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

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Study Justification:
– Anemia and suboptimal gestational weight gain (GWG) are associated with negative maternal and birth outcomes.
– Limited research suggests that balanced energy-protein (BEP) supplements can improve GWG.
– This study aimed to assess the efficacy of a micronutrient-fortified BEP supplement on anemia, GWG, and GWG rate compared to an iron-folic acid (IFA) tablet.
Highlights:
– The study was conducted in rural Burkina Faso among pregnant women aged 15-40 years.
– Women were randomly assigned to receive either BEP and IFA supplements or IFA alone.
– Hemoglobin concentrations and maternal weight were measured at baseline and antenatal care visits.
– The study found no significant differences in anemia prevalence, GWG, GWG rate, or GWG adequacy between the two groups.
– The findings suggest that fortified BEP supplementation does not reduce maternal anemia or increase GWG compared to IFA.
Recommendations:
– Further investigation is needed to explore additional biochemical and postnatal outcomes related to maternal BEP supplementation.
– The study recommends considering the effects of BEP supplementation on birth outcomes, which have shown some positive effects in previous research.
Key Role Players:
– Pregnant women in rural Burkina Faso
– Researchers and study personnel
– Community support staff
– Health center staff
– Project employees involved in randomization and data collection
– Data and Safety Monitoring Board
Cost Items for Planning Recommendations:
– Fortified BEP supplements and IFA tablets
– Malaria prophylaxis
– Training and supervision of community support staff
– Ultrasound equipment and trained personnel
– Data collection tablets and software
– Quality checks and revisions of data
– Ethics committee review and approval
– Data analysis and reporting
Please note that the provided information is based on the given description and may not include all details from the original study.

The strength of evidence for this abstract is 6 out of 10.
The evidence in the abstract is rated 6 because the study is a randomized controlled trial, which is a strong study design. However, the results indicate that there were no significant differences in the outcomes between the intervention and control groups, suggesting that the evidence is not very strong. To improve the evidence, future studies could consider increasing the sample size to improve statistical power and conducting a longer follow-up period to assess the long-term effects of the intervention. Additionally, researchers could consider including a placebo group to further strengthen the study design.

Background: Anemia and suboptimal gestational weight gain (GWG) are associated with adverse maternal and birth outcomes. Limited research indicates that balanced energy-protein (BEP) supplements reduce the incidence of inadequate GWG. Objectives: We assessed the efficacy of a micronutrient-fortified BEP supplement on the secondary outcomes of anemia, GWG, GWG rate, and GWG in relation to the Institute of Medicine (IOM)’s recommendations, as compared with an iron–folic acid (IFA) tablet. Methods: We conducted a randomized controlled trial in Burkina Faso, among pregnant women (15–40 y old) enrolled at <21 weeks of gestation. Women received either BEP and IFA (intervention) or IFA (control). Hemoglobin (g/dL) concentrations were measured at baseline and the third antenatal care visit (ANC), whereas maternal weight was measured at baseline and all subsequent ∼7-weekly ANCs. GWG (kg) was calculated as a woman's last weight measurement (at ∼36 weeks of gestation) minus weight at enrollment, whereas GWG rate (kg/wk) was GWG divided by the time between the first and last weight measurements. GWG adequacy (%) was computed as GWG divided by the IOM's recommendation. Binary outcomes included severely inadequate, inadequate, and excessive GWG. Statistical analyses followed the intention-to-treat principle. Linear regression and probability models were fitted for the continuous and binary outcomes, respectively, adjusting for baseline measurements. Results: Women in the BEP group tended to have higher, but nonsignificantly different, GWG (0.28 kg; 95% CI: −0.05, 0.58 kg; P = 0.099). Furthermore, there were no significant differences in prenatal anemia prevalence, GWG rate, GWG adequacy, or incidence of inadequate or excessive GWG. Findings were robust to model adjustments and complete case and per protocol analyses. Conclusions: This trial does not provide evidence that fortified BEP supplementation reduces maternal anemia or increases GWG, as compared with IFA. In conjunction with the small, but positive, effects of maternal BEP supplementation on birth outcomes, our findings warrant the investigation of additional biochemical and postnatal outcomes. This trial was registered at clinicaltrials.gov as NCT03533712.

