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

Kok, Brenda de; Toe, Laeticia Celine; Hanley-Cook, Giles; Argaw, Alemayehu; Ouédraogo, Moctar; Compaoré, Anderson; Vanslambrouck, Katrien; Dailey-Chwalibóg, Trenton; Ganaba, Rasmané; Kolsteren, Patrick; Huybregts, Lieven; Lachat, Carl

doi:10.1371/journal.pmed.1004002

Cited by 18 publications

(39 citation statements)

References 40 publications

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“…Hence, among a subsample of MISAME-III women, dietary micronutrient intakes of the base diet (i.e., excluding supplements) during pregnancy were inadequate to cover the Estimated Average Requirements (EARs) and the mean daily energy intake was estimated to be approximately 1,940 kcal at the end of the preharvest season [ 30 ]. Furthermore, findings from MISAME-III indicate high burden of adverse birth outcomes, including small-for-gestational age (26%) and low birthweight (10%) [ 25 ]. In addition, a survey in the same region found a high prevalence of child stunting (21%) and wasting (7%), whereas the rate of EBF was reported to be 62% [ 31 ].…”

Section: Methodsmentioning

confidence: 99%

“…BEP supplements are a similar type of ready-to-use supplements that provide multiple micronutrients and, specifically, energy and protein in a balanced composition (<25% of total kcal content from protein) to address maternal malnutrition during pregnancy and lactation. We previously reported on the modest efficacy of prenatal BEP supplementation on weight and length increments at birth and the lower prevalence of low birth weight in the MIcronutriments pour la SAnté de la Mere et de l’Enfant-III (MISAME-III) trial [ 25 ]. The objective of the current study was to evaluate the efficacy of BEP supplementation during 6 months postpartum on infant growth and nutritional status, to assess possible interactions between prenatal and postnatal BEP supplementation, and to investigate whether the effects of the prenatal BEP supplementation persist at the age of 6 months.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2023

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Background Optimal nutrition is crucial during the critical period of the first 1,000 days from conception to 2 years after birth. Prenatal and postnatal supplementation of mothers with multimicronutrient-fortified balanced energy–protein (BEP) supplements is a potential nutritional intervention. However, evidence on the long-term effects of BEP supplementation on child growth is inconsistent. We evaluated the efficacy of daily fortified BEP supplementation during pregnancy and lactation on infant growth in rural Burkina Faso. Methods and findings A 2 × 2 factorial individually randomized controlled trial (MISAME-III) was implemented in 6 health center catchment areas in Houndé district under the Hauts-Bassins region. From October 2019 to December 2020, 1,897 pregnant women aged 15 to 40 years with gestational age <21 completed weeks were enrolled. Women were randomly assigned to the prenatal intervention arms receiving either fortified BEP supplements and iron–folic acid (IFA) tablets (i.e., intervention) or IFA alone (i.e., control), which is the standard of care during pregnancy. The same women were concurrently randomized to receive either of the postnatal intervention, which comprised fortified BEP supplementation during the first 6 months postpartum in combination with IFA for the first 6 weeks (i.e., intervention), or the postnatal control, which comprised IFA alone for 6 weeks postpartum (i.e., control). Supplements were provided by trained village-based project workers under direct observation during daily home visits. We previously reported the effect of prenatal BEP supplementation on birth outcomes. The primary postnatal study outcome was length-for-age z-score (LAZ) at 6 months of age. Secondary outcomes were anthropometric indices of growth (weight-for length and weight-for-age z-scores, and arm and head circumferences) and nutritional status (prevalence rates of stunting, wasting, underweight, anemia, and hemoglobin concentration) at 6 months. Additionally, the longitudinal prevalence of common childhood morbidities, incidence of wasting, number of months of exclusive breastfeeding, and trajectories of anthropometric indices from birth to 12 months were evaluated. Prenatal BEP supplementation resulted in a significantly higher LAZ (0.11 standard deviation (SD), 95% confidence interval (CI) [0.01 to 0.21], p = 0.032) and lower stunting prevalence (−3.18 percentage points (pp), 95% CI [−5.86 to −0.51], p = 0.020) at 6 months of age, whereas the postnatal BEP supplementation did not have statistically significant effects on LAZ or stunting at 6 months. On the other hand, postnatal BEP supplementation did modestly improve the rate of monthly LAZ increment during the first 12 months postpartum (0.01 z-score/month, 95% CI [0.00 to 0.02], p = 0.030), whereas no differences in growth trajectories were detected between the prenatal study arms. Furthermore, except for the trend towards a lower prevalence of underweight found for the prenatal BEP intervention at 6 months (−2.74 pp, 95% CI [−5.65 to 1.17], p = 0.065), no other secondary outcome was significantly affected by the pre- or postnatal BEP supplementation. Conclusions This study provides evidence that the benefits obtained from prenatal BEP supplementation on size at birth are sustained during infancy in terms of linear growth. Maternal BEP supplementation during lactation may lead to a slightly better linear growth towards the second half of infancy. These findings suggest that BEP supplementation during pregnancy can contribute to the efforts to reduce the high burden of child growth faltering in low- and middle-income countries. Trial registration ClinicalTrials.gov: NCT03533712.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2023

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“…Nutrition interventions during pregnancy such as supplementing with multiple micronutrients and balanced protein energy have been shown to reduce LBW by 12% in low and middle income countries, but not SGA. 28 29 30 However, the role of infection related interventions is unclear. 31 Evidence is lacking about the impact of preconception health or nutrition interventions on LBW, SGA, and preterm births.…”

Section: Discussionmentioning

confidence: 99%

“…We will briefly summarise the results of previous trials. Nutrition interventions during pregnancy such as supplementing with multiple micronutrients and balanced protein energy have been shown to reduce LBW by 12% in low and middle income countries, but not SGA 282930. However, the role of infection related interventions is unclear 31.…”

Section: Discussionmentioning

confidence: 99%

“…Findings of other secondary outcomes related to the mothers and their children are shown in the supplementary appendix (fig S7, tables S10-S13). One noteworthy finding was that the proportion of infants exclusively breastfed at 5 months of age was [28][29][30] However, the role of infection related interventions is unclear. 31 Evidence is lacking about the impact of preconception health or nutrition interventions on LBW, SGA, and preterm births.…”

Section: Other Secondary Outcomesmentioning

confidence: 99%

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Impact of a package of health, nutrition, psychosocial support, and WaSH interventions delivered during preconception, pregnancy, and early childhood periods on birth outcomes and on linear growth at 24 months of age: factorial, individually randomised controlled trial

Taneja

Chowdhury

Dhabhai

et al. 2022

BMJ

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Objective To determine the effect of integrated and concurrent delivery of health, nutrition, water, sanitation and hygiene (WaSH), and psychosocial care interventions during the preconception period alone, during pregnancy and early childhood, and throughout preconception, pregnancy, and early childhood on birth outcomes and linear growth at 24 months of age compared with routine care. Design Individually randomised factorial trial. Setting Low and middle income neighbourhoods of Delhi, India. Participants 13 500 women were randomised to receive preconception interventions (n=6722) or routine care (n=6778). 2652 and 2269 pregnant women were randomised again to receive pregnancy and early childhood interventions or routine care. The analysis of birth outcomes included 1290 live births for the preconception, pregnancy, and early childhood interventions (group A), 1276 for the preconception intervention (group B), 1093 for the pregnancy and early childhood interventions (group C), and 1093 for the control (group D). Children aged 24 months by 30 June 2021 were included in the 24 month outcome analysis (453 in group A, 439 in B, 293 in C, and 271 in D). Interventions Health, nutrition, psychosocial care and support, and WaSH interventions were delivered during preconception, pregnancy, and early childhood periods. Main outcome measures The primary outcomes were low birth weight, small for gestational age, preterm, and mean birth weight. At 24 months, the outcomes were mean length-for-age z scores and proportion stunted. Three prespecified comparisons were made: preconception intervention groups (A+B) versus no preconception intervention groups (C+D); pregnancy and early childhood intervention groups (A+C) versus routine care during pregnancy and early childhood (B+D) and preconception, pregnancy, and early childhood interventions groups (A) versus control group (D). Results The proportion with low birth weight was lower in the preconception intervention groups (506/2235) than in the no preconception intervention groups (502/1889; incidence rate ratio 0.85, 98.3% confidence interval 0.75 to 0.97; absolute risk reduction −3.80%, 98.3% confidence interval −6.99% to −0.60%). The proportion with low birth weight was lower in the pregnancy intervention groups (502/2096) than in the no pregnancy intervention groups (506/2028) but the upper limit of the confidence interval crossed null effect (0.87, 0.76 to 1.01; −1.71%, −4.96% to 1.54%). There was a larger effect on proportion with low birth weight in the group that received interventions in the preconception and pregnancy periods (267/1141) compared with the control group (267/934; 0.76, 0.62 to 0.91; −5.59%, −10.32% to −0.85%). The proportion stunted at 24 months of age was substantially lower in the pregnancy and early childhood intervention groups (79/746) compared with the groups that did not receive these interventions (136/710; 0.51, 0.38 to 0.70; −8.32%, −12.31% to −4.32%), and in the group that received preconception, pregnancy, and early childhood interventions (47/453) compared with the control group (51/271; 0.49, 0.32 to 0.75; −7.98%, −14.24% to −1.71%). No effect on stunting at 24 months was observed in the preconception intervention groups (132/892) compared with the no preconception intervention groups (83/564). Conclusions An intervention package delivered during preconception, pregnancy, and early childhood substantially reduced low birth weight and stunting at 24 months. Pregnancy and early childhood interventions alone had lower but important effects on birth outcomes and 24 month outcomes. Preconception interventions alone had an important effect on birth outcomes but not on 24 month outcomes. Trial registration Clinical Trial Registry—India CTRI/2017/06/008908.

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Perspective: Peer Evaluation of Recommendations for CONSORT Guidelines for Randomized Controlled Trials in Nutrition

Weaver,

Ahles,

Murphy

et al. 2024

Advances in Nutrition

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

Cited by 18 publications

References 40 publications

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

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

Impact of a package of health, nutrition, psychosocial support, and WaSH interventions delivered during preconception, pregnancy, and early childhood periods on birth outcomes and on linear growth at 24 months of age: factorial, individually randomised controlled trial

Perspective: Peer Evaluation of Recommendations for CONSORT Guidelines for Randomized Controlled Trials in Nutrition

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