Diabetes mellitus type 2, Non-insulin dependent diabetes Diabetes
Conditions
Interventions
Participants in the intervention group will receive weekly healthy plant-based food boxes, coaching sessions with a dietitian, and culinary and health workshops, for six months. 
Participants in the control group will only receive coaching sessions with a dietitian, since this is usual care.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Diagnosed type 2 diabetesBMI > 25 kg/m2 Aged 18-75 yearsBe living in Rotterdam South or Rotterdam WestYearly income below 25.000 euro
Exclusion criteria
Exclusion criteria: Pregnancy or lactation during the trialSevere psychiatric disorders, use of antipsychotic drugsSerious heart conditions such as: significant heart arrhythmia, unstable angina pectoris, decompensated congestive heart failureOrgan failureUntreated hypothyroidism End-stage renal failure CarcinomasTransplants, myocardial infarct, cerebrovascular accident, or any large-scale surgery within the last 3 months Corticosteroid-induced diabetes (in patients still using corticosteroids)Start with GLP-1 agonists within the last 3 months or during the studyFood allergies for the products delivered in the food boxes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between-group difference in weight (kg) from baseline to six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Nutritional assessment: height (cm), waist circumference (cm), fat mass and lean body mass measured with Bio-electrical Impedance Analysis (Bodystat 4000, Euromedix, Leuven, Belgium) and grip strength (kg, Jamar)Cardiovascular risk factors: HbA1c (mmol/mol), fasting blood glucose (mmol/l), total cholesterol (mmol/l), LDL cholesterol (mmol/l), HDL cholesterol (mmol/l), triglycerides (mmol/l) and blood pressure (mmHg), measured with routine lab proceduresLiver-related markers: alanine aminotransferase (U/L), aspartate aminotransferase (U/L), gamma-glutamyl transferase (U/L), alkaline phosphatase (U/L), total bilirubin (µmol/L), thrombocytes (x 10?/L), measured with routine lab proceduresFood intake and adherence to the diet intervention (3-day food diary)Quality of life (SF-36 Questionnaire)Patient satisfaction (Diabetes Treatment Satisfaction Questionnaire (DTSQ))Gut microbiome (sub-study): gut microbiome composition and selected stool biomarkers assessed in a randomly selected subgroup (50% of participants per study arm)Social impact based on focus groups (Ripple Effect Method)Demographic variables, drug use, smoking and drinking habits, exercise and (diabetes) medication use (self-developed questionnaire)Physical activity (Short Questionnaire to asses health enhancing physical activity (SQUASH))Household Food Security Survey Scale (HFSS)Number of participants that drop out (categorized by reason for drop-out) | — |
Countries
Netherlands
Contacts
Public ContactC. Dietvorst
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed