Mi Vida Saludable: Maintaining Diet and Physical Activity Changes Among Latina Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Change in daily servings of fruit/vegetables
研究概览
简要总结
The investigators will conduct a 2x2 factorial randomized controlled trial to test the separate and synergistic effects of an in-person hands-on dietary and physical activity change curriculum (i.e., Mi Vida Saludable program) and e-communication strategies (text messaging, emailed newsletters and an interactive website) on changing dietary and physical activity behaviors among a diverse population of Latina breast cancer survivors who have completed breast cancer treatment. Participants will be evenly randomized to 4 arms: in-person education alone, e-communication alone, in-person education plus e-communication, or control.
详细描述
There are clear diet and physical activity guidelines for cancer survivors: eat a diet high in fruits/vegetables and low in energy-dense foods and engage in 150 minutes of moderate-to-vigorous physical activity each week. However, cancer survivors are provided with few, if any, resources to meet these guidelines and there are limited data supporting how cancer survivors can achieve sustained dietary change. There are even fewer behavioral change resources available to minority cancer survivors. Few studies have examined the separate and synergistic effects of in-person education and electronic or "e-"communication strategies in changing and maintaining health behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •21 years of age or older.
- •Self-identify as Hispanic/Latina.
- •Speak Spanish or English.
- •Disease Related Criteria
- •Medical history of histologically confirmed stage 0, I, II, III breast cancer, with no evidence of metastatic disease.
- •Prior/ Current Therapy Criteria
- •At least 90 days post chemotherapy, biologic therapy, or radiation therapy treatment and/or breast surgery. Current use of hormonal therapy is permitted (e.g., tamoxifen and aromatase inhibitors).
- •Accessibility Criteria
- •Have access to computer or smartphone.
- •Clinical/ Laboratory Criteria
- •No history of smoking within the past 30 days.
- •No uncontrolled diabetes mellitus defined as Hgb A1C >7%
- •Consume <5 servings of fruits and vegetables per day and/or engages in <150 weekly minutes of moderate to vigorous physical activity.
排除标准
- •Any criterion not met under inclusion.
结局指标
主要结局
Change in daily servings of fruit/vegetables
时间窗: Baseline, 6 months, 12 months
Self-reported habitual fruit and vegetable intake will be assessed using the 10-item National Cancer Institute (NCI) All-Day Fruit and Vegetable screener.
Change in energy density
时间窗: Baseline, 6 months, 12 months
次要结局
- Change in Physical Activity(Baseline, 6 months, 12 months)
研究者
Dawn L. Hershman
Professor
Columbia University