ACTRN12624000811505尚未招募Unknown
A randomised controlled trial to improve activity-sleep patterns and enhance glucose control in higher-risk mid-aged adults: The Move & Sleep Study.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 324
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 45 Years 至 64 Years（—）
- 性别
- All
入选标准
- •All of the following criteria will have to be met:
- •1) Compliance with the run-in protocol for more than 5 out of 7 days
- •2) Aged 45 – 64 years
- •3) Not meeting physical activity guidelines (i.e., less than 150 minutes of MVPA and less than 2 muscle strengthening sessions per week)
- •4) Self-report poor sleep health (i.e., reporting more or equal to 3 of the 6 RU-SATED sleep health dimensions as poor)
- •5) report elevated waist circumference (i.e., using sex/ethnicity-specific cut points as per clothing size in line with the AUSDRisk online tool from Diabetes Australia)
- •6) Impaired fasting glucose in prediabetes range (i.e., 6.1-6.9 mmol/L)
- •7) Access to a smartphone and/or computer to access the internet
- •Run-in period
- •Those who meet eligibility criteria will be asked to complete a 1-week run-in period, which is intended to identify non-compliant participants and thus, limit attrition/non-compliance in the actual study. To minimise the risk of potential confounding, participants will be asked to use an online form in REDCap to self-monitor their daily fluid intake including the amount and type/s of fluids consumed (i.e., water, soft drink, coffee, tea, alcohol). Participants who complete this form on less than 5 out of 7 days will be omitted from participating the trial. Those who are deemed compliant will be invited to have their FBG assessed using a point-of-care device (CardioChek PA) at one of the University of Newcastle locations. Participants whose FBG falls within the prediabetes range (6.1-6.9mmol/L) will proceed to complete baseline assessments.
排除标准
- •1) Doctor-diagnosed type-1 or type-2 diabetes
- •2) Diagnosed sleep apnoea or at high risk of sleep apnoea (i.e., (STOP Score equal or more than 2 + Male + BMI score more than 35)
- •3) Diagnosed insomnia or severe insomnia symptoms (i.e., Insomnia Severity Index Score equal or more than 22)
- •4) Reporting a condition that would make it unsafe to change physical activity and/or sleep
- •5) Employed in night shift-work (i.e., outside of 9 am-5 pm work hours)
- •6) No internet access
- •7) Currently taking prescribed medications to promote sleep
研究者
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