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Evaluation of the Effectiveness of a Lifestyle Medicine Program Compared with Standard Care for Achieving Diabetes Remission among Patients with NonInsulin Dependent Type 2 Diabetes over a Six-Month Period

Evaluation of the Effectiveness of a Lifestyle Medicine Program Compared with Standard Care for Achieving Diabetes Remission among Patients with NonInsulin-Dependent Type 2 Diabetes over a Six-Month Period

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260310001
Enrollment
28000
Registered
2026-03-10
Start date
2025-04-30
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus (T2DM) / Noninsulin-treated T2DM Diabetes remission (medication-free remission) Diabetes Mellitus, Type 2 Lifestyle Medicine Remission Induction Treatment Outcome Hemoglobin A1C Hypoglycemic Agents Quality of Life Cost-Benefit Analysis Health Care Costs Primary Health Care Community Health Workers Social Support Exercise Diet Thailand

Interventions

A structured, intensive Lifestyle Medicine program addressing six pillars: nutrition, physical activity, stress management, sleep, avoidance of addictive substances, and social support. The program is
Experimental Behavioral,Active Comparator Behavioral
Comprehensive Lifestyle Medicine (LM) Program (DREAM),Standard Diabetes Care (Usual Care)

Sponsors

Health Systems Research Institute (HSRI)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Participants must meet all of the following criteria: 1.Male or female, aged 18 to 80 years 2.Diagnosed with type 2 diabetes mellitus 3.Most recent HbA1c less than 9%, measured within the past one year 4.Duration of diabetes less than 6 years since diagnosis 5.No diabetes related complications, including heart disease or chronic kidney disease 6. Body mass index more than 23 kilograms per square metre 7. Most recent eGFR more than 45 mL/min/1.73 square metre , measured within the past one year. 8. High cardiovascular risk, as assessed by a CVD risk score Willing to participate in the project, participants who do not meet one or more criteria in items 3 to 8 may still be eligible if, in the opinion of the healthcare team, they can appropriately undergo the LM care process, with agreement from the treating physician and the patient (informed consent obtained).

Exclusion criteria

Exclusion criteria: 1.Individuals who are likely to change their healthcare facility within one year after enrolment in the program 2.Pregnant or breastfeeding women. 3.Individuals who are currently participating as volunteers/participants in another research study.

Design outcomes

Primary

MeasureTime frame
Type 2 diabetes remission (medication-free) Three to six months after enrolment (follow-up visit) Proportion of participants with HbA1c less than 6.5% and no glucose lowering-medications for at least 3 months

Secondary

MeasureTime frame
Diabetes medication expenditure Six months after enrolment Change in diabetes medication costs (THB) over follow-up, derived from prescribing/dispensing databases,Discontinuation of glucose-lowering medications Three to six months after enrolment Proportion of participants who discontinued all glucose-lowering medications,HbA1c Baseline and three to six months after enrolment Mean HbA1c (%) measured by hospital laboratory,Fasting plasma glucose Baseline and three to six months after enrolment Mean fasting plasma glucose (mg/dL) measured by hospital laboratory,Body mass index (BMI) Baseline and three to six months after enrolment Mean BMI (kilograms per square metre) ,Waist circumference Baseline and three to six months after enrolment Mean waist circumference (cm) measured using standard clinic procedures,Blood pressure Baseline and three to six months after enrolment Mean systolic and diastolic blood pressure (mmHg) measured in clinic,Kidney function (eGFR) Baseline and three to six months after enrolment Mean eGFR calculated from serum creatinine per hospital laboratory method,Health-related quality of life (EQ-5D) Baseline and three to six months after enrolment Mean EQ-5D index score from EQ-5D questionnaire

Countries

Thailand

Contacts

Public ContactDr.Thanawat Wongphan

Trat Province Public Health Office

thanawat@ihpp.thaigov.net039511011

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026