A Physical Activity Intervention to Promote Cognitive Health, Cardiovascular Health and Sleep in Older Latinos
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Change from Baseline Physical Activity Frequency at 12 months
研究概览
简要总结
This study is a randomized, single-blind, controlled trial that will test a multilevel intervention, Tiempo Juntos para la Salud, (Time Together for Health) designed to promote moderate-intensity physical activity; theoretically grounded mediators; and secondary outcomes of cardiovascular health, sleep and cognitive function. Participants will have 4 visits over a year long period. Data collection will occur at baseline, 3 months, 6 months, and 12 months among 216 Spanish language-dominant Latinos aged 55 and older with Mild Cognitive Impairment (MCI) [Montreal Cognitive Assessment (MoCA) score 23 to 26 for Latino populations].
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Can provide informed consent
- •55+ years
- •Self-identify as Hispanic/Latino
- •Spanish as primary language
- •Willing to attend intervention / education sessions
- •Access to phone/cell
- •less than 150 min of activity / week (sedentary)
- •Montreal Cognitive Assessment (MoCA) score (score ≥ 23 to 26 for Latino populations)
排除标准
- •Cannot provide informed consent
- •Mobility disability
- •Musculoskeletal problem / co-morbidity (prevents moderate PA)
研究组 & 干预措施
Tiempo Juntos Intervention
If assigned to this group, participants will take part in weekly 1-hour group sessions twice a week for 3 months. The sessions will be with a trained Community Health Worker that will involve group (5-6 participants) moderate-intensity walking. They will take place at community partner sites during times when all participants can attend. In case of adverse weather, indoor locations are available through community partners. Walks will reflect participant goals and abilities, initially lasting 10 minutes, with 5-minute stretching "warm-up" and 5-minute "cool down" exercises, for a total of 20 minutes. Walk duration will increase by 5 minutes/week to at least 30 minutes with program content delivery time decreasing to accommodate increased walk times within the 1-hour session. Upon completing the 3 months of physical activity sessions, for the next 3 months, they will receive motivational "booster" sessions delivered every other week via phone calls/text messaging.
干预措施: Tiempo Juntos Intervention (Behavioral)
Attention Control
If assigned to this group, participants will take part in 1-hour group (5-6 participants) sessions delivered twice a week for 3 months. The sessions will be with a trained Community Health Worker or qualified staff that will involve reviewing education topics in Spanish related to adult health. They will take place at community partner sites or remotely during times when all participants can attend. In case of adverse weather, indoor locations, or remote options will be available. Upon completing the 3 months of education sessions, for the next 3 months, they will receive educational "booster" sessions delivered every other week via phone calls/text messaging.
结局指标
主要结局
Change from Baseline Physical Activity Frequency at 12 months
时间窗: 48 weeks
Number of activity sessions
Change from Baseline Physical Activity Intensity at 6 months
时间窗: 24 weeks
Light, moderate, or vigorous (determined by counts per minute)
Change from Baseline Physical Activity Duration at 3 months
时间窗: 12 weeks
Total time spent in activity (hours and minutes)
Change from Baseline Physical Activity Frequency at 3 months
时间窗: 12 weeks
Number of activity sessions
Change from Baseline Physical Activity Duration at 6 months
时间窗: 24 weeks
Total time spent in activity (hours and minutes)
Change from Baseline Physical Activity Frequency at 6 months
时间窗: 24 weeks
Number of activity sessions
Change from Baseline Physical Activity Intensity at 3 months
时间窗: 12 weeks
Light, moderate, or vigorous (determined by counts per minute)
Change from Baseline Physical Activity Intensity at 12 months
时间窗: 48 weeks
Light, moderate, or vigorous (determined by counts per minute)
Change from Baseline Physical Activity Duration at 12 months
时间窗: 48 weeks
Total time spent in activity (hours and minutes)
次要结局
未报告次要终点
研究者
Gloria Adriana Perez
Principal Investigator
University of Pennsylvania