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Completed

NCT Number: NCT05351359

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of General Practice

Prague, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mHealth

Behavioral

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).

phone counselling

Behavioral

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.

Fitbit tracker

Behavioral

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.

Brief Advice

Behavioral

A brief advice will be provided by the general practitioner at the start of the study.

Primary outcomes

  1. step count

    Time frame: from baseline to 12-month assessment

    change in daily step count

Secondary outcomes

  1. chair-stand test

    Time frame: at 6 and 12 months

    functional 30s chair-stand test

  2. HbA1c

    Time frame: at 6 and 12 months

    haemoglobin A1c

  3. glycemia

    Time frame: at 6 and 12 months

    fasting plasma glucose

  4. lipid profile

    Time frame: at 12 months

    total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerids

  5. step count

    Time frame: at 6 months

    change in daily step count

  6. physical behaviour - average acceleration

    Time frame: at 6 and 12 months

    metric of physical activity volume

  7. physical behaviour - intensity gradient

    Time frame: at 6 and 12 months

    metric of physical activity intensity

  8. sedentary time

    Time frame: at 6 and 12 months

    time per day spent sedentary (in minutes)

  9. sedentary bouts

    Time frame: at 6 and 12 months

    time per day (in minutes) spent sedentary in bouts of 30 mins and longer

  10. walking cadence

    Time frame: at 6 and 12 months

    cadence (steps/min) in 5 (non-consecutive) highest-cadence minutes

  11. blood pressure

    Time frame: at 6 and 12 months

    systolic and diastolic blood pressure

  12. Hospital Anxiety and Depression Scale (HADS)

    Time frame: at 6 and 12 months

    symptoms of anxiety and depression: 14 items on a scale 0-3 (a higher score means a worse outcome)

  13. Short Form Survey (SF-12)

    Time frame: 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)

  14. body mass index

    Time frame: at 6 and 12 months

    weigh in kilograms divided by height in meters squared

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • St George's, University of London
  • University Ghent
  • University of Hradec Kralove
  • University of Leicester

Registry information

Official study title

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

Acronym: ENERGISED

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 28, 2022
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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