A Feasibility Study of Integrating Maternal Nutrition Interventions Into Antenatal Care Services in Ethiopia

February 23, 2022 updated by: International Food Policy Research Institute

A Feasibility Study of Integrating Maternal Nutrition Interventions Into Antenatal Care Services in Ethiopia: A Cluster-Randomized Evaluation

Alive & Thrive (A&T) is an initiative that supports the scaling up of nutrition interventions to save lives, prevent illnesses, and contribute to healthy growth and development through improved maternal nutrition, breastfeeding and complementary feeding practices. In Ethiopia, A&T integrated a package of maternal nutrition interventions into existing antenatal care (ANC) services delivered through government health facilities (counselling on diet quality during pregnancy, distribution and promotion of iron-folic acid (IFA) supplementation, weight gain monitoring, counselling on early breastfeeding practices, and systems strengthening through training and supportive supervision) and community platforms (home visits, Pregnant Women Conferences/Mother Support groups, and community gatherings). The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys in 2019 and 2021.

Study Overview

Detailed Description

There is wide recognition of the importance of integrating maternal nutrition interventions in ANC to improve maternal and child health. In 2016, World Health Organization ANC guidelines were updated to place a high priority on nutrition interventions during pregnancy to improve perinatal outcomes and women's experience of care.

In Ethiopia, the government has adopted a package of maternal nutrition interventions into national guidelines (see Ethiopia's Federal Ministry of Health National Guideline on Adolescent, Maternal, Infant and Young Child Nutrition). Despite these efforts, the coverage and quality of maternal nutrition interventions remains low.

A&T Ethiopia integrated a package of maternal nutrition interventions into existing ANC services delivered through government health facilities (counselling on diet quality during pregnancy, distribution and promotion of IFA supplementation, weight gain monitoring, counselling on early breastfeeding practices, and systems strengthening through training and supportive supervision) and community platforms (home visits, Pregnant Women Conferences/Mother Support groups, and community gatherings) that align with the latest global evidence. IFPRI tested the feasibility of the behavior-change interventions and examined their impacts on pregnant women's health and nutrition practices and breastfeeding practices of recently delivered women, compared with standard antenatal care services provided in control areas.

The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys of pregnant and recently delivered women who attended government ANC services. The unit of randomization is the health center and associated health posts in the catchment area. 18 health centers and 2 hospitals in SNNPR and 10 health centers in Somali were randomly assigned to intervention/control. The baseline survey was conducted in October-November 2019, and the endline survey took place in July-September 2021. In 2020, program activities were interrupted between April and July 2020 due to the COVID-19 pandemic. The endline survey was postponed to July-September 2021 to maximize implementation duration.

The overall study objective was to determine the feasibility and impact of integrating locally relevant maternal nutrition interventions into existing ANC services on diet quality and utilization of nutrition interventions during pregnancy.

Research questions include:

  1. What are the program impacts on maternal practices: (1) consumption of diversified foods during pregnancy; (2) consumption of IFA supplements during pregnancy; and (3) early breastfeeding practices?
  2. Can the coverage and utilization of key maternal nutrition interventions during ANC be improved through system strengthening approaches?
  3. What factors influenced the integration and strengthening of maternal nutrition interventions into the government ANC service delivery platform?

Study Type

Interventional

Enrollment (Actual)

4256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • District of Columbia
      • Washington, District of Columbia, United States, 20005
        • International Food Policy Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Currently pregnant or recently delivered with a child 0-5.9 months of age
  • Attended at least 1 ANC visit at a government health center or health post
  • Resides in the same kebeles as the government health center catchment area
  • Given informed consent
  • Service providers and health facilities in the catchment areas

Exclusion Criteria:

