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

Primary Purpose

Obesity, Metabolic Syndrome, Lifestyle Intervention

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Minimal intensity intervention
HOMBRE
Sponsored by
Palo Alto Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring Latino, Male

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Latino of any race
  • BMI >27 kg/m2
  • One or more metabolic syndrome component (high triglycerides, blood pressure, fasting glucose, central obesity, or low HDL cholesterol)
  • Primary Care Physician approval of patient study contact
  • Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of tow study arms, participate in follow-up for 18 months, and authorize the extraction of relevant information form the Electronic Health Record.

Exclusion Criteria:

Medical exclusions:

  • Previous diagnosis of diabetes or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening;
  • Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years;
  • Inability to walk without the assistance of another person;
  • Severe medical co-morbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure;
  • Diagnosis of a terminal illness and/or in hospice care;
  • Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication
  • Initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (The patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.)
  • Have had or plan to undergo bariatric surgery during the study period

Other exclusions:

  • Having no reliable telephone service
  • Plan to move out of the area during the study period
  • Family/household member of another study participant or of a study staff member
  • Investigator discretion for clinical safety or protocol adherence reasons

Sites / Locations

  • Palo Alto Medical Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Minimal intensity intervention

HOMBRE

Arm Description

Patients assigned to this group will received the Minimal intensity intervention.

Patients assigned to this group will receive the HOMBRE intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Trajectory of Weight Change From Baseline Through 18 Months
Slope of changes in weights abstracted from EHR from baseline through 18 months
Changes in Weight From Baseline
Weight measurements were abstracted from EHR.
Changes in Weight From Baseline
Weight measurements were abstracted from EHR.
Changes in Weight From Baseline
Weight measurements were abstracted from EHR.
Change in Waist Circumference From Baseline
Waist circumference at 18 months - waist circumference at baseline
Change in Systolic Blood Pressure From Baseline
Systolic blood pressure at 18 months - systolic blood pressure at baseline
Change in Diastolic Blood Pressure From Baseline
Diastolic blood pressure at 18 months - diastolic blood pressure at baseline
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
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.

Full Information

First Posted
March 15, 2017
Last Updated
October 19, 2021
Sponsor
Palo Alto Medical Foundation
Collaborators
Patient-Centered Outcomes Research Institute, University of Illinois at Chicago, RTI International, University of Pittsburgh, Arizona State University, Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03092960
Brief Title
The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
Acronym
HOMBRE
Official Title
The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palo Alto Medical Foundation
Collaborators
Patient-Centered Outcomes Research Institute, University of Illinois at Chicago, RTI International, University of Pittsburgh, Arizona State University, Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic Syndrome, Lifestyle Intervention, Pre Diabetes
Keywords
Latino, Male

