Clinical trial NCT04125368: A Feasibility Study of Integrating Maternal Nutrition Interventions Into Antenatal Care Services in Ethiopia
Official title: A Feasibility Study of Integrating Maternal Nutrition Interventions Into Antenatal Care Services in Ethiopia: A Cluster-Randomized Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Dietary Diversity
Iron-Folic Acid Supplementation
Early Initiation of Breastfeeding
Keywords: Maternal Nutrition
Antenatal Care
Ethiopia
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: Addis Continental Institute of Public Health
name: FHI 360
First posted: 2019-10-14
Enrollment: 4256
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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?

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

Primary outcomes:
measure: Dietary diversity during pregnancy
timeFrame: Approximately 2 years after baseline in a cross-sectional endline survey
measure: Minimum dietary diversity during pregnancy
timeFrame: Approximately 2 years after baseline in a cross-sectional endline survey
measure: Consumption of iron-folic acid tablets during pregnancy
timeFrame: Approximately 2 years after baseline in a cross-sectional endline survey
measure: Consumption of 90+ iron-folic acid tablets during pregnancy
timeFrame: Approximately 2 years after baseline in a cross-sectional endline survey
Secondary outcomes:
measure: Early initiation of breastfeeding
timeFrame: Approximately 2 years after baseline in a cross-sectional endline survey
measure: Use of ANC services during pregnancy
timeFrame: Approximately 2 years after baseline in a cross-sectional endline survey
measure: Exposure to maternal nutrition interventions from ANC
timeFrame: Approximately 2 years after baseline in a cross-sectional endline survey
measure: Women's knowledge of maternal nutrition and breastfeeding
timeFrame: Approximately 2 years after baseline in a cross-sectional endline survey
measure: Health worker knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy, and early initiation of and exclusive breastfeeding.
timeFrame: Approximately 2 years after baseline in a cross-sectional endline survey
measure: Availability of ANC service supports
timeFrame: Approximately 2 years after baseline in a cross-sectional endline survey
Other outcomes:
Locations:
city: Washington
country: United States
facility: International Food Policy Research Institute
state: District of Columbia
Study officials:
References: