mHealth Intervention to Increase Physical Activity in Prediabetes and Type 2 Diabetes
- Conditions
- PreDiabetesType 2 Diabetes
- Interventions
- Behavioral: mHealthBehavioral: brief adviceBehavioral: phone counsellingBehavioral: Fitbit tracker
- Registration Number
- NCT05351359
- Lead Sponsor
- Charles University, Czech Republic
- Brief Summary
Sedentary behaviour has a detrimental effect on the mortality, morbidity, and well-being of patients with type 2 diabetes and prediabetes, and general practitioners should advise patients on how to self-monitor and increase their physical activity. The emergence of mobile health (mHealth) technologies unlocks the potential to further improve physical behaviour using an innovative "just-in-time" adaptive approach whereby behavioural support is provided in real-time, based on data from wearable sensors. Thus, the investigators aim to evaluate the effect of a just-in-time mHealth intervention administered by general practitioners on the physical activity and sedentary behaviour of patients with type 2 diabetes and prediabetes. A total of 340 patients will be recruited from 20 general practices across the Czech Republic and randomly assigned to either an active control or intervention group. Both groups will receive brief physical activity advice from their general practitioners and a Fitbit fitness tracker to self-monitor their daily steps, but the intervention group will also receive a mHealth-enabled just-in-time adaptive intervention and regular monthly phone counselling in the first 6 months. The mHealth intervention will be delivered using a custom-developed system (HealthReact) connected to the Fitbit that will trigger just-in-time text messages. For example, a prompt to take a break from sedentary behaviour will be triggered after 30 sedentary minutes or a motivational message with a specific goal to take more steps will be triggered when the total step count is too low. The primary outcome will be the change in daily step count at 6 months, other outcomes include changes in other physical behaviour measures, blood tests, anthropometry and patient-reported outcomes at 6 and 12 months. If the intervention is effective, this study will provide a model of health prevention that can be directly implemented and commissioned within primary care using existing infrastructure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 340
- Diagnosis of prediabetes or T2DM according to the Czech guidelines for GPs on diabetes mellitus1 and prediabetes2, i.e. fasting plasma glucose 5.6-6.9 mmol/l, or 2-h plasma glucose of 7.8-11.0 mmol/l after ingestion of 75 g of oral glucose load for the diagnosis of prediabetes, and fasting plasma glucose ≥ 7.0 mmol/l, or 2-h plasma glucose ≥ 11.1 mmol/l after ingestion of 75 g of the oral glucose load for the diagnosis of T2DM
- Age 18 years or older.
- Registered at a participating general practice.
- Regular users of a smartphone and willing to use it as part of the study.
- Written informed consent obtained before any assessment related to the study.
- unable to walk
- pregnancy
- taking insulin
- living in a residential or nursing care home
- co-morbid conditions that would affect their adherence to the trial procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Fitbit tracker The patients in the intervention group will be exposed to the same procedures as those from the active control group, but will also receive a mHealth-enabled just-in-time adaptive intervention and regular monthly phone counselling in the first 6 months. Active control Fitbit tracker The patients from the active control group will receive brief physical activity advice from their general practitioners at baseline, and they will also receive the Fitbit tracker to self-monitor their daily steps. Active control brief advice The patients from the active control group will receive brief physical activity advice from their general practitioners at baseline, and they will also receive the Fitbit tracker to self-monitor their daily steps. Intervention mHealth The patients in the intervention group will be exposed to the same procedures as those from the active control group, but will also receive a mHealth-enabled just-in-time adaptive intervention and regular monthly phone counselling in the first 6 months. Intervention brief advice The patients in the intervention group will be exposed to the same procedures as those from the active control group, but will also receive a mHealth-enabled just-in-time adaptive intervention and regular monthly phone counselling in the first 6 months. Intervention phone counselling The patients in the intervention group will be exposed to the same procedures as those from the active control group, but will also receive a mHealth-enabled just-in-time adaptive intervention and regular monthly phone counselling in the first 6 months.
- Primary Outcome Measures
Name Time Method step count from baseline to 12-month assessment change in daily step count
- Secondary Outcome Measures
Name Time Method lipid profile at 12 months total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerids
HbA1c at 6 and 12 months haemoglobin A1c
chair-stand test at 6 and 12 months functional 30s chair-stand test
glycemia at 6 and 12 months fasting plasma glucose
step count at 6 months change in daily step count
walking cadence at 6 and 12 months cadence (steps/min) in 5 (non-consecutive) highest-cadence minutes
physical behaviour - average acceleration at 6 and 12 months metric of physical activity volume
physical behaviour - intensity gradient at 6 and 12 months metric of physical activity intensity
sedentary time at 6 and 12 months time per day spent sedentary (in minutes)
blood pressure at 6 and 12 months systolic and diastolic blood pressure
Hospital Anxiety and Depression Scale (HADS) at 6 and 12 months symptoms of anxiety and depression: 14 items on a scale 0-3 (a higher score means a worse outcome)
Short Form Survey (SF-12) at 6 and 12 months measure of health-related quality of life: 12 items using various scales converted to a score 0-100 (a higher score means a better outcome)
body mass index at 6 and 12 months weigh in kilograms divided by height in meters squared
sedentary bouts at 6 and 12 months time per day (in minutes) spent sedentary in bouts of 30 mins and longer
Trial Locations
- Locations (1)
Institute of General Practice
🇨🇿Prague, Czechia