Phase II: Healthy Bodies, Hearts After Menopause
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
The overall aim of Healthy Bodies, Healthy Hearts research study is to promote physical activity in women aged 45-65 years to promote reduced risk of cardiovascular disease. The investigators are conducting an intervention for 12 weeks that promotes physical activity through support groups, group exercise sessions or through information that is given at the baseline appointment. Participants will be randomly assigned to a group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Not currently exercising for at least 100 minutes per week
- •Have a Body Mass Index (BMI) of 25 or greater
- •Has a physician in one of the three participating practices
排除标准
- •Not able to walk 1/2 mile or 1 flight of stairs without assistance from another person or an assistive device
研究组 & 干预措施
At Home
Participants in the At Home group receive a workbook from the research staff at their baseline visit that outlines an accepted nutrition and physical activity program to complete on their own.
干预措施: At Home (Behavioral)
In Person
Participants in the In Person group have weekly visits for the 12 weeks to the research office. The first visit can last up to one and a half hours and each subsequent visit can last approximately one hour. Group meetings provide appropriate nutrition and physical activity information as well as behavioral change strategies. Sessions also include some light physical activity (equal to brisk walking).
干预措施: In Person (Behavioral)
结局指标
主要结局
Weight loss
时间窗: 6 months
The goal of the intervention is for participants to have a 10% reduction in body weight
次要结局
- Increase physical activity(3 months)