Preventing Cardiometabolic Disease in HIV-Infected Latino Men Through a Culturally-Tailored Health Promotion Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of Eligible Participants Refusing to Participate.
研究概览
简要总结
The purpose of this study is to examine the feasibility of an intervention to prevent chronic diseases like diabetes, high blood pressure, and obesity in midlife and older Latino adults living with HIV. The investigators expect that the participant will be in this study for seven months. Participants will be interviewed and asked to take part in walking groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •are Latino (self-identified);
- •are age 50+ years;
- •are male;
- •are HIV infected but are virologically suppressed (viral load <200 copies/mL);
- •volunteer informed consent;
- •have medical clearance by a physician;
- •expect to stay in Miami for the next 6 months; and
- •have documented risk of cardiometabolic disease.
排除标准
- •diabetes diagnosis;
- •at baseline meet criteria for current major depressive disorder or generalized anxiety disorder;
- •meet criteria for current alcohol or other substance abuse disorders;
- •have a lifetime history of bipolar disorder or other psychotic disorder;
- •have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam score <24;
- •have contraindications to physical activity outlined in the American College of Sports Medicine standards;
- •have high suicide risk i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire);
- •are unable to complete 10 m walk test;
- •currently residing in a nursing or group home;
- •have a terminal physical illness expected to result in the death within one year;
- •have an acute or severe medical illness that precludes them from safely participating in a health promotion intervention.
研究组 & 干预措施
Happy Older Latinos are Active (HOLA)
A 16-week multi-component, health promotion intervention
干预措施: HOLA Component 1 (Behavioral)
Happy Older Latinos are Active (HOLA)
A 16-week multi-component, health promotion intervention
干预措施: HOLA Component 2 (Behavioral)
Happy Older Latinos are Active (HOLA)
A 16-week multi-component, health promotion intervention
干预措施: HOLA Component 3 (Behavioral)
Happy Older Latinos are Active (HOLA)
A 16-week multi-component, health promotion intervention
干预措施: HOLA Component 4 (Behavioral)
结局指标
主要结局
Number of Eligible Participants Refusing to Participate.
时间窗: Baseline
Number of eligible participants refusing to participate.
Retention Rate
时间窗: Up to 3 months post intervention
Retention rate will be reported as the number of participants completing the post-intervention assessment.
Acceptability of Intervention
时间窗: Up to week 16
As measured by the total number of sessions attended by the participants as a whole.
次要结局
- Change in Cardiometabolic Risk as Measured by Waist Circumference(Baseline, 7 months post intervention)
- Change in Health-related Quality of Life as Measured by the Short Form Health Survey (SF-12)(Baseline, Month 4, Month 7)
- Change in Psychosocial Functioning as Measured by Depression Severity Scale(Baseline, Month 4, Month 7)
- Change in Lipid Profile as Measured by Total Cholesterol, HDL-C, LDL-C, Triglycerides(Baseline, Month 4, Month 7)
- Change in Psychosocial Functioning as Measured by the Patient Health Questionnaire (PHQ-9)(Baseline, Month 4, Month 7)
- Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Generalized Anxiety Disorder Scale(Baseline, Month 4, Month 7)
- Change in Psychosocial Functioning as Measured by the Social Support Received(Baseline, Month 4, Month 7)
- Change in Glucose as Measured by Glycated Hemoglobin (Hba1c)(Baseline, Month 4, Month 7)
- Change in Psychosocial Functioning as Measured by the Severity of Anxiety Using the Perceived Stress Scale(Baseline, Month 4, Month 7)
- Change in Hypertension as Measured by Systolic and Diastolic Blood Pressure.(Baseline, Month 4, Month 7)
研究者
Daniel Enrique Jimenez
Associate Professor
University of Miami