scholarly journals The Impact of an Antenatal Balanced Plate Nutrition Education Intervention on Infant Birthweight: A Cluster Randomized Controlled Trial in Rural Bangladesh (OR25-01-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Morseda Chowdhury ◽  
Michael Dibley ◽  
Ashraful Alam ◽  
Patrick J Kelly ◽  
Camille Raynes-Greenow
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Nutrition Education ◽  
Rural Population ◽  
Low Birthweight ◽  
Controlled Trial ◽  
Education Intervention ◽  
Community Based ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Objectives Low birthweight (LBW) is strongly associated with neonatal mortality. Evidence that nutrition education improves diet during pregnancy and reduces LBW is still weak. We investigated the effect of a nutrition education intervention for pregnant women in improving birthweight of infants. Our primary hypothesis was that women who receive the ‘balanced plate nutrition education’ during pregnancy would deliver babies 100 g heavier than those who receive standard nutrition education. Methods We conducted a parallel, two-arm, cluster-randomized controlled trial in Bangladesh, in which we randomly assigned 36 clusters in equal ratio to intervention or standard care. Participants in the intervention clusters received ‘balanced plate nutrition education’ with a practical demonstration from community health workers 4–7 times starting from the first trimester of pregnancy. The participants in the control clusters received standard nutrition education delivered by healthcare providers during antenatal care. Eligible participants were pregnant women of 12 weeks gestation or less. The primary outcome was mean birthweight and incidence of LBW (defined as birthweight less than 2500 gm). The trial is registered with number ACTRN12616000080426. Results We included all assigned participants in the intervention (445) and comparison (448) groups in the analyses (Figure 1). Baseline characteristics were balanced between the treatment groups (Table 1). The mean birthweight increased by 125.3 g (95% confidence interval (CI) 5·7, 244·9; P = 0·04) and the risk of LBW was reduced by 54% (relative risk (RR) 0·46; 95% CI 0·28, 0·78; P = 0·004) in the intervention compared to the comparison group (Table 2). In post hoc analyses amongst adolescent mothers we observed a significant improvement in birthweight and reduction in LBW (mean difference 297·3 g; 95% CI 85·0, 509·6; P = 0·006 and RR 0·31; 95% CI 0·12, 0·77; P = 0·01). Conclusions A community-based balanced plate nutrition education was effective in increasing birthweight and reducing the incidence of LBW in a rural population of Bangladesh. A community-based, balanced-plate nutrition education was effective in increasing birthweight and reducing the incidence of low birthweight in a rural population of Bangladesh. Funding Sources James P. Grant School of Public Health; Bangladesh, and Sydney Medical School; Australia. Supporting Tables, Images and/or Graphs

scholarly journals Community-Based Cluster Randomized Controlled Trial: Empowering Households to Identify and Provide Appropriate Care for Low-Birthweight Newborns in Nepal

2020 ◽  
Author(s):  
Stephen Hodgins ◽  
Binamra Rajbhandari ◽  
Deepak Joshi ◽  
Bharat Ban ◽  
Subarna Khatry ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Birthweight ◽  
Controlled Trial ◽  
Care Seeking ◽  
Apparent Effect ◽  
Community Based ◽  
Randomized Controlled ◽  
Appropriate Care ◽  
Cluster Randomized ◽  
Skin To Skin

Abstract Background: Most newborn deaths occur among those of low birthweight (LBWt), due to prematurity &/or impaired fetal growth. Simple practices can mitigate this risk. In low-income country settings where many births occur at home, strategies are needed that empower mothers to determine if their babies are higher risk and take protective measures. Earlier studies suggest that foot-length may be a good proxy for birthweight. An earlier Nepal study found a 6.9cm cut-off performed relatively well, differentiating normal from low birthweight.Methods: Community-based, cluster-randomized controlled trial. Objective: to determine whether family-administered screening, with targeted messages improves care practices known to mitigate LBWt risks. Participants: pregnant women participating in a parent trial in rural Nepal. Women were given a 6.9cm card to assess whether the baby’s foot is small; if so, to call number on the card for advice. Follow-up visits were made over 2 weeks following the birth, assessing for: reported skin-to-skin thermal care, and care-seeking outside the home; restricting to low birthweight (using 2 cutoffs: 2,500g and 2,000g). Randomization: 17 clusters intervention, 17 control. The study also documented steps along the presumed causal chain from intervention through behavioral impact.Results: 2,022 into intervention, 2,432 into control. Intervention arm: 519 with birthweight <2,500g (vs. 663 among controls), of which 503 were available for analysis (vs. 649 among controls). No significant difference on care-seeking; for those <2,500g RR 1.13 (95%CI: 0.97-1.131). More of those in the intervention arm reported skin-to-skin thermal care than among controls; for those <2,500g RR 2.50 (95%CI: 2.01-3.1). Process measures suggest this apparent effect cannot be attributed to the intervention; the card performed poorly as a proxy for LBWt, misclassifying 84.5% of those <2,000 as normal.Conclusions: Although the trial found an apparent effect on one key behavioral outcome, this cannot be attributed to the intervention; most likely it was a result of pure chance. Other approaches are needed for identifying at-risk babies in such settings, and targeting them for appropriate care messaging.Trial registration : clinicaltrials.gov identifier: NCT02802332, registered 16 June 2016, https://clinicaltrials.gov/ct2/show/NCT02802332

scholarly journals Effect of community-based kangaroo mother care package on neonatal mortality among preterm and low birthweight infants in rural Pakistan: Protocol for a cluster randomized controlled trial (Preprint)

2021 ◽  
Author(s):  
Sajid Soofi
Keyword(s):  
Randomized Controlled Trial ◽  
Neonatal Mortality ◽  
Low Birthweight ◽  
Controlled Trial ◽  
Kangaroo Mother Care ◽  
Community Based ◽  
Randomized Controlled ◽  
Breastfeeding Practices ◽  
Care Package ◽  
Cluster Randomized

BACKGROUND Neonatal mortality, due to preterm birth and low birthweight, remains a major challenge for Pakistan. Kangaroo mother care is a unique, low-cost intervention proven to reduce neonatal mortality and morbidity and increase exclusive breastfeeding rates. Kangaroo mother care has not been tried in community settings in Pakistan. We aim to implement and evaluate the effectiveness of community-based kangaroo mother care package to reduce neonatal morbidity and mortality among preterm/low birthweight infants. This will provide evidence for policy development and large-scale implementation of KMC across the country to reduce neonatal. OBJECTIVE The primary objective of this trial is to reduce neonatal mortality among preterm/low birthweight infants. The secondary objectives are growth measured as weight gain, reduction in incidence of possible serious bacterial infection (PSBI), increased exclusive breastfeeding and continued breastfeeding practices. METHODS We designed a community-based cluster randomized controlled trial in one rural district of Pakistan. Stable, low birth weight babies ≥1200-<2500 grams are included in the study. Kangaroo mother care package adopted after formative research consisting of KMC kit, information and counseling material, and community mobilization using KMC champions (volunteers) is implemented in the intervention clusters. The standard essential newborn care offered in the control clusters. Infants would be recruited and followed up by independent teams of data collectors. Data is collected on the duration of skin to skin contact, growth breastfeeding practices, the incidence of possible serious bacterial infection, neonatal mortality and impact on neurodevelopment. RESULTS The study protocol was approved by the Ethics Review Committee of Aga Khan University, Pakistan on February 2017. Data collection began in August 2019 and will be completed in December 2021. Data analyses are yet to be completed. Data analysis will be by intention to treat principle. The cox regression model will be used for the primary outcome of neonatal mortality, to calculate hazard ratios. The secondary outcomes will be assessed using linear or logistic regression. We expect the results to be published in peer-reviewed journals presentations at relevant conferences by autumn of 2022. CONCLUSIONS This intervention, if effective, has the “potential to be translated into a safe, effective, affordable, and widely utilized intervention” to prevent sepsis and subsequently improve survival in LBW neonates in Pakistan, and other low-and middle-income countries. CLINICALTRIAL Clinicaltrials.gov: NCT03545204

scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2019 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

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