Improving activity-sleep patterns to enhance glucose control in higher risk mid aged adults.
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 Newcastle
108 participants
Aug 1, 2024
Interventional
Conditions
Summary
A large proportion (i.e., approximately 30%) of individuals with prediabetes develop type-2 diabetes. Improving glucose control by increasing regular physical activity can help to prevent diabetes, and for adults with poor sleep, improving sleep can also improve glucose control and strengthen the effect of physical activity. A 2-group randomised control trial to compare the effect of different digital interventions to improve lifestyle behaviours and the effect this has on glucose control in mid-aged adults (45 years and above). The two groups are a physical activity and sleep group and an education-only control group. Outcomes will be assessed at 6 weeks, 12 weeks (primary endpoint), and 24 weeks after intervention commencement. The intervention program will provide participants continuous access to a mobile app and website for the 24-week study period, where participants can manually set and review goals, enter (i.e., self-monitor) their behavioural data on group-respective target behaviours, and view feedback, historical log data (i.e., representing progress over time) and educational materials.
Eligibility
Inclusion Criteria11
- Aged 45 years or above
- Not meeting physical activity guidelines (i.e., less than 150 minutes of MVPA and less than 2 muscle strengthening sessions per week)
- Poor sleep health
- Impaired fasting glucose control in the prediabetes range based on the following parameters:
- a. Capillary blood sample of fasting blood glucose in prediabetes range (5.6-6.9mmol/L), OR
- b. Capillary blood sample of HbA1c (5.7-6.4%) OR
- c. Pathology blood test result for fasting blood glucose in prediabetes range (5.6-6.9mmol/L), OR
- d. Pathology blood test result for HbA1c in prediabetes range (5.7-6.4%), OR
- e. Pathology blood test result for 2Hr Glucose following 75g OGTT in prediabetes range (>= 7.8 and < 11.0 mmol/L)
- Access to a smartphone and/or computer to access the internet
- Those who are eligible will be invited to have their FBG and HbA1c1 Now levels assessed using a point-of-care device (CardioChek PA and HbA1C1 Now+) at one of the University of Newcastle locations. Participants whose FBG falls within the prediabetes range (5.6-6.9mmol/L) OR HbA1C1 levels between 5.7-6.4% will proceed to complete the baseline assessments. Alternatively, if a participant's pathology blood results indicate that they are within the pre-diabetic range for their fasting blood glucose (5.6-6.9mmol/L) OR HbA1c (5.7-6.4%) OR for 2Hr Glucose following 75g OGTT (>= 7.8 and < 11.0 mmol/L), they will also be eligible to complete the baseline assessment.
Exclusion Criteria5
- Doctor-diagnosed type-1 or type-2 diabetes
- Reporting a condition that would make it unsafe to change physical activity and/or sleep
- Employed in night shift-work (i.e., outside of 9 am-5 pm work hours)
- No internet access
- Currently taking prescribed medications to promote sleep
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Interventions
A 2-arm (PAS vs. Control) randomised clinical trial will be conducted to examine the efficacy of a combined physical activity and sleep (PAS) intervention to an education only control group over 24 weeks. The allocation into these PAS: CON would be 2:1. Arm 1: Participants in the PAS arm will receive access to a digital platform, including mobile app, and website via the Balanced digital platform. The intervention is designed to improve physical activity and sleep health using evidence-based behaviour change strategies. Intervention components and materials are described in more detail below. a. information on the recommended amounts of physical activity and sleep duration for Australian adults as per national guidelines and the benefits of physical activity and improved sleep b. action planning and goal setting tools c. ideas on how to overcome barriers d. Action planning strategies e. Example activity plans f. videos demonstrating muscle strengthening activities g. a self-monitoring section where participants can manually log (i.e., self-monitor) daily physical activity {minutes of Moderate to vigorous intensity physical activity (MVPA), sessions of muscle strengthening activity (MSA)}, sitting time, sleep health {sleep duration and quality (1-5 Likert Scale), time to bed and wake}, and daily sleep hygiene behaviours (e.g., alcohol and caffeine intake) and set personalised goals for physical activity (daily MVPA, and MSA), sitting, and sleep health, and update these goals in line with their progress. h. personalised feedback and detailed weekly summaries (e.g., most active days, number of days goals were achieved) of progress towards goals i. audio and text-based resources to guide participants in practicing mindfulness, cognitive restructuring in relation to sleep, stress management, and relaxation techniques. The Balanced intervention will be accessible by website, smartphone, and tablet. Access to the intervention materials will be restricted using a unique identifier (password + login) for each participant to ensure participants only receive intervention content related to their group allocation. Intervention materials will promote participation in physical activity by increasing activity levels to level consistent with the 2014 National Physical Activity Guidelines for Australian Adults (i.e. 150 minutes of moderate-to-vigorous intensity physical activity, equal to or more than 2 sessions of muscle strengthening activity, minimise long periods of sitting and break up sitting regularly). Intervention materials promoting sleep will promote healthy sleep (i.e. a regular timing, quality, and duration of sleep that a person is satisfied with) and the Australian Sleep Health Foundation sleep duration guidelines for adults. Intervention materials will promote adherence to these guidelines dependent on group allocation throughout the intervention period. The intervention platform will require participants set goals for target behaviours using a goal setting tool and goals can be updated at any time. Participants will manually enter information on activity and sleep into the platform to self-monitor the target behaviours. Resource materials/articles will provide participants with strategies to overcome common barriers to engaging in activity and health sleep. Resource materials/articles will also provide participants with example action planning resources and information to engage in action planning activities to help with overcoming barriers. Example weekly activity plans provide participants with suggested activity plans that vary in the volume of activity suggested based on different baseline activity levels (e.g., no prior activity, a little prior activity, some prior activity). This includes instructions on how to complete muscle strengthening activities using body weight and free weights (if participants have these). Participants will be asked to use the Balanced app daily for self-monitoring of behaviours but are instructed they can use the app as much or as little as they like, and they will have access to the app continuously throughout the entire study period. Intervention platform generated feedback via the intervention portal, SMS/Email is provided to participants based on their self-monitored behaviours in relation to their goals and guidelines for target behaviours. Intervention platform generated reminders are also used to prompt login and use of the intervention platform based on user usage patterns.
Locations(1)
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ACTRN12624000811505