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
424 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimal intensity intervention
Arm Type
Active Comparator
Arm Description
Patients assigned to this group will received the Minimal intensity intervention.
Arm Title
HOMBRE
Arm Type
Experimental
Arm Description
Patients assigned to this group will receive the HOMBRE intervention
Intervention Type
Behavioral
Intervention Name(s)
Minimal intensity intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HOMBRE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number and Percentage of Men Achieving 5% Weight Loss or More
Description
Number and Percentage of men who achieve 5% or more of weight loss compared to their baseline weight
Time Frame
Baseline, 18 months
Secondary Outcome Measure Information:
Title
Trajectory of Weight Change From Baseline Through 18 Months
Description
Slope of changes in weights abstracted from EHR from baseline through 18 months
Time Frame
18 months
Title
Changes in Weight From Baseline
Description
Weight measurements were abstracted from EHR.
Time Frame
6 months
Title
Changes in Weight From Baseline
Description
Weight measurements were abstracted from EHR.
Time Frame
12 months
Title
Changes in Weight From Baseline
Description
Weight measurements were abstracted from EHR.
Time Frame
18 months
Title
Change in Waist Circumference From Baseline
Description
Waist circumference at 18 months - waist circumference at baseline
Time Frame
Baseline, 18 months
Title
Change in Systolic Blood Pressure From Baseline
Description
Systolic blood pressure at 18 months - systolic blood pressure at baseline
Time Frame
Baseline, 18 months
Title
Change in Diastolic Blood Pressure From Baseline
Description
Diastolic blood pressure at 18 months - diastolic blood pressure at baseline
Time Frame
Baseline, 18 months
Title
Change in Health Behavior: Leisure Time Physical Activity
Description
Physical activity measured at 18 months minus physical activity measured at baseline using Stanford 7-day physical activity recall
Time Frame
Baseline, 18 months
Title
Change in Health Behavior: Energy Expenditure
Description
The Stanford 7-day Physical Activity Recall data also provided estimates of total daily energy expenditures. Total energy expenditure = sleep hours × 1 MET + light activity hours × 1.5 METs + moderate activity hours × 4 METs + hard activity hours × 6 METs + very hard activity hours × 10 METs. Total daily energy expenditure at 18 months - Total daily energy expenditure at baseline.
Time Frame
Baseline, 18 months
Title
Change in Health Behavior: Sedentary Behavior
Description
Weekly hours of sedentary behavior measured at 18 months minus weekly hours of sedentary behavior at baseline using the Sedentary behavior Questionnaire
Time Frame
Baseline, 18 months
Title
Change in Health Behavior: Diet Quality
Description
Dietary intake was measured using the gold-standard approach of multiple pass 24-hour recalls in Spanish or English using Nutrition Data System for Research (NDSR). Diet quality was assessed by the Dietary Approaches to Stop Hypertension (DASH) score. DASH scores were calculated based on combining nine nutrient targets (i.e. total fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium and potassium). A higher score reflects higher diet quality. The minimum score is 8 and the maximum is 40. DASH score at 18 months - DASH score at baseline.
Time Frame
Baseline, 18 months
Title
Change in Health Behavior: Fruit and Vegetable Intake
Description
Fruit and vegetable intake measured at 18 months minus fruit and vegetable intake measured at baseline using 24-hour multiple pass recalls. Fruit and vegetable intake is measured in servings per day.
Time Frame
Baseline, 18 months
Title
Change in Health Behavior: Total Calorie Intake
Description
Total calorie intake per day measured at 18 months minus total calorie intake per day measured at baseline using 24-hour multiple pass dietary recalls.
Time Frame
Baseline, 18 months
Title
Change in Health Behavior: Total Fat
Description
Total fat consumption per day measured at 18 months minus total fat consumption per day measured at baseline using 24-hour multiple pass dietary recalls.
Time Frame
Baseline, 18 months
Title
Change in Psychosocial Well-being: Obesity-specific Quality of Life
Description
Obesity-related Problem Scale, average scores of 8 questions with a range from 0 (no at all) to 3 (extremely). The average score is then multiplied by 100 and divided by 3 to convert to a scale of 0-100, with a higher score indicating more obesity-related problems. Obesity-related quality of life measured at 18 months - obesity-related quality of life measured at baseline.
Time Frame
Baseline, 18 months
Title
Change in Psychosocial Well-being: Depressive Symptoms
Description
The Patient Health Questionnaire PHQ-9 is a self-report questionnaire with 9 items. Respondents answered questions regarding how often a symptom has bothered them over the last two weeks. Each item is rated on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). PHQ-9 total score is the sum of the nine items, ranging from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. PHQ-9 score at 18 months - PHQ-9 score at baseline.
Time Frame
Baseline, 18 months
Title
Change in Perceived Stress
Description
Perceived stress scale with a range of 0 to 40 with higher scores indicating higher stress. Perceived stress at 18 months - Perceived stress at baseline.
Time Frame
Baseline, 18 months
Title
Change in Psychosocial Well-being: Sleep Disturbance T-score
Description
Sleep disturbance T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. Sleep disturbance score at 18 months - sleep disturbance score at baseline.
Time Frame
Baseline, 18 months
Title
Change in Psychosocial Well-being: Sleep Impairment T-score
Description
Sleep Impairment T-score, a population scale with a range from 25 (extreme disturbance or impairment) to 80 (not at all) converted from the raw total score of 8-item questionnaire. A score of 50 represents the average of the calibration sample, which was generally more enriched for chronic illness. Sleep impairment score at 18 months - sleep impairment at baseline.
Time Frame
Baseline, 18 months
Title
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
Description
Utility-based quality of life was measured by EuroQol EQ-5D. Number and percentage of participants who had no problems with mobility.
Time Frame
18 months
Title
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
Description
Number and percentage of participants who had no problems with self care was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100.
Time Frame
18 months
Title
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
Description
Number and percentage of participants who had no problems with usual activities (e.g. work, study, housework, family or leisure activities).
Time Frame
18 months
Title
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
Description
Number and percentage of participants who had no problems with pain was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100.
Time Frame
18 months
Title
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
Description
Number and percentage of participants who had no problems with anxiety and depression was measured using the Euro-QoL 5D (EQ-5D-5L), which includes 5 domains (mobility, self-care, usual activities, pain and discomfort, and depression and anxiety) scored on 5 levels (no, slight, moderate, severe, or extreme problems) and current health rated on a visual analogue scale from 0 to 100.
Time Frame
18 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-identifies as male.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Latino of any race BMI >27 kg/m2 One or more metabolic syndrome component (high triglycerides, blood pressure, fasting glucose, central obesity, or low HDL cholesterol) Primary Care Physician approval of patient study contact Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of tow study arms, participate in follow-up for 18 months, and authorize the extraction of relevant information form the Electronic Health Record. Exclusion Criteria: Medical exclusions: Previous diagnosis of diabetes or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening; Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years; Inability to walk without the assistance of another person; Severe medical co-morbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure; Diagnosis of a terminal illness and/or in hospice care; Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication Initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (The patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.) Have had or plan to undergo bariatric surgery during the study period Other exclusions: Having no reliable telephone service Plan to move out of the area during the study period Family/household member of another study participant or of a study staff member Investigator discretion for clinical safety or protocol adherence reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Goldman Rosas, PhD, MPH
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristen M Azar, RN, MSN, MPH
Organizational Affiliation
Sutter Health Research Development & Dissemination
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto Medical Foundation
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35654660
Citation
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.
Results Reference
derived
PubMed Identifier
35119377
Citation
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.
Results Reference
derived

Learn more about this trial

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

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