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

• ClinicalTrials.gov Identifier: NCT03092960
• Recruitment Status: Completed
• First Posted: March 28, 2017
• Results First Posted: November 17, 2021
• Last Update Posted: November 17, 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
• Information provided by (Responsible Party): Palo Alto Medical Foundation

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).

Condition or disease	Intervention/treatment	Phase
Obesity; Metabolic Syndrome; Lifestyle Intervention; Pre Diabetes	Behavioral: Minimal intensity intervention; Behavioral: HOMBRE	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 424 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
• Actual Study Start Date: April 3, 2017
• Actual Primary Completion Date: May 31, 2020
• Actual Study Completion Date: May 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Minimal intensity intervention; Patients assigned to this group will received the Minimal intensity intervention.	Behavioral: 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.
Experimental: HOMBRE; Patients assigned to this group will receive the HOMBRE intervention	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Number and Percentage of Men Achieving 5% Weight Loss or More [ Time Frame: Baseline, 18 months ]
   Number and Percentage of men who achieve 5% or more of weight loss compared to their baseline weight

Secondary Outcome Measures :

1. Trajectory of Weight Change From Baseline Through 18 Months [ Time Frame: 18 months ]
   Slope of changes in weights abstracted from EHR from baseline through 18 months
2. Changes in Weight From Baseline [ Time Frame: 6 months ]
   Weight measurements were abstracted from EHR.
3. Changes in Weight From Baseline [ Time Frame: 12 months ]
   Weight measurements were abstracted from EHR.
4. Changes in Weight From Baseline [ Time Frame: 18 months ]
   Weight measurements were abstracted from EHR.
5. Change in Waist Circumference From Baseline [ Time Frame: Baseline, 18 months ]
   Waist circumference at 18 months - waist circumference at baseline
6. Change in Systolic Blood Pressure From Baseline [ Time Frame: Baseline, 18 months ]
   Systolic blood pressure at 18 months - systolic blood pressure at baseline
7. Change in Diastolic Blood Pressure From Baseline [ Time Frame: Baseline, 18 months ]
   Diastolic blood pressure at 18 months - diastolic blood pressure at baseline
8. Change in Health Behavior: Leisure Time Physical Activity [ Time Frame: Baseline, 18 months ]
   Physical activity measured at 18 months minus physical activity measured at baseline using Stanford 7-day physical activity recall
9. Change in Health Behavior: Energy Expenditure [ Time Frame: Baseline, 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.
10. Change in Health Behavior: Sedentary Behavior [ Time Frame: Baseline, 18 months ]
    Weekly hours of sedentary behavior measured at 18 months minus weekly hours of sedentary behavior at baseline using the Sedentary behavior Questionnaire
11. Change in Health Behavior: Diet Quality [ Time Frame: Baseline, 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.
12. Change in Health Behavior: Fruit and Vegetable Intake [ Time Frame: Baseline, 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.
13. Change in Health Behavior: Total Calorie Intake [ Time Frame: Baseline, 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.
14. Change in Health Behavior: Total Fat [ Time Frame: Baseline, 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.
15. Change in Psychosocial Well-being: Obesity-specific Quality of Life [ Time Frame: Baseline, 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.
16. Change in Psychosocial Well-being: Depressive Symptoms [ Time Frame: Baseline, 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.
17. Change in Perceived Stress [ Time Frame: Baseline, 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.
18. Change in Psychosocial Well-being: Sleep Disturbance T-score [ Time Frame: Baseline, 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.
19. Change in Psychosocial Well-being: Sleep Impairment T-score [ Time Frame: Baseline, 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.
20. 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 [ Time Frame: 18 months ]
    Utility-based quality of life was measured by EuroQol EQ-5D. Number and percentage of participants who had no problems with mobility.
21. 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 [ Time Frame: 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.
22. 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 [ Time Frame: 18 months ]
    Number and percentage of participants who had no problems with usual activities (e.g. work, study, housework, family or leisure activities).
23. 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 [ Time Frame: 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.
24. 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 [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Self-identifies as male.
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Palo Alto Medical Foundation

Palo Alto, California, United States, 94301

Sponsors and Collaborators

Palo Alto Medical Foundation

Patient-Centered Outcomes Research Institute

University of Illinois at Chicago

RTI International

University of Pittsburgh

Arizona State University

Stanford University

Investigators

• Principal Investigator: Lisa Goldman Rosas, PhD, MPH; Stanford University
• Principal Investigator: Kristen M Azar, RN, MSN, MPH; Sutter Health Research Development & Dissemination

  Study Documents (Full-Text)

Documents provided by Palo Alto Medical Foundation:

Study Protocol and Statistical Analysis Plan  [PDF] February 23, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Palo Alto Medical Foundation
• ClinicalTrials.gov Identifier: NCT03092960
• Other Study ID Numbers: 981746
• First Posted: March 28, 2017
• Results First Posted: November 17, 2021
• Last Update Posted: November 17, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Palo Alto Medical Foundation:

Latino; Male

Additional relevant MeSH terms:

Metabolic Syndrome; Prediabetic State; Chronic Disease; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Pathologic Processes; Diabetes Mellitus; Endocrine System Diseases