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Home- and community-based growth monitoring to reduce early life growth faltering: an open-label, cluster-randomized controlled trial.

ABSTRACT: Background: Despite the continued high prevalence of faltering growth, height monitoring remains limited in many low- and middle-income countries.Objective: The objective of this study was to test whether providing parents with information on their child's height can improve children's height and developmental outcomes.Design: Villages in Chipata District, Zambia (n = 127), were randomly assigned with equal probability to 1 of 3 groups: home-based growth monitoring (HBGM), community-based growth monitoring including nutritional supplementation for children with stunted growth (CBGM+NS), and control. Primary study outcomes were individual height-for-age z score (HAZ) and overall child development assessed with the International Fetal and Newborn Growth Consortium for the 21st Century Neurodevelopment Assessment tool. Secondary outcomes were weight-for-age z score (WAZ), protein consumption, breastfeeding, and general dietary diversity.Results: We enrolled a total of 547 children with a median age of 13 mo at baseline. Estimated mean difference (?) in HAZ was 0.127 (95% CI: -0.107, 0.361) for HBGM and -0.152 (95% CI: -0.341, 0.036) for CBGM+NS. HBGM had no impact on child development [?: -0.017 (95% CI: -0.133, 0.098)]; CBGM+NS reduced overall child development scores by -0.118 SD (95% CI: -0.230, -0.006 SD). Both interventions had larger positive effects among children with stunted growth at baseline, with estimated interaction effects of 0.503 (95% CI: 0.160, 0.846) and 0.582 (95% CI: 0.134, 1.030) for CBGM+NS and HBGM, respectively. HBGM increased mean WAZ [? = 0.183 (95% CI: 0.037, 0.328)]. Both interventions improved parental reports of children's protein intake.Conclusions: The results from this trial suggest that growth monitoring has a limited effect on children's height and development, despite improvements in self-reported feeding practices. HBGM had modest positive effects on children with stunted growth. Given its relatively low cost, this intervention may be a cost-effective tool for increasing parental efforts toward reducing children's physical growth deficits. This trial was registered at clinicaltrials.gov as NCT02242539.

SUBMITTER: Fink G

PROVIDER: S-EPMC5611784 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Home- and community-based growth monitoring to reduce early life growth faltering: an open-label, cluster-randomized controlled trial.

Fink Günther G Levenson Rachel R Tembo Sarah S Rockers Peter C PC

The American journal of clinical nutrition 20170823 4

Background: Despite the continued high prevalence of faltering growth, height monitoring remains limited in many low- and middle-income countries.Objective: The objective of this study was to test whether providing parents with information on their child's height can improve children's height and developmental outcomes.Design: Villages in Chipata District, Zambia (n = 127), were randomly assigned with equal probability to 1 of 3 groups: home-based growth monitoring (H ...[more]