Our research was reported using the CONSORT 2010 checklist (22). The prenatal phase of the MISAME-III study ({"type":"clinical-trial","attrs":{"text":"NCT03533712","term_id":"NCT03533712"}}NCT03533712) was conducted between the first enrollment on 30 October, 2019 and the last delivery on 7 August, 2021 in the catchment areas of 6 rural health centers of the health district of Houndé, Tuy Province, in the Hauts-Bassins region of Burkina Faso. In the preceding MISAME-I (23) and MISAME-II (24) RCTs, 48.4% and 45.5% of pregnant women were anemic [hemoglobin (Hb) 10% of the examinations regularly by an external gynecologist, using a quality checklist and scoring sheet. The trained project workers collected daily data on fortified BEP and IFA compliance in both prenatal study arms via smartphone-assisted personal interviewing programmed in CSPro version 7.3.1 (U.S. Census Bureau, ICF, and Serpro) . Six supervisors performed monthly lot quality assurance sampling schemes of each home visitor’s work on a random day (34). All data collection forms are available on the study’s website: https://misame3.ugent.be/resources. The study protocol was approved by the Ethics Committee of Ghent University Hospital in Belgium (B670201734334) and the ethics committee of Centre Muraz in Burkina Faso (N°2018–22/MS/SG/CM/CEI). An independent Data and Safety Monitoring Board (DSMB), comprising an endocrinologist, 2 pediatricians, a gynecologist, and an ethicist of both Belgian and Burkinabe nationalities, was established before the start of the efficacy trial. The DSMB conducted remote safety reviews for adverse and serious events at 9 and 20 mo after the start of enrollment. Analyses were recorded in the MISAME-III statistical analysis plan that was validated on 24 October, 2019 and published online on 3 November, 2020 on the study’s website: https://www.misame3.ugent.be/resource-files/MISAME-III_SAP_v1_102019.pdf. For consistency and comparability of study findings, the present analyses followed the analytical procedures used to assess the efficacy of the prenatal fortified BEP intervention on birth outcomes (21). The MISAME-III efficacy trial specified 1 primary prenatal outcome: SGA [<10th percentile of the International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st) newborn size standards (35)]. Secondary maternal outcomes of the prenatal BEP intervention included anemia (Hb < 11 g/dL) at the third ANC visit and GWG (kg) between the first and last ANC visits (or before delivery). Furthermore, we estimated the GWG rate, defined as the absolute GWG divided by the time interval between the first and last maternal weight measurements, and the expected weight gain for each woman at the time of their last observed weight measurement using the following IOM 2009 formula (1): The expected total weight gain during the first trimester was assumed to be 2 kg for underweight (BMI < 18.5) and normal-weight women (BMI = 18.5–24.9), 1 kg for overweight women (BMI = 25–29.9), and 0.5 kg for obese women (BMI ≥ 30); and the recommended rates of GWG for the second and third trimesters were 0.51, 0.42, 0.28, and 0.22 kg/wk for underweight, normal-weight, overweight, and obese women, respectively (1). Finally, the percentage adequacy of GWG was calculated by dividing the actual GWG by the expected GWG at the last observed weight measurement, multiplied by 100. This is a continuous measure that has been used in previous GWG studies in Africa (36, 37). Following Liu et al. (37), we further categorized the percentage adequacy of GWG into binary outcome measures. Inadequate GWG was defined as a