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

Sponsor
Kazakh Academy of Nutrition
Study ID
NCT07728669
Status
Recruiting
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Conditions

  • Metabolic Syndrome
  • Obesity (Disorder)
  • Overweight
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • No Intervention: Control Group
    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.
  • Experimental: NutriSteppe Intervention Group
    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.

Primary Outcome Measure

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline and Week 12 ]

Central Contacts

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