PMID: 28835364

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Project description:BackgroundChildhood stunting remains common in many low-income settings and is associated with increased morbidity and mortality, as well as impaired child development.MethodsThe main objective of the study was to assess whether home-installed growth charts as well as small-quantity lipid-based nutrient supplements (SQ-LNS) can reduce growth faltering among infants. All caregivers of infants between 2 and 10 months of age at baseline, and at least 6 months old at the beginning of the interventions, in 282 randomly selected enumeration areas in Choma, Mansa and Lusaka districts in Zambia were invited to participate in the study. Cluster randomisation was stratified by district. A software-generated random number draw was used to assign clusters to one of four arms: (1) no intervention (control); (2) home installation of a wall chart that contained a growth monitoring tool along with key messages on infant and young child feeding and nutrition (growth charts only); (3) 30 sachets of SQ-LNS delivered each month (SQ-LNS only) or (4) growth charts+SQ LNS. The primary outcomes were children's height-for-age z-score (HAZ) and stunting (HAZ <-2) after 18 months of intervention. Secondary outcomes were haemoglobin (Hb), anaemia (Hb<110.0 g/L), weight-for-height, weight-for-age z-score (WAZ), underweight (WAZ<-2) and child development measured by the Global Scales of Early Development (GSED). Outcomes were analysed intention to treat using adjusted linear and logistic regression models and compared each of the three interventions to the control group. Assessors and analysts were blinded to the treatment-blinding of participating families was not possible.ResultsA total of 2291 caregiver-child dyads across the 282 study clusters were included in the study. 70 clusters (557 dyads) were assigned to the control group, 70 clusters (643 dyads) to growth charts only, 71 clusters (525 dyads) to SQ-LNS and 71 clusters (566 dyads) to SQ-LNS and growth charts. SQ-LNS improved HAZ by 0.21 SD (95% CI 0.06 to 0.36) and reduced the odds of stunting by 37% (adjusted OR, aOR 0.63, 95% CI (0.46 to 0.87)). No HAZ or stunting impacts were found in the growth charts only or growth charts+SQ LNS arms. SQ-LNS only improved WAZ (mean difference, MD 0.17, 95% CI (0.05 to 0.28). No impacts on WAZ were seen for growth charts and the combined intervention. Child development was higher in the growth charts only (MD 0.18, 95% CI (0.01 to 0.35)) and SQ-LNS only arms (MD 0.28, 95% CI (0.09 to 0.46). SQ-LNS improved average haemoglobin levels (MD 2.9 g/L (0.2, 5.5). The combined intervention did not have an impact on WAZ, Hb or GSED but reduced the odds of anaemia (aOR 0.72, 95% CI (0.53 to 0.97)). No adverse events were reported.InterpretationSQ-LNS appears to be effective in reducing growth faltering as well as improving anaemia and child development. Growth charts also show the potential to reduce anaemia and improve child development but do not seem as effective in addressing growth faltering. Further research is needed to better understand reduced effectiveness when both interventions are combined.Trial registration numberNCT051204272.

Project description:BACKGROUND:The Global Programme to Eliminate Lymphatic Filariasis (GPELF) provides antifilarial medications to hundreds of millions of people annually to treat filarial infections and prevent elephantiasis. Recent trials have shown that a single-dose, triple-drug treatment (ivermectin with diethylcarbamazine and albendazole [IDA]) is superior to a two-drug combination (diethylcarbamazine plus albendazole [DA]) that is widely used in LF elimination programs. This study was performed to assess the safety of IDA and DA in a variety of endemic settings. METHODS AND FINDINGS:Large community studies were conducted in five countries between October 2016 and November 2017. Two studies were performed in areas with no prior mass drug administration (MDA) for filariasis (Papua New Guinea and Indonesia), and three studies were performed in areas with persistent LF despite extensive prior MDA (India, Haiti, and Fiji). Participants were treated with a single oral dose of IDA (ivermectin, 200 ?g/kg; diethylcarbamazine, 6 mg/kg; plus albendazole, a fixed dose of 400 mg) or with DA alone. Treatment assignment in each study site was randomized by locality of residence. Treatment was offered to residents who were ?5 years of age and not pregnant. Adverse events (AEs) were assessed by medical teams with active follow-up for 2 days and passive follow-up for an additional 5 days. A total of 26,836 persons were enrolled (13,535 females and 13,300 males). A total of 12,280 participants were treated with DA, and 14,556 were treated with IDA. On day 1 or 2 after treatment, 97.4% of participants were assessed for AEs. The frequency of all AEs was similar after IDA and DA treatment (12% versus 12.1%, adjusted odds ratio for IDA versus DA 1.15, 95% CI 0.87-1.52, P = 0.316); 10.9% of participants experienced mild (grade 1) AEs, 1% experienced moderate (grade 2) AEs, and 0.1% experienced severe (grade 3) AEs. Rates of serious AEs after DA and IDA treatment were 0.04% (95% CI 0.01%-0.1%) and 0.01% (95% CI 0.00%-0.04%), respectively. Severity of AEs was not significantly different after IDA or DA. Five of six serious AEs reported occurred after DA treatment. The most common AEs reported were headache, dizziness, abdominal pain, fever, nausea, and fatigue. AE frequencies varied by country and were higher in adults and in females. AEs were more common in study participants with microfilaremia (33.4% versus 11.1%, P < 0.001) and more common in microfilaremic participants after IDA than after DA (39.4% versus 25.6%, P < 0.001). However, there was no excess of severe or serious AEs after IDA in this subgroup. The main limitation of the study was that it was open-label. Also, aggregation of AE data from multiple study sites tends to obscure variability among study sites. CONCLUSIONS:In this study, we observed that IDA was well tolerated in LF-endemic populations. Posttreatment AE rates and severity did not differ significantly after IDA or DA treatment. Thus, results of this study suggest that IDA should be as safe as DA for use as a MDA regimen for LF elimination in areas that currently receive DA. TRIAL REGISTRATION:Clinicaltrials.gov registration number: NCT02899936.

