Impact of Health Promotion Interventions in Changing Mother's Behavior and Improving Child Health in Hufash District- Al-Mahweet, Yemen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Change in weight-for-height z-score (WHZ) among children age 6 - 59 months
研究概览
简要总结
While household-level water, sanitation and hygiene has been investigated extensively, this is the first comprehensive study to investigate the impact of improved water, sanitation and hygiene and nutrition at household on child health in Yemen.
详细描述
This study was conducted in Hufash district, Al-Mahweet Province, which is located on the southwest of the capital Sana'a, and takes about (113)kilometers from it. The study aimed to highlight the key role of the community based interventions in reducing child morbidity and mortality in rural Yemen.A community - randomized controlled field trail was implemented to evaluate the role of public health promotion on reducing child diarrhea, acute respiratory infection, nutrition, immunization in children under age of five at enrollment over a six month of study period. Due to the nature of the study, blinding is not possible so some measures would be done to reduce the non-blinding bias like, to keep the study staff blinded as much as possible, the observers and survey staff were not informed about the study design. The sample size required to measure the primary and secondary outcomes before and after the intervention in both groups was estimated using STATA 14.0.Based on data of a previous meta analysis, estimates of required sample size assumed a 20% reduction in the proportion of diarrhea. Intra-cluster correlation coefficient (ICC) was set low at 0.04 and the cluster sizes (number of subjects in a cluster, m) were expected to be 18. The sample size was multiplied by a design effect of 1.68, calculated using DE=1+ICC (m-1), to accommodate the clustering effect. The sample was further adjusted for a potential 20% loss to follow-up over one year, thus requiring a sample of 180 per group. Therefore, the present study estimated that a total of 20 clusters inhabited by 358 households with child aged 6 to 59 months would have 80% power to detect the 20% reduction in the proportion in diarrhea at 5% level of significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
After baseline survey was carried out, two sub-districts (10 clusters each) were allocated into intervention and control clusters in a 1:1 ratio (10 intervention and 10 control clusters). This allocation of intervention and control clusters was randomly carried out and each sub district had an equal chance of being in either group. For randomization, the two sub districts were listed (1 to 2) and drew randomly by health manager there. Intervention group was informed that participants had been received the intervention, hence it was impossible to fully mask (blind) the study participants. The primary outcomes of interest were measured by observers who were not connected with the intervention implementation, in order to reduce the observer bias
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one child aged between 6 - 59 months
- •Family planning to stay in their home for the next 12 months
- •Written consent taken from the head of household
排除标准
- •Child had chronic diseases or severely malnourished.
- •Family that might leave their house before one year.
- •Household that the lord of house refuses to participate.
结局指标
主要结局
Change in weight-for-height z-score (WHZ) among children age 6 - 59 months
时间窗: at month 6
Investigators used 2006 WHO growth reference to calculate WHZ score. Child was considered wasting when child weight for height Z score is below - 2 of the median WHO growth standards
change in prevalence of acute respiratory infection among children under five years old
时间窗: at month 6
At the end of the six month trial, each household in intervention and control groups are visited by trained field workers to collect morbidity data from mothers or caretakers regarding the signs and symptoms of child acute respiratory infection. The case definition of acute respiratory infection was as cough or difficulties with breathing by a child with a raised respiratory rate on two consecutive measurement over a 2 weeks period prior to data collection.
Change in weight-for-age z-score (WAZ) among children age 6 - 59 months
时间窗: at month 6
Investigators used 2006 WHO growth reference to calculate WAZ score. Child was considered underweight when child weight for age Z score is below - 2 of the median WHO growth standards
Change in prevalence of diarrhea among children under five years old
时间窗: at month 6
At the end of the six month trial, each household in intervention and control groups are visited by trained field workers to collect morbidity data from mothers or caretakers regarding the daily occurrence of signs and symptoms of child diarrhea. The case definition of diarrhea was 3 or more loose or watery stools over a 24-hour period prior to data collocation.
Change in height-for-age z-score (HAZ) among children age 6 - 59 months
时间窗: at month6
Investigators used 2006 WHO growth reference to calculate HAZ score. Child was considered stunted when child height for age Z score is below - 2 of the median WHO growth standards
次要结局
- change in mother hygiene, water and sanitation as well as child feeding behaviors.(at month 6)
- To evaluate the change in mother knowledge about hygiene, water and sanitation as well as child feeding.(at month 6)
研究者
Mansour Abdu Salah Al-taj
principle investigator
Sana'a University