NCT05351359

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

1.4 years

First QC Date

April 19, 2022

Last Update Submit

October 3, 2022

Conditions

Type 2 DiabetesPreDiabetes

Outcome Measures

Primary Outcomes (1)

  • step count

    change in daily step count

    from baseline to 12-month assessment

Secondary Outcomes (14)

  • chair-stand test

    at 6 and 12 months

  • HbA1c

    at 6 and 12 months

  • glycemia

    at 6 and 12 months

  • lipid profile

    at 12 months

  • step count

    at 6 months

  • +9 more secondary outcomes

Study Arms (2)

Active control

ACTIVE COMPARATOR

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.

Behavioral: Fitbit trackerBehavioral: brief advice

Intervention

EXPERIMENTAL

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.

Behavioral: mHealthBehavioral: phone counsellingBehavioral: Fitbit trackerBehavioral: brief advice

Interventions

mHealthBEHAVIORAL

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
phone counsellingBEHAVIORAL

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
Fitbit trackerBEHAVIORAL

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.

Active controlIntervention
brief adviceBEHAVIORAL

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

Active controlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of General Practice

Prague, Czechia

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40394706DERIVED

  • 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.

    PMID: 36997936DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic State

Interventions

TelemedicineCrisis Intervention

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Bohumil Seifert, MD, PhD

    Charles University, Czech Republic

    STUDY CHAIR

Central Study Contacts

Tomas Vetrovsky, MD, PhD

CONTACT

+420724600710tomas.vetrovsky@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 19, 2022

First Posted

April 28, 2022

Study Start

April 25, 2022

Primary Completion

September 1, 2023

Study Completion

June 1, 2024

Last Updated

October 5, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)