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

NCT03092960 | Completed Results DMC

• 1 other identifier: 981746
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Metabolic Syndrome; Lifestyle Intervention; Pre Diabetes

Keywords

Latino; Male

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 18 months

Secondary Outcomes (24)

• Trajectory of Weight Change From Baseline Through 18 Months

  18 months

• Changes in Weight From Baseline

  6 months

• Changes in Weight From Baseline

  12 months

• Changes in Weight From Baseline

  18 months

• Change in Waist Circumference From Baseline

  Baseline, 18 months

Study Arms (2)

Minimal intensity intervention

ACTIVE COMPARATOR

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

Behavioral: Minimal intensity intervention

HOMBRE

EXPERIMENTAL

Patients assigned to this group will receive the HOMBRE intervention

Behavioral: HOMBRE

Interventions

Minimal intensity intervention BEHAVIORAL

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.

Minimal intensity intervention

HOMBRE BEHAVIORAL

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.

HOMBRE

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identifies as male.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Palo Alto Medical Foundation: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Illinois at Chicago: collaborator
• RTI International: collaborator
• University of Pittsburgh: collaborator
• Arizona State University: collaborator
• Stanford University: collaborator

Study Sites (1)

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

Related Publications (2)

• 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.

  PMID: 35654660 DERIVED

• 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.

  PMID: 35119377 DERIVED

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Glucose Intolerance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia

Results Point of Contact

• Title: Lisa Goldman Rosas
• Organization: Stanford University

lgrosas@stanford.edu

(650) 721-8415

Study Officials

• Lisa Goldman Rosas, PhD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

• Kristen M Azar, RN, MSN, MPH

  Sutter Health Research Development & Dissemination

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 28, 2017
• Study Start: April 3, 2017
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: November 17, 2021
• Results First Posted: November 17, 2021

Record last verified: 2021-10

Locations

US (1)