Clinical trial NCT04155437: Assessing the Feasibility of Integrating a Package of Maternal Nutrition Interventions Into Antenatal Care Services in Burkina Faso
Official title: Assessing the Feasibility of Integrating a Package of Maternal Nutrition Interventions Into Antenatal Care Services in Burkina Faso: 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
Burkina Faso
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: AFRICSanté
name: FHI 360
First posted: 2019-11-07
Enrollment: 8110
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 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.

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?

Eligibility criteria: 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

Primary outcomes:
measure: Dietary diversity during pregnancy
timeFrame: Approximately 16 months after baseline in a cross-sectional endline survey
measure: Minimum dietary diversity during pregnancy
timeFrame: Approximately 16 months after baseline in a cross-sectional endline survey
measure: Consumption of iron-folic acid tablets during pregnancy
timeFrame: Approximately 16 months after baseline in a cross-sectional endline survey
measure: Consumption of 90+ iron-folic acid tablets during pregnancy
timeFrame: Approximately 16 months after baseline in a cross-sectional endline survey
Secondary outcomes:
measure: Micronutrient, protein and energy adequacy during pregnancy
timeFrame: Approximately 16 months after baseline in a cross-sectional endline survey
measure: Early initiation of breastfeeding
timeFrame: Approximately 16 months after baseline in a cross-sectional endline survey
measure: Use of ANC services during pregnancy
timeFrame: Approximately 16 months after baseline in a cross-sectional endline survey
measure: Exposure to nutrition interventions during ANC
timeFrame: Approximately 16 months after baseline in a cross-sectional endline survey
measure: Women's knowledge of maternal nutrition and breastfeeding
timeFrame: Approximately 16 months after baseline in a cross-sectional endline survey
measure: Health worker knowledge of IFA supplementation, dietary diversity, weight gain during pregnancy, and early and exclusive breastfeeding.
timeFrame: Approximately 16 months after baseline in a cross-sectional endline survey
measure: Availability of ANC service supports
timeFrame: Approximately 16 months 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:
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. No abstract available.
citation: 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.
citation: 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/
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.
citation: United Nations Children's Fund (UNICEF). 2016. The state of the world's children 2016: A fair chance for every child. New York: UNICEF.
citation: Alkema L, New JR, Pedersen J, You D; UN Inter-agency Group for Child Mortality Estimation; Technical Advisory Group. Child mortality estimation 2013: an overview of updates in estimation methods by the United Nations Inter-agency Group for Child Mortality Estimation. PLoS One. 2014 Jul 11;9(7):e101112. doi: 10.1371/journal.pone.0101112. eCollection 2014.