AIM: The purpose of this study was to assess the efficacy of an educational intervention based on the Behavior Change Wheel (BCW) framework for individuals with type 2 diabetes mellitus (T2DM) on dietary and physical activity recommendations in a Spanish region. METHODS: A two-arm pragmatic randomized pilot trial was developed. The intervention consisted of a 6-month period with three components: face-to-face counseling, a phone call, and specially designed written guidelines focusing on dietary and physical activity recommendations The primary outcome was changes in dietary and physical activity recommendations. The secondary outcome, the impact of the intervention on HbA1c levels, body mass index, and the frequency of consultations to primary care. RESULTS: n=208 patients were recruited. Individuals in the intervention experienced a significative improvement in adherence to dietary recommendations (+0.52
p-value<
0.001), physical activity (+0.79
p-value<
0.001), and a decrease in HbA1c levels (0.11 %
p-value=0.04). CONCLUSION: The 6-month intervention, designed for T2DM patients and based on the BCW model, has demonstrated effectiveness in improving adherence to healthy dietary and physical activity recommendations, as well as reducing HbA1c levels.