- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04125368
A Feasibility Study of Integrating Maternal Nutrition Interventions Into Antenatal Care Services in Ethiopia
A Feasibility Study of Integrating Maternal Nutrition Interventions Into Antenatal Care Services in Ethiopia: A Cluster-Randomized Evaluation
Study Overview
Status
Conditions
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:
- 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?
- Can the coverage and utilization of key maternal nutrition interventions during ANC be improved through system strengthening approaches?
- What factors influenced the integration and strengthening of maternal nutrition interventions into the government ANC service delivery platform?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
District of Columbia
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Washington, District of Columbia, United States, 20005
- International Food Policy Research Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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NO_INTERVENTION: Control
Comparison areas: standard antenatal care services delivered at government health facilities and in the community
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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.
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Approximately 2 years after baseline in a cross-sectional endline survey
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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.
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Approximately 2 years after baseline in a cross-sectional endline survey
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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.
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Approximately 2 years after baseline in a cross-sectional endline survey
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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.
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Approximately 2 years after baseline in a cross-sectional endline survey
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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.
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Approximately 2 years after baseline in a cross-sectional endline survey
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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.
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Approximately 2 years after baseline in a cross-sectional endline survey
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Exposure to maternal nutrition interventions from ANC
Time Frame: Approximately 2 years after baseline in a cross-sectional endline survey
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Proportion of recently delivered women with children <6 months of age exposed to maternal nutrition interventions from ANC and other sources.
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Approximately 2 years after baseline in a cross-sectional endline survey
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Women's knowledge of maternal nutrition and breastfeeding
Time Frame: Approximately 2 years after baseline in a cross-sectional endline survey
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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.
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Approximately 2 years after baseline in a cross-sectional endline survey
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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
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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.
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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
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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.
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Approximately 2 years after baseline in a cross-sectional endline survey
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PHND-19-0948
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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