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).

• Keywords
• Active control, Ecological Momentary Assessment (EMA), Fitbit, Just-in-time adaptive intervention (JITAI), Micro-randomisation, Phone counselling, Text messages, Primary care, Self-monitoring, Step-count,
• MeSH
• Exercise MeSH
• Diabetes Mellitus, Type 2 * prevention & control   MeSH
• Humans MeSH
• Multicenter Studies as Topic MeSH
• Pragmatic Clinical Trials as Topic MeSH
• General Practice * MeSH
• Prediabetic State * therapy   MeSH
• Randomized Controlled Trials as Topic MeSH
• Sedentary Behavior MeSH
• Telemedicine * MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Clinical Trial Protocol MeSH

(1) Background: Cardiometabolic diseases are the most common cause of death worldwide. As part of a collaborative European study, this paper aims to explore the implementation of primary care selective-prevention services in five European countries. We assessed the implementation process of the selective-prevention services, participants' cardiometabolic profile and risk and participants' evaluation of the services, in terms of feasibility and impact in promoting a healthy lifestyle. (2) Methods: Eligible participants were primary care patients, 40-65 years of age, without any diagnosis of cardiometabolic disease. Two hundred patients were invited to participate per country. The extent to which participants adopted and completed the implementation of selective-prevention services was recorded. Patient demographics, lifestyle-related cardiometabolic risk factors and opinions on the implementation's feasibility were also collected. (3) Results: Acceptance rates varied from 19.5% (n = 39/200) in Sweden to 100% (n = 200/200) in the Czech Republic. Risk assessment completion rates ranged from 65.4% (n = 70/107) in Greece to 100% (n = 39/39) in Sweden. On a ten-point scale, the median (25-75% quartile) of participant-reported implementation feasibility ranged from 7.4 (6.9-7.8) in Greece to 9.2 (8.2-9.9) in Sweden. Willingness to change lifestyle exceeded 80% in all countries. (4) Conclusions: A substantial variation in the implementation of selective-prevention receptiveness and patient risk profile was observed among countries. Our findings suggest that the design and implementation of behavior change cardiometabolic programmes in each country should be informed by the local context and provide some background evidence towards this direction, which can be even more relevant during the current pandemic period.

• Keywords
• cardio-vascular diseases, cardiometabolic diseases, feasibility study, prevention, primary care, risk reduction,
• MeSH
• Adult MeSH
• Cardiovascular Diseases * epidemiology   prevention & control   MeSH
• Middle Aged MeSH
• Humans MeSH
• Primary Health Care * MeSH
• Aged MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Geographicals
• Czech Republic MeSH
• Europe MeSH
• Greece MeSH
• Sweden epidemiology   MeSH

Cardio-metabolic diseases (CMD; cardiovascular disease, type 2 diabetes, chronic kidney disease) represent a global public health problem. Worldwide, nearly half a billion people are currently diagnosed with diabetes, and cardiovascular disease is the leading cause of death. Most of these diseases can be assuaged/prevented through behavior change. However, the best way to implement preventive interventions is unclear. We aim to fill this knowledge gap by creating an evidence-based and adaptable "toolbox" for the design and implementation of selective prevention initiatives (SPI) targeting CMD. We built our toolbox based on evidence from a pan-European research project on primary-care SPIs targeting CMD. The evidence includes (1) two systematic reviews and two surveys of patient and general practitioner barriers and facilitators of engaging with SPIs, (2) a consensus meeting with leading experts to establish optimal SPI design, and (3) a feasibility study of a generic, evidence-based primary-care SPI protocol in five European countries. Our results related primarily to the five different national health-care contexts from which we derived our data. On this basis, we generated 12 general recommendations for how best to design and implement CMD-SPIs in primary care. We supplement our recommendations with practical, evidence-based suggestions for how each recommendation might best be heeded. The toolbox is generic and adaptable to various national and systemic settings by clinicians and policy makers alike. However, our product needs to be kept up-to-date to be effective and we implore future research to add relevant tools as they are developed.

• Keywords
• Behavior change, Cardiovascular disease, Lifestyle-related disease, Prevention, Preventive health care, Primary care, Self-efficacy,
• Publication type
• Journal Article MeSH
• Review MeSH

Background: Selective prevention of cardiometabolic diseases (CMD)-that is, preventive measures specifically targeting the high-risk population-may represent the most effective approach for mitigating rising CMD rates. Objectives: To develop a universal concept of selective CMD prevention that can guide implementation within European primary care. Methods: Initially, 32 statements covering different aspects of selective CMD prevention programmes were identified based on a synthesis of evidence from two systematic literature reviews and surveys conducted within the SPIMEU project. The Rand/UCLA appropriateness method (RAM) was used to find consensus on these statements among an international panel consisting of 14 experts. Before the consensus meeting, statements were rated by the experts in a first round. In the next step, during a face-to-face meeting, experts were provided with the results of the first rating and were then invited to discuss and rescore the statements in a second round. Results: In the outcome of the RAM procedure, 28 of 31 statements were considered appropriate and three were rated uncertain. The panel deleted one statement. Selective CMD prevention was considered an effective approach for preventing CMD and a proactive approach was regarded as more effective compared to case-finding alone. The most efficient method to implement selective CMD prevention systematically in primary care relies on a stepwise approach: initial risk assessment followed by interventions if indicated. Conclusion: The final set of statements represents the key characteristics of selective CMD prevention and can serve as a guide for implementing selective prevention actions in European primary care.

• Keywords
• Selective prevention, cardiometabolic disease, consensus development, general practice, primary care,
• MeSH
• Risk Assessment methods   MeSH
• Cardiovascular Diseases prevention & control   MeSH
• Consensus MeSH
• Humans MeSH
• Metabolic Diseases prevention & control   MeSH
• Delivery of Health Care organization & administration   MeSH
• Primary Health Care organization & administration   MeSH
• Risk Factors MeSH
• Preventive Health Services organization & administration   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Geographicals
• Europe MeSH