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

NCT ID: NCT05351359

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-25
• Study Completion Date: 2024-06-30

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.

Conditions

Type 2 Diabetes; PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Active control

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.

Group Type: ACTIVE_COMPARATOR

Fitbit tracker

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Intervention

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.

Group Type: EXPERIMENTAL

mHealth

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

brief advice

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hradec Kralove

UNKNOWN

Sponsor Role: collaborator

St George's, University of London

OTHER

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: collaborator

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Tomáš Větrovský

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bohumil Seifert, MD, PhD

Role: STUDY_CHAIR

Charles University

Locations

Institute of General Practice

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Tomas Vetrovsky, MD, PhD

Role: CONTACT

tomas.vetrovsky@gmail.com

+420724600710

Facility Contacts

Bohumil Seifert

Role: primary

References

Vetrovsky T, Kral N, Pfeiferova M, Seifert B, Capek V, Jurkova K, Steffl M, Cimler R, Kuhnova J, Harris T, Ussher M, Wahlich C, Malisova K, Pelclova J, Dygryn J, Elavsky S, Maes I, Van Dyck D, Rowlands A, Yates T. mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): statistical analysis plan. Trials. 2025 May 20;26(1):166. doi: 10.1186/s13063-025-08865-z.

Reference Type: DERIVED

PMID: 40394706 (View on PubMed)

Vetrovsky T, Kral N, Pfeiferova M, Kuhnova J, Novak J, Wahlich C, Jaklova A, Jurkova K, Janek M, Omcirk D, Capek V, Maes I, Steffl M, Ussher M, Tufano JJ, Elavsky S, Van Dyck D, Cimler R, Yates T, Harris T, Seifert B. mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED): rationale and study protocol for a pragmatic randomised controlled trial. BMC Public Health. 2023 Mar 31;23(1):613. doi: 10.1186/s12889-023-15513-1.

Reference Type: DERIVED

PMID: 36997936 (View on PubMed)

Other Identifiers

ENERGISED

Identifier Type: -

Identifier Source: org_study_id