JMIR Publications

ABSTRACT

Objective Healthy eating can improve the course of Type 2 Diabetes Mellitus (T2DM) considerably. This article describes the study protocol of an invention study that will examine the effects of a new nutritional program for T2DM on food literacy and wellbeing: the SALUD (Salutogenic intervention for T2DM) program. Methods A semi-blinded Randomised Controlled Trial (RCT) will be performed in The Netherlands. A sample size of 56 (including a 30% drop-out rate) people with T2DM has been calculated, of whom half (n= 28) will follow the SALUD program (intervention) and half will receive usual care (control). Recruitment strategies consist of advertisement via local health care professionals, posters, social media, and local newspapers. The SALUD program consists of 12 weekly online group sessions under supervision of a certified lifestyle coach. Fidelity of the delivery is guaranteed by use of an intervention manual, training of the coach, weekly evaluation forms, and recording several sessions. The theoretical principle of the intervention is mobilising two important psychosocial resources required for organising healthy eating in everyday life: self-identity and social support. Measurements will be performed at three times: baseline (=T0), post-intervention (after 12 weeks =T1), and at follow-up (after 24 weeks =T2). The primary outcome is food literacy measured with the SPFLS questionnaire (expected effect size = 0.9). Secondary outcomes are self-efficacy, quality of life (QoL), sense of coherence (SoC), diet quality, body weight, BMI, and waist-hip ratio (WHR). All outcomes will be tested with linear mixed models, following an intention-to-treat approach and standard principles of RCTs. Discussion This study assesses the effects of the SALUD program on skills required for navigating different food environments, as well as on wellbeing. The results can contribute to more effective, personalised interventions for T2DM. Trial registration The trial is registered at www.trialregister.nl with registration number NL8963. Medical ethical approval has been granted by the Medical Ethical Committee (METC) Oost-Nederland (METC number 2021-12949).