A randomised controlled trial to improve activity-sleep patterns and enhance glucose control in higher-risk mid-aged adults: The Move & Sleep Study.

The University of Newcastle0 sites324 target enrollmentJuly 2, 2024

ConditionsGlucose control (Pre-diabetes)Metabolic and Endocrine - Diabetes Public Health - Health promotion/education Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Overview

Phase: 未知
Intervention: Not specified
Conditions: Glucose control (Pre-diabetes)
Sponsor: The University of Newcastle
Enrollment: 324
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 2, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

The University of Newcastle

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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