Bahir Dar University
Bahir Dar, Ethiopia
NCT Number: NCT07522047
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.
Trial opening soon.
Get Notified15 year–49 year
Female
Interventional
Not applicable
Bahir Dar, Ethiopia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Bahir Dar University
Other
Improving the Health and Nutritional Status of Mothers and Children Using Indigenous Community Structure in Northwest Ethiopia
Acronym: SoNIMCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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