Salutogenic intervention for Diabetes Type 2

Rationale: Healthy eating is challenging for people with Type 2 Diabetes Mellitus (T2DM). Science has demonstrated impressive effects of nutritional therapy in controlled research settings, but in everyday-life, things are more complex. Therefore, we have used the Salutogenic Model of Health –focused on the resources which are required to organise behavioural change within the everyday-life context– to develop an intervention to enable healthy eating: the Salutogenic intervention of Type 2 Diabetes Mellitus (SALUD)-intervention. Our hypothesis is that the SALUD-intervention will lead to healthier eating practices and increased psychosocial and physical health for people with T2DM compared to people with T2DM following the standard Dutch T2DM healthcare.
Objective: to determine the effect of the SALUD-intervention on eating practices (measured with food literacy)
Study design: two arms, blinded, Randomized Controlled Trial (RCT)
Study population: 56 individuals (28 in each arm) that are officially diagnosed with T2DM, aged >18-75 years, fluent in Dutch that are competent to make own decisions, are in possession of a laptop/computer with internet connection, do not suffer from severe disease other than T2DM, are not pregnant or lactating, do not had bariatric surgery, and do not have eating disorders.
Intervention: The SALUD intervention distinguishes from the standard T2DM care by its holistic, salutogenic and pragmatic approach towards a healthier diet. The SALUD intervention is a multicomponent intervention consisting of 12 weekly online group sessions. In the online group sessions, participants are supported in setting and working on personal health goals by reflection on goal process every week. Each session has its own theme related to building trust, food skills, stress management, social support or self-identity. For one session, participants will choose the theme of this session themselves. All sessions are supervised by a certified lifestyle coach who is sometimes supported by a dietician. Three months after the final session, there is a booster session. The control group will receive the standard Dutch T2DM provided by their regular practice nurse/GP. Measurements for all participants will be performed at T0 (baseline), T1 (post-intervention; 11 weeks) and T2 (follow-up; 24 weeks).
Main study parameters/endpoints: adjusted mean change in food literacy score (via questionnaire) at T1 and T2. Secondary outcomes: the adjusted mean changes in BMI, waist-hip ratio, self-efficacy, quality of life, Sense of Coherence, the diet quality and at T1 and T2.
Nature and extent of the burden and risks associated with participation: The overall risks and the burdens associated with participation can be considered negligible. The SALUD-study does not test a drug or medicine that can potentially result in adverse effects affecting vital organ systems or in life-threatening situations. Instead, the SALUD-intervention recommends a safe and healthy diet. Burdens may include the the psychosocial questionnaires (3x), and the time commitment (30 hours for the intervention group, 6 hours for the control group). The harm will be avoided/reduced by ensuring that the participants are given enough information in a sufficiently clear manner, monitoring the psychosocial health of participants. Furthermore, the participants will receive a reward of 150 euro after completion of the study.

Our hypothesis is that the SALUD-intervention will lead to healthier eating practices and increased health in people with T2DM compared to people with T2DM following the standard Dutch T2DM healthcare

0 wk (t0; baseline), 12 wk (t1; post-intervention) and 24 wk (t2; follow-up)

The SALUD intervention distinguishes from the standard T2DM care by its holistic, salutogenic and pragmatic approach towards a healthier diet. The SALUD intervention is a multicomponent intervention consisting of 12 weekly online group sessions. In the group sessions, participants are supported in setting and working on personal health goals by reflection on goal process every week. Each session has its own theme related to building trust, food skills, stress management, social support or self-identity. For one session, participants will choose the theme of this session themselves. All sessions are supervised by a certified lifestyle coach. A dietician is present at specific sessions.