Clinical trial NCT05351359: mHealth Intervention to Increase Physical Activity in Prediabetes and Type 2 Diabetes
Official title: mHealth Intervention Delivered in General Practice to Increase Physical Activity and Reduce Sedentary Behaviour of Patients With Prediabetes and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
PreDiabetes
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: University of Hradec Kralove
name: St George's, University of London
name: University of Leicester
name: University Ghent
First posted: 2022-04-28
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: step count
timeFrame: from baseline to 12-month assessment
Secondary outcomes:
measure: chair-stand test
timeFrame: at 6 and 12 months
measure: HbA1c
timeFrame: at 6 and 12 months
measure: glycemia
timeFrame: at 6 and 12 months
measure: lipid profile
timeFrame: at 12 months
measure: step count
timeFrame: at 6 months
measure: physical behaviour - average acceleration
timeFrame: at 6 and 12 months
measure: physical behaviour - intensity gradient
timeFrame: at 6 and 12 months
measure: sedentary time
timeFrame: at 6 and 12 months
measure: sedentary bouts
timeFrame: at 6 and 12 months
measure: walking cadence
timeFrame: at 6 and 12 months
measure: blood pressure
timeFrame: at 6 and 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: at 6 and 12 months
measure: Short Form Survey (SF-12)
timeFrame: at 6 and 12 months
measure: body mass index
timeFrame: at 6 and 12 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute of General Practice
Study officials:
affiliation: Charles University
name: Bohumil Seifert, MD, PhD
role: STUDY_CHAIR
References: