Assessing the Feasibility of Integrating a Package of Maternal Nutrition Interventions Into Antenatal Care Services in Burkina Faso

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

Assessing the Feasibility of Integrating a Package of Maternal Nutrition Interventions Into Antenatal Care Services in Burkina Faso: 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 Burkina Faso, A&T developed an intensive package of maternal nutrition interventions to be integrated into existing ANC services delivered through government health facilities that align with the latest global evidence. These included intensified counseling and support on dietary diversity and quality during pregnancy, iron-folic acid (IFA) supplements consumption, importance of ANC and increasing the number of visits, adequate weight-gain monitoring, and early initiation of and exclusive breastfeeding. The evaluation used a two-arm cluster-randomized, non-masked trial design, consisting of two cross-sectional surveys of pregnant and recently delivered women (i.e. with a child under 6 months of age) in 2019 and 2021.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Routine antenatal care (ANC) offers opportunities to receive a broad range of health promotion and prevention services including support for adequate nutritional care for pregnant women and their newborns, and any required medical treatment. In 2016, World Health Organization (WHO) updated its guidelines on ANC with a high priority placed on nutrition interventions. These guidelines also recommended increasing the number of ANC from at least four to eight contacts to improve women's positive experience of care and to reduce perinatal morbidity and mortality. Following these new recommendations, the government of Burkina Faso is working with WHO and other partners to revise the national guidelines on ANC and test elements of the essential core package of routine ANC needed by women throughout pregnancy.

A&T Burkina Faso, developed an intensive package of maternal nutrition interventions to be integrated into existing ANC services delivered through government health facilities that align with the latest global evidence. These included intensified counseling and support on dietary diversity and quality during pregnancy, iron-folic acid (IFA) supplements consumption, importance of ANC and increasing the number of visits, adequate weight-gain monitoring, and early initiation of and exclusive breastfeeding. 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 study was designed as a two-arm cluster-randomized, non-masked trial, consisting of two cross-sectional surveys at baseline and endline. The unit of randomization was the health and social promotion center (CSPS, Centre de Santé et de Promotion Social in French) catchment area. 40 CSPS in Boucle du Mouhoun and 40 CSPS in Hauts-Bassins were randomly assigned to intervention/control. A baseline cluster/facility-level and household survey took place in November-December 2019. Soon after the completion of the baseline survey, the interventions were implemented at the CSPS and villages within the intervention areas for approximately 10 months (less than 1 year, caused by brief service interruptions in March-April 2020 due to the COVID-19 pandemic). The endline survey took place in January-March 2021.

The overall study objective is to evaluate the feasibility of integrating locally relevant maternal nutrition interventions into ANC services provided by the government health system and their impact on diet quality and quantity and utilization of nutrition interventions during pregnancy.

The implementation research study addresses three research questions:

  1. What are the program impacts on maternal nutrition practices: (1) consumption of diversified foods and adequate intake of micronutrient, protein and energy compared to recommended intakes; (2) consumption of IFA supplements during pregnancy; and (3) early breastfeeding practices?
  2. Can the coverage and utilization of key nutrition interventions (maternal nutrition counseling, weight gain monitoring, distribution of and counseling on IFA supplementation, and breastfeeding counseling) and number of ANC contacts be improved through health system strengthening and nutrition-focused social and behavior change communication (SBCC; interpersonal communication and community mobilization) approaches?
  3. What factors influenced integration and strengthening of maternal nutrition interventions into the government ANC service delivery platform?

