NCT03092960已完成不适用
The HOMBRE Trial: Comparing Two Innovative Approaches to Reduce Chronic Disease Risk Among Latino Men
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 2
- 主要终点
- Number and Percentage of Men Achieving 5% Weight Loss or More
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Number and Percentage of Men Achieving 5% Weight Loss or More
时间窗: Baseline, 18 months
Number and Percentage of men who achieve 5% or more of weight loss compared to their baseline weight
次要结局
- Change in Diastolic Blood Pressure From Baseline(Baseline, 18 months)
- Trajectory of Weight Change From Baseline Through 18 Months(18 months)
- Change in Health Behavior: Fruit and Vegetable Intake(Baseline, 18 months)
- Change in Psychosocial Well-being: Depressive Symptoms(Baseline, 18 months)
- 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)
- Change in Waist Circumference From Baseline(Baseline, 18 months)
- Change in Health Behavior: Diet Quality(Baseline, 18 months)
- Change in Psychosocial Well-being: Sleep Disturbance T-score(Baseline, 18 months)
- 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)
- 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)
- 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)
- Change in Health Behavior: Leisure Time Physical Activity(Baseline, 18 months)
- Change in Psychosocial Well-being: Obesity-specific Quality of Life(Baseline, 18 months)
- Change in Perceived Stress(Baseline, 18 months)
- Changes in Weight From Baseline(18 months)
- Change in Systolic Blood Pressure From Baseline(Baseline, 18 months)
- Change in Health Behavior: Energy Expenditure(Baseline, 18 months)
- Change in Health Behavior: Sedentary Behavior(Baseline, 18 months)
- Change in Health Behavior: Total Calorie Intake(Baseline, 18 months)
- Change in Health Behavior: Total Fat(Baseline, 18 months)
- Change in Psychosocial Well-being: Sleep Impairment T-score(Baseline, 18 months)
- 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)
研究者
研究点 (2)
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