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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,788
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.
Routine iron and folic acid supplementation.
Houndé district
Houndé, Tuy, Burkina Faso
Small-for-Gestational-age (SGA)
Incidence of Small-for-Gestational-age (SGA) defined as \<10th centile of birthweight for gestational age standard, InterGrowth 21st reference.
Time frame: within 72h after birth
Length-for-age Z-scores (LAZ)
Mean of Length-for-Age Z-scores (LAZ), WHO multi-country reference.
Time frame: at 6 months (and 12 months on a subsample)
Birth weight
Time frame: within 72h after birth
Birth length
Time frame: within 72h after birth
Chest circumference
Time frame: within 72h after birth
Head circumference
Time frame: within 72h after birth
Mid-upper arm circumference
Time frame: within 72h after birth
Gestational age
Time frame: at delivery
Preterm birth
Incidence of preterm birth at \<37 weeks of gestation
Time frame: at delivery
Large-for-gestational age
Defined as a birth weight ≥90th centile intergrowth 21st reference
Time frame: within 72h after birth
Ponderal or Rohrer's index'
Defined as birth weight/birth length3
Time frame: within 72 hours after birth
Fetal loss
Fetal death at \<24 completed weeks of gestational age
Time frame: during pregnancy
Stillbirths
Fetal death at ≥ 24 weeks gestational age
Time frame: during pregnancy
Neonatal mortality
(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
Time frame: between birth and ≤ 28 days of life
Prenatal weight gain
Weight change between study inclusion until just before delivery: total and trimester specific
Time frame: between study inclusion until just before delivery
Gestational weight change
Difference in maternal weight between maternal weight one month after delivery and maternal weight at study inclusion
Time frame: between study inclusion until 1 month after delivery
Probable and possible maternal postnatal depression
Measured using the 10-item Edinburgh postnatal depression scale. Probable depression is defined as EPDS\>12. Possible depression is defined as EPDS\>9 .
Time frame: (1) at 2 months of child age; (2) at 6 months of child age
Women's minimum and mean dietary diversity score
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.
Time frame: from study inclusion until delivery
Maternal anemia
Hemoglobin concentration \<11g/dL
Time frame: at the third antenatal consultation
Weight-for-Age Z-score
WAZ, calculated using the WHO growth reference
Time frame: at 6 months of age
Weight-for-Length Z-score
WLZ, calculated using the WHO growth reference
Time frame: at 6 months of age
Stunting
Length-for-Age Z-score (LAZ) \<-2, calculated using the WHO growth reference
Time frame: at 6 months of age
Wasting
Weight-for-Length Z-score (WLZ) \<-2, calculated using the WHO growth reference
Time frame: at 6 months of age
Underweight
Weight-for-Age Z-score (WAZ) \<-2, calculated using the WHO growth reference
Time frame: at 6 months of age
Incidence of child wasting
Time frame: over first 6 months of life
Child weight gain
Monthly change in child weight
Time frame: over first 6 months of life
Monthly change in LAZ
Time frame: over first 6 months of life
Monthly change in WHZ
Time frame: over first 6 months of life
Monthly change in WAZ
Time frame: over first 6 months of life
Monthly change in head circumference
Time frame: over first 6 months of life
Exclusive breastfeeding
Duration of exclusive breastfeeding
Time frame: during the first 6 months of life
Child mortality
Time frame: between birth and 6 months of age
Child morbidity symptoms
Signs include fever, vomiting, diarrhea, cough, difficult breathing, running nose
Time frame: over first 6 months of life
Child anemia
Hemoglobin concentration \<11g/dL
Time frame: at 6 months of age
Hemoglobin concentration
Time frame: at 6 months of age
Infant body composition
Sub-sample
Time frame: first 3 months of life
Maternal body composition
Sub-sample
Time frame: first 3 months after delivery
Breast milk composition
Sub-sample
Time frame: between 1-2 and 3-4 months
Relative average telomere length
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.
Time frame: At birth
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