percentage adequacy of GWG < 90%, severely inadequate GWG as a percentage adequacy of GWG < 70%, and excessive GWG as a percentage adequacy of GWG ≥ 125%. The cutoffs 90% and 125% correspond to the lower and upper limits of the recommended total weight gain during pregnancy by the IOM's guideline. The recommended range is 12.5–18 kg for women who are underweight (BMI < 18.5), 11.5–16 kg for normal weight (BMI = 18.5–24.9), 7–11.5 kg for overweight (BMI = 25–29.9), and 5–9 kg for obese (BMI ≥ 30) (1). Only singleton pregnancies were included in the analysis. All analyses were conducted by the intention-to-treat (ITT) principle to reduce potential bias arising from missing data. Therefore, before analyses, we performed multiple imputation of missing maternal Hb concentration (g/dL), maternal weight before delivery (kg), and gestational duration (wk) under the “missing at random” assumption. Fifty imputations of missing continuous outcome data for cases lost to follow-up were run to estimate the regression coefficients, based on the following predictors at baseline: maternal height (cm), maternal weight (kg), MUAC (mm), Hb (g/dL), and age (y) at inclusion; GA at baseline (wk); primiparity; and month of inclusion. Anemia and GWG adequacy variables were calculated from the imputed continuous data. Descriptive data are presented as percentages or means ± SDs. Unadjusted and adjusted group differences were estimated by fitting linear regression models for the continuous outcomes, to estimate the mean group difference, and using linear probability models with robust variance estimators for the binary outcomes, to estimate risk differences in percentage points (pp). All models were adjusted for the baseline value of the outcome of interest [i.e., either Hb or maternal weight at study enrollment, thus an ANCOVA (38, 39)] and contained health center and randomization block as fixed effects to account for clustering by the study design. Adjusted models in addition contained potential baseline prognostic factors of maternal outcomes, including maternal height (cm), MUAC (mm), and age (y) at inclusion; GA at baseline (wk); and primiparity. We did not adjust for any other sociodemographic variables, owing to balanced baseline characteristics across the prenatal study groups (i.e., < |2.5| pp difference). To assess the robustness of the primary findings, we conducted the following sensitivity analyses: 1) complete case analysis (i.e., excluding women who were lost to follow-up for birth outcomes); and 2) per protocol analysis restricting the intervention sample to women with fortified BEP compliance of ≥75%. The strict compliance rate was calculated by dividing the total number of BEP supplements effectively taken under direct observation of a trained home visitor by the theoretical maximum number of prenatal BEP supplements allowed (i.e., the number of days between study inclusion and delivery). Moreover, to assess the potential underestimation of absolute GWG, we replicated our complete case analysis among mothers who had a baseline weight measurement taken at <14 weeks of gestation (i.e., first trimester). In addition, for complete cases, we used the INTERGROWTH-21st GWG standards to derive GWG z scores (40). Because the currently available GWG equation for recommended weight gain is for normal-weight women with a GA between 14 and 40 wk, we restricted this outcome to normal-weight women with a GA of ≤40 completed weeks at their last ANC visit. Statistical significance was set at P < 0.05 for all 2-sided tests. All analyses were conducted with Stata version 16.1 (StataCorp).

