Community-Based Study on Breastfeeding Practices in Hadiya Zone, Ethiopia

Study Setting and Period

This research will be conducted in the rural regions of the Hadiya Zone, located in South Ethiopia, approximately 232 km from Addis Ababa, the country’s capital. The Hadiya Zone has a total population of about 1.8 million, with a fairly even gender distribution: 49.6% male and 50.4% female. Notably, women of childbearing age (15–49 years) represent 23.3% of the population. The region anticipates around 61,092 pregnancies, constituting 3.46% of the total population. Healthcare services in Hadiya Zone include one general hospital, three primary hospitals, 62 health centers, and 311 health posts, which are distributed across 17 districts, comprising 12 rural areas and 5 urban administrations. This study will specifically focus on four rural districts—Mirab Soro, Gombora, Soro, and Duna—encompassing 98 administrative clusters (known as kebeles). The research period will extend from March 24, 2024, to May 20, 2025.

Study Design

This investigation will utilize a three-arm, parallel, cluster randomized controlled trial design, centering on a post-test-only structure to assess breastfeeding outcomes after women give birth. The kebeles will act as clusters, and participants will be divided into three groups: pregnant women alone, pregnant women accompanied by their mother-in-laws, and pregnant women receiving routine care (the control group). Baseline socio-demographic data will be compiled to ensure homogeneity among the groups and to provide a clear characterization of the participants.

Randomization Process

A simple randomization technique will be employed to assign clusters to the three study arms. A biostatistician, independent from the study, will execute the randomization using a random number generator in Open Epi software. Ensuring that clusters are non-adjacent avoids information contamination, allowing participants from different clusters limited interaction. The randomization involves preparing three opaque envelopes for each arm, sorting clusters alphabetically, assigning unique codes, and utilizing a random number generator to select clusters for each arm. The random allocation will include two intervention arms and one control arm. While participants and investigators cannot be entirely blinded due to the nature of the trial, data collectors will be blind to the study’s objectives to maintain integrity in the data collection process.

Population, Intervention, Control, and Outcomes (PICO)

Population

The target population comprises null-parous pregnant women aged between the end of their first trimester and early second trimester (under 16 weeks of pregnancy). Eligible women must have resided in the area for a minimum of six months and must consent to participate. Exclusion criteria include those with a history of stillbirth or whose mother-in-law is deceased or unavailable.

Intervention

The nutrition education intervention will be based on guidelines from the World Health Organization (WHO) and USAID. Key objectives include promoting optimal breastfeeding practices, such as avoiding pre-lacteal feeding, endorsing colostrum feeding, initiating breastfeeding early, and encouraging exclusive breastfeeding. Both intervention groups will receive standardized information, while the control group will receive routine care that includes basic hygiene and maternal and child health services, albeit with less depth.

Control

Participants in the control group will benefit from routine health services provided by health extension workers, including antenatal and postnatal care, immunization, and basic education on breastfeeding. They will not receive specialized educational content like participants in the intervention arms.

Outcomes

The primary outcomes to be measured include pre-lacteal feeding practices, colostrum feeding, early initiation of breastfeeding, and exclusive breastfeeding rates. Data will be collected through structured questionnaires administered within one week of delivery.

Sample Size and Sampling Procedure

The sample size is estimated using G*Power software, considering a 20% expected difference in breastfeeding practices between the intervention and control groups. After calculating for design effects due to cluster randomization, 510 pregnant women (170 in each arm) will be targeted. Fifty-one clusters will be purposefully chosen to minimize contamination, and participants will be selected using simple random sampling techniques.

Data Collection Procedures

Baseline data will be collected via structured interviews prepared in English and translated into local dialects. Health extension workers will implement home visits for participant registration and conduct follow-ups. The consistency in translation and study protocols will be ensured through pre-testing in similar settings for data reliability.

Quality Control and Monitoring

Rigorous training programs for data collectors, intervention implementers, and supervisors will ensure that all team members are knowledgeable about local cultures and fluent in the local language. Supervisors will closely monitor data collection and adherence to intervention protocols to minimize discrepancies. A fidelity checklist will be utilized to guarantee compliance with intervention guidelines.

Analysis

Data analysis will be conducted using R software, with descriptive statistics summarizing the study participant characteristics. To evaluate the impact of the interventions, various statistical methods will be employed, including mixed-effects models and logistic regression analyses, to accommodate the cluster design.

Dissemination Plan

Results from this study will be shared with key stakeholders, including the local health department and policy-making bodies, ensuring that the findings contribute to better health practices in maternal and child health. Reports will be presented in conferences, with plans for publishing in reputable academic journals.

For more detailed guidance on maternal and child health practices, consider visiting World Health Organization or USAID.