Project description:BackgroundTrivalent oral polio vaccine (tOPV) was replaced worldwide from April, 2016, by bivalent types 1 and 3 oral polio vaccine (bOPV) and one dose of inactivated polio vaccine (IPV) where available. The risk of transmission of type 2 poliovirus or Sabin 2 virus on re-introduction or resurgence of type 2 poliovirus after this switch is not understood completely. We aimed to assess the risk of Sabin 2 transmission after a polio vaccination campaign with a monovalent type 2 oral polio vaccine (mOPV2).MethodsWe did an open-label cluster-randomised trial in villages in the Matlab region of Bangladesh. We randomly allocated villages (clusters) to either: tOPV at age 6 weeks, 10 weeks, and 14 weeks; or bOPV at age 6 weeks, 10 weeks, and 14 weeks and either one dose of IPV at age 14 weeks or two doses of IPV at age 14 weeks and 18 weeks. After completion of enrolment, we implemented an mOPV2 vaccination campaign that targeted 40% of children younger than 5 years, regardless of enrolment status. The primary outcome was Sabin 2 incidence in the 10 weeks after the campaign in per-protocol infants who did not receive mOPV2, as assessed by faecal shedding of Sabin 2 by reverse transcriptase quantitative PCR (RT-qPCR). The effect of previous immunity on incidence was also investigated with a dynamical model of poliovirus transmission to observe prevalence and incidence of Sabin 2 virus. This trial is registered at ClinicalTrials.gov, number NCT02477046.FindingsBetween April 30, 2015, and Jan 14, 2016, individuals from 67 villages were enrolled to the study. 22 villages (300 infants) were randomly assigned tOPV, 23 villages (310 infants) were allocated bOPV and one dose of IPV, and 22 villages (329 infants) were assigned bOPV and two doses of IPV. Faecal shedding of Sabin 2 in infants who did not receive the mOPV2 challenge did not differ between children immunised with bOPV and one or two doses of IPV and those who received tOPV (15 of 252 [6%] vs six of 122 [4%]; odds ratio [OR] 1·29, 95% CI 0·45-3·72; p=0·310). However, faecal shedding of Sabin 2 in household contacts was increased significantly with bOPV and one or two doses of IPV compared with tOPV (17 of 751 [2%] vs three of 353 [1%]; OR 3·60, 95% CI 0·82-15·9; p=0·045). Dynamical modelling of within-household incidence showed that immunity in household contacts limited transmission.InterpretationIn this study, simulating 1 year of tOPV cessation, Sabin 2 transmission was higher in household contacts of mOPV2 recipients in villages receiving bOPV and either one or two doses of IPV, but transmission was not increased in the community as a whole as shown by the non-significant difference in incidence among infants. Dynamical modelling indicates that transmission risk will be higher with more time since cessation.FundingBill & Melinda Gates Foundation.

