Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.

Conditions

Infant Malnutrition, Low Birth Weight, Prematurity, Small for Gestational Age at Delivery

Brief summary

The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts. The present proposal therefore will 1) perform a formative study to identify the most suitable (acceptability and utilization) BEP supplement for pregnant women in rural Burkina Faso (phase 1) and 2) evaluate the efficacy of this supplement to improve birth weight, fetal and infant growth (phase 2). The nutritional composition of the BEP supplement was established during an expert convening at the BMGF in September 2016. Private sector partners will prepare the supplements in the selected forms with the recommended nutrient composition.

Detailed description

Pregnancy remains a challenging period in the life of many women in low- and middle-income countries. Maternal mortality remains high and many newborns suffer from premature delivery and /or gestational growth retardation both in length and in weight accumulation. The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts. The purpose of this study is to assess the efficacy of a fortified BEP supplement for pregnant and lactating women to improve birth weight, fetal and infant growth. This research includes 2 phases: * Phase 1 - part 1: Formative research to identify preferred product types of a fortified BEP supplement; * Phase 1 - part 2: Formative research with a 10-week home-feeding trial to determine the acceptability of a fortified BEP supplement for longer-term consumption. * Phase 2: A community-based, individually randomized efficacy trial of the fortified BEP food supplement including 1,776 pregnant and lactating women aimed at testing 2 hypothesis: supplementing pregnant and lactating women with a fortified BEP supplement will improve fetal growth; improving fetal growth will have a positive effect on health and growth during infancy.

Kelsey Fehr, Andrew Mertens, Chi-Hung Shu, Trenton Dailey-Chwalibóg, Liat Shenhav et al. (36 authors)

Frontiers in Nutrition2025-06-104 citations

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Maternal balanced energy-protein supplementation reshapes the maternal gut microbiome and enhances carbohydrate metabolism in infants: a randomized controlled trial.

Deng L, Taelman S, Olm MR, Toe LC, Balini E, Ouédraogo LO, Bastos-Moreira Y, Argaw A, Tesfamariam K, Sonnenburg ED, Hanley-Cook GT, Ouédraogo M, Ganaba R, Van Criekinge W, Huybregts L, Stock M, Kolsteren P, Sonnenburg JL, Lachat C, Dailey-Chwalibóg T.

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Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso

Alemayehu Argaw, Laéticia Céline Toe, Giles Hanley‐Cook, Trenton Dailey-Chwalibóg, Brenda de Kok et al. (14 authors)

PLoS Medicine2023-07-241 citations

10.1371/journal.pmed.1004242

Fortified balanced energy–protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 × 2 factorial individually randomized controlled trial

Alemayehu Argaw, Brenda de Kok, Laéticia Céline Toe, Giles Hanley‐Cook, Trenton Dailey-Chwalibóg et al. (12 authors)

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10.1371/journal.pmed.1004186

Fortified Balanced Energy-Protein Supplementation, Maternal Anemia, and Gestational Weight Gain: A Randomized Controlled Efficacy Trial among Pregnant Women in Rural Burkina Faso.

Hanley-Cook G, Toe LC, Tesfamariam K, de Kok B, Argaw A, Compaoré A, Ouédraogo M, Dailey-Chwalibóg T, Kolsteren P, Lachat C, Huybregts L.

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Seasonality and Day-to-Day Variability of Dietary Diversity: Longitudinal Study of Pregnant Women Enrolled in a Randomized Controlled Efficacy Trial in Rural Burkina Faso.

Hanley-Cook GT, Argaw A, de Kok B, Toe LC, Dailey-Chwalibóg T, Ouédraogo M, Kolsteren P, Huybregts L, Lachat C.

2022-09-0120 citations

10.1093/jn/nxac104

Prenatal fortified balanced energy-protein supplementation and birth outcomes in rural Burkina Faso: A randomized controlled efficacy trial

Brenda de Kok, Laéticia Céline Toe, Giles Hanley‐Cook, Alemayehu Argaw, Moctar Ouédraogo et al. (12 authors)

PLoS Medicine2022-05-1337 citations

10.1371/journal.pmed.1004002

Fortified Balanced Energy-Protein Supplements Increase Nutrient Adequacy without Displacing Food Intake in Pregnant Women in Rural Burkina Faso.

de Kok B, Argaw A, Hanley-Cook G, Toe LC, Ouédraogo M, Dailey-Chwalibóg T, Diop L, Becquey E, Kolsteren P, Lachat C, Huybregts L.

2021-12-0114 citations

10.1093/jn/nxab289

Effect of balanced energy-protein supplementation during pregnancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial

Katrien Vanslambrouck, Brenda de Kok, Laéticia Céline Toe, Nathalie De Cock, Moctar Ouédraogo et al. (11 authors)

BMJ Open2021-03-0128 citations

10.1136/bmjopen-2020-038393

Interventions

DIETARY_SUPPLEMENTFortified balanced energy-protein (BEP) supplement

The product contains the following target nutrients: * Total energy: 250-500 kcal per daily serving * Fat content: 10-60% of energy intake * Protein content: 16 g (range 14-18 g) with a Digestible Indispensable Amino Acid Score (DIAAS) of ≥ 0.9 * Carbohydrate (CHO) Content: no specific recommendations, relative to fat and protein content. * Trans Fats: \<1% energy intake Micronutrients include the following: A, D, E, K, B1 (thiamin), B2 (riboflavin), B3 (niacin), B6 (pyridoxine), B9 (folate), B12 and C; minerals: iron, zinc, iodine, calcium, phosphorous, copper, and selenium. The final composition of macro en micronutrients will be available after the acceptability testing (phase 1) and will be determined by 1) the product type and 2) the preferred taste.

