A study to evaluate a structured lifestyle modification program for glycemic control in Type 2 Diabetes

Effectiveness of a Structured Lifestyle Modification Framework on Glycemic Control in Type 2 Diabetes Mellitus: A Quasi-Experimental Study - Nil

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101479

Enrollment

120

Registered

2026-01-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Structured lifestyle modification framework: Structured lifestyle modification framework consisting of structured diet, physical activity and sleep Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged thirty to sixty years with a diagnosis of type two diabetes mellitus for a duration of at least one year Glycated hemoglobin value between seven percent and ten percent Stable use of oral antidiabetic medications for the previous three months Ownership and regular use of a smartphone to enable follow up and monitoring Willingness to make modifications in dietary habits, sleep patterns, and physical activity behaviours Willingness to provide written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Current treatment with insulin therapy Pregnant or lactating women Presence of comorbid medical conditions or physical limitations that restrict participation in physical activity History of psychiatric illness or cognitive impairment that may interfere with study compliance Current enrolment in any other structured lifestyle intervention or weight management programme Presence of medical contraindications to physical exercise

Design outcomes

Primary

Measure	Time frame
Change in glycaemic control as measured by HbA1c (%) from baseline to 6 months (24 weeks) following the structured lifestyle modification intervention in adults with type 2 diabetes mellitus.Timepoint: Baseline, at 3 months and 6 months	—

Secondary

Measure	Time frame
Change in anthropometric parameters from baseline to 6 months Change in blood pressure from baseline to 6 months Change in body composition from baseline to 6 months Change in HbA1c at 3 months from baseline Change in quality of life from baseline to 6 months Adherence, feasibility, and acceptability of the structured lifestyle modification intervention over 6 monthsTimepoint: Baseline, at 3 months and 6 months	—

Measure

Time frame

Change in anthropometric parameters from baseline to 6 months Change in blood pressure from baseline to 6 months Change in body composition from baseline to 6 months Change in HbA1c at 3 months from baseline Change in quality of life from baseline to 6 months Adherence, feasibility, and acceptability of the structured lifestyle modification intervention over 6 monthsTimepoint: Baseline, at 3 months and 6 months

—

Countries

India

Contacts

Public ContactDr B Dharani

ACS Medical College and Hospital

dharani.physio@acsmch.ac.in8610263796

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026