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

mHealth Intervention Delivered in General Practice to Increase Physical Activity and Reduce Sedentary Behaviour of Patients With 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.

Study Overview

• Status: Recruiting
• Conditions: PreDiabetes; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Fitbit tracker; Behavioral: brief advice; Behavioral: mHealth; Behavioral: phone counselling

• Study Type: Interventional
• Enrollment (Anticipated): 340
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomas Vetrovsky, MD, PhD; Phone Number: +420724600710; Email: tomas.vetrovsky@gmail.com

Study Locations

• Czechia
  • Prague, Czechia
    • Recruiting
    • Institute of General Practice
    • Contact: Bohumil Seifert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
step count	change in daily step count	from baseline to 12-month assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chair-stand test	functional 30s chair-stand test	at 6 and 12 months
HbA1c	haemoglobin A1c	at 6 and 12 months
glycemia	fasting plasma glucose	at 6 and 12 months
lipid profile	total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerids	at 12 months
step count	change in daily step count	at 6 months
physical behaviour - average acceleration	metric of physical activity volume	at 6 and 12 months
physical behaviour - intensity gradient	metric of physical activity intensity	at 6 and 12 months
sedentary time	time per day spent sedentary (in minutes)	at 6 and 12 months
sedentary bouts	time per day (in minutes) spent sedentary in bouts of 30 mins and longer	at 6 and 12 months
walking cadence	cadence (steps/min) in 5 (non-consecutive) highest-cadence minutes	at 6 and 12 months
blood pressure	systolic and diastolic blood pressure	at 6 and 12 months
Hospital Anxiety and Depression Scale (HADS)	symptoms of anxiety and depression: 14 items on a scale 0-3 (a higher score means a worse outcome)	at 6 and 12 months
Short Form Survey (SF-12)	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)	at 6 and 12 months
body mass index	weigh in kilograms divided by height in meters squared	at 6 and 12 months

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: University Ghent; University of Leicester; St George's, University of London; University of Hradec Kralove
• Investigators: Study Chair: Bohumil Seifert, MD, PhD, Charles University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 24, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: ENERGISED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No