Digital Dietary Intervention for Patients Receiving GLP-1 Receptor Agonist Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-65
SponsorKazakh Academy of Nutrition
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
NutriSteppe Digital Dietary Intervention
BehavioralThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: NutriSteppe Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 12Secondary outcomes
1
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 122
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 123
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 124
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 12Other outcomes
1
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 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kazakh Academy of Nutrition
Lead sponsor
Science Committee of the Ministry of Science and Higher Education of the Republic of Kazakhstan
Collaborator
Source ClinicalTrials.gov