Effectiveness of WHO PEN- Guided Life style Intervention on Blood Pressure, Health Behaviors and Medication Adherence among Industrial Workers with Hypertension in Hosur: A Quasi Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Change in Blood Pressure
研究概览
简要总结
This quasi-experimental study aims to evaluate the effectiveness of a WHO PEN–guided lifestyle intervention on blood pressure control, health behaviors, and medication adherence among industrial workers with hypertension in Hosur, Tamil Nadu. Two large industries (>10,000 workers) will be selected from SIPCOT Phase I and II using multistage stratified sampling. One industry will be assigned to the intervention group and the other to the control group by simple randomization (coin toss).
A total of 358 hypertensive workers (179 per group) will be selected through simple random sampling from occupational health records. The intervention group will receive structured WHO PEN-based lifestyle counseling at baseline, 2, 4, and 6 months, along with weekly reinforcement messages. The control group will receive routine health education practiced in the industry.
Primary outcome: change in systolic and diastolic blood pressure over 6 months. Secondary outcomes: changes in dietary practices, physical activity, tobacco/alcohol use, and medication adherence (MMAS-8).
Blood pressure, anthropometry, and lifestyle parameters will be assessed at baseline and at 6 months. Data will be analyzed using paired/unpaired t-tests, chi-square tests, and repeated measures ANOVA. The study aims to generate evidence on integrating WHO PEN lifestyle counseling into industrial health systems to improve hypertension management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Blue-collar workers. Diagnosed with hypertension.
- •BP more than or equal to 140/90 mmHg, regardless of current treatment status.
排除标准
- •Individuals with uncontrolled/severe comorbid conditions.
- •Pregnant/lactating women.
- •White-collar workers.
结局指标
主要结局
Change in Blood Pressure
时间窗: Baseline and post 6 months of intervention
次要结局
- changes in dietary practices, physical activity, tobacco/alcohol use, and medication adherence (MMAS-8).(Baseline and post 6 months of intervention)
研究者
Dr Mounika V
St. Peter’s Medical College, Hospital and Research Institute, Hosur