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Currently pregnant or recently delivered with a child 0-5.9 months of age
  • Residency in the health facility catchment area
  • Informed consent

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
A&T intervention areas: intensified maternal nutrition behavior change interventions during antenatal care delivered through government health facilities.
Behavioral: Health Facility Level Interventions
  • Intensified counseling on maternal dietary diversity and quality using job aids
  • Counseling on purpose of IFA supplementation, managing side effects, and importance of adherence to daily consumption
  • Distribution/prescription of IFA tablets at each ANC visit
  • Use of pill card/reminders for pregnant women and their spouses
  • Monthly IFA tablet stock monitoring to assure sufficient supplies
  • Measurement of weight gain during each ANC visit and advise on healthy weight gain
  • Checks for functioning scales and use of monitoring sheets
  • Intensified counseling on early initiation of breastfeeding and exclusive breastfeeding using job aids
  • Reminder on importance of early ANC attendance and 4+ visits
Behavioral: Community Level Interventions
  • Advocacy among community leaders (traditional and religious leaders, local associations, etc.) about ANC
  • Gatherings among grandmothers, husbands, and other influencers about ANC and their roles
  • Promotion of ANC service utilisation and the importance of early ANC visit during the first trimester.
  • Early identification of pregnant women
  • Support women's group discussions
  • 2-3 home visits per pregnant woman by community health workers (Agent de santé a base communautaire; ASBC) which will include counseling on diet quality, breastfeeding, importance on adherence to daily IFA consumption and side effect management, etc.
Behavioral: Health System Level Interventions
  • Training on nutrition interventions during ANC for all ANC providers and community health workers
  • Semi-annual supervision by the Regional Health Directorate (Direction Regionale de la Santé; DRS)
  • Quarterly supportive supervision of health facility staff by the health district management team
  • Monthly supportive supervision of ASBCs
  • Monthly review between health facilities and ASBCs
  • Training and use of data registers
  • Training and use of mother's cards to record up to 8 ANC visits and nutrition services
  • Training on data utilization to improve coverage and quality
No Intervention: Control
Comparison areas: standard antenatal care services delivered at government health facilities.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dietary diversity during pregnancy
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
Mean number of food groups consumed by pregnant women on the day preceding the interview.
Approximately 16 months after baseline in a cross-sectional endline survey
Minimum dietary diversity during pregnancy
Time Frame: Approximately 16 months 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 16 months after baseline in a cross-sectional endline survey
Consumption of iron-folic acid tablets during pregnancy
Time Frame: Approximately 16 months 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 16 months after baseline in a cross-sectional endline survey
Consumption of 90+ iron-folic acid tablets during pregnancy
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
Proportion of women who consumed 90+ IFA tablets during last pregnancy by recently delivered women with a child 0-5.9 months of age.
Approximately 16 months after baseline in a cross-sectional endline survey

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Micronutrient, protein and energy adequacy during pregnancy
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
Proportion of pregnant women whose micronutrient, protein and energy intakes are equal to or above the dietary reference intake.
Approximately 16 months after baseline in a cross-sectional endline survey
Early initiation of breastfeeding
Time Frame: Approximately 16 months 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 16 months after baseline in a cross-sectional endline survey
Use of ANC services during pregnancy
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
Total number of ANC visits and month of first ANC first during last pregnancy reported by recently delivered women with a child age 0-5.9 months.
Approximately 16 months after baseline in a cross-sectional endline survey
Exposure to nutrition interventions during ANC
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
Proportion of recently delivered women with children 0-5.9 months of age who received nutrition interventions during their last pregnancy during ANC and in the community based on survey responses.
Approximately 16 months after baseline in a cross-sectional endline survey
Women's knowledge of maternal nutrition and breastfeeding
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
Proportion of recently delivered women with children 0-5.9 months of age with correct knowledge of maternal nutrition and appropriate breastfeeding practices based on survey responses.
Approximately 16 months after baseline in a cross-sectional endline survey
Health worker knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy, and early and exclusive breastfeeding.
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
Proportion of Nurse-Midwives and community health workers (ASBCs) with correct knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy and appropriate breastfeeding practices based on survey responses.
Approximately 16 months after baseline in a cross-sectional endline survey
Availability of ANC service supports
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
Proportion of health facilities with ANC materials and equipment based on enumerator observation.
Approximately 16 months after baseline in a cross-sectional endline survey

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Food Policy Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
FHI 360
AFRICSante

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHND-19-1052

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
  • Informed Consent Form (ICF)

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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