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Background: The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza. Methods/design: This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation. Discussion: The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice. Trial registration: ClinicalTrials.gov NCT01365013 [ABSTRACT FROM AUTHOR]

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Background & Aims: Few studies have compared micronutrient intake and fulfilment of average requirements (EAR) in non-diabetic, pre-diabetic and diabetic adults at high cardiovascular risk. We assessed these variables in a large sample of participants in the PREDIMED-PLUS randomized trial of primary cardiovascular prevention with diet and physical activity., Design: Baseline assessment of nutritional adequacy in n = 5792 men and women, aged 55-75 years, with overweight/obesity and some metabolic syndrome features., Methods: Participants were categorised as non-diabetic (n = 2390), pre-diabetic (n = 1322) or diabetic (n = 2080) by standard criteria. Food and nutrient intake were assessed using a validated food frequency questionnaire. Micronutrients examined were vitamins B1, B2, B3, B6, B12, A, C, D, E and folic acid; Ca, K, P, Mg, Fe, Se, Cr, Zn, and iodine. The proportion of micronutrient inadequacy was evaluated using the EAR or adequate intake (AI) cut-offs. Diet quality was also determined using a 17-item energy-restricted Mediterranean diet (MedDiet) questionnaire., Results: Compared to non-diabetic participants, those with pre-diabetes had lower intakes of total carbohydrates (CHO) and higher intakes of total fat and saturated fatty acids (SFA) and were more likely to be below EAR for folic, while diabetic participants had lower intakes of total CHO and higher intakes of protein, total fat, monounsaturated fatty acids, SFA and cholesterol and were less likely to be below EAR for vitamins B2, and B6, Ca, Zn and iodine. Diabetic participants disclosed higher adherence to the MedDiet than the other two groups., Conclusions: Older Mediterranean individuals with metabolic syndrome and diabetes had better nutrient adequacy and adherence to the MedDiet than those with pre-diabetes or no diabetes., (Copyright © 2019 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.)

Background: There is a lack of evidence concerning the effectiveness of different strategies to engage healthcare professionals in collaborative processes that seek to optimise clinical practice. The PREDIAPS project aims to assess the effect of different primary health care (PHC) providers' engagement procedures in the creation and execution of a facilitated interprofessional collaborative process to optimise the integration of the recommended clinical practice for the prevention of type-2 diabetes (T2D) in routine PHC., Methods: This will be a randomised cluster type II hybrid implementation trial. Nine PHC centres from the Basque Health Service (Osakidetza) will be allocated to two different procedures to engage family doctors and nurses and create an interprofessional collaborative practice to optimise the integration of a T2D primary prevention programme. All centres and PHC professionals will receive training on current guidelines in primary prevention of T2D and effective interventions to promote healthy lifestyles. Headed by a local leader and an external facilitator, centres will conduct a collaborative structured process to model and adapt the intervention and its implementation to the specific context of professionals and centres. One of the groups will apply this strategy globally, promoting the cooperation of all health professionals from the beginning. The other will perform it sequentially, centred first on nurses, who will then seek the pragmatic cooperation of doctors. All patients without diabetes aged ≥ 30 years old who attend collaborating centres at least once during the study period and found to be at high risk of developing T2D will be eligible for programme inclusion. The main outcome measures focus on changes observed in indicators of T2D prevention clinical practice at centre level after 12 and 24 months, associated with the application of one or other engagement procedure. Secondary outcomes will compare their clinical effectiveness in changing eligible exposed patients' main lifestyle behaviours and risk factors (physical activity and diet, weight, etc.) after 12 months., Discussion: The PREDIAPS project will generate scientific knowledge on procedures for engaging PHC professional to facilitate feasible and effective adoption of proven interventions for the prevention of T2D in routine clinical practice through the application of implementation strategies., Trial Registration: Clinicaltrials.gov identifier: NCT03254979 . Registered 16 August 2017.