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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of Illinois at Chicago | OTHER |
| RTI International | OTHER |
| University of Pittsburgh |
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The purpose of this study is to test a flexible lifestyle program designed to help Latino men make healthy lifestyle changes to lower their risk of developing diabetes and heart disease. The program is called HOMBRE (Hombres con Opciones para Mejorar el Bienestar y bajar el Riesgo de Enfermedades crónicas; English translation: Men with choices to improve well being and decrease chronic disease risk).
This study is a comparative effectiveness trial where obese Latino men will receive, by random assignment, the HOMBRE intervention or a minimal intensity intervention.
The study is designed to test whether a flexible lifestyle program with choices for program engagement will lead to better health outcomes, compared to a minimal intensity self-directed lifestyle program. If proven successful, this study has the potential to significantly impact health outcomes that matter to Latino men through the innovative design of lifestyle interventions to prevent chronic disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimal intensity intervention | Active Comparator | Patients assigned to this group will received the Minimal intensity intervention. |
|
| HOMBRE | Experimental | Patients assigned to this group will receive the HOMBRE intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimal intensity intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Trajectory of Weight Change From Baseline Through 18 Months | Slope of changes in weights abstracted from EHR from baseline through 18 months | 18 months |
| Changes in Weight From Baseline | Weight measurements were abstracted from EHR. |
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Inclusion Criteria:
Exclusion Criteria:
Medical exclusions:
Other exclusions:
Self-identifies as male.
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Goldman Rosas, PhD, MPH | Stanford University | Principal Investigator |
| Kristen M Azar, RN, MSN, MPH | Sutter Health Research Development & Dissemination | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto Medical Foundation | Palo Alto | California | 94301 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35654660 | Derived | Rosas LG, Lv N, Xiao L, Venditti EM, Lewis MA, Azar KMJ, Hooker SP, Zavella P, Ma J. HOMBRE: A Trial Comparing 2 Weight Loss Approaches for Latino Men. Am J Prev Med. 2022 Sep;63(3):341-353. doi: 10.1016/j.amepre.2022.03.032. Epub 2022 May 30. | |
| 35119377 | Derived | Rosas LG, Lv N, Xiao L, Azar KM, Hooker SP, Venditti EM, Lewis MA, Zavella P, Ma J. Preferences for Technology-Mediated Behavioral Lifestyle Interventions With Different Levels of Coach and Peer Support Among Latino Men: Comparative Study Within One Arm of a Randomized Controlled Trial. JMIR Form Res. 2022 Feb 4;6(2):e29537. doi: 10.2196/29537. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Baseline, 18 months |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endocrine disorders | Endocrine disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endocrine Disorders | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Goldman Rosas | Stanford University | (650) 721-8415 | lgrosas@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2018 | Oct 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
| Arizona State University | OTHER |
| Stanford University | OTHER |
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| HOMBRE | Behavioral | 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. |
|
| 6 months |
| Changes in Weight From Baseline | Weight measurements were abstracted from EHR. | 12 months |
| Changes in Weight From Baseline | Weight measurements were abstracted from EHR. | 18 months |
| Change in Waist Circumference From Baseline | Waist circumference at 18 months - waist circumference at baseline | Baseline, 18 months |
| Change in Systolic Blood Pressure From Baseline | Systolic blood pressure at 18 months - systolic blood pressure at baseline | Baseline, 18 months |
| Change in Diastolic Blood Pressure From Baseline | Diastolic blood pressure at 18 months - diastolic blood pressure at baseline | 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 | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 18 months |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight, kg | Mean | Standard Deviation | kg |
|
|
|
| Secondary | Trajectory of Weight Change From Baseline Through 18 Months | Slope of changes in weights abstracted from EHR from baseline through 18 months | 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. | Posted | Mean | Standard Deviation | kg/month | 18 months |
|
|
|
| Secondary | Changes in Weight From Baseline | Weight measurements were abstracted from EHR. | 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. | Posted | Mean | Standard Deviation | kg | 6 months |
|
|
|
| Secondary | Changes in Weight From Baseline | Weight measurements were abstracted from EHR. | 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. | Posted | Mean | Standard Deviation | kg | 12 months |
|
|
|
| Secondary | Changes in Weight From Baseline | Weight measurements were abstracted from EHR. | 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. | Posted | Mean | Standard Deviation | kg | 18 months |
|
|
|
| Secondary | Change in Waist Circumference From Baseline | Waist circumference at 18 months - waist circumference at baseline | 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. | Posted | Mean | Standard Deviation | cm | Baseline, 18 months |
|
|
|
| Secondary | Change in Systolic Blood Pressure From Baseline | Systolic blood pressure at 18 months - systolic blood pressure at baseline | 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. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 18 months |
|
|
|
| Secondary | Change in Diastolic Blood Pressure From Baseline | Diastolic blood pressure at 18 months - diastolic blood pressure at baseline | 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. | Posted | Mean | Standard Deviation | mm Hg | 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 | 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. | Posted | Mean | Standard Deviation | MET minutes/week | 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. | 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. | Posted | Mean | Standard Deviation | kcal/kg/day | 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 | 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. | Posted | Mean | Standard Deviation | hours/week | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | servings/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. | 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. | Posted | Mean | Standard Deviation | kilocalories/day | 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. | 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. | Posted | Mean | Standard Deviation | g/day | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 18 months |
|
|
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| 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. | 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. | Posted | Count of Participants | Participants | 18 months |
|
|
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| 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. | 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. | Posted | Count of Participants | Participants | 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). | 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. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Count of Participants | Participants | 18 months |
|
|
|
| 0 |
| 212 |
| 15 |
| 212 |
| 48 |
| 212 |
| EG001 | 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. | 0 | 212 | 14 | 212 | 52 | 212 |
| Gastrointestinal Disorders | Gastrointestinal disorders | Systematic Assessment |
|
| Immune System Disorders | Immune system disorders | Systematic Assessment |
|
| Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Renal and Urinary Disorders | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin and Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | Systematic Assessment |
|
| General disorders | General disorders | Systematic Assessment |
|
| Infections and Infestations | Infections and infestations | Systematic Assessment |
|
| Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nervous System Disorders | Nervous system disorders | Systematic Assessment |
|
| Renal and Urinary Disorder | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory, Thoracic and Mediastinal Disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Skin and Subcutaneous Tissue Disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D006943 | Hyperglycemia |