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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: NutriSteppe Digital Dietary Intervention (Behavioral)
结局指标
主要结局
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12
时间窗: 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.
次要结局
- Change From Baseline in Fasting Plasma Glucose at Week 12(Baseline and Week 12)
- Proportion of Participants Achieving HbA1c Below 6.5% at Week 12(Week 12)
- Change From Baseline in Body Weight at Week 12(Baseline and Week 12)
- Percentage Change From Baseline in Body Weight at Week 12(Baseline and Week 12)
- Proportion of Participants Achieving at Least 5% Weight Loss at Week 12(Baseline and Week 12)
- Change From Baseline in Body Mass Index at Week 12(Baseline and Week 12)
- Change From Baseline in Waist Circumference at Week 12(Baseline and Week 12)
- Change From Baseline in LDL Cholesterol at Week 12(Baseline and Week 12)
- Change From Baseline in HDL Cholesterol at Week 12(Baseline and Week 12)
- Change From Baseline in Total Cholesterol at Week 12(Baseline and Week 12)
- Change From Baseline in Triglycerides at Week 12(Baseline and Week 12)
- Change From Baseline in LDL-C to HDL-C Ratio at Week 12(Baseline and Week 12)
- Proportion of Participants Achieving LDL-C Below 2.6 mmol/L at Week 12(Week 12)
- Change From Baseline in Systolic Blood Pressure at Week 12(Baseline and Week 12)
- Change From Baseline in Diastolic Blood Pressure at Week 12(Baseline and Week 12)
- Proportion of Participants Achieving Blood Pressure Below 130/80 mmHg at Week 12(Week 12)
- Number of Participants With Adverse Events by Severity(From informed consent through 30 days after the Week 12 visit)
- Number of Participants With Serious Adverse Events(From informed consent through 30 days after the Week 12 visit)
- Change From Baseline in Vital Signs Through Week 12(Baseline through Week 12)
- Change From Baseline in Safety Laboratory Parameters at Week 12(Baseline and Week 12)
- Proportion of Participants Who Discontinue the Study Early(Baseline through Week 12)
- Usability of the NutriSteppe Application Assessed Using the System Usability Scale(Week 12)
- Change From Baseline in the Adapted 14-Item Mediterranean Diet Adherence Screener Score at Week 12(Baseline and Week 12)
- Change From Baseline in the 12-Item Short Form Health Survey Physical Component Summary Score at Week 12(Baseline and Week 12)
- Change From Baseline in the 12-Item Short Form Health Survey Mental Component Summary Score at Week 12(Baseline and Week 12)
- Mean Item Score on the Study-Specific Dietary Adherence Self-Assessment Questionnaire(Weeks 4, 8, and 12)
- Overall Self-Rated Dietary Adherence in the Intervention Group(Weeks 4, 8, and 12)