The innovation mentioned in the title is the use of fortified balanced energy-protein (BEP) supplementation to improve access to maternal health. The study conducted a randomized controlled trial in Burkina Faso to assess the efficacy of a micronutrient-fortified BEP supplement on maternal anemia, gestational weight gain (GWG), GWG rate, and GWG adequacy.

The study compared the intervention group, which received a daily fortified BEP supplement and iron-folic acid (IFA) tablet, with the control group, which received only an IFA tablet. The outcomes measured included anemia prevalence, GWG, GWG rate, and GWG adequacy.

The findings of the study did not provide evidence that fortified BEP supplementation reduces maternal anemia or increases GWG compared to IFA. However, the study did find small, positive effects of maternal BEP supplementation on birth outcomes.

The study highlights the importance of investigating additional biochemical and postnatal outcomes related to maternal BEP supplementation.

Overall, the innovation of using fortified BEP supplementation aims to improve maternal health by addressing anemia and suboptimal GWG, which are associated with adverse maternal and birth outcomes.
AI Innovations Description
The recommendation from the study is to implement fortified balanced energy-protein (BEP) supplementation for pregnant women to improve access to maternal health. The study conducted a randomized controlled trial in Burkina Faso, comparing the efficacy of a micronutrient-fortified BEP supplement with an iron-folic acid (IFA) tablet. The study aimed to assess the impact of the BEP supplement on anemia, gestational weight gain (GWG), GWG rate, and GWG adequacy.

The findings of the study showed that there were no significant differences in prenatal anemia prevalence, GWG rate, GWG adequacy, or the incidence of inadequate or excessive GWG between the BEP group and the IFA group. However, women in the BEP group tended to have higher GWG, although this difference was not statistically significant.

Based on these results, it is recommended to further investigate additional biochemical and postnatal outcomes related to maternal BEP supplementation. While the study did not provide evidence that fortified BEP supplementation reduces maternal anemia or increases GWG compared to IFA, it is important to consider the potential positive effects of maternal BEP supplementation on birth outcomes.

Implementing fortified BEP supplementation as part of maternal health programs can help address the issue of inadequate GWG and anemia among pregnant women. This intervention can contribute to improving maternal and birth outcomes, especially in areas with limited dietary diversity and inadequate micronutrient intake. Further research and evaluation are needed to fully understand the impact of fortified BEP supplementation on maternal health.
AI Innovations Methodology
Based on the provided information, the study conducted a randomized controlled trial in Burkina Faso to assess the efficacy of a micronutrient-fortified balanced energy-protein (BEP) supplement on maternal anemia and gestational weight gain (GWG) among pregnant women. The study compared the intervention group receiving the BEP supplement and iron-folic acid (IFA) tablet with the control group receiving only the IFA tablet.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could be developed as follows:

1. Define the target population: Identify the specific population group that would benefit from improved access to maternal health, such as pregnant women in rural areas of Burkina Faso.

2. Identify the key recommendations: Based on the study findings, identify the key recommendations that can improve access to maternal health. In this case, the recommendation would be the provision of a micronutrient-fortified BEP supplement along with an IFA tablet during pregnancy.

3. Determine the indicators: Select indicators that can measure the impact of the recommendations on improving access to maternal health. In this case, the indicators could include the prevalence of anemia, GWG, GWG rate, GWG adequacy, and the incidence of inadequate or excessive GWG.

4. Collect baseline data: Gather baseline data on the selected indicators from the target population before implementing the recommendations. This data will serve as a reference point for comparison.

5. Implement the recommendations: Introduce the provision of the micronutrient-fortified BEP supplement and IFA tablet to pregnant women in the target population.

6. Monitor and collect data: Continuously monitor the implementation of the recommendations and collect data on the selected indicators. This can be done through regular antenatal care visits and other data collection methods.

7. Analyze the data: Analyze the collected data to assess the impact of the recommendations on the selected indicators. Compare the post-implementation data with the baseline data to determine any improvements in access to maternal health.

8. Evaluate the results: Evaluate the results of the analysis to determine the effectiveness of the recommendations in improving access to maternal health. Consider factors such as the prevalence of anemia, GWG, and other indicators to assess the overall impact.

9. Adjust and refine the recommendations: Based on the evaluation results, make any necessary adjustments or refinements to the recommendations to further improve access to maternal health.

10. Repeat the process: Continuously repeat the process of monitoring, analyzing, and evaluating the impact of the recommendations to ensure ongoing improvement in access to maternal health.

By following this methodology, it would be possible to simulate the impact of the recommendations from the study on improving access to maternal health in the target population. The data collected and analyzed would provide valuable insights into the effectiveness of the recommendations and guide further interventions to address maternal health challenges.

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