 in the Minimal Intensity intervention had utility-based quality of life usual activity data at 18 months.
Number and percentage of participants who had no problems with usual activities (e.g. work, study, housework, family or leisure activities).
Outcome measures
| Measure |
Minimal Intensity Intervention
n=104 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=108 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
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
|
96 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 108 in the HOMBRE intervention and 104 in the Minimal Intensity intervention had utility-based quality of life pain/discomfort data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=104 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=108 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
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
|
55 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: At 18 months, 186 in HOMBRE and 180 in Minimal Intensity intervention had either study-measured weight, EHR-abstracted weight, or self-reported weight, therefore were counted in retention in the Participant Flow module. Among them 108 in the HOMBRE intervention and 104 in the Minimal Intensity intervention had utility-based quality of life anxiety/depression data at 18 months.
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.
Outcome measures
| Measure |
Minimal Intensity Intervention
n=104 Participants
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=108 Participants
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
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
|
72 Participants
|
85 Participants
|
Adverse Events
Minimal Intensity Intervention
HOMBRE
Serious adverse events
| Measure |
Minimal Intensity Intervention
n=212 participants at risk
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=212 participants at risk
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders
|
0.47%
1/212 • Number of events 1 • 18 months
|
0.47%
1/212 • Number of events 1 • 18 months
|
|
Cardiac disorders
Cardiac disorders
|
0.94%
2/212 • Number of events 2 • 18 months
|
0.94%
2/212 • Number of events 2 • 18 months
|
|
Endocrine disorders
Endocrine disorders
|
1.4%
3/212 • Number of events 3 • 18 months
|
0.00%
0/212 • 18 months
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
0.47%
1/212 • Number of events 1 • 18 months
|
0.00%
0/212 • 18 months
|
|
Immune system disorders
Immune System Disorders
|
0.00%
0/212 • 18 months
|
0.47%
1/212 • Number of events 2 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
3.3%
7/212 • Number of events 7 • 18 months
|
4.2%
9/212 • Number of events 11 • 18 months
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
0.00%
0/212 • 18 months
|
0.47%
1/212 • Number of events 1 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders
|
0.47%
1/212 • Number of events 1 • 18 months
|
0.00%
0/212 • 18 months
|
Other adverse events
| Measure |
Minimal Intensity Intervention
n=212 participants at risk
Patients assigned to this group will received the Minimal intensity intervention.
Minimal intensity intervention: The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
|
HOMBRE
n=212 participants at risk
Patients assigned to this group will receive the HOMBRE intervention
HOMBRE: HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
|
|---|---|---|
|
Endocrine disorders
Endocrine Disorders
|
0.47%
1/212 • Number of events 1 • 18 months
|
0.00%
0/212 • 18 months
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
0.47%
1/212 • Number of events 1 • 18 months
|
1.4%
3/212 • Number of events 3 • 18 months
|
|
General disorders
General disorders
|
0.94%
2/212 • Number of events 2 • 18 months
|
2.8%
6/212 • Number of events 7 • 18 months
|
|
Infections and infestations
Infections and Infestations
|
0.94%
2/212 • Number of events 4 • 18 months
|
0.00%
0/212 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
16.0%
34/212 • Number of events 41 • 18 months
|
13.2%
28/212 • Number of events 35 • 18 months
|
|
Nervous system disorders
Nervous System Disorders
|
0.94%
2/212 • Number of events 2 • 18 months
|
0.94%
2/212 • Number of events 2 • 18 months
|
|
Renal and urinary disorders
Renal and Urinary Disorder
|
0.94%
2/212 • Number of events 2 • 18 months
|
0.00%
0/212 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders
|
0.47%
1/212 • Number of events 1 • 18 months
|
1.4%
3/212 • Number of events 3 • 18 months
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders
|
1.4%
3/212 • Number of events 3 • 18 months
|
0.94%
2/212 • Number of events 2 • 18 months
|
|
Cardiac disorders
Cardiac disorders
|
0.00%
0/212 • 18 months
|
3.8%
8/212 • Number of events 8 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place