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

Early Initiation of Breastfeeding Clinical Trial

Official title:

Assessing the Feasibility of Integrating a Package of Maternal Nutrition Interventions Into Antenatal Care Services in Burkina Faso: A Cluster-Randomized Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04155437
• Other study ID #: PHND-19-1052
• Status: Completed
• Phase: N/A
• Start date: November 6, 2019
• Est. completion date: March 5, 2021

Study information

• Verified date: February 2022
• Source: International Food Policy Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8110
• Est. completion date: March 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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.
• 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

Locations

Country	Name	City	State
United States	International Food Policy Research Institute	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
International Food Policy Research Institute	AFRICSanté, FHI 360

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Review. — View Citation

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. — View Citation

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.

WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary diversity during pregnancy	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
Primary	Minimum dietary diversity during pregnancy	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
Primary	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 16 months after baseline in a cross-sectional endline survey
Primary	Consumption of 90+ iron-folic acid tablets during pregnancy	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	Micronutrient, protein and energy adequacy during pregnancy	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
Secondary	Early initiation of breastfeeding	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
Secondary	Use of ANC services during pregnancy	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
Secondary	Exposure to nutrition interventions during ANC	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
Secondary	Women's knowledge of maternal nutrition and breastfeeding	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
Secondary	Health worker knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy, and early and exclusive breastfeeding.	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
Secondary	Availability of ANC service supports	Proportion of health facilities with ANC materials and equipment based on enumerator observation.	Approximately 16 months after baseline in a cross-sectional endline survey