Project description:BackgroundHospitalized preterm infants with compromised skin barrier function treated topically with sunflower seed oil (SSO) have shown reductions in sepsis and neonatal mortality rate (NMR). Mustard oil and products commonly used in high-mortality settings may possibly harm skin barrier integrity and enhance risk of infection and mortality in newborn infants. We hypothesized that SSO therapy may reduce NMR in such settings.Methods and findingsThis was a population-based, cluster randomized, controlled trial in 276 clusters in rural Uttar Pradesh, India. All newborn infants identified through population-based surveillance in the study clusters within 7 days of delivery were enrolled from November 2014 to October 2016. Exclusive, 3 times daily, gentle applications of 10 ml of SSO to newborn infants by families throughout the neonatal period were recommended in intervention clusters (n = 138 clusters); infants in comparison clusters (n = 138 clusters) received usual care, such as massage practice typically with mustard oil. Primary analysis was by intention-to-treat with NMR and post-24-hour NMR as the primary outcomes. Secondary analysis included per-protocol analysis and subgroup analyses for NMR. Regression analysis was adjusted for caste, first-visit weight, delivery attendant, gravidity, maternal age, maternal education, sex of the infant, and multiple births. We enrolled 13,478 (52.2% male, mean weight: 2,575.0 grams ± standard deviation [SD] 521.0) and 13,109 (52.0% male, mean weight: 2,607.0 grams ± SD 509.0) newborn infants in the intervention and comparison clusters, respectively. We found no overall difference in NMR in the intervention versus the comparison clusters [adjusted odds ratio (aOR) 0.96, 95% confidence interval (CI) 0.84 to 1.11, p = 0.61]. Acceptance of SSO in the intervention arm was high at 89.3%, but adherence to exclusive applications of SSO was 30.4%. Per-protocol analysis showed a significant 58% (95% CI 42% to 69%, p < 0.01) reduction in mortality among infants in the intervention group who were treated exclusively with SSO as intended versus infants in the comparison group who received exclusive applications of mustard oil. A significant 52% (95% CI 12% to 74%, p = 0.02) reduction in NMR was observed in the subgroup of infants weighing ≤1,500 g (n = 589); there were no statistically significant differences in other prespecified subgroup comparisons by low birth weight (LBW), birthplace, and wealth. No severe adverse events (SAEs) were attributable to the intervention. The study was limited by inability to mask allocation to study workers or participants and by measurement of emollient use based on caregiver responses and not actual observation.ConclusionsIn this trial, we observed that promotion of SSO therapy universally for all newborn infants was not effective in reducing NMR. However, this result may not necessarily establish equivalence between SSO and mustard oil massage in light of our secondary findings. Mortality reduction in the subgroup of infants ≤1,500 g was consistent with previous hospital-based efficacy studies, potentially extending the applicability of emollient therapy in very low-birth-weight (VLBW) infants along the facility-community continuum. Further research is recommended to develop and evaluate therapeutic regimens and continuum of care delivery strategies for emollient therapy for newborn infants at highest risk of compromised skin barrier function.Trial registrationISRCTN Registry ISRCTN38965585 and Clinical Trials Registry-India (CTRI/2014/12/005282) with WHO UTN # U1111-1158-4665.

Project description:BackgroundHypertension is a major global public health problem. Elevated blood pressure can cause cardiovascular and kidney diseases. We assessed the effectiveness of health education sessions and home support programs in reducing blood pressure among patients with uncontrolled hypertension in a suburban community of Nepal.MethodsWe conducted a community-based, open-level, parallel-group, cluster randomized controlled trial in Birendranagar municipality of Surkhet, Nepal. We randomly assigned four clusters (wards) into intervention and control arms. We provided four health education sessions, frequent home and usual care for intervention groups over six months. The participants of the control arm received only usual care from health facilities. The primary outcome of this study was the proportion of controlled systolic blood pressure (SBP). The analysis included all participants who completed follow-up at six months.Results125 participants were assigned to either the intervention (n = 63) or the control (n = 62) group. Of them, 60 participants in each group completed six months follow-up. The proportion of controlled SBP was significantly higher among the intervention participants compared to the control (58.3% vs. 40%). Odds ratio of this was 2.1 with 95% CI: 1.01-4.35 (p = 0.046) and that of controlled diastolic blood pressure (DBