Health Promotion Intervention Package for Prevention of Underlying Behavioral Risk Factors of Chronic Diseases: A Cluster Randomized Controlled Trial in School Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 813
- 试验地点
- 1
- 主要终点
- Prevention of behavioral risk factors (unbalanced diet, physical inactivity, use of tobacco and alcohol) of Diabetes and Hypertension among school going adolescents, their parents & teachers in a school setting through a school based health promotion intervention
研究概览
简要总结
Chronicdiseases like diabetes, cardiovascular diseases and cancers are on the rise.Most of the risk factors of these diseases commence in adolescence. Therefore, a cluster randomized controlled trialis designed to evaluate the effect of school-based health promotionintervention on the risk factors of chronic diseases.
Considering school as a cluster, twelveschools will be randomly selected from the public schools of Chandigarh, a cityin India. After baseline assessment, six schools will be randomly allocated tointervention and six to control arm. Study participants will be students of 8thgrade (age 10-16 years), their parents and teachers. A sample of 360 students(12 clusters x 30 students) has been estimated to provide statistically validinference.
The PRECEDE PROCEEDModel will be used for developing health promotion interventions to prevent useof unbalanced diet, physical inactivity, alcohol, and tobacco. Interventionswill be implemented over a period of six-months in school setting. Forstudents, intervention will comprise of interactive learning sessions of 30minutes duration per week and physical activity session of 30 minutes durationfour times every week. For parents and teachers, educational sessions will beconducted for 30 minutes four times during the intervention period.
Primary outcomes will be change in prevalenceof behavioural risk factors from pre- to post-intervention. Changes inanthropometric, physiological, and biochemical measures will be the secondaryoutcomes. The difference-in-difference (DID) methodwill be used to measure the net change in the outcomes.
It is important to understand whether healthpromotion interventions implemented in the school setting simultaneouslytargeting adolescents, their teachers and parents are effective. The use of thePRECEDE-PROCEDE model for planning, implementing, and evaluating theintervention as part of a cluster Randomized Controlled Trial design with DIDanalysis, could provide an objective assessment of the impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 11.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adolescents: Age: 11-16 years Adults (parents and teachers): Age below 65 years Participants willing to give consent Participants residing in UT Chandigarh for at least next one more year For teachers, all teachers having interaction with the randomly selected class of a school will be included, as, all subject teachers, class teacher, mid-day meal in-charges, physical activity teachers, counsellors and medical in-charges.
排除标准
- •Adolescents not falling in age group of 11-16 years Adults (parents and teachers)- Age not below 65 years Participants not willing to give consent Participants not residing in UT Chandigarh for at least next one more year Teachers not having direct contact with randomly selected class of school.
结局指标
主要结局
Prevention of behavioral risk factors (unbalanced diet, physical inactivity, use of tobacco and alcohol) of Diabetes and Hypertension among school going adolescents, their parents & teachers in a school setting through a school based health promotion intervention
时间窗: Baseline assessment: 10-12 months | Development and implemention of intervention- 12 months | End-line assessment: 10 months
次要结局
- Impact of health promotion intervention on knowledge and practices, anthropometric measurements (BMI, WHR, TSFT, SSFT, MUAC and maximum hand grip strength), physiological measurement (BP) and on objective measurements (sodium excretion from 24-hour urine samples and lipids and FPG levels from blood samples) related to risk factors of diabetes & hypertension among adolescents, their parents & teachers.(Assessment of impact on knowledge and practices: 2 months)