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临床试验/NCT07522047
NCT07522047尚未招募不适用

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

Bahir Dar University1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
700
试验地点
1
主要终点
Maternal Health Service Utilization

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS) (Behavioral)

Standard Care (Routine Health Services)

Active Comparator

干预措施: Community-based Health and Nutrition Counseling via Indigenous Social Support Structures (ISSS) (Behavioral)

结局指标

主要结局

Maternal Health Service Utilization

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Endalkachew Worku Mengesha, PhD

Principal Investigator

Bahir Dar University

研究点 (1)

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