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

NCT04155437 | Completed

• 1 other identifier: PHND-19-1052
• Study Type: interventional
• Target: 8,110
• 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 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.

Conditions

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

Keywords

maternal nutrition; antenatal care; Burkina Faso

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 16 months 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 16 months 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 16 months after baseline in a cross-sectional endline survey

• 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 Outcomes (7)

• Micronutrient, protein and energy adequacy during pregnancy

  Approximately 16 months after baseline in a cross-sectional endline survey

• Early initiation of breastfeeding

  Approximately 16 months after baseline in a cross-sectional endline survey

• Use of ANC services during pregnancy

  Approximately 16 months after baseline in a cross-sectional endline survey

• Exposure to nutrition interventions during ANC

  Approximately 16 months after baseline in a cross-sectional endline survey

• Women's knowledge of maternal nutrition and breastfeeding

  Approximately 16 months 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.

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

Control

NO INTERVENTION

Comparison areas: standard antenatal care services delivered at government health facilities.

Interventions

Health Facility Level Interventions BEHAVIORAL

* 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

Intervention

Community Level Interventions BEHAVIORAL

* 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.

Intervention

Health System Level Interventions BEHAVIORAL

* 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

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
• Residency in the health facility catchment area
• Informed consent

You may not qualify if:

• Age \<15 years or \>49 years

Sponsors & Collaborators

• International Food Policy Research Institute: lead
• AFRICSanté: collaborator
• FHI 360: collaborator

Study Sites (1)

International Food Policy Research Institute

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

Location

Related Publications (6)

• 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.

  PMID: 26433230 BACKGROUND

• 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.

  PMID: 18207566 BACKGROUND

• 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/

  PMID: 28079998 BACKGROUND

• 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.

  BACKGROUND

• United Nations Children's Fund (UNICEF). 2016. The state of the world's children 2016: A fair chance for every child. New York: UNICEF.

  BACKGROUND

• 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.

  PMID: 25013954 BACKGROUND

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: November 5, 2019
• First Posted: November 7, 2019
• Study Start: November 6, 2019
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: March 10, 2022

Record last verified: 2022-02

Data Sharing

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

Locations

US (1)