A socio-ecological approach to reduce the physical activity drop-out ratio in primary care-based patients with type 2 diabetes: the SENWI study protocol for a randomized control trial

BACKGROUND: Physical activity (PA) is a key behaviour for patients with type 2 diabetes (T2DM). However, healthcare professionals' (HCP) recommendations (walking advice), which are short-term and individually focused, did not reduce the PA drop-out ratio in the long run. Using a socio-ecological model approach may contribute to reducing patient dropout and improving adherence to PA. The aim of this study is threefold: first, to evaluate the effectiveness of a theory-driven Nordic walking intervention using a socio-ecological approach with T2DM patients in Spain; second, to explore the feasibility on the PA adherence process in T2DM patients while participating in the SENWI programme; and third, to understand the HCPs' opinion regarding its applicability within the Spanish healthcare system. METHODS: A three-arm randomized control trial (n = 48 each group) will assess the efficacy of two primary care-based PA interventions (Nordic walking vs. Nordic walking plus socio-ecological approach; two sessions per week for twelve weeks) compared to a control group (usual HCPs' walking advice on PA). Inclusion criteria will include physically inactive patients with T2DM, older than 40 years and without health contraindications to do PA. PA levels and drop-out ratio, quality of life and metabolic and health outcomes will be assessed at baseline, post-intervention and at 9- and 21-month follow-ups. The effect of the different interventions will be assessed by a two-factor analysis of variance: treatment group vs time. Also, a two-factor ANOVA test will be performed with linear mixed models for repeated measures. A qualitative analysis using focus groups will explore the reasons for the (in)effectiveness of the new PA interventions. Qualitative outcomes will be assessed at post-intervention using thematic analysis. DISCUSSION: Compared with the general PA walking advice and Nordic walking prescriptions, integrating a socio-ecological approach into Spanish primary care visits could be an effective way to reduce the PA drop-out ratio and increase PA levels in patients with T2DM. Such interventions are necessary to understand the role that multiple socio-complex process in day-to-day PA behaviour has in patients with T2DM in the Spanish context. TRIAL REGISTRATION: ClinicalTrials.gov NCT05159089. Physical Activity Drop-out Ratio in Patients' Living with Type 2 Diabetes. Prospectively registered on 15 December 2021.