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

NCT04125368 | Completed

• 1 other identifier: PHND-19-0948
• Study Type: interventional
• Target: 4,256
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Dietary Diversity; Iron-Folic Acid Supplementation; Early Initiation of Breastfeeding

Keywords

Maternal Nutrition; Antenatal Care; Ethiopia

Outcome Measures

Primary Outcomes (4)

• Dietary diversity during pregnancy

  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

  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

  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

  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 Outcomes (6)

• Early initiation of breastfeeding

  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

• Exposure to maternal nutrition interventions from ANC

  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

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

A\&T intervention areas: intensified maternal nutrition behavior change interventions during antenatal care delivered through government health facilities and in the community

Behavioral: Health Facility Interventions; Behavioral: Community Interventions; Behavioral: Health System Interventions

Control

NO INTERVENTION

Comparison areas: standard antenatal care services delivered at government health facilities and in the community

Interventions

Health Facility Interventions BEHAVIORAL

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.

Intervention

Community Interventions BEHAVIORAL

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.

Intervention

Health System Interventions BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 15 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Age \<15 years or \>49 years

Sponsors & Collaborators

• International Food Policy Research Institute: lead
• Addis Continental Institute of Public Health: collaborator
• FHI 360: collaborator

Study Sites (1)

International Food Policy Research Institute

Washington D.C., District of Columbia, 20005, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 14, 2019
• Study Start: October 8, 2019
• Primary Completion: September 4, 2021
• Study Completion: September 4, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Fully anonymized datasets will be made publicly available one year after the end of the project.

Locations

US (1)