Title: Comparative Effectiveness of Pedometer-Based Walking Interventions: WalkMore
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Resting systolic blood pressure
研究概览
简要总结
The WalkMore study will help find out how walking interventions can help overweight/obese postmenopausal women with increased risk of cardiovascular disease lower their blood pressure.
详细描述
Baseline assessment, then a three month intervention or control condition, followed by another assessment at the end of the study. Participants will be screened for blood pressure, height, weight, and the distance around the waist. Participants who meet the eligibility criteria will be given a pedometer to log steps for one week. During visit 2, participants will return the pedometer, and are able to self-monitor appropriately, they will be given an accelerometer to wear for one week.
Pedometry:
Participants will wear a small device which will measure the amount of steps accumulated for 7 days during the first week of the run-in period and again at follow-up (Control group will not perform follow-up pedometry).
Accelerometry:
Participants will be asked to wear a small device similar to a pedometer attached to a belt at the hip to measure physical activity levels for 7 days during the second week of the run-in period and again at the week prior to follow-up.
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 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman between 45-74 years of age
- •Have not had a menstrual period for at least 12 months
- •Are not regularly physically active (self-reported non-exerciser for previous 6 months)
- •Have a body mass index (BMI) between 25-45 kg/m2
- •Have high normal blood pressure or (systolic pressure of 130-179 mmHg or a diastolic pressure of 85-99 mmHg)
- •Not limited in your ability to walk
- •Understand these criteria
- •Are willing to provide informed consent
- •Willing to be randomized to either type of walking intervention or a control group being studied, and are willing to follow the protocol for the group to which they have been assigned
排除标准
- •Have a past history and/or physical examination or laboratory findings of a medical condition including (but not limited to):
- •Have any medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise
- •Have been diagnosed with diabetes
- •Blood pressure is greater than 179 mmHg systolic or 99 mmHg diastolic.
- •Participating in another research study which may effect the results of WalkMore
研究组 & 干预措施
Basic Pedometry Intervention
Basic pedometry intervention: Participants will have a goal of obtaining 10,000 steps/day (with no direction with regards to walking intensity/speed/cadence)
干预措施: Basic Intervention (Behavioral)
Enhanced Pedometry Intervention
Enhanced pedometry Intervention: Participants will have the goal of obtaining 10,000 steps/day and at least 30 minutes in moderate intensity (i.e., at a cadence of at least 100 steps/min);
干预措施: Enhanced Pedometry (Behavioral)
Control Group
Control group: Will maintain their usual activity and return for follow-up measures
干预措施: Control Group (Behavioral)
结局指标
主要结局
Resting systolic blood pressure
时间窗: 3 Months
Measured in the seated position using AHA blood pressure measurement guidelines
次要结局
- Brachial Ultrasound(3 Months)
- Accelerometry(3 Months)
- Resting diastolic blood pressure(3 Months)
- Waist Circumference(3 Months)
- Walking gait(3 Months)