Healthy Immigrant Community: Mobilizing the Power of Social Networks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 475
- 试验地点
- 1
- 主要终点
- Change in Weight
研究概览
简要总结
The objective of this study is to leverage existing social networks for health behavior change relevant to obesity and cardiovascular risk among immigrant populations in Southeast, Minnesota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identification as Hispanic or Somali.
- •Member of a social network identified in the social network analysis.
- •Willingness to participate in all aspects of the study.
- •Provision of informed consent.
排除标准
- •Pregnancy at the time of enrollment.
- •Serious medical conditions or disabilities that would make physical activity difficult.
- •To avoid stigmatization, a normal weight (BMI<25) will not exclude individuals from participating in the intervention, but they will be excluded from the measurements and analyses.
研究组 & 干预措施
Immediate Community-Based Mentoring and Education Sessions
Subjects will receive the intervention of community-based mentoring and education sessions immediately after enrollment.
干预措施: Community-based mentoring and education sessions (Behavioral)
Delayed Community-Based Mentoring and Education Sessions
Subjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment.
干预措施: Community-based mentoring and education sessions (Behavioral)
结局指标
主要结局
Change in Weight
时间窗: Baseline, 6 months, 12 months
Difference in weight (measured in kilograms) from baseline to 6 months and from baseline to 12 months
Change in Waist Circumference From Baseline to 6 Months and From Baseline to 12 Months
时间窗: Baseline, 6 months, 12 months
Measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest.
Change in "Life's Simple 6" Composite Score From Baseline to 6 Months and From Baseline to 12 Months
时间窗: Baseline, 6 months, 12 months
Adapted from the American Heart Association standards based on health assessment data. Point values are assigned to each component: 2 points for ideal, 1 point for intermediate, 0 points for poor. The total sum allows for a continuous measure of cardiovascular health ranging from poor to ideal (0-12 points).
Lost >5% of Body Weight
时间窗: 6 months, 12 months
Number of participants in each arm who lost a clinically significant amount of weight (\>5%).
次要结局
- Change in Systolic Blood Pressure(Baseline, 6 months, 12 months)
- Change in Fasting Glucose Level(Baseline, 6 months, 12 months)
- Change in Low-density Lipoprotein (LDL)(Baseline, 6 months, 12 months)
- Change in Dietary Quality(Baseline, 6 months, 12 months)
- Change in Physical Activity(Baseline, 6 months, 12 months)
- Change in Diastolic Blood Pressure(Baseline, 6 months, 12 months)
研究者
Mark L Wieland
Principal Investigator
Mayo Clinic