An interventional study of NutriSteppe Digital Dietary Intervention in Type 2 Diabetes Mellitus (T2DM), Obesity (Disorder) and Overweight, sponsored by Kazakh Academy of Nutrition. Recruiting at 1 site in Kazakhstan. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Kazakh Academy of Nutrition · Not applicable, Interventional, and Other
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:
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Kazakh Academy of Nutrition is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive routine medical care, including GLP-1 receptor agonist therapy and other medications prescribed by their treating physician outside the study, together with general lifestyle advice. Participants do not have access to the NutriSteppe personalized dietary intervention during the 12-week study period. Participants photograph all eating occasions for dietary intake measurement. The photographs are analyzed automatically using Tagam-AI, and the analysis results are displayed to participants. The photographic recording, automated analysis, and display of results are identical in both study groups. Participants in the control group do not receive personalized dietary recommendations generated from these data.
Participants receive routine medical care, including GLP-1 receptor agonist therapy and other medications prescribed by their treating physician outside the study, together with a 12-week personalized digital dietary intervention delivered through the NutriSteppe application. Participants photograph all eating occasions for dietary intake measurement. The photographs are analyzed automatically using Tagam-AI, and the analysis results are displayed to participants. The photographic recording, automated analysis, and display of results are identical in both study groups. Only participants in this group receive personalized dietary recommendations generated from these data through the NutriSteppe application.
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.
Change From Baseline in Glycated Hemoglobin (HbA1c) at 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.
Time frame: Baseline and Week 12
Change From Baseline in Fasting Plasma Glucose at 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.
Time frame: Baseline and Week 12
Proportion of Participants Achieving HbA1c Below 6.5% at 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.
Time frame: Week 12
Change From Baseline in Body Weight at 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.
Time frame: Baseline and Week 12
Percentage Change From Baseline in Body Weight at 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.
Time frame: Baseline and Week 12
Proportion of Participants Achieving at Least 5% Weight Loss at Week 12
The proportion of participants whose body weight decreases by at least 5% from baseline to week 12 will be calculated.
Time frame: Baseline and Week 12
Change From Baseline in Body Mass Index at 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.
Time frame: Baseline and Week 12
Change From Baseline in Waist Circumference at 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.
Time frame: Baseline and Week 12
Change From Baseline in LDL Cholesterol at 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.
Time frame: Baseline and Week 12
Change From Baseline in HDL Cholesterol at 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.
Time frame: Baseline and Week 12
Change From Baseline in Total Cholesterol at 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.
Time frame: Baseline and Week 12
Change From Baseline in Triglycerides at 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.
Time frame: Baseline and Week 12
Change From Baseline in LDL-C to HDL-C Ratio at 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.
Time frame: Baseline and Week 12
Proportion of Participants Achieving LDL-C Below 2.6 mmol/L at Week 12
The proportion of participants with low-density lipoprotein cholesterol below 2.6 mmol/L at week 12 will be calculated.
Time frame: Week 12
Change From Baseline in Systolic Blood Pressure at 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.
Time frame: Baseline and Week 12
Change From Baseline in Diastolic Blood Pressure at 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.
Time frame: Baseline and Week 12
Proportion of Participants Achieving Blood Pressure Below 130/80 mmHg at 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.
Time frame: Week 12
Number of Participants With Adverse Events by Severity
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.
Time frame: From informed consent through 30 days after the Week 12 visit
Number of Participants With Serious Adverse Events
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.
Time frame: From informed consent through 30 days after the Week 12 visit
Change From Baseline in Vital Signs Through Week 12
Changes in vital signs, including blood pressure and heart rate, will be assessed during study visits.
Time frame: Baseline through Week 12
Change From Baseline in Safety Laboratory Parameters at 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.
Time frame: Baseline and Week 12
Proportion of Participants Who Discontinue the Study Early
The proportion of participants who discontinue study participation before completing the week 12 visit will be calculated.
Time frame: Baseline through Week 12
Change From Baseline in the Adapted 14-Item Mediterranean Diet Adherence Screener Score at 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.
Time frame: Baseline and Week 12
Change From Baseline in the 12-Item Short Form Health Survey Physical Component Summary Score at 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.
Time frame: Baseline and Week 12
Change From Baseline in the 12-Item Short Form Health Survey Mental Component Summary Score at 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.
Time frame: Baseline and Week 12
Mean Item Score on the Study-Specific Dietary Adherence Self-Assessment Questionnaire
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.
Time frame: Weeks 4, 8, and 12
Overall Self-Rated Dietary Adherence in the Intervention Group
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.
Time frame: Weeks 4, 8, and 12
Usability of the NutriSteppe Application Assessed Using the System Usability Scale
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.
Time frame: Week 12
Frequency of Self-Reported Dietary Adherence Difficulties
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.
Time frame: Weeks 4, 8, and 12
Plan to share: Yes — De-identified individual participant data may be shared with qualified researchers upon reasonable request after publication of the primary study results.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The data and supporting information will become available after publication of the primary study results. The protocol does not specify an end date for availability.
Access criteria: De-identified individual participant data may be provided to qualified researchers upon submission of a reasonable research request. Access will require a data sharing agreement and ethics committee approval.
No publications or documents are linked to this record.
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Kazakh Academy of Nutrition