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临床试验/CTRI/2025/12/099435
CTRI/2025/12/099435尚未招募不适用

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

St. Peter’s Medical College, Hospital and Research Institute, Hosur1 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2025年12月22日最近更新:

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

发起方
St. Peter’s Medical College, Hospital and Research Institute, Hosur
申办方类型
Other [Government aided Medical college and Hospital]
责任方
Principal Investigator
主要研究者

Dr Mounika V

St. Peter’s Medical College, Hospital and Research Institute, Hosur

研究点 (1)

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