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

Not Applicable

Recruiting

• Conditions: Breastfeeding, Exclusive; Complementary Feeding; Postnatal Care; Food Security; Morbidity;Newborn; Birth Preparedness and Complication Readiness Plan; Neonatal Care; Health Care Seeking Behavior; Integrated Community-based Intervention Package; Knowledge, Attitudes, Practice
• Interventions: Behavioral: Behaviour Change Communication and Male involvement intervention

• Registration Number: NCT05517577
• Lead Sponsor: Jimma University

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.

Detailed Description

Background: Maternal, newborn, infant's morbidity and mortality are unacceptably high in sub-Saharan Africa including Ethiopia. Despite considerable efforts made in maternal and child health care, poor maternal, neonatal and child health problems remained a significant public health concern globally and particularly in low and middle-income countries. Community-based Interventions and strategies for improving maternal, newborn, and child health care have been recommended through a continuum of care approach. However, few efforts have been made to identify synergies and integrate different intervention packages across the country.

Objective: This study aims to assess the effectiveness of an integrated community-based intervention package in improving maternal, neonatal and infant health outcomes in Jimma Zone, Southwest Ethiopia: a cluster randomized controlled trial.

Methods: This is a parallel-arm, single-blind, cluster randomized controlled trial conducted in the Dedo and Seka Chekorsa districts of the Jimma zone. After excluding 10 kebeles from each district to be considered as a buffer zone, we will assign 26 kebeles to the intervention arm and 26 to the control arm. A total of 624 pregnant women in their third trimester who reside in the kebeles assigned to the intervention clusters will be identified and enrolled (312 in intervention and 312 in control groups). The intervention includes Behavioral Change Communication, and male involvement. Various multidisciplinary professionals and experts regularly monitor the overall process of the research and intervention activities. The effect of the intervention in comparison with the routine care will be assessed by fitting mixed-effects linear regression models for the continuous outcomes and mixed-effects linear probability models for the binary outcomes. In all analyses, adjustment will be made for clustering at the kebele level and covariate. All tests will be two-sided and the level of significance will be set at alpha \< 0.05.

Budget: A total of 579,888.4ETB will be required. Key words: community-based intervention, maternal, neonatal, infant, health outcome, randomized controlled trial

Study Timeline

• Study Start: 2022-08-20
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10
• Primary Completion: 2023-04-20
• Study Completion: 2023-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 624

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Behaviour Change Communication and Male involvement intervention	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.

Primary Outcome Measures

Name	Time	Method
Neonatal care practices	At month one after delivery	Prevalence of neonatal care practices
Feeding practice	At month one after delivery	prevalence of early initiation and exclusive breastfeeding

Secondary Outcome Measures

Name	Time	Method
Neonatal morbidity	At month one after delivery	Prevalence of neonatal morbidity
Maternal morbidity	At month one after delivery	Prevalence of maternal morbidity
Birth preparedness and complication readiness plan	At month one after delivery	Proportion of women who had Birth preparedness and complication readiness plan
Maternal feeding practice	: At month one after delivery	Prevalence of minimum dietary diversity
Skilled delivery	At month one after delivery	Prevalence of women who delivered at health institution

Trial Locations

Locations (1)

Jimma University; 🇪🇹 Jimma, Oromia, Ethiopia