Clinical trial NCT03092960: The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
Official title: The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Lifestyle Intervention
Pre Diabetes
Keywords: Latino
Male
Lead sponsor: Palo Alto Medical Foundation
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Illinois at Chicago
name: RTI International
name: University of Pittsburgh
name: Arizona State University
name: Stanford University
First posted: 2017-03-28
Enrollment: 424
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number and Percentage of Men Achieving 5% Weight Loss or More
timeFrame: Baseline, 18 months
Secondary outcomes:
measure: Trajectory of Weight Change From Baseline Through 18 Months
timeFrame: 18 months
measure: Changes in Weight From Baseline
timeFrame: 6 months
measure: Changes in Weight From Baseline
timeFrame: 12 months
measure: Changes in Weight From Baseline
timeFrame: 18 months
measure: Change in Waist Circumference From Baseline
timeFrame: Baseline, 18 months
measure: Change in Systolic Blood Pressure From Baseline
timeFrame: Baseline, 18 months
measure: Change in Diastolic Blood Pressure From Baseline
timeFrame: Baseline, 18 months
measure: Change in Health Behavior: Leisure Time Physical Activity
timeFrame: Baseline, 18 months
measure: Change in Health Behavior: Energy Expenditure
timeFrame: Baseline, 18 months
measure: Change in Health Behavior: Sedentary Behavior
timeFrame: Baseline, 18 months
measure: Change in Health Behavior: Diet Quality
timeFrame: Baseline, 18 months
measure: Change in Health Behavior: Fruit and Vegetable Intake
timeFrame: Baseline, 18 months
measure: Change in Health Behavior: Total Calorie Intake
timeFrame: Baseline, 18 months
measure: Change in Health Behavior: Total Fat
timeFrame: Baseline, 18 months
measure: Change in Psychosocial Well-being: Obesity-specific Quality of Life
timeFrame: Baseline, 18 months
measure: Change in Psychosocial Well-being: Depressive Symptoms
timeFrame: Baseline, 18 months
measure: Change in Perceived Stress
timeFrame: Baseline, 18 months
measure: Change in Psychosocial Well-being: Sleep Disturbance T-score
timeFrame: Baseline, 18 months
measure: Change in Psychosocial Well-being: Sleep Impairment T-score
timeFrame: Baseline, 18 months
measure: 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
timeFrame: 18 months
measure: 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
timeFrame: 18 months
measure: 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
timeFrame: 18 months
measure: 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
timeFrame: 18 months
measure: 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
timeFrame: 18 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation
state: California
Study officials:
affiliation: Stanford University
name: Lisa Goldman Rosas, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Sutter Health Research Development & Dissemination
name: Kristen M Azar, RN, MSN, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.