DIETARY_SUPPLEMENTFe and folic acid supplement

Routine iron and folic acid supplementation.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

The intervention study is a randomized controlled 2x2 factorial efficacy trial. At study inclusion, eligible pregnant women will be randomly assigned to the prenatal intervention or control group, and randomly assigned to a postnatal intervention or control group. The intervention group will receive daily a fortified BEP supplement to be consumed under supervision for the duration of pregnancy/lactation. Both control and intervention group will receive the standard iron and folic acid tablet through the regular ante natal care program.

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Participant age (15-40 years). * Pregnant as determined by a pregnancy test and confirmed by ultrasound. * Women who signed the informed consent form (in case of minors the parents or husband signs)

Exclusion criteria

* Women planning to leave the area before delivery. * Women who plan to deliver outside the area. * Pregnancies with a gestational age \> 20 weeks at study inclusion. * Women with multi-fetal gestation (exclusion from analysis). * Women who are allergic to peanuts.

Design outcomes

Primary

Measure	Time frame	Description
Small-for-Gestational-age (SGA)	within 72h after birth	Incidence of Small-for-Gestational-age (SGA) defined as \<10th centile of birthweight for gestational age standard, InterGrowth 21st reference.
Length-for-age Z-scores (LAZ)	at 6 months (and 12 months on a subsample)	Mean of Length-for-Age Z-scores (LAZ), WHO multi-country reference.

Secondary

Measure	Time frame	Description
Birth length	within 72h after birth	—
Chest circumference	within 72h after birth	—
Head circumference	within 72h after birth	—
Mid-upper arm circumference	within 72h after birth	—
Gestational age	at delivery	—
Preterm birth	at delivery	Incidence of preterm birth at \<37 weeks of gestation
Large-for-gestational age	within 72h after birth	Defined as a birth weight ≥90th centile intergrowth 21st reference
Ponderal or Rohrer's index'	within 72 hours after birth	Defined as birth weight/birth length3
Fetal loss	during pregnancy	Fetal death at \<24 completed weeks of gestational age
Neonatal mortality	between birth and ≤ 28 days of life	(1) Early neonatal mortality: deaths between birth and ≤ 7 days of life; (2) Neonatal mortality: deaths between birth and ≤28 days of life; (3) Late neonatal mortality deaths between \>7 days and ≤28 days of life
Prenatal weight gain	between study inclusion until just before delivery	Weight change between study inclusion until just before delivery: total and trimester specific
Gestational weight change	between study inclusion until 1 month after delivery	Difference in maternal weight between maternal weight one month after delivery and maternal weight at study inclusion
Probable and possible maternal postnatal depression	(1) at 2 months of child age; (2) at 6 months of child age	Measured using the 10-item Edinburgh postnatal depression scale. Probable depression is defined as EPDS\>12. Possible depression is defined as EPDS\>9 .
Women's minimum and mean dietary diversity score	from study inclusion until delivery	Measured biweekly using the 10 food group indicator as proposed by FAO. Minimum dietary diversity is defined as having consumed at least 5 food groups over the last 24 hours.
Maternal anemia	at the third antenatal consultation	Hemoglobin concentration \<11g/dL
Weight-for-Age Z-score	at 6 months of age	WAZ, calculated using the WHO growth reference
Weight-for-Length Z-score	at 6 months of age	WLZ, calculated using the WHO growth reference
Stillbirths	during pregnancy	Fetal death at ≥ 24 weeks gestational age
Wasting	at 6 months of age	Weight-for-Length Z-score (WLZ) \<-2, calculated using the WHO growth reference
Underweight	at 6 months of age	Weight-for-Age Z-score (WAZ) \<-2, calculated using the WHO growth reference
Incidence of child wasting	over first 6 months of life	—
Child weight gain	over first 6 months of life	Monthly change in child weight
Monthly change in LAZ	over first 6 months of life	—
Monthly change in WHZ	over first 6 months of life	—
Monthly change in WAZ	over first 6 months of life	—
Monthly change in head circumference	over first 6 months of life	—
Exclusive breastfeeding	during the first 6 months of life	Duration of exclusive breastfeeding
Child mortality	between birth and 6 months of age	—
Child morbidity symptoms	over first 6 months of life	Signs include fever, vomiting, diarrhea, cough, difficult breathing, running nose
Child anemia	at 6 months of age	Hemoglobin concentration \<11g/dL
Hemoglobin concentration	at 6 months of age	—
Infant body composition	first 3 months of life	Sub-sample
Maternal body composition	first 3 months after delivery	Sub-sample
Breast milk composition	between 1-2 and 3-4 months	Sub-sample
Relative average telomere length	At birth	The umbilical cord blood will be analyzed to verify telomere length using qPCR on a sub-sample. Telomere lengths will be expressed as the ratio of telomere copy number to single-copy gene number (T/S) relative to the mean T/S ratio of the entire sample.
Stunting	at 6 months of age	Length-for-Age Z-score (LAZ) \<-2, calculated using the WHO growth reference
Birth weight	within 72h after birth	—

Countries

Burkina Faso

Outcome results

None listed