N/A
N=424
The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
Obesity · Metabolic Syndrome · Lifestyle Intervention · Pre Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03092960 ↗Enrolled (actual)
424
Serious AEs
6.8%
Results posted
Nov 2021
Primary outcome: Primary: Number and Percentage of Men Achieving 5% Weight Loss or More — 37; 51 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Minimal intensity intervention (Behavioral); HOMBRE (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Palo Alto Medical Foundation
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Percentage of Men Achieving 5% Weight Loss or More |
37; 51 | — |
| SECONDARY Trajectory of Weight Change From Baseline Through 18 Months |
-0.11; -0.13 | — |
| SECONDARY Changes in Weight From Baseline |
-1.67; -2.46 | — |
| SECONDARY Changes in Weight From Baseline |
-1.67; -2.46 | — |
| SECONDARY Changes in Weight From Baseline |
-1.67; -2.46 | — |
| SECONDARY Change in Waist Circumference From Baseline |
-0.0; -0.8 | — |
| SECONDARY Change in Systolic Blood Pressure From Baseline |
0.4; 0.8 | — |
| SECONDARY Change in Diastolic Blood Pressure From Baseline |
-2.7; -2.3 | — |
| SECONDARY Change in Health Behavior: Leisure Time Physical Activity |
-113; -369 | — |
| SECONDARY Change in Health Behavior: Energy Expenditure |
-1.1; -2.1 | — |
| SECONDARY Change in Health Behavior: Sedentary Behavior |
-1.5; -2.4 | — |
| SECONDARY Change in Health Behavior: Diet Quality |
0.2; 0.3 | — |
| SECONDARY Change in Health Behavior: Fruit and Vegetable Intake |
0.3; -0.4 | — |
| SECONDARY Change in Health Behavior: Total Calorie Intake |
4.0; 4.1 | — |
| SECONDARY Change in Health Behavior: Total Fat |
-23.2; -14.8 | — |
| SECONDARY Change in Psychosocial Well-being: Obesity-specific Quality of Life |
-6.3; -7.4 | — |
| SECONDARY Change in Psychosocial Well-being: Depressive Symptoms |
-0.8; -0.6 | — |
| SECONDARY Change in Perceived Stress |
0.0; -1.1 | — |
| SECONDARY Change in Psychosocial Well-being: Sleep Disturbance T-score |
-0.7; -0.2 | — |
| SECONDARY Change in Psychosocial Well-being: Sleep Impairment T-score |
-0.1; -2.9 | — |
| 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 |
91; 96 | — |
| 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 |
101; 106 | — |
| 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 |
96; 97 | — |
| 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 |
55; 66 | — |
| 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 |
72; 85 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT03092960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.