To identify how effective are weekly group sessions focused on lifestyle changes are helping people with type II diabetes at a major hospital in South India

To evaluate the impact of intensive wellness lifestyle therapy delivered through weekly group sessions on patients with type II diabetes at a tertiary care hospital in South India- An open label randomized control trial.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089061

Enrollment

108

Registered

2025-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: structured peer support group weekly session: Intervention is the weekly structured peer support group session by the wellness educator. People are randomized into both arms, and the in

Eligibility

Inclusion criteria

Inclusion criteria: i.All patients were already diagnosed according to the American Diabetes Association (ADA) diagnostic criteria for Type II Diabetes and the type of diabetes was further identified by careful history and clinical examination. ii.Diagnosed at age more than 18yr iii.HBA1c at OPD visit should be 7-10 g per dl. iv.Those who have access to a smart phone or computer and understand tamil language. v.Able to comprehend their participation in this study and willing to give informed written consent, Agree to come for follow up

Exclusion criteria

Exclusion criteria: 1.Subjects unwilling to give consent. 2.Pregnant women 3.excluded any patient with uncertain type of diabetes 4.patients on drugs known to cause hyperglycemia (e.g., steroids, Anti psychotics) 5.renal transplant, chronic kidney disease with creatinine clearance less than 50 ml per min, advanced liver disease 6.critically ill 7.hemoglobinopathy 8.TG more than 500 mg/dl 9.pancreatitis (acute or chronic) 10.hypothyroidism, malignancy. 11.Psychiatric illness 12.Fasting sugars more than 250 or hba1c more than 10

Design outcomes

Primary

Measure	Time frame
To measure the change in insulin resistance as measured by HOMA-IR among type II diabetes patients who received intensive wellness lifestyle therapy through weekly group sessions compared to the group who received only the standard of careTimepoint: end of 4weeks	—

Secondary

Measure	Time frame
Assess the change in body composition profile and anthropometric parameters (BMI, WHR)Timepoint: end of 4weeks;mean Hba1c, FLPTimepoint: end of 4weeks;IV.To assess for change in Diet questionnaire, IPAQ- physical activity score, Sleep PSQI, Stress assessment general health QuestionnaireTimepoint: end of 4weeks;III.Change in systolic and diastolic Blood pressureTimepoint: end of 4weeks	—

Countries

India

Contacts

Public ContactSamuel George Hansdak

Christian Medical College Vellore

hansdaksg@yahoo.com8870005828

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026