An Integrated Community-based Intervention Package in Improving Maternal and Neonatal Health Outcomes

NCT05517577 | Unknown

• 1 other identifier: JUIH/IRB/110/22
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to improve maternal, neonatal and infant health outcomes through an integrated community-based intervention package in Jimma Zone, Southwest Ethiopia.

Conditions

Integrated Community-based Intervention Package; Breastfeeding, Exclusive; Morbidity;Newborn; Complementary Feeding; Knowledge, Attitudes, Practice; Food Security; Birth Preparedness and Complication Readiness Plan; Neonatal Care; Health Care Seeking Behavior; Delivery Care; Postnatal Care

Keywords

community-based intervention,; maternal,; neonatal,; infant,; health outcome,; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Neonatal care practices

  Prevalence of neonatal care practices

  At month one after delivery

• Feeding practice

  prevalence of early initiation and exclusive breastfeeding

  At month one after delivery

Secondary Outcomes (5)

• Neonatal morbidity

  At month one after delivery

• Maternal morbidity

  At month one after delivery

• Birth preparedness and complication readiness plan

  At month one after delivery

• Maternal feeding practice

  : At month one after delivery

• Skilled delivery

  At month one after delivery

Study Arms (2)

Intervention group

EXPERIMENTAL

An integrated Community-based package of interventions An integrated intervention consisting of behaviourchange communication, and male involvement will be delivered to pregnant women in their third trimester. They will receive 2 prenatal and five home visits. each visit will last 40-60 minutes. After delivery mother-newborn pairs will be followed up until six weeks.

Behavioral: Behaviour Change Communication and Male involvement intervention

Control group

NO INTERVENTION

First, we selected two districts that have similar characteristics and are adjacent to each other. Both districts have a total of 72 kebeles (the smallest administrative unit), 36 in each district. Then, we chose 20, 10 from each district, kebeles on the boundary of the two districts to act as a buffer zone, to prevent information contamination between the intervention and control clusters. Finally, 26 kebeles in the Dedo district will be assigned to the intervention group while 26 kebeles in the Seka Chekorsa district are assigned to control clusters. Allocation concealment will not be done for study participants, as they would certainly know if they are in the intervention group or not. However, data collectors will be blinded to the allocation assignment by not being informed about it, not being part of the trial implementers, and not being inhabitants of any of the kebeles. Moreover, data analysts will be blinded to group allocation.

Interventions

Behaviour Change Communication and Male involvement intervention BEHAVIORAL

For the integration of the intervention, it is planned to deliver both service at the same time a by the same means to the women and the men. Pregnant women who fail to take one of the intevetion will not be considered as the participant who received integrated intervention. The intervention will be provided through Women Developmental army (WDA) leaders imparted through gatherings and home visits whereas the Broadcast will be used to strengthen and as a frequent remidinng of the conveyed messages.

Also known as: BCC

Intervention group

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women in the third trimester
• Live in the selected cluster

You may not qualify if:

• Serious illness or clinical complications requiring hospitalization
• Maternal death
• Newborn death
• Stillbirth
• Twin gestation
• Preterm birth (at \<37 weeks)

Sponsors & Collaborators

• Jimma University: lead

Study Sites (1)

Jimma University

Jimma, Oromiya, 378, Ethiopia

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Behavior; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Feeding Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Bekelu Teka, MPH

  Jimma University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bekelu Teka, MPH

CONTACT

+251 945 031 001; bekelut23@gmail.com

Misra Abdulahi, MPH

CONTACT

+251912010293; misra_ab@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Allocation concealment will not be done for study participants, as they would certainly know if they are in the intervention group or not. However, data collectors will be blinded to the allocation assignment by not being informed about it, not being part of the trial implementers, and not being inhabitants of any of the kebeles. Moreover, data analysts will be blinded to group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and researcher

Model Details: First, we selected two districts that have similar characteristics and are adjacent to each other. Both districts have a total of 72 kebeles (the smallest administrative unit), 36 in each district. Then, we chose 20, 10 from each district, kebeles on the boundary of the two districts to act as a buffer zone, to prevent information contamination between the intervention and control clusters. Finally, 26 kebeles in the Dedo district will be assigned to the intervention group while 26 kebeles in the Seka Chekorsa district are assigned to control clusters

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: August 20, 2022
• Primary Completion: April 20, 2023
• Study Completion: September 20, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)