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ObesityHOMBRENCT03092960

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

A study testing Minimal intensity intervention and HOMBRE in people with Obesity and Metabolic Syndrome, run by Palo Alto Medical Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Minimal intensity intervention and HOMBRE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
1 siteUnited States
Study dates
3 Apr 2017to 31 May 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Palo Alto Medical Foundation

    Palo Alto, California, 94301

Other trials in United States

About this study

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).

Read the 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.

Being tested
Minimal intensity intervention, HOMBRE
Keywords
Latino, Male
Medical subject headings
Obesity, Metabolic Syndrome, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minimal intensity interventionBehavioural

    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.

  • HOMBREBehavioural

    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.

Study groups in NCT03092960
Study groupRoleWhat they receive
Minimal intensity interventionActive comparatorPatients assigned to this group will received the Minimal intensity intervention.
Receives: Behavioral: Minimal intensity intervention
HOMBREExperimentalPatients assigned to this group will receive the HOMBRE intervention
Receives: Behavioral: HOMBRE

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, 18 months

Secondary outcomes (24)
  1. Trajectory of Weight Change From Baseline Through 18 Months

    Slope of changes in weights abstracted from EHR from baseline through 18 months

    Measured: 18 months

  2. Changes in Weight From Baseline

    Weight measurements were abstracted from EHR.

    Measured: 6 months

  3. Changes in Weight From Baseline

    Weight measurements were abstracted from EHR.

    Measured: 12 months

  4. Changes in Weight From Baseline

    Weight measurements were abstracted from EHR.

    Measured: 18 months

  5. Change in Waist Circumference From Baseline

    Waist circumference at 18 months - waist circumference at baseline

    Measured: Baseline, 18 months

  6. Change in Systolic Blood Pressure From Baseline

    Systolic blood pressure at 18 months - systolic blood pressure at baseline

    Measured: Baseline, 18 months

  7. Change in Diastolic Blood Pressure From Baseline

    Diastolic blood pressure at 18 months - diastolic blood pressure at baseline

    Measured: Baseline, 18 months

  8. Change in Health Behavior: Leisure Time Physical Activity

    Physical activity measured at 18 months minus physical activity measured at baseline using Stanford 7-day physical activity recall

    Measured: Baseline, 18 months

  9. Change in Health Behavior: Energy Expenditure

    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.

    Measured: Baseline, 18 months

  10. Change in Health Behavior: Sedentary Behavior

    Weekly hours of sedentary behavior measured at 18 months minus weekly hours of sedentary behavior at baseline using the Sedentary behavior Questionnaire

    Measured: Baseline, 18 months

  11. Change in Health Behavior: Diet Quality

    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.

    Measured: Baseline, 18 months

  12. Change in Health Behavior: Fruit and Vegetable Intake

    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.

    Measured: Baseline, 18 months

  13. Change in Health Behavior: Total Calorie Intake

    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.

    Measured: Baseline, 18 months

  14. Change in Health Behavior: Total Fat

    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.

    Measured: Baseline, 18 months

  15. Change in Psychosocial Well-being: Obesity-specific Quality of Life

    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.

    Measured: Baseline, 18 months

  16. Change in Psychosocial Well-being: Depressive Symptoms

    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.

    Measured: Baseline, 18 months

  17. Change in Perceived Stress

    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.

    Measured: Baseline, 18 months

  18. Change in Psychosocial Well-being: Sleep Disturbance T-score

    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.

    Measured: Baseline, 18 months

  19. Change in Psychosocial Well-being: Sleep Impairment T-score

    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.

    Measured: Baseline, 18 months

  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

    Utility-based quality of life was measured by EuroQol EQ-5D. Number and percentage of participants who had no problems with mobility.

    Measured: 18 months

  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

    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.

    Measured: 18 months

  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

    Number and percentage of participants who had no problems with usual activities (e.g. work, study, housework, family or leisure activities).

    Measured: 18 months

  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

    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.

    Measured: 18 months

  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

    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.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2017
  2. Study start3 Apr 2017
  3. Primary completion31 May 2020
  4. Study completion31 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03092960
Sponsor's protocol ID
981746
Acronym
HOMBRE
Status last verified
Oct 2021
First submitted
15 Mar 2017
Last updated
17 Nov 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35654660
  • 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.

    PubMed 35119377

Questions about this trial

What is this clinical trial studying?

A study testing Minimal intensity intervention and HOMBRE in people with Obesity and Metabolic Syndrome, run by Palo Alto Medical Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Percentage of Men Achieving 5% Weight Loss or More (time frame: Baseline, 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03092960, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.

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