NDLI: 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

Content Provider	Springer Nature : BioMed Central
Author	Vetrovsky, Tomas Kral, Norbert Pfeiferova, Marketa Kuhnova, Jitka Novak, Jan Wahlich, Charlotte Jaklova, Andrea Jurkova, Katerina Janek, Michael Omcirk, Dan Capek, Vaclav Maes, Iris Steffl, Michal Ussher, Michael Tufano, James J. Elavsky, Steriani Van Dyck, Delfien Cimler, Richard Yates, Tom Harris, Tess Seifert, Bohumil
Abstract	Background The growing number of patients with type 2 diabetes and prediabetes is a major public health concern. Physical activity is a cornerstone of diabetes management and may prevent its onset in prediabetes patients. Despite this, many patients with (pre)diabetes remain physically inactive. Primary care physicians are well-situated to deliver interventions to increase their patients' physical activity levels. However, effective and sustainable physical activity interventions for (pre)diabetes patients that can be translated into routine primary care are lacking. Methods We describe the rationale and protocol for a 12-month pragmatic, multicentre, randomised, controlled trial assessing the effectiveness of an mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED). Twenty-one general practices will recruit 340 patients with (pre)diabetes during routine health check-ups. Patients allocated to the active control arm will receive a Fitbit activity tracker to self-monitor their daily steps and try to achieve the recommended step goal. Patients allocated to the intervention arm will additionally receive the mHealth intervention, including the delivery of several text messages per week, with some of them delivered just in time, based on data continuously collected by the Fitbit tracker. The trial consists of two phases, each lasting six months: the lead-in phase, when the mHealth intervention will be supported with human phone counselling, and the maintenance phase, when the intervention will be fully automated. The primary outcome, average ambulatory activity (steps/day) measured by a wrist-worn accelerometer, will be assessed at the end of the maintenance phase at 12 months. Discussion The trial has several strengths, such as the choice of active control to isolate the net effect of the intervention beyond simple self-monitoring with an activity tracker, broad eligibility criteria allowing for the inclusion of patients without a smartphone, procedures to minimise selection bias, and involvement of a relatively large number of general practices. These design choices contribute to the trial’s pragmatic character and ensure that the intervention, if effective, can be translated into routine primary care practice, allowing important public health benefits. Trial registration ClinicalTrials.gov (NCT05351359, 28/04/2022).
Related Links	https://bmcpublichealth.biomedcentral.com/counter/pdf/10.1186/s12889-023-15513-1.pdf
Ending Page	16
Page Count	16
Starting Page	1
File Format	HTM / HTML
ISSN	14712458
DOI	10.1186/s12889-023-15513-1
Journal	BMC Public Health
Issue Number	1
Volume Number	23
Language	English
Publisher	BioMed Central
Publisher Date	2023-03-31
Access Restriction	Open
Subject Keyword	Public Health Medicine Epidemiology Biostatistics Vaccine Environmental Health Step-count Just-in-time adaptive intervention (JITAI) Primary care Fitbit Active control Self-monitoring Ecological Momentary Assessment (EMA) Micro-randomisation Phone counselling Text messages Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Public Health, Environmental and Occupational Health
Journal Impact Factor	3.5/2023
5-Year Journal Impact Factor	3.9/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Participatory development of an mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED)

A Hybrid Ecological Momentary Compassion-Focused Intervention for Enhancing Resilience in Help-Seeking Young People: Prospective Study of Baseline Characteristics in the EMIcompass Trial.

Smartphone App-Based Noncontact Ecological Momentary Assessment With Experienced and Naïve Older Participants: Feasibility Study.

The “Worktivity” mHealth intervention to reduce sedentary behaviour in the workplace: a feasibility cluster randomised controlled pilot study

Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial

Boosting healthy food choices by meal colour variety: results from two experiments and a just-in-time Ecological Momentary Intervention

Mobile Ecological Momentary Assessment and Intervention and Health Behavior Change Among Adults in Rakai, Uganda: Pilot Randomized Controlled Trial.

Ecological Momentary Assessment and Smartphone Application Intervention in Adolescents with Substance Use and Comorbid Severe Psychiatric Disorders: Study Protocol

App-Based Ecological Momentary Assessment to Enhance Clinical Care for Postpartum Depression: Pilot Acceptability Study.

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

Similar Documents

Participatory development of an mHealth intervention delivered in general practice to increase physical activity and reduce sedentary behaviour of patients with prediabetes and type 2 diabetes (ENERGISED)

A Hybrid Ecological Momentary Compassion-Focused Intervention for Enhancing Resilience in Help-Seeking Young People: Prospective Study of Baseline Characteristics in the EMIcompass Trial.

Smartphone App-Based Noncontact Ecological Momentary Assessment With Experienced and Naïve Older Participants: Feasibility Study.

The “Worktivity” mHealth intervention to reduce sedentary behaviour in the workplace: a feasibility cluster randomised controlled pilot study

Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial

Boosting healthy food choices by meal colour variety: results from two experiments and a just-in-time Ecological Momentary Intervention

Mobile Ecological Momentary Assessment and Intervention and Health Behavior Change Among Adults in Rakai, Uganda: Pilot Randomized Controlled Trial.

Ecological Momentary Assessment and Smartphone Application Intervention in Adolescents with Substance Use and Comorbid Severe Psychiatric Disorders: Study Protocol

App-Based Ecological Momentary Assessment to Enhance Clinical Care for Postpartum Depression: Pilot Acceptability Study.

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