Health Promotion Intervention to Reduce Child Morbidity (intervention)

Sana'a University

Status: Completed

Conditions: Diarrhea; Nutritional

Treatments: Behavioral: health promotion

Study type: Interventional

Funder types: Other

Identifiers

NCT03810430

202016000191-85

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 360 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

intervention group

Active Comparator group

Description:

ten clusters (villages) were received health promotion activities during six months of interventions

Treatment:

Behavioral: health promotion

control group

No Intervention group

Description:

10 clusters (villages) were not received intervention during the intervention period and by the end of study, it will be compared with the intervention group to measure the change in the primary and secondary outcomes.