ENLACE: A Promotora-Led Physical Activity Intervention Trial for Latinas in Texas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 712
- 试验地点
- 2
- 主要终点
- Change from baseline Moderate-to-vigorous physical activity (MVPA)
研究概览
简要总结
The purpose of this study it to determine if a promotora-led intervention that takes a comprehensive, multi-level, community-based approach to promoting physical activity (PA) is effective among a particularly underserved segment of Latinas. We hypothesize that Latinas in the promotora-led PA Intervention will significantly increase minutes per week of moderate-to-vigorous physical activity (MVPA) compared to Latinas in the attention-control group.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women ages 18-64 years
- •self-identify as Hispanic
- •have a personal telephone
- •reside within and intend to stay in the specified areas over the entire study period
- •understand Spanish
- •do not currently meet national PA recommendations
排除标准
- •currently pregnant or plan to become pregnant
- •insulin dependent diabetic
- •uncontrolled hypertension
- •undergoing therapy for life-threatening illnesses (chemotherapy or radiation therapy)
- •positive (risk) responses on the PA Readiness Questionnaire (PAR-Q) and subsequent physician disapproval
研究组 & 干预措施
Physical Activity
Weekly promotora-led group sessions on physical activity (16 weeks) and followed by monthly telephone counseling and newsletters during the 24 week maintenance period. Promotoras will also implement environmental change strategies to increase the number of PA program offerings available to study participants.
干预措施: Health education (Behavioral)
Physical Activity
Weekly promotora-led group sessions on physical activity (16 weeks) and followed by monthly telephone counseling and newsletters during the 24 week maintenance period. Promotoras will also implement environmental change strategies to increase the number of PA program offerings available to study participants.
干预措施: Telephone Counseling (Behavioral)
Physical Activity
Weekly promotora-led group sessions on physical activity (16 weeks) and followed by monthly telephone counseling and newsletters during the 24 week maintenance period. Promotoras will also implement environmental change strategies to increase the number of PA program offerings available to study participants.
干预措施: Newsletter (Other)
Physical Activity
Weekly promotora-led group sessions on physical activity (16 weeks) and followed by monthly telephone counseling and newsletters during the 24 week maintenance period. Promotoras will also implement environmental change strategies to increase the number of PA program offerings available to study participants.
干预措施: Environmental Change (Other)
Community Health and Safety
Weekly promotora-led group sessions on home safety/first aid (16 weeks) followed by and monthly generic health education materials and informational telephone calls during the 24 week maintenance period.
干预措施: Health education (Behavioral)
结局指标
主要结局
Change from baseline Moderate-to-vigorous physical activity (MVPA)
时间窗: 16 weeks
Minutes per week of MVPA is assessed a baseline and immediate post-intervention (16 weeks) using accelerometry. The primary outcome is the amount of change between baseline and immediate post-intervention.
次要结局
- Weight maintenance (Percent Body Fat)(40 weeks)
- Change from baseline in Physical Fitness(40 weeks)
- Weight maintenance (Body Mass Index)(40 weeks)
- Change from baseline Moderate-to-vigorous physical activity (MVPA)(40 weeks)
- Weight maintenance (Waist Circumference)(40 weeks)
研究者
Deborah Parra-Medina
Professor
The University of Texas Health Science Center at San Antonio