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

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.

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