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NCT ID: NCT05792241 Completed - Iodine Deficiency Clinical Trials

Acceptability and Nutritional Impact of Double-fortified Salt Containing Iodine and Folic Acid - Phase 1

DFS-IoFA-1
Start date: June 26, 2023
Phase:
Study type: Observational

The overarching objective of this two-phase project is to assess the effects of fortifying iodized salt with folic acid on improving women's folate status and thereby reduce the risk of neural tube defects (NTDs), which are highly prevalent in Ethiopia. The project will be conducted in two phases. The purpose of Phase 1, described herein, is to complete formative research in preparation for a community-based, randomized trial, which will be carried out in Phase 2. The objectives of Phase 1 are to: 1) assess the hematological condition and nutritional status with respect to folate, iodine, and other micronutrients among non-pregnant women of reproductive age (WRA) in the study communities, and 2) measure discretionary salt and dietary folate intakes of the women and their households.

NCT ID: NCT05791305 Recruiting - Obesity Clinical Trials

Double Duty Interventions and Its Impact on Double Burden of Malnutrition in Children Under Five Years

DBM
Start date: April 10, 2023
Phase: N/A
Study type: Interventional

Background: Double burden of malnutrition is an emerging public health problem among children under-five years due to the inevitable consequences of nutritional transition. Addressing these two contrasting forms of malnutrition (undernutrition and overnutrition) simultaneously brings an enormous challenge to the food and nutrition policies of developing countries like Ethiopia. Children under five ages are more vulnerable to DBM, especially during the first year of their life due to high growth and inadequate diet. Hence, there has been a paradigm shift in thinking to reduce its effect on the health of children. However, interventions that are used to address these different kinds of malnutrition are implemented through different governance and still, they are isolated and disintegrated each other. Therefore, double-duty interventions can tackle the risk of both nutritional problems simultaneously in an integrated approach through nutrition behavior change communication. Objective: Therefore, the main aim of this pilot study is to assess the effect of selected double-duty interventions on the double burden of malnutrition among children under five years in Debre Berhan City, Ethiopia.

NCT ID: NCT05754398 Completed - Frailty Clinical Trials

A Nurse-led Intervention on Frailty Status of Ethiopian Older Persons

Start date: January 3, 2023
Phase: N/A
Study type: Interventional

The goals of this study are to design, implement, and evaluate the effects of a nurse-led intervention on the frailty and quality of life of older persons living in the community in Ethiopia. The main hypothesis aims to test the following: 1. Effects of a nurse-led intervention on frailty, including physical, social, and psychological domains of older persons living in the community in Bahir Dar, Ethiopia. 2. Effects of a nurse-led intervention improve the quality of life among the older persons living in the community of Bahir Dar, Ethiopia. The nurse-led intervention consists of six independent interconnected education sessions focused on specific topic areas consisting of ageing and age-related changes, healthy nutrition, physical activity, mental health, social interaction, and support, and lastly an overall discussion on the intervention. The intervention is delivered one-on-one and face-to-face to the family homes of older people living in the community by specialist nurses who are community health workers (CHWs). Each CHW will be provided with a notebook to record the progress of each participant undertaking the program and any questions that need to be followed up at a subsequent session.

NCT ID: NCT05716178 Recruiting - Maternal Health Clinical Trials

Effectiveness of Trained Religious Leaders' Engagement in Maternal Health Education in Ethiopia

Start date: March 2023
Phase: N/A
Study type: Interventional

Community education and demand generation activities by involving family members, traditional and religious leaders in maternal health behaviours are potential solutions. Knowledge about maternal and neonatal health service utilization can be increased through community-based structures, such as religious organizations.

NCT ID: NCT05708183 Active, not recruiting - Birth Weight Clinical Trials

Healthy Mums, Healthy Babies: Multiple Micronutrient Supplementation in Ethiopia

Start date: January 15, 2023
Phase:
Study type: Observational

Background: This programme effectiveness study responds to the need for evidence on the effect on birthweight of switching from iron-folic acid supplementation (IFA) to multiple micronutrient supplementation (MMS) as part of routine antenatal care in Ethiopia. A 2019 meta-analysis of trial data reported a mean improvement of 35g in newborn birthweight amongst newborns born to women who took MMS in pregnancy compared to those who took IFA. Responding to this evidence, in 2020 the World Health Organisation updated its global guideline on MMS from 'not recommended' to 'recommended in the context of rigorous research'. The guideline identifies priority research being 'to establish the impact of switching routine antenatal IFA to MMS on important health outcomes, equity, acceptability, feasibility, sustainability and health-care resources in different country settings.' In 2022 the Ministry of Health of Ethiopia (MoH), will change from MMS to IFA in a set of pilot districts. EPHI and LSHTM have been asked to evaluate the effect of this change on mean birthweight and propose the current trial for this purpose. The overall aim is to evaluate the programme effectiveness on mean birthweight of providing MMS as part of routine antenatal care, compared to providing IFA. Findings will support the MoH to make evidence-informed decisions about the large-scale implementation of MMS in Ethiopia and also contribute to the global evidence base on the effectiveness of MMS in a programmatic setting. Methods: A two-arm cluster randomized trial will be used to estimate the effect of the programme change on mean birthweight, with cost-effectiveness and process evaluations embedded in the trial design. Women aged 15-49 who deliver a live born child in a study district health facility (mother/infant dyads) will be eligible for enrolment in the study. The primary outcome measure will be birthweight, recorded in facilities at the time of birth as part of the routine maternity care. Secondary objectives include costs of providing MMS, acceptability of MMS, adherence to antenatal micronutrient supplementation and implementation challenges.

NCT ID: NCT05682261 Active, not recruiting - Anemia Clinical Trials

The Effect of Multiple Micronutrient Supplements in Reducing Anemia in Women of Reproductive Age

Start date: March 23, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the effect of multiple micronutrient supplements in reducing anemia in women of reproductive age in comparison with iron-folic acid. The main questions it aims to answer are: - What is the effect of multiple micronutrient supplements in reducing anemia among women of reproductive age in comparison with iron-folic acid? - What is the effect of multiple micronutrient supplements in reducing iron deficiency among women of reproductive age in comparison with iron-folic acid? Participants will - be given multiple micronutrient supplements, iron folic acid, or placebo twice weekly for 17 weeks - be asked to respond to the interview - provide blood, urine, and stool samples Researchers will compare the control group with the intervention groups to see the effect of multiple micronutrient supplements on iron deficiency and anemia reduction.

NCT ID: NCT05669209 Completed - Anemia Clinical Trials

Causes of Anemia Among Women of Reproductive Age

Start date: December 16, 2022
Phase:
Study type: Observational

The goal of this observational study is to assess the causes of anemia in women of reproductive age. The main questions it aims to answer are: - What are the causes of anemia among women of reproductive age? - What is the contribution of iron deficiency to overall anemia? - What is the prevalence of hemoglobinopathies among women of reproductive age with anemia? Participants will be asked to respond to the interview questions, and provide blood, urine, and stool samples.

NCT ID: NCT05666050 Recruiting - Neonatal Care Clinical Trials

Mobile Health Intervention to Improve Neonatal Care Practice

NCP
Start date: December 5, 2022
Phase: N/A
Study type: Interventional

Effectiveness of interactive mobile health intervention (IMHI) to improve neonatal care practice among postpartum women in Dessie and Kombolcha town zones, north east Ethiopia: behavioral cluster randomized control trial.

NCT ID: NCT05666037 Recruiting - Clinical trials for Other Cardiovascular Diseases of Mother, Postpartum

Interactive Mobile Health Intervention to Improve Early Postpartum Modern Contraceptive Method Uptake

EPPMC
Start date: December 5, 2022
Phase: N/A
Study type: Interventional

The main aim of this study is to determine effectiveness of mobile health intervention to improve early postpartum modern contraceptive service uptake among postpartum women in Dessie and Kombolcha town zones, North east Ethiopia. This study will be conducted in Dessie and Kombolcha zones in Amhara region, North east Ethiopia. The largest sample size will be taken and total sample size will be 784.

NCT ID: NCT05652400 Recruiting - HIV-1-infection Clinical Trials

HIV Transmission in the Era of Scaling up Antiretroviral Therapy in Ethiopia

THESA
Start date: July 1, 2022
Phase:
Study type: Observational

The goal of this observational study is to understand patterns of HIV transmission in a high-prevalence area in Ethiopia, and to compare viral genetic information in people with HIV who are newly diagnosed and have not been exposed to antiretroviral therapy with persons receiving antiretroviral therapy without viral suppression. The main questions it aims to answer are: - Do people with HIV who fail to achieve viral suppression contribute to the ongoing spread of HIV in Ethiopia, or does HIV transmission mainly occur between persons with no exposure to such therapy? - Are viruses with drug-resistance mutations transmitted onwards from people with HIV receiving antiretroviral therapy who fail to achieve viral suppression? * Which factors are involved in treatment failure and emergence of drug-resistant viruses longitudinally? Participants will be enrolled with regard to history of antiretroviral therapy exposure (newly diagnosed/treatment-naïve vs. treatment-experienced with lack of viral suppression), using persons on antiretroviral therapy with viral suppression for control. We will compare the following outcomes between these groups: - Clustering of viral genetic sequences at inclusion (implying linked transmission) - Prevalence of drug-resistance-associated mutations at inclusion - Viral suppression and emergence of drug-resistance mutations during follow-up