- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04155437
Assessing the Feasibility of Integrating a Package of Maternal Nutrition Interventions Into Antenatal Care Services in Burkina Faso
Assessing the Feasibility of Integrating a Package of Maternal Nutrition Interventions Into Antenatal Care Services in Burkina Faso: A Cluster-Randomized Evaluation
Study Overview
Status
Conditions
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:
- 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?
- 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?
- What factors influenced 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
- Residency in the health facility catchment area
- Informed consent
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention
A&T intervention areas: intensified maternal nutrition behavior change interventions during antenatal care delivered through government health facilities.
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No Intervention: Control
Comparison areas: standard antenatal care services delivered at government health facilities.
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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 16 months after baseline in a cross-sectional endline survey
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Mean number of food groups consumed by pregnant women on the day preceding the interview.
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Approximately 16 months after baseline in a cross-sectional endline survey
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Minimum dietary diversity during pregnancy
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
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Proportion of pregnant women who consumed 5 or more food groups on the day preceding the interview.
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Approximately 16 months after baseline in a cross-sectional endline survey
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Consumption of iron-folic acid tablets during pregnancy
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
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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 16 months after baseline in a cross-sectional endline survey
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Consumption of 90+ iron-folic acid tablets during pregnancy
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
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Proportion of women who consumed 90+ IFA tablets during last pregnancy by recently delivered women with a child 0-5.9 months of age.
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Approximately 16 months after baseline in a cross-sectional endline survey
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Micronutrient, protein and energy adequacy during pregnancy
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
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Proportion of pregnant women whose micronutrient, protein and energy intakes are equal to or above the dietary reference intake.
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Approximately 16 months after baseline in a cross-sectional endline survey
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Early initiation of breastfeeding
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
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Proportion of children aged 0-5.9 months who were breastfed within 1 hour of birth.
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Approximately 16 months after baseline in a cross-sectional endline survey
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Use of ANC services during pregnancy
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
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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.
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Approximately 16 months after baseline in a cross-sectional endline survey
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Exposure to nutrition interventions during ANC
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
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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.
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Approximately 16 months after baseline in a cross-sectional endline survey
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Women's knowledge of maternal nutrition and breastfeeding
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
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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.
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Approximately 16 months 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 and exclusive breastfeeding.
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
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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.
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Approximately 16 months after baseline in a cross-sectional endline survey
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Availability of ANC service supports
Time Frame: Approximately 16 months after baseline in a cross-sectional endline survey
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Proportion of health facilities with ANC materials and equipment based on enumerator observation.
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Approximately 16 months after baseline in a cross-sectional endline survey
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Collaborators and Investigators
Publications and helpful links
General Publications
- Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
- WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/
- Hanson MA, Bardsley A, De-Regil LM, Moore SE, Oken E, Poston L, Ma RC, McAuliffe FM, Maleta K, Purandare CN, Yajnik CS, Rushwan H, Morris JL. The International Federation of Gynecology and Obstetrics (FIGO) recommendations on adolescent, preconception, and maternal nutrition: "Think Nutrition First". Int J Gynaecol Obstet. 2015 Oct;131 Suppl 4:S213-53. doi: 10.1016/S0020-7292(15)30034-5. No abstract available.
- Partnership for Maternal, Newborn and Child Health (PMNCH). 2006. Opportunities for Africa's newborns: Practical data, policy and programmatic support for newborn care in Africa. Edited by Joy Lawn and Kate Kerber. Cape Town: PMNCH.
- United Nations Children's Fund (UNICEF). 2016. The state of the world's children 2016: A fair chance for every child. New York: UNICEF.
- United Nations Inter-agency Group for Child Mortality Estimation (UN IGME). 2018. Levels & Trends in Child Mortality: Report 2018, Estimates developed by the United Nations Inter-agency Group for Child Mortality Estimation. New York: UNICEF.
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-19-1052
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
- Informed Consent Form (ICF)
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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