TAME Health: Testing Activity Monitors' Effect on Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator
研究概览
简要总结
Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to physical activity. Most older adults do not participate in healthy levels of physical activity. Physical activity promotion and counseling from a primary health care provider is important for disease prevention. In addition to counseling, an activity monitor can increase physical activity through self-regulation. Two types of monitors are available: pedometers and electronic activity monitors (EAMs). Research shows that both monitors are motivational devices that can increase physical activity. Pedometers count steps of the wearer. EAMs can monitor steps, monitor burned calories, quality of sleep, and sedentary time. EAMs may also offer more behavioral change techniques and opportunities for self-monitoring. The goal of this study is to compare the effectiveness of EAMs compared to a pedometer on increasing physical activity and decreasing cardiovascular risk within older adult, primary care patients. The study will include sedentary, overweight primary care patients, 55-74 years of age with access to a smart phone or tablet. All participants will receive brief physical activity counseling. Participants will then be randomized to receive a self-monitoring device (Digi-walker CW-700/701 or UP24 by Jawbone) to wear for 3 months. Investigators will evaluate the following outcomes: physical activity, cardiovascular risk (Framingham risk calculator, fitness), psychological feeling toward exercise, physical function, health status, exercise motivation and self-regulation. The investigators hypothesize that EAMs will be more effective than pedometers in improving these outcomes. The results of this pilot test will aid in the translation of effective physical activity intervention components to primary care clinics for cardiovascular disease prevention.
详细描述
Cardiovascular disease (CVD) is prevalent and the leading cause for mortality in the United States. The American Heart Association's (AHA) 2020 Impact Goal is to improve the cardiovascular health of all Americans by 20 percent while reducing deaths from CVD and stroke by 20 percent. Maintaining healthy levels of physical activity (PA) is critical in maintaining cardiovascular health, but older adults are inactive. Inactivity may be influenced by low levels of motivation. Standard behavioral counseling techniques typically implemented within the primary care setting target increased motivation, but lack the key component of self-control. The addition of electronic activity monitors (EAMs) that provide interactive self-monitoring, feedback, and social support may further increase motivation for exercise by providing more effective behavior change techniques than standard protocols. Investigators will conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (N = 40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer. Investigators propose two Specific Aims:
AIM 1: Evaluate the feasibility and acceptability of implementing a technology-enhanced brief intervention to increase physical activity in a primary care setting. Measures of feasibility will include days the EAM was worn, usage of the app, technological problems, attrition, and adverse events. Acceptability will be measured by self-report and focus groups.
AIM 2: Compare the counseling plus EAM intervention to a counseling plus pedometer intervention. Primary outcomes will be changes in PA and cardiovascular risk. We will also investigate secondary outcomes (differences in adherence, weight and body composition, health status, motivation, physical function, psychological feelings, self-regulation).
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •physically inactive (less than 60 minutes per week)
- •BMI between 25-35
- •in good health measured by Par-Q+
- •access to a smart phone
排除标准
- •physical activity is inadvisable by their doctor
- •involved in another physical activity intervention within the past 6 months
- •used an activity monitor in the past 6 months
- •unwilling to travel for scheduled visits
- •currently taking medications that affect body composition
- •current smoker
- •report alcohol or drug problem
- •institutionalized for psychiatric illness within the last year
- •do not consent
结局指标
主要结局
Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator
时间窗: Cardiovascular risk at the end of the 12 week intervention
Factors within the risk calculator include of age in years, systolic blood pressure, gender, and body mass index. These factors are used to create a composite score to estimate the individual's risk for a cardiac event within the next 10 years. The risk score is not bound by maximums and minimums, however a lower number is more favorable. Among women, a composite risk score of 10 equates to a 6% risk of a cardiovascular event, a risk score of 15 equates to a 13% risk, a risk score of 20 equates to a 28.5% risk, and a risk score of 21 or higher equates to \>30% risk of a cardiovascular event within the next 10 years. Among men, a composite risk score of 10 equates to a 9% risk, a risk score of 15 equates to a 21.5% risk, and a risk score of 18 or higher equates to \>30% risk of a cardiovascular event within the next 10 years.
6-minute Walk Test
时间窗: Fitness at the end of the 12 week intervention
distance walked in 6 minutes
Steps Per Day
时间窗: Steps per day at the end of the 12 week intervention
Measured by a SenseWear Armband. Average steps per day over a 7 day period
Physical Activity Minutes Measured by a SenseWear Armband
时间窗: Physical activity minutes at the end of the 12 week intervention
Minutes of moderate-vigorous physical activity over a 7 day period
次要结局
- Weight(Weight at the end of the 12 week intervention)
- Body Mass Index (BMI)(BMI at the end of the 12 week intervention)
- Blood Pressure(Blood pressure at the end of the 12 week intervention)
- Exercise Motivation(Exercise motivation at the end of the 12 week intervention)
- Quality of Life Measured by the SF-36 Questionnaire(Quality of life at the end of the 12 week intervention)
- Change From Baseline in Self-regulation(Change in self-regulation from baseline and 12-weeks)
- Waist-to-Hip Ratio(Waist-to-hip ratio at the end of the 12 week intervention)
- Physical Function Measured by the Short Physical Performance Battery(Physical function at the end of the 12 week intervention)
- Psychological Feelings(Psychological feelings at the end of the 12 week intervention)
- Resting Pulse(Resting pulse at the end of the 12 week intervention)