Health Promotion Intervention to Reduce Child Morbidity

NCT03810430 | Completed DMC

• 1 other identifier: 202016000191-85
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diarrhea; Nutritional

Outcome Measures

Primary Outcomes (5)

• Change in prevalence of diarrhea among children under five years old

  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.

  at month 6

• change in prevalence of acute respiratory infection among children under five years old

  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.

  at month 6

• Change in weight-for-age z-score (WAZ) among children age 6 - 59 months

  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

  at month 6

• Change in weight-for-height z-score (WHZ) among children age 6 - 59 months

  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

  at month 6

• Change in height-for-age z-score (HAZ) among children age 6 - 59 months

  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

  at month6

Secondary Outcomes (2)

• To evaluate the change in mother knowledge about hygiene, water and sanitation as well as child feeding.

  at month 6

• change in mother hygiene, water and sanitation as well as child feeding behaviors.

  at month 6

Study Arms (2)

intervention group

ACTIVE COMPARATOR

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

Behavioral: health promotion

control group

NO INTERVENTION

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.

Interventions

health promotion BEHAVIORAL

health promotion on water, sanitation and hygiene and child feeding along with hygiene kits were delivered to the mothers in the intervention arm

intervention group

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sana'a University: lead

Study Sites (1)

Sanaa University

Sanaa, +967, Yemen

Location

Related Publications (1)

• Aiello AE, Coulborn RM, Perez V, Larson EL. Effect of hand hygiene on infectious disease risk in the community setting: a meta-analysis. Am J Public Health. 2008 Aug;98(8):1372-81. doi: 10.2105/AJPH.2007.124610. Epub 2008 Jun 12.

  PMID: 18556606 BACKGROUND

MeSH Terms

Conditions

Diarrhea

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Abdulwahed A Alserouri, Professor

  Sanaa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: The frame work used in this study depends on the Evo-Eco theory of behavior change.This approach consists of five steps; assess, build, create, develop and evaluate (A, B, C, D and E). In the assessment steps, the researcher made a review about the role of water, hygiene and infant feeding promotion in reducing child morbidity and changing mothers' behavior. Based on this review and experience, the researcher developed a baseline questionnaire that was used two months ago before starting the intervention. Based on the results of baseline survey and literature, the researcher with expert team developed the health promotion messages. After developing the messages, interventions took six months. Furthermore, the implementation of the health promotion intervention was at household and community level. Two months later of performing the intervention, the post intervention survey was carried out to measure the primary and secondary outcome of the interventions.

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 18, 2019
• Study Start: April 20, 2015
• Primary Completion: December 20, 2015
• Study Completion: December 31, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

YE (1)