Type 2 diabetes mellitus, aged more than 18 years, diagnosed within the past 5 years, and who are overweight Diabetes Mellitus, Type 2 Diabetes remission Intensive lifestyle intervention
Conditions
Interventions
Participants will undergo a Thai-style intensive lifestyle intervention focused on healthy eating using the 2:1:1 Siam Diet approach. This diet divides a 9-inch plate into four equal parts (2 parts be
Experimental Procedure/Surgery,Experimental Procedure/Surgery,No Intervention Other
2:1:1 Siam Diet ,SIAM Diet with very-low to low-calorie restriction,Control Group
Sponsors
Health Systems Research Institute (HSRI)
WHO Country Cooperation Strategy on NCDs
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Demonstrated willingness and commitment to behavioral change (assessed by trained medical personnel) 2. Type 2 diabetes mellitus 3. Diagnosed with diabetes for no more than 5 years 4. Body mass index above 23 kilograms/ per square meter 5. HbA1C less than 9% 6. Capable of using a smartphone and accessing the internet
Exclusion criteria
Exclusion criteria: 1. On treatment with insulin, GLP-1 receptor agonists, or SGLT-2 inhibitors 2. Pregnant or breastfeeding women or those planning pregnancy within 2 years 3. History of severe or unstable heart failure, recent ischemic heart disease, or stroke within the past 6 months 4. Patients with cirrhosis (Child-Pugh C), chronic kidney disease stage 3b or higher (GFR less than 45 mL/min), or severe diabetic retinopathy (NPDR or PDR) 5. Severe arthritis or physical limitations affecting the ability to follow the program 6. Life expectancy less than 1 year 7. Severe psychiatric disorders that impede behavioral change (e.g., major depressive disorder, schizophrenia, bipolar disorder, or eating disorders) 8. Use of medications that significantly affect blood glucose or appetite and require long-term administration (e.g., corticosteroids, herbal/traditional medicines, psychiatric medications, chemotherapy) 9. Limitations in reading, writing, or comprehension that hinder participation (e.g., dementia, visual or hearing impairment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Initial diabetes remission 3 months after discontinuing medication HbA1C | — |
Secondary
| Measure | Time frame |
|---|---|
| Diabetes remission at 1 year 1 year after discontinuing medication HbA1C,Diabetes remission at 2 years 2 years after discontinuing medication HbA1C,Patient characteristics associated with successful remission following intensive lifestyle intervention 1 year body weight, waist circumference, blood pressure, lipid profiles, quality of life, patient-reported outcomes and experiences, diabetes-related distress,Comparing clinical parameters before and after the intervention 1 year body weight, waist circumference, blood pressure, lipid profiles, quality of life, patient-reported outcomes and experiences, diabetes-related distress, and healthcare costs,Implentation 1 year Assess the feasibility of implementing Thai-style intensive lifestyle interventions in real-world clinical practice within Thai public health system,Economics 1 year Evaluate the cost-effectiveness of the Thai-style intensive lifestyle intervention in achieving diabetes remission among T2DM patients | — |
Countries
Thailand
Contacts
Public ContactWeerachai Srivanichakorn
Mahidol University
Outcome results
None listed