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

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Lifestyle Intervention; Obesity; Pre Diabetes
• Interventions: Behavioral: Minimal intensity intervention; Behavioral: HOMBRE

• Registration Number: NCT03092960
• Lead Sponsor: Palo Alto Medical Foundation

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.

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-28
• Study Start: 2017-04-03
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Results First Submitted: 2020-12-28
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-19
• Last Update Submitted: 2021-10-19
• Results First Posted: 2021-11-17
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 424

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimal intensity intervention	Minimal intensity intervention	Patients assigned to this group will received the Minimal intensity intervention.
HOMBRE	HOMBRE	Patients assigned to this group will receive the HOMBRE intervention

Primary Outcome Measures

Name	Time	Method
Number and Percentage of Men Achieving 5% Weight Loss or More	Baseline, 18 months	Number and Percentage of men who achieve 5% or more of weight loss compared to their baseline weight

Secondary Outcome Measures

Name	Time	Method
Change in Diastolic Blood Pressure From Baseline	Baseline, 18 months	Diastolic blood pressure at 18 months - diastolic blood pressure at baseline
Trajectory of Weight Change From Baseline Through 18 Months	18 months	Slope of changes in weights abstracted from EHR from baseline through 18 months
Change in Health Behavior: Fruit and Vegetable Intake	Baseline, 18 months	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.
Change in Psychosocial Well-being: Depressive Symptoms	Baseline, 18 months	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.
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	18 months	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.
Change in Waist Circumference From Baseline	Baseline, 18 months	Waist circumference at 18 months - waist circumference at baseline
Change in Health Behavior: Diet Quality	Baseline, 18 months	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.
Change in Psychosocial Well-being: Sleep Disturbance T-score	Baseline, 18 months	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.
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	18 months	Utility-based quality of life was measured by EuroQol EQ-5D. Number and percentage of participants who had no problems with mobility.
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	18 months	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.
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	18 months	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.
Change in Health Behavior: Leisure Time Physical Activity	Baseline, 18 months	Physical activity measured at 18 months minus physical activity measured at baseline using Stanford 7-day physical activity recall
Change in Psychosocial Well-being: Obesity-specific Quality of Life	Baseline, 18 months	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.
Change in Perceived Stress	Baseline, 18 months	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.
Changes in Weight From Baseline	18 months	Weight measurements were abstracted from EHR.
Change in Systolic Blood Pressure From Baseline	Baseline, 18 months	Systolic blood pressure at 18 months - systolic blood pressure at baseline
Change in Health Behavior: Energy Expenditure	Baseline, 18 months	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.
Change in Health Behavior: Sedentary Behavior	Baseline, 18 months	Weekly hours of sedentary behavior measured at 18 months minus weekly hours of sedentary behavior at baseline using the Sedentary behavior Questionnaire
Change in Health Behavior: Total Calorie Intake	Baseline, 18 months	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.
Change in Health Behavior: Total Fat	Baseline, 18 months	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.
Change in Psychosocial Well-being: Sleep Impairment T-score	Baseline, 18 months	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.
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	18 months	Number and percentage of participants who had no problems with usual activities (e.g. work, study, housework, family or leisure activities).

Trial Locations

Locations (1)

Palo Alto Medical Foundation; 🇺🇸 Palo Alto, California, United States