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Clinical Trials/NCT04125368
NCT04125368
Completed
N/A

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

International Food Policy Research Institute1 site in 1 country4,256 target enrollmentOctober 8, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Maternal Dietary Diversity
Sponsor
International Food Policy Research Institute
Enrollment
4256
Locations
1
Primary Endpoint
Consumption of 90+ iron-folic acid tablets during pregnancy
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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?

Registry
clinicaltrials.gov
Start Date
October 8, 2019
End Date
September 4, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

Secondary Outcomes

  • Availability of ANC service supports(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.(Approximately 2 years after baseline in a cross-sectional endline survey)
  • Exposure to maternal nutrition interventions from ANC(Approximately 2 years after baseline in a cross-sectional endline survey)
  • Use of ANC services during pregnancy(Approximately 2 years after baseline in a cross-sectional endline survey)
  • Women's knowledge of maternal nutrition and breastfeeding(Approximately 2 years after baseline in a cross-sectional endline survey)
  • Early initiation of breastfeeding(Approximately 2 years after baseline in a cross-sectional endline survey)

Study Sites (1)

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