NCT05351359

mHealth Intervention to Increase Physical Activity in Prediabetes and Type 2 Diabetes

mHealth Intervention Delivered in General Practice to Increase Physical Activity and Reduce Sedentary Behaviour of Patients With Prediabetes and Type 2 Diabetes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• PreDiabetes

Interventions

Type	Name	Description
BEHAVIORAL	mHealth	A mHealth-enabled just-in-time adaptive intervention that is based on the HealthReact system developed by the participating centre at the Faculty of Science of the University of Hradec Kralove. The HealthReact system consists of a server-side application that is connected to the Fitbit server. As such, the system allows for just-in-time text messages triggered by pre-defined context as recorded by the Fitbit wearable monitor. For example, a prompt to take a break from sedentary behaviour can be triggered after 30 sedentary minutes, a suggestion to increase walking cadence can be triggered when continuous, but slow walking is detected, or a motivational message with a specific goal to take more steps to reach their usual daily step count can be triggered when the total daily steps are too low. The mHealth component will be delivered for the entire duration of the study (i.e., 12 months).
BEHAVIORAL	phone counselling	Regular monthly phone calls by trained counsellors support participants in their effort to increase physical activity and reduce sedentary behaviours. The counsellors will use various behaviour change techniques, such as goal-setting, feedback, action planning, etc. The phone counselling will be provided during the first six months, i.e. 6 phone calls will be delivered.
BEHAVIORAL	Fitbit tracker	Fitbit Inspire 2 will be provided by the general practitioner to study participants at the start of the study to enable objective self-monitoring of physical activity.
BEHAVIORAL	brief advice	A brief advice will be provided by the general practitioner at the start of the study.

Timeline

• Start date: 2022-04-25
• Primary completion: 2023-09-01
• Completion: 2024-06-01
• First posted: 2022-04-28
• Last updated: 2022-10-05

Locations

1 site across 1 country: Czechia