NCT07070206

Brief Summary

Background: Inadequate dietary consumption is a primary risk factor contributing to undernutrition during pregnancy and adversely affect birth outcomes. Despite this, in Ethiopia, 59.9% to 84.8% of pregnant women have inadequate dietary intake. Maternal nutrition education on healthy diet during pregnancy is one of the cost-effective interventions to improve dietary intake of pregnant women. However, nutrition education during pregnancy is not properly implemented in the country. Objectives: The aim of this project is to investigate effectiveness of culturally customized maternal nutrition education for health professionals in improving their counseling capacity in Ethiopia. Methods: A two arm parallel cluster randomized controlled trial will be conducted in Bahir Dar city adminstration and Bahir Dar Zuria district, Ethiopia, from 08/01/2024-8/20/2025. A Nonadjacent cluster (health institutions) will be selected using cluster sampling technique and randomized into the intervention and control groups. Data will be collected before and after the intervention using a structured questionnaire. Effect of the intervention will be assessed using generalized linear mixed-effects models. Intervention strategies: The intervention will be in-service training about culturally customized maternal nutrition education for health professionals working at antenatal, delivery, and postnatal care units in the capacity building group. It will be given for five days monthly for four months using education guide. Health professionals in the routine capacity building group will receive routine capacity building training that will be given by the health system. Project outcomes: Maternal nutrition counselling practices of health professionals will be the primary outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

January 28, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

Counseling practiceHealth professionalsIn-service training

Outcome Measures

Primary Outcomes (2)

  • Knowledge of the health professionals on diet during pregnancy will be the primary outcome of this study.

    Health professionals' knowledge will be assessed using twenty four " yes/no " type questions on counselling and maternal diet. Health professionals who scored above 80% of knowledge assessment questions will be knowledgable, otherwise not knowledgeable.

    One year

  • Nutrition counselling practices of the health professionals will be the primary outcome of this study.

    Counselling practices of health professionals will also be assessed using eighteen " yes/no " type questions that will be filled by observing health professionals nutrition counseling practices. Health professionals who properly practiced more than 80% practice related activities will have good counselling practice, otherwise not.

    One year

Secondary Outcomes (1)

  • Birth weight

    one year

Study Arms (2)

capacity building arm

EXPERIMENTAL

Health professionals in the capacity building arm will receive capacity building in-service training for the health professionals.

Behavioral: The health professionals in the capacity building arm will receive in-service training about culturally customized maternal nutrition education.

routine capacity building arm

OTHER

Health professionals in the routine capacity building arm will receive capacity building in-service training given through the health care system.

Behavioral: The health professionals in the capacity building arm will receive in-service training about culturally customized maternal nutrition education.

Interventions

The health professionals in the routine capacity building arm will receive in-service training given through the health are system.

Also known as: Routine capacity building in-service training
capacity building armroutine capacity building arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • On annual leave during enrolment of the study participants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahir Dar University

Bahir Dar, Amhara, 79, Ethiopia

Location

Related Publications (5)

  • Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.

    PMID: 23746772BACKGROUND
  • Wakwoya EB, Belachew T, Girma T. Determinants of nutritional status among pregnant women in East Shoa zone, Central Ethiopia. Front Nutr. 2022 Dec 15;9:958591. doi: 10.3389/fnut.2022.958591. eCollection 2022.

    PMID: 36590215BACKGROUND
  • Fite MB, Tura AK, Yadeta TA, Oljira L, Roba KT. Factors associated with undernutrition among pregnant women in Haramaya district, Eastern Ethiopia: A community-based study. PLoS One. 2023 Mar 9;18(3):e0282641. doi: 10.1371/journal.pone.0282641. eCollection 2023.

    PMID: 36893154BACKGROUND
  • Demilew YM, Alene GD, Belachew T. Dietary practices and associated factors among pregnant women in West Gojjam Zone, Northwest Ethiopia. BMC Pregnancy Childbirth. 2020 Jan 6;20(1):18. doi: 10.1186/s12884-019-2702-z.

    PMID: 31906981BACKGROUND
  • Demilew YM, Alene GD, Belachew T. Effect of guided counseling on dietary practices of pregnant women in West Gojjam Zone, Ethiopia. PLoS One. 2020 May 26;15(5):e0233429. doi: 10.1371/journal.pone.0233429. eCollection 2020.

    PMID: 32453774BACKGROUND

Study Officials

  • Getu D Alene

    Bahir Dar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors willnot be aware about the objective of this intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A two arm parallel cluster randomized controlled trial will be conducted in Bahir Dar city adminstration and Bahir Dar Zuria district, Ethiopia.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 28, 2025

First Posted

July 17, 2025

Study Start

August 1, 2024

Primary Completion

August 20, 2025

Study Completion

August 20, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Locations