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NCT Number: NCT07728669

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity (Disorder) Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kazakh Academy of Nutrition LLP

Almaty, 050008, Kazakhstan

Location status: Recruiting

Location contact

Almaz Sharman

CONTACT

[email protected]

+77771114202

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NutriSteppe Digital Dietary Intervention

Behavioral

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Change From Baseline in Triglycerides at Week 12

    Time frame: Baseline and Week 12

    Triglycerides 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.

  12. Change From Baseline in LDL-C to HDL-C Ratio at Week 12

    Time frame: Baseline and Week 12

    The ratio of low-density lipoprotein cholesterol to high-density lipoprotein cholesterol will be calculated at baseline and at week 12. Change will be calculated as the week 12 ratio minus the baseline ratio.

  13. Proportion of Participants Achieving LDL-C Below 2.6 mmol/L at Week 12

    Time frame: Week 12

    The proportion of participants with low-density lipoprotein cholesterol below 2.6 mmol/L at week 12 will be calculated.

  14. Change From Baseline in Systolic Blood Pressure at Week 12

    Time frame: Baseline and Week 12

    Systolic blood pressure will be measured in mmHg at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value.

  15. Change From Baseline in Diastolic Blood Pressure at Week 12

    Time frame: Baseline and Week 12

    Diastolic blood pressure will be measured in mmHg at baseline and at week 12. Change will be calculated as the week 12 value minus the baseline value.

  16. Proportion of Participants Achieving Blood Pressure Below 130/80 mmHg at Week 12

    Time frame: Week 12

    The proportion of participants with systolic blood pressure below 130 mmHg and diastolic blood pressure below 80 mmHg at week 12 will be calculated.

  17. Number of Participants With Adverse Events by Severity

    Time frame: From informed consent through 30 days after the Week 12 visit

    Adverse events will be recorded and graded by severity according to the Common Terminology Criteria for Adverse Events version 5.0. Events will be classified as grade 1 mild, grade 2 moderate, grade 3 severe, grade 4 life-threatening, or grade 5 fatal.

  18. Number of Participants With Serious Adverse Events

    Time frame: From informed consent through 30 days after the Week 12 visit

    The number of participants experiencing at least one serious adverse event will be recorded. Serious adverse events include death, a life-threatening event, hospitalization or prolonged hospitalization, significant disability, congenital anomaly, or another medically important event.

  19. Change From Baseline in Vital Signs Through Week 12

    Time frame: Baseline through Week 12

    Changes in vital signs, including blood pressure and heart rate, will be assessed during study visits.

  20. Change From Baseline in Safety Laboratory Parameters at Week 12

    Time frame: Baseline and Week 12

    Changes in safety laboratory parameters will be assessed from baseline to week 12. Evaluations include liver function tests and renal function tests specified in the study protocol.

  21. Proportion of Participants Who Discontinue the Study Early

    Time frame: Baseline through Week 12

    The proportion of participants who discontinue study participation before completing the week 12 visit will be calculated.

  22. Change From Baseline in the Adapted 14-Item Mediterranean Diet Adherence Screener Score at Week 12

    Time frame: Baseline and Week 12

    Diet quality will be assessed using the adapted 14-item Mediterranean Diet Adherence Screener (MEDAS). Each item is scored as 0 or 1, and the item scores are summed to produce a total score ranging from 0 to 14. Higher scores indicate greater adherence to healthy dietary recommendations. Scores from 0 to 5 indicate low adherence, scores from 6 to 9 indicate moderate adherence, and scores from 10 to 14 indicate high adherence. These categories are used only for descriptive reporting. The primary analysis uses the total score as a continuous variable. Change will be calculated as the week 12 score minus the baseline score.

    The adapted version differs from the original PREDIMED MEDAS. It assesses unsweetened green or herbal tea instead of wine and does not require at least one vegetable serving to be consumed raw. The adapted version has not been psychometrically validated.

  23. Change From Baseline in the 12-Item Short Form Health Survey Physical Component Summary Score at Week 12

    Time frame: Baseline and Week 12

    Physical health-related quality of life will be assessed using the Physical Component Summary (PCS) score of the 12-Item Short Form Health Survey (SF-12). The PCS score is calculated using the official licensed QualityMetric/Optum Insight scoring algorithm and is reported on a norm-based scale ranging from 0 to 100. Higher scores indicate better physical health-related quality of life. Change will be calculated as the week 12 score minus the baseline score.

  24. Change From Baseline in the 12-Item Short Form Health Survey Mental Component Summary Score at Week 12

    Time frame: Baseline and Week 12

    Mental health-related quality of life will be assessed using the Mental Component Summary (MCS) score of the 12-Item Short Form Health Survey (SF-12). The MCS score is calculated using the official licensed QualityMetric/Optum Insight scoring algorithm and is reported on a norm-based scale ranging from 0 to 100. Higher scores indicate better mental health-related quality of life. Change will be calculated as the week 12 score minus the baseline score.

  25. Mean Item Score on the Study-Specific Dietary Adherence Self-Assessment Questionnaire

    Time frame: Weeks 4, 8, and 12

    Dietary adherence in the intervention group will be assessed using the study-specific Dietary Adherence Self-Assessment Questionnaire developed for this study. The instrument contains 9 positively worded items. Each item is scored from 1 (never) to 5 (always), with no reverse scoring. The primary measure is the mean item score, ranging from 1.0 to 5.0. Higher scores indicate better self-reported dietary adherence.

    If 1 or 2 items are missing, the mean is calculated using the answered items. If 3 or more items are missing, the score is considered invalid and recorded as missing. The instrument has not been validated and has no validated cut-off values.

  26. Overall Self-Rated Dietary Adherence in the Intervention Group

    Time frame: Weeks 4, 8, and 12

    Overall dietary adherence will be self-rated using a study-specific numerical scale ranging from 0 to 100. Higher scores indicate better self-reported dietary adherence. This score is analyzed separately and is not combined with the mean score from the 9 questionnaire items. The scale has not been validated and has no validated cut-off values.

  27. Usability of the NutriSteppe Application Assessed Using the System Usability Scale

    Time frame: Week 12

    Application usability will be assessed using the 10-item System Usability Scale (SUS). The total score ranges from 0 to 100, with higher scores indicating better perceived usability of the "NutriSteppe" application.

Other outcomes

  1. Frequency of Self-Reported Dietary Adherence Difficulties

    Time frame: Weeks 4, 8, and 12

    Participants in the intervention group will select one or more dietary adherence difficulties experienced during the previous week. Responses are not summed into a score. Each difficulty will be reported separately as the number and proportion of participants selecting that response. Therefore, this outcome has no minimum or maximum scale value.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayaulym Omirbekova

CONTACT

[email protected]

+77757211170

Sponsors and collaborators

Lead sponsor

Kazakh Academy of Nutrition

Other

Collaborators

  • Science Committee of the Ministry of Science and Higher Education of the Republic of Kazakhstan

Registry information

Official study title

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

Acronym: NutriSteppe

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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