Current partner codePEPTIDESDE
NCT07728669·Not applicable·INTERVENTIONAL

Digital Dietary Intervention for Patients Receiving GLP-1 Receptor Agonist Therapy

Status

Recruiting

Phase

Not applicable

Enrollment

120

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

BEHAVIORAL

NutriSteppe Digital Dietary Intervention

The NutriSteppe mobile application provides personalized meal planning, a food diary, nutritional analysis, dietary goals, educational modules, culturally adapted recipes, progress monitoring, reminders, and dietary recommendations intended to support metabolic health and food tolerance during GLP-1 receptor agonist therapy. Participants use the application for 12 weeks, complete the food diary at least 5 days per week, record body weight weekly, review dietary suggestions, and complete weekly educational modules.

Timeline

From registration to results.

  1. First posted

    Jul 27, 2026

  2. Study start

    Jul 20, 2026

  3. Primary completion

    Nov 2026

  4. Study completion

    Jan 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 28, 2026

Outcomes

What the study measures.

Primary outcomes

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12

Time frame · Baseline and Week 12

HbA1c will be measured as a percentage at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value. A negative change indicates a reduction in HbA1c.

Secondary outcomes

Change From Baseline in Fasting Plasma Glucose at Week 12

Time frame · Baseline and Week 12

Fasting plasma glucose will be measured in mmol/L at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value. A negative change indicates a reduction in fasting plasma glucose.

Proportion of Participants Achieving HbA1c Below 6.5% at Week 12

Time frame · Week 12

The proportion of participants with glycated hemoglobin (HbA1c) below 6.5% at week 12 will be calculated as the number of participants meeting this threshold divided by the number of participants assessed.

Change From Baseline in Body Weight at Week 12

Time frame · Baseline and Week 12

Body weight will be measured in kilograms at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value. A negative change indicates weight loss.

Percentage Change From Baseline in Body Weight at Week 12

Time frame · Baseline and Week 12

Percentage change in body weight will be calculated as the difference between body weight at week 12 and baseline body weight, divided by baseline body weight and multiplied by 100. A negative value indicates weight loss.

Proportion of Participants Achieving at Least 5% Weight Loss at Week 12

Time frame · Baseline and Week 12

The proportion of participants whose body weight decreases by at least 5% from baseline to week 12 will be calculated.

Change From Baseline in Body Mass Index at Week 12

Time frame · Baseline and Week 12

Body mass index will be calculated in kg/m² at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value. A negative change indicates a reduction in body mass index.

Change From Baseline in Waist Circumference at Week 12

Time frame · Baseline and Week 12

Waist circumference will be measured in centimeters at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value. A negative change indicates a reduction in waist circumference.

Change From Baseline in LDL Cholesterol at Week 12

Time frame · Baseline and Week 12

Low-density lipoprotein cholesterol will be measured in mmol/L at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value.

Change From Baseline in HDL Cholesterol at Week 12

Time frame · Baseline and Week 12

High-density lipoprotein cholesterol will be measured in mmol/L at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value.

Change From Baseline in Total Cholesterol at Week 12

Time frame · Baseline and Week 12

Total cholesterol will be measured in mmol/L at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value.

Eligibility

Who can take part.

Minimum age
21 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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. Exclusion Criteria: * Diagnosis of type 1 diabetes mellitus. * History of diabetic ketoacidosis or hyperglycemic hyperosmolar state. * Initiation of GLP-1 receptor agonist therapy less than 4 weeks before screening. * Current insulin therapy. * Personal or family history of medullary thyroid carcinoma. * Personal history of multiple endocrine neoplasia type 2 (MEN2). * History of acute or chronic pancreatitis. * Active gallbladder disease or history of gallbladder disease within 6 months before screening. * Severe gastrointestinal disease, including gastroparesis. * Major cardiovascular event within 6 months before screening, including myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass grafting, or percutaneous coronary intervention. * Uncontrolled arterial hypertension, defined as systolic blood pressure above 160 mmHg or diastolic blood pressure above 100 mmHg at screening. * Chronic kidney disease with an estimated glomerular filtration rate below 30 mL/min/1.73 m² using the MDRD or CKD-EPI formula. * Severe hepatic impairment classified as Child-Pugh class C, or ALT or AST greater than three times the upper limit of normal. * Active malignancy or history of malignancy within 5 years, except successfully treated basal cell or squamous cell carcinoma of the skin. * Established HIV infection, active hepatitis B defined as HBsAg positive with detectable HBV DNA, or hepatitis C virus infection. * History of bariatric surgery or bariatric surgery planned during the study. * Anorexia nervosa, bulimia nervosa, or binge eating disorder diagnosed or active within the past year. * Pregnancy or breastfeeding. * Planning pregnancy during the study. * Woman of childbearing potential unwilling to use effective contraception. * Use of weight-loss medication, including orlistat, phentermine, combinations with topiramate, naltrexone-bupropion, or other weight-loss medication within 3 months before screening. * Use of systemic corticosteroids, excluding inhaled or topical corticosteroids, for more than 2 weeks within 3 months before screening. * Use of antipsychotic medication associated with significant weight gain unless used at a stable dose for more than 6 months. * Participation in another interventional clinical study within 30 days before screening. * Known hypersensitivity to semaglutide or any excipient. * No smartphone or unwillingness to use digital health technology. * Severe mental disorder impairing the ability to provide informed consent or comply with the protocol. * Active alcohol or drug dependence within the past year. * Any condition that, in the investigator's opinion, may compromise participant safety or the integrity of the study.

Study locations

1 registered sites.

Kazakhstan. Showing up to 24 locations stored in the fast local snapshot.

Kazakh Academy of Nutrition LLP

Almaty, Kazakhstan

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.