Social Networks for Improving Maternal & Child Health (SoNIMCH)

Improving the Health and Nutritional Status of Mothers and Children Using Indigenous Community Structure in Northwest Ethiopia

Brief Summary: Improving Maternal and Child Health via Indigenous Structures

The goal of this cluster randomized controlled community trial is to assess the effect of community-based interventions using indigenous community structures on the improvement of health and nutritional status in pregnant women (recruited before 16 weeks of gestation) and their children in Northwest Ethiopia. The main questions it aims to answer are:

• Does a community-based intervention using indigenous structures significantly improve the uptake of maternal health services (ANC, delivery, and PNC)?
• Does the intervention effectively reduce the prevalence of maternal depression during the pregnancy and postpartum periods?
• To what extent does the intervention improve the nutritional status (reducing thinness and stunting) of mothers and their children? Researchers will compare a group of women receiving counseling from trained indigenous social support groups to a control group receiving only the routine health and nutrition education provided by the standard healthcare system to see if the indigenous approach leads to better health and nutritional outcomes.

Participants will:

• Receive four counseling sessions during pregnancy (starting before 16 weeks of gestation) and four additional sessions during the lactation period, conducted in their homes by trained social support groups.
• Receive educational leaflets containing core health and nutrition messages and appropriate pictures.
• Participate in two rounds of surveys (baseline, and endline) involving interviewer-administered questionnaires.
• Undergo physical measurements, specifically mid-upper arm circumference (MUAC), to assess nutritional status.

Study Overview

• Status: Not yet recruiting
• Conditions: Maternal and Child Health; Maternal Nutrition
• Intervention / Treatment: Behavioral: Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS)

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Endalkachew Worku Mengesha, PhD; Phone Number: +251 930316799; Email: endalkwk@gmail.com

Study Locations

• Ethiopia
  • Bahir Dar, Ethiopia
    • Bahir Dar University
    • Contact: Endalkachew Worku Mengesha, PhD; Phone Number: +251 930316799; Email: endalkwk@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Pregnant women residing in the selected study clusters (kebeles)

Pregnant women who are in their first trimester (gestational age less than 16 weeks) at the time of recruitment.

Pregnant women who intend to reside in the study area for the duration of the pregnancy and at least six months postpartum.

Exclusion Criteria:

Pregnant women with known pre-existing chronic medical conditions (e.g., chronic hypertension, diabetes mellitus, or cardiac disease) that require specialized medical management.

Pregnant women who are unable to communicate or undergo the interview process due to severe illness or cognitive impairment.

Pregnant women who are already participating in another clinical trial or health intervention study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Indigenous Social Support Structure (ISSS) Intervention; Participants in this arm will receive a community-based intervention delivered via indigenous social support structures (such as Idir, Senbete, or Equb). The intervention consists of eight (8) community-based counseling sessions: four during the pregnancy period (beginning before 16 weeks of gestation) and four during the lactation period. Counseling is provided by trained members of these indigenous structures and focuses on maternal health service uptake (ANC, delivery, PNC), maternal nutrition, and mental health.	Behavioral: Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS); The intervention consists of a structured behavioral and educational program delivered via existing indigenous social support structures (ISSS), such as Idir, Senbete, or Equb. Key components include: Frequency: Eight (8) community-based counseling sessions in total. Four sessions occur during pregnancy (starting before 16 weeks gestation) and four sessions occur during the lactation period (up to 6 months postpartum). Personnel: Counseling is delivered by trained members of the indigenous social support groups who live within the same community as the participants. Content: Standardized counseling on maternal health service uptake (ANC, institutional delivery, PNC), maternal and child nutrition, and perinatal mental health. Materials: Distribution of educational leaflets containing core health and nutrition messages with culturally appropriate pictorial aids to reinforce the counseling sessions.
Active Comparator: Standard Care (Routine Health Services)	Behavioral: Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS); The intervention consists of a structured behavioral and educational program delivered via existing indigenous social support structures (ISSS), such as Idir, Senbete, or Equb. Key components include: Frequency: Eight (8) community-based counseling sessions in total. Four sessions occur during pregnancy (starting before 16 weeks gestation) and four sessions occur during the lactation period (up to 6 months postpartum). Personnel: Counseling is delivered by trained members of the indigenous social support groups who live within the same community as the participants. Content: Standardized counseling on maternal health service uptake (ANC, institutional delivery, PNC), maternal and child nutrition, and perinatal mental health. Materials: Distribution of educational leaflets containing core health and nutrition messages with culturally appropriate pictorial aids to reinforce the counseling sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Health Service Utilization	The proportion of women who utilized the full continuum of care, defined as attending at least 8 ANC contacts, having an institutional delivery, and attending at least 1 PNC visit.	From enrollment (<16 weeks gestation) to 6 weeks postpartum.
Maternal Nutritional Status	Measured using Mid-Upper Arm Circumference (MUAC). Thinness is defined as a MUAC measurement of less than 23 cm.	Baseline (<16 weeks) and 6 weeks postpartum

Collaborators and Investigators

• Sponsor: Bahir Dar University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 21, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 40005/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No