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| Name | Class |
|---|---|
| Harvard School of Public Health (HSPH) | OTHER |
| Institut de Recherche en Sciences de la Sante, Burkina Faso | OTHER_GOV |
| AfricSanté, Burkina Faso | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fortified BEP supplement | Experimental | Intervention: Dietary Supplement: Fortified balanced energy-protein (BEP) supplement + iron and folic acid supplement. |
|
| Fe and folic acid | Active Comparator | Dietary Supplement: Fe and folic acid supplement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortified balanced energy-protein (BEP) supplement | Dietary Supplement | The product contains the following target nutrients:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 72h after birth |
| Length-for-age Z-scores (LAZ) | Mean of Length-for-Age Z-scores (LAZ), WHO multi-country reference. | at 6 months (and 12 months on a subsample) |
| Measure | Description | Time Frame |
|---|---|---|
| Birth weight | within 72h after birth | |
| Birth length | within 72h after birth | |
| Chest circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Kolsteren, Prof. dr. | University Ghent | Study Chair |
| Carl Lachat, Prof. dr. | University Ghent | Study Director |
| Katrien W Vanslambrouck, MD | University Ghent | Principal Investigator |
| Brenda PH de Kok, MSc. | University Ghent | Principal Investigator |
| Lieven F Huybregts, PhD | IFPRI | Principal Investigator |
| Laeticia Celine Toe, MD MSc. | IRSS | Principal Investigator |
| Sheila Isanaka, Asst. Prof. | Harvard School of Public Health (HSPH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houndé district | Houndé | Tuy | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37486952 | Derived | Argaw A, Toe LC, Hanley-Cook G, Dailey-Chwalibog T, de Kok B, Ouedraogo L, Compaore A, Ouedraogo M, Sawadogo A, Ganaba R, Vanslambrouck K, Kolsteren P, Lachat C, Huybregts L. 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. PLoS Med. 2023 Jul 24;20(7):e1004242. doi: 10.1371/journal.pmed.1004242. eCollection 2023 Jul. | |
| 36745684 |
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Share study data with a similar study ongoing in Nepal.
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| International Food Policy Research Institute |
| OTHER |
| University of California, Davis | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
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.
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|
| Fe and folic acid supplement | Dietary Supplement | Routine iron and folic acid supplementation. |
|
| within 72h after birth |
| Head circumference | within 72h after birth |
| Mid-upper arm circumference | within 72h after birth |
| Gestational age | at delivery |
| Preterm birth | Incidence of preterm birth at <37 weeks of gestation | at delivery |
| Large-for-gestational age | Defined as a birth weight ≥90th centile intergrowth 21st reference | within 72h after birth |
| Ponderal or Rohrer's index' | Defined as birth weight/birth length3 | within 72 hours after birth |
| Fetal loss | Fetal death at <24 completed weeks of gestational age | during pregnancy |
| Stillbirths | Fetal death at ≥ 24 weeks gestational age | 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 | between birth and ≤ 28 days of life |
| Prenatal weight gain | Weight change between study inclusion until just before delivery: total and trimester specific | 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 | 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 . | (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. | from study inclusion until delivery |
| Maternal anemia | Hemoglobin concentration <11g/dL | at the third antenatal consultation |
| Weight-for-Age Z-score | WAZ, calculated using the WHO growth reference | at 6 months of age |
| Weight-for-Length Z-score | WLZ, calculated using the WHO growth reference | at 6 months of age |
| Stunting | Length-for-Age Z-score (LAZ) <-2, calculated using the WHO growth reference | at 6 months of age |
| Wasting | Weight-for-Length Z-score (WLZ) <-2, calculated using the WHO growth reference | at 6 months of age |
| Underweight | Weight-for-Age Z-score (WAZ) <-2, calculated using the WHO growth reference | at 6 months of age |
| Incidence of child wasting | over first 6 months of life |
| Child weight gain | Monthly change in child weight | over first 6 months of life |
| 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 | Duration of exclusive breastfeeding | during the first 6 months of life |
| Child mortality | between birth and 6 months of age |
| Child morbidity symptoms | Signs include fever, vomiting, diarrhea, cough, difficult breathing, running nose | over first 6 months of life |
| Child anemia | Hemoglobin concentration <11g/dL | at 6 months of age |
| Hemoglobin concentration | at 6 months of age |
| Infant body composition | Sub-sample | first 3 months of life |
| Maternal body composition | Sub-sample | first 3 months after delivery |
| Breast milk composition | Sub-sample | 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. | At birth |
| Derived |
| Argaw A, de Kok B, Toe LC, Hanley-Cook G, Dailey-Chwalibog T, Ouedraogo M, Compaore A, Vanslambrouck K, Ganaba R, Kolsteren P, Lachat C, Huybregts L. Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 x 2 factorial individually randomized controlled trial. PLoS Med. 2023 Feb 6;20(2):e1004186. doi: 10.1371/journal.pmed.1004186. eCollection 2023 Feb. |
| 35906874 | Derived | Hanley-Cook G, Toe LC, Tesfamariam K, de Kok B, Argaw A, Compaore A, Ouedraogo M, Dailey-Chwalibog T, Kolsteren P, Lachat C, Huybregts L. Fortified Balanced Energy-Protein Supplementation, Maternal Anemia, and Gestational Weight Gain: A Randomized Controlled Efficacy Trial among Pregnant Women in Rural Burkina Faso. J Nutr. 2022 Oct 6;152(10):2277-2286. doi: 10.1093/jn/nxac171. |
| 35560315 | Derived | de Kok B, Toe LC, Hanley-Cook G, Argaw A, Ouedraogo M, Compaore A, Vanslambrouck K, Dailey-Chwalibog T, Ganaba R, Kolsteren P, Huybregts L, Lachat C. Prenatal fortified balanced energy-protein supplementation and birth outcomes in rural Burkina Faso: A randomized controlled efficacy trial. PLoS Med. 2022 May 13;19(5):e1004002. doi: 10.1371/journal.pmed.1004002. eCollection 2022 May. |
| 35524695 | Derived | Hanley-Cook GT, Argaw A, de Kok B, Toe LC, Dailey-Chwalibog T, Ouedraogo M, Kolsteren P, Huybregts L, Lachat C. 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. J Nutr. 2022 Sep 6;152(9):2145-2154. doi: 10.1093/jn/nxac104. |
| 34494113 | Derived | de Kok B, Argaw A, Hanley-Cook G, Toe LC, Ouedraogo M, Dailey-Chwalibog T, Diop L, Becquey E, Kolsteren P, Lachat C, Huybregts L. Fortified Balanced Energy-Protein Supplements Increase Nutrient Adequacy without Displacing Food Intake in Pregnant Women in Rural Burkina Faso. J Nutr. 2021 Dec 3;151(12):3831-3840. doi: 10.1093/jn/nxab289. |
| 33762226 | Derived | Vanslambrouck K, de Kok B, Toe LC, De Cock N, Ouedraogo M, Dailey-Chwalibog T, Hanley-Cook G, Ganaba R, Lachat C, Huybregts L, Kolsteren P. 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. BMJ Open. 2021 Mar 24;11(3):e038393. doi: 10.1136/bmjopen-2020-038393. |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D007228 | Infant Nutrition Disorders |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C038328 | BEP protocol |
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