Effectiveness of a Structured Lifestyle Modification Framework on Glycemic Control in Type 2 Diabetes Mellitus: A Quasi-Experimental Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
This quasi-experimental study aims to evaluate the effectiveness of a culturally adapted structured lifestyle modification framework on glycemic control in adults with type 2 diabetes mellitus. Participants will undergo a 6-month intervention focusing on diet, physical activity, and sleep hygiene, with digital follow-up for adherence monitoring. Glycemic control will be assessed using HbA1c at baseline, 3 months, and 6 months. Secondary outcomes include changes in anthropometric measures, blood pressure, body composition, quality of life, and feasibility and acceptability of the intervention. The study seeks to generate evidence for a low-cost, scalable lifestyle intervention suitable for real-world Indian settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
Dr B Dharani
ACS Medical College and Hospital