A Feasibility Study on the Effects of Tailored Communication and Health Coach Support on Physical Activity in Overweight Postmenopausal Women: BePHIT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in time taken to complete a one mile walk.
研究概览
简要总结
This randomized clinical trial studies the feasibility of tailored physical activity intervention that is administered using Interactive Voice Response technology and cell phones. Interactive voice response and health coach support may motivate overweight postmenopausal women to stick to their exercise regimen to reduce the risk of getting breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To design, develop and test the feasibility of implementing a physical activity intervention using tailored communication and Interactive Voice Response (IVR) technology. We will to address four basic questions to accomplish this aim:
- Among overweight, postmenopausal women, who pass the screening criteria, what is the percentage of women who are willing to participate in a 12-week physical activity intervention that includes two 1-mile walk tests and two visits to the General Clinical Research Center (GCRC)?
- After beginning the study, what proportion of women use the cell phone and land line at least 5 days a week to get a physical activity intervention message?
- How many participants are enrolled and participating in the study at the end of the 12-week intervention period?
- On average, how many steps per day do participants walk? How many of the participants reach the 10,000 steps-per-day target by the end of the 12 week-intervention?
SECONDARY OBJECTIVES:
I. The effectiveness (satisfaction, convenience, ease of operation) of all the materials and processes.
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
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Present a letter/documentation from a primary physician stating that they can participate in a physical activity program that will require walking up to 10,000 steps per day
- •Have a body mass index (BMI) between 25 and 40 kg/m^2 (inclusive)
- •Be postmenopausal, defined as no period for 12 months if over age 55, or no period for 12 months; also, women who have had their ovaries removed will be considered as postmenopausal
- •Willing to participate in a wellness program that lasts 12 weeks and involves walking for at least 30 minutes a day on most days
- •Has access to a cell phone during the 12-week intervention
- •Functional knowledge of English (ability to both read and write)
排除标准
- •Taking hormone replacement therapy within 3 months of enrollment
- •Taking Tamoxifen or Raloxifene within 3 months of enrollment
- •Enrolled in a weight management program, such as Weight Watchers
- •Engaged in regular, planned walking of at least 30 minutes a day
- •Previous history of breast cancer
- •Premenopausal
- •Age > 75 years, to minimize co-morbidities
- •Cannot walk one mile
结局指标
主要结局
Change in time taken to complete a one mile walk.
时间窗: 12 weeks
次要结局
- If the self-reported steps per day, derived from daily activity logs, relates to the change in performance on the 1-mile walk test between baseline and end of study.(12 Week)
- Changes in anthropometrics, psychometrics and the benefits of a health coach.(12 weeks)
- Weekly effectiveness (satisfaction, convenience, ease of operation) of all the materials and processes as assessed by questionnaires.(12 weeks)
研究者
Electra Paskett
Associate Director for Population Sciences, Comprehensive Cancer Center, Ohio State University; Marion N. Rowley Professor of Cancer Research and Director, Division of Cancer Prevention and Control
Ohio State University Comprehensive Cancer Center