Efficacy of a Digital Dietary Intervention (NutriSteppe Application) in Improving Metabolic Parameters in Adults With Type 2 Diabetes Mellitus, Obesity or Overweight With Comorbidities Who Are Receiving GLP-1 Receptor Agonist Therapy and Other Medications Prescribed Under Routine Clinical Protocols
The goal of this clinical trial is to learn whether adding the NutriSteppe digital dietary intervention to routine medical care improves metabolic health in adults aged 21 to 65 years with type 2 diabetes mellitus, obesity, or overweight with related health conditions. Participants are already receiving or have been prescribed glucagon-like peptide-1 (GLP-1) receptor agonist therapy by their treating physicians outside the study. The main question is: Does the NutriSteppe digital dietary intervention improve glycated hemoglobin (HbA1c), a measure of average blood glucose, after 12 weeks compared with routine medical care alone? The study will also assess changes in fasting blood glucose, body weight, body mass index, waist circumference, cholesterol, triglycerides, blood pressure, diet quality, quality of life, dietary adherence, and safety. Researchers will randomly assign participants to one of two groups. The control group will continue routine medical care and receive general lifestyle advice. The intervention group will continue routine medical care and use the NutriSteppe application for 12 weeks to receive personalized dietary support. Participants in both groups will: * Attend study visits and complete the examinations, laboratory tests, and questionnaires specified in the study protocol. * Photograph everything they eat and drink. * Have their food photographs automatically analyzed using Tagam-AI, a system developed for this study. * Be able to view the results of the food photograph analysis. The photography and automated analysis procedures will be the same in both groups. Only participants in the intervention group will receive personalized dietary recommendations generated from these data through the NutriSteppe application.
• Age 21-65 years inclusive at the time of signing informed consent.
• Male or female.
• Overweight with at least one comorbidity, including diabetes mellitus; arterial hypertension of at least 130/85 mmHg or use of antihypertensive medication; dyslipidemia defined as triglycerides of at least 1.7 mmol/L, reduced HDL cholesterol below 1.0 mmol/L in men or below 1.3 mmol/L in women, or use of lipid-lowering medication; cardiovascular disease; respiratory or joint disease; non-alcoholic fatty liver disease; sleep disorders; or other comorbidities.
• For participants with overweight: body mass index of 25.0-29.9 kg/m² for the Caucasian population or 23.0-27.4 kg/m² for the Asian population, together with abdominal obesity defined as waist circumference of at least 94 cm in men and 80 cm in women of the European population, or at least 90 cm in men and 80 cm in women of the Asian population.
• Class I-III obesity where diet combined with physical activity has been ineffective, defined as weight loss of less than 5% over 3 months.
• Class I obesity: body mass index of 30.0-34.9 kg/m² for the Caucasian population or 27.5-32.4 kg/m² for the Asian population.
• Class II obesity: body mass index of 35.0-39.9 kg/m² for the Caucasian population or 32.5-37.4 kg/m² for the Asian population.
• Type 2 diabetes mellitus with HbA1c of at least 6.5% (48 mmol/mol), fasting glucose of at least 6.1 mmol/L in capillary whole blood or at least 7.0 mmol/L in venous plasma, glucose of at least 11.1 mmol/L two hours after an oral glucose tolerance test, or random glucose of at least 11.1 mmol/L.
• Body mass index of at least 25 kg/m² and no more than 40 kg/m² at screening.
• Already receiving, or prescribed, GLP-1 receptor agonist therapy with semaglutide by the treating physician independently of the study. The study does not prescribe or modify this therapy.
• Stable doses of medications for chronic conditions, including antihypertensive agents and statins, for at least 8 weeks before screening.
• Ownership of an iOS or Android smartphone with internet access and willingness to download and use the NutriSteppe application if assigned to the intervention group.
• Ability and willingness to provide written informed consent and comply with study procedures.
• Women of childbearing potential must use effective contraception throughout the study.