Improving activity-sleep patterns to enhance glucose control in higher risk mid aged adults.

Not Applicable

• Conditions: Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Glucose control (Pre-diabetes); Metabolic and Endocrine - Diabetes; Public Health - Health promotion/education

• Registration Number: ACTRN12624000811505
• Lead Sponsor: The University of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-02
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 324

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified