Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- To evaluate the feasibility of the ( PA) Physical Activity intervention.
研究概览
简要总结
To test the use of a continuous activity and heart rate tracker (Fitbit) and continuous glucose monitor (CGM) in monitoring daily exercise-related activities.
详细描述
Primary objective:
To evaluate the feasibility of a CGM-based physical activity intervention that includes the use of CGM and Fitbit®.
Secondary objectives:
To examine changes in physical activity motivation and other related psychosocial variables (e.g., intention, perceived benefits, outcome expectancy) before and after the intervention.
Exploratory objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women at least 18 years old
- •Body mass index (BMI) 25 kg/m2
- •Engage in less than 150 minutes of moderate-intensity PA per week in the past month
- •Capable of participating in moderate-vigorous unsupervised exercise (as determined by the Physical Activity Readiness Questionnaire (PARQ) or a medical release from their physician)
- •Self-reported ability to walk one block without pain or discomfort
- •Have a smart phone with daily internet access that is compatible with the LibreLink app
- •Ability to speak, read, and write in English
- •For the cancer survivor cohort (participant accession number #21 and beyond), individuals must have been diagnosed with stage I-III breast or colorectal cancer and completed adjuvant therapy (i.e., chemo and/or radiation therapy).
排除标准
- •Self-reported current diagnosis or history of type 1 diabetes or type 2 diabetes
- •Self-reported use of oral antidiabetic agents (OADs)
- •Previous or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator)
- •Current use of a continuous glucose monitor
- •Fasting glucose > 125 mg/dL
- •Pregnancy
- •Self-reported health issues that limit physical activity
- •On dialysis
- •Work overnight shifts
- •Unwilling to use CGM
- •Current participation in other wellness or weight loss-related program or intervention
- •Currently on a low-carb diet
- •Unable to receive REDCap survey through their mobile phones
研究组 & 干预措施
Heart Rate Tracker (Fitbit)
continuous heart rate activity
干预措施: Fitbit (Other)
Heart Rate Tracker (Fitbit)
continuous heart rate activity
干预措施: Continuous Glucose Monitor (Other)
Continuous Glucose Monitor (CGM)
monitoring daily exercise-related activities
干预措施: Fitbit (Other)
Continuous Glucose Monitor (CGM)
monitoring daily exercise-related activities
干预措施: Continuous Glucose Monitor (Other)
结局指标
主要结局
To evaluate the feasibility of the ( PA) Physical Activity intervention.
时间窗: through study completion, an average of 1 year
The use of CGM through the following criteria: CGM-specific refusal rate \<20% at the participant recruitment phase and protocol adherence rates \>80% at the end of the monitoring period.
次要结局
未报告次要终点