Effects of a Salutogenic Healthy Eating Program in Type 2 Diabetes (the SALUD Study): Protocol for a Randomized Controlled Trial.

Background: Healthy eating can improve the course of type 2 diabetes mellitus (T2DM) considerably. As changing eating behaviors in everyday is challenging, there is a need for a nutritional strategy with an eye for everyday life of people with T2DM. A theory centered around the everyday life context is salutogenesis. Salutogenic principles have been operationalized in a new nutritional program for T2DM on food literacy and well-being: the Salutogenic Intervention for Type 2 Diabetes (SALUD) program.

Objective: This study aims to describe the protocol of the invention study that will examine the quantitative and qualitative effects of the SALUD program.

Methods: A semiblinded randomized controlled trial will be performed in the Netherlands. A sample size of 56 (including a 30% dropout rate) people with T2DM has been calculated, of whom half (n=28, 50%) will follow the SALUD program (intervention) and half (n=28, 50%) 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 web-based group sessions under the supervision of a certified lifestyle coach. Fidelity of the delivery is guaranteed by selecting a salutogenic coach, use of an intervention manual, training of the coach, weekly evaluation forms, and recording several sessions. The theoretical salutogenic principle of the intervention is mobilizing 2 important psychosocial resources required for organizing healthy eating in everyday life: self-identity and social support. Measurements will be performed at 3 times: at baseline (T0), after 12 weeks (postintervention; T1), and after 24 weeks (follow-up; T2). The primary outcome is food literacy, measured with the self-perceived food literacy scale questionnaire (expected effect size=0.9). Secondary outcomes are self-efficacy, quality of life, sense of coherence, diet quality, body weight, BMI, and waist-hip ratio. All outcomes will be tested with linear mixed models, following an intention-to-treat approach and standard principles of randomized controlled trials. In addition, a qualitative analysis will be performed.

Results: The proposed study will provide useful information on the effects of a salutogenic program on healthy eating and well-being in people with T2DM in everyday life. Recruitment started on October 1, 2021. The intervention participants followed the SALUD program between January and August, 2022. The acquisition of the data was completed on August 1, 2022; publications are expected in 2023.

Conclusions: This study will be one of the first salutogenic interventions for T2DM, which will provide valuable information on what salutogenic intervention entail. The SALUD program may serve as a concrete, web-based tool. The combination of quantitative and qualitative measures allows a comprehensive evaluation of effects. These insights can be used for further optimalization of T2DM interventions.

Trial Registration: Netherlands Trial Registry, NL8963; https://trialsearch.who.int/Trial2.aspx?TrialID=NL8963.

International Registered Report Identifier (irrid): DERR1-10.2196/40490.