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

Kazakh Academy of Nutrition120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

120

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts