Maternal and Child HealthSoNIMCHNCT07522047
Social Networks for Improving Maternal & Child Health
A study testing Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS) in people with Maternal and Child Health and Maternal Nutrition, run by Bahir Dar University at 1 site in Ethiopia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal and Child Health, Maternal Nutrition
- What is being tested?
- Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Apr 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia1 site
Bahir Dar University
Bahir Dar
Endalkachew Worku Mengesha, PhD, +251 930316799, endalkwk@gmail.com
About this study
Official title: 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:
Read more
- 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.
- Conditions
- Maternal and Child Health, Maternal Nutrition
- Being tested
- Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Indigenous Social Support Structure (ISSS) Intervention | Experimental | 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. Receives: Behavioral: Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS) |
| Standard Care (Routine Health Services) | Active comparator | Not described Receives: Behavioral: Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (<16 weeks) and 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal and Child HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahir Dar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Endalkachew Worku Mengesha, PhD, Bahir Dar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522047
- Sponsor's protocol ID
- 40005/2024
- Acronym
- SoNIMCH
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Health and Nutritional Status of Mothers and Children Using Indigenous Community Structure in Northwest Ethiopia
- ClinicalTrials.gov ID
- NCT07522047
- Acronym / sponsor ID
- SoNIMCH / 40005/2024
- Conditions
- Maternal and Child Health, Maternal Nutrition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Bahir Dar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indigenous Social Support Structure (ISSS) Intervention | Experimental | Behavioral: Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS)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. |
| Standard Care (Routine Health Services) | Active comparator | Behavioral: Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS) |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Indigenous Social Support Structure (ISSS) Intervention, Standard Care (Routine Health Services) |
Primary outcome
Maternal Health Service Utilization
Time frame: From enrollment (<16 weeks gestation) to 6 weeks postpartum.
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.
Maternal Nutritional Status
Time frame: Baseline (<16 weeks) and 6 weeks postpartum
Measured using Mid-Upper Arm Circumference (MUAC). Thinness is defined as a MUAC measurement of less than 23 cm.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS) in people with Maternal and Child Health and Maternal Nutrition, run by Bahir Dar University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Endalkachew Worku Mengesha, PhD (+251 930316799, endalkwk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Health Service Utilization (time frame: From enrollment (<16 weeks gestation) to 6 weeks postpartum.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.