  • Age <15 years or >49 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
A&T intervention areas: intensified maternal nutrition behavior change interventions during antenatal care delivered through government health facilities and in the community
  1. Intensified counselling on dietary diversity and increased meal frequency during pregnancy.
  2. Strengthened government distribution of IFA supplies with counseling about its importance, managing side effects, and reminder about subsequent supplies.
  3. Weight-gain monitoring with messaging to mothers about healthy diet and adequate rest; excess weight gain as a danger sign.
  4. Intensified counseling on importance, benefits, and how-tos of early initiation of breastfeeding and exclusive breastfeeding.
  1. Home visits to pregnant women by HEWs to discuss maternal nutrition (dietary diversity, adequate food intake, IFA supplementation, and weight gain), early breastfeeding practices, provide ANC and Pregnant Women Conference referrals, and engage husbands.
  2. HEWs use A&T intervention tools (e.g. posters and maternal nutrition follow-up card) at Pregnant Women Conferences/ Mother Support Groups to reinforce maternal nutrition messages, encourage ANC attendance, distribute IFA tablets, measure and track weight gain, promote early breastfeeding practices, and encourage husband participation.
  3. HEWs and community volunteers (Women's Development Army (WDA), imams, etc.) deliver maternal nutrition messages and encourage ANC visits at kebele and community meetings.
  1. Trainings on the maternal nutrition interventions for health center heads, nurse-midwives, HEWs, community volunteers (WDA, imams, etc.), woreda health officers, and other key actors.
  2. Supportive supervision of maternal nutrition activities conducted by woreda nutrition officers, woreda health officers, TDA or A&T.
NO_INTERVENTION: Control
Comparison areas: standard antenatal care services delivered at government health facilities and in the community

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary diversity during pregnancy
Time Frame: Approximately 2 years after baseline in a cross-sectional endline survey
Mean number of food groups consumed by pregnant women on the day preceding the interview.
Approximately 2 years after baseline in a cross-sectional endline survey
Minimum dietary diversity during pregnancy
Time Frame: Approximately 2 years after baseline in a cross-sectional endline survey
Proportion of pregnant women who consumed 5 or more food groups on the day preceding the interview.
Approximately 2 years after baseline in a cross-sectional endline survey
Consumption of iron-folic acid tablets during pregnancy
Time Frame: Approximately 2 years after baseline in a cross-sectional endline survey
Mean number of IFA tablets consumed during last pregnancy by recently delivered women with a child 0-5.9 months of age.
Approximately 2 years after baseline in a cross-sectional endline survey
Consumption of 90+ iron-folic acid tablets during pregnancy
Time Frame: Approximately 2 years after baseline in a cross-sectional endline survey
Proportion of women who consumed 90+ IFA supplements during pregnancy by recently delivered women with a child 0-5.9 months of age.
Approximately 2 years after baseline in a cross-sectional endline survey

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early initiation of breastfeeding
Time Frame: Approximately 2 years after baseline in a cross-sectional endline survey
Proportion of children aged 0-5.9 months who were breastfed within 1 hour of birth.
Approximately 2 years after baseline in a cross-sectional endline survey
Use of ANC services during pregnancy
Time Frame: Approximately 2 years after baseline in a cross-sectional endline survey
Total number of ANC visits and month of first ANC visit during last pregnancy reported by recently delivered women with a child age 0-5.9 months.
Approximately 2 years after baseline in a cross-sectional endline survey
Exposure to maternal nutrition interventions from ANC
Time Frame: Approximately 2 years after baseline in a cross-sectional endline survey
Proportion of recently delivered women with children <6 months of age exposed to maternal nutrition interventions from ANC and other sources.
Approximately 2 years after baseline in a cross-sectional endline survey
Women's knowledge of maternal nutrition and breastfeeding
Time Frame: Approximately 2 years after baseline in a cross-sectional endline survey
Proportion of recently delivered women with children <6 months of age with correct knowledge of maternal nutrition and appropriate breastfeeding practices based on survey responses.
Approximately 2 years after baseline in a cross-sectional endline survey
Health worker knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy, and early initiation of and exclusive breastfeeding.
Time Frame: Approximately 2 years after baseline in a cross-sectional endline survey
Proportion of nurse-midwives and health extension workers with correct knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy and appropriate breastfeeding practices based on survey responses.
Approximately 2 years after baseline in a cross-sectional endline survey
Availability of ANC service supports
Time Frame: Approximately 2 years after baseline in a cross-sectional endline survey
Proportion of health facilities with service supports (IFA supplies, records/registers and regular review of nutrition intervention coverage and IFA supply data, weight measurement equipment, counseling materials, and training and supervision for health workers) based on enumerator observation.
Approximately 2 years after baseline in a cross-sectional endline survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 8, 2019

Primary Completion (ACTUAL)

September 4, 2021

Study Completion (ACTUAL)

September 4, 2021

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (ACTUAL)

October 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PHND-19-0948

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In compliance with donor open access policy requirements, fully anonymized datasets will be made publicly available one year after the end of the project. Metadata and other documentation of data collection procedures (such as the codebook, data collection instruments and interviewer guides/protocols) will also be made publicly available.

IPD Sharing Time Frame

Fully anonymized datasets will be made publicly available one year after the end of the project.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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