An Interpersonal Relationships Intervention for Improving Cardiovascular Health in Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 2
- 主要终点
- Metabolic symptoms
研究概览
简要总结
The purpose of this study is to determine whether random assignment to a mentor-mentee relationship is associated with beneficial cardiovascular health effects in both mentors and mentees.
详细描述
Participants will be undergraduate students randomly assigned to either being in the mentor or comparison group. A second set of participants will be randomly assigned to either being in the mentee or comparison group. These participants will come from Chicago Public School elementary schools. In total, there will be 125 mentors, 125 comparators, 125 mentees, and 125 comparators. Participants will come for a laboratory visit in which cardiovascular health measures will be taken (details below). Visits will occur once at baseline (before the intervention starts), and once post-intervention. There will be a mid-point assessment of questionnaires. Participants in the intervention group will engage in one-on-one mentoring sessions (mentors together with mentees) once a week after school for the school year. Participants in the comparator group will receive written versions of all materials covered in the mentoring sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •undergraduate students for mentors
- •Chicago Public School students for mentees
排除标准
- 未提供
研究组 & 干预措施
Intervention (Mentor/Mentee)
Youth in the intervention group will participate in one-on-one mentoring sessions (between mentors and mentees) once per week after school. Mentoring sessions will focus on social relationships, coping behaviors, and healthy lifestyles.
干预措施: Mentoring (Behavioral)
Comparison group - written materials
Youth in the comparator group will receive written versions of all materials covered in the mentoring sessions.
干预措施: Comparison group - written materials (Behavioral)
结局指标
主要结局
Metabolic symptoms
时间窗: Change in metabolic symptoms from baseline to approximately 1 year later
Metabolic symptoms per International Diabetes Federation guidelines
HOMA-IR
时间窗: Change in HOMA-IR score from baseline to approximately 1 year later
Homeostatic Model Assessment of Insulin Resistance
Flow-mediated vasodilation
时间窗: Change in flow-mediated vasodilation from baseline to approximately 1 year later
Brachial artery diameter change
次要结局
- Glucocorticoid sensitivity(Change from baseline to approximately 1 year later)
- Stimulated cytokine production(Change from baseline to approximately 1 year later)
- Pro-inflammatory cytokines(Change from baseline to approximately 1 year later)
研究者
Edith Chen
Professor
Northwestern University