An embedded experimental model to assess the effectiveness of a health promotion intervention on non-communicable disease risk factors among fishermen in rural Puducherry – A one-phase approach.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Nijanthan D
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change in mean non-communicable disease (NCD) risk-factor profile among fishermen following a WHO PEN Protocol 2-based health-promotion intervention. Indicators include systolic and diastolic blood pressure, body mass index (BMI), tobacco and alcohol use status, fruit and vegetable intake, physical-activity levels, and stress score (PSS-10)
概览
简要总结
This interventional community-based study aims to assess the effectiveness of a health promotion intervention based on WHO PEN Protocol 2 in reducing non-communicable disease (NCD) risk factors among fishermen in rural Puducherry. The study follows a one-phase embedded experimental design with two groups – intervention and control. A total of 116 adult fishermen aged 18–65 years will be enrolled, with 58 participants in each arm. The intervention group will receive structured health education and counselling sessions on tobacco cessation, alcohol moderation, healthy diet, physical activity, stress management, and sleep hygiene. The control group will receive routine health advice through existing PHC services.
Pre and post-intervention assessments will be carried out using standardized tools – WHO STEPS questionnaire (for risk factors), GPAQ (for physical activity), PSS-10 (for stress), and PSQI (for sleep quality). Anthropometric and blood pressure measurements will be taken using standard methods. The primary outcome will be the change in mean NCD risk-factor profile after three months of intervention. Secondary outcomes include improvement in sleep quality and knowledge regarding healthy lifestyle practices.
The study will be conducted at Veerampattinam village, under the field practice area of Aarupadai Veedu Medical College and Hospital, Puducherry. Ethical clearance has been obtained from the Institutional Human Ethics Committee (ECR/847/INST/PY/2016/RR-20).
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Male
入选标准
- •Fishermen with NCD risk factors Fishermen above 18 years of age to 65 years Fishermen who are permanent residence of the study area.
排除标准
- •Fishermen who are not actively engaged in fishing for past one year Fishermen who were sick during baseline data collection.
结局指标
主要结局
Change in mean non-communicable disease (NCD) risk-factor profile among fishermen following a WHO PEN Protocol 2-based health-promotion intervention. Indicators include systolic and diastolic blood pressure, body mass index (BMI), tobacco and alcohol use status, fruit and vegetable intake, physical-activity levels, and stress score (PSS-10)
时间窗: Baseline and 6 months post-intervention
次要结局
- Improvement in mean Pittsburgh Sleep Quality Index (PSQI) score among participants.(Baseline and 3 months)
- Change in knowledge and attitude scores regarding healthy lifestyle practices.(Baseline and 3 months)
研究者
NIJANTHAN
Aarupadai Veedu Medical College