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

Charles University, Czech Republic

Status: Enrolling

Conditions: Type 2 Diabetes; PreDiabetes

Treatments: Behavioral: phone counselling; Behavioral: brief advice; Behavioral: mHealth; Behavioral: Fitbit tracker

Study type: Interventional

Funder types: Other

Identifiers

NCT05351359

ENERGISED

Details and patient eligibility

About

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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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340 participants in 2 patient groups

Active control

Active Comparator group

Description:

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.

Treatment:

Behavioral: brief advice

Behavioral: Fitbit tracker

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: phone counselling

Behavioral: mHealth

Behavioral: brief advice

Behavioral: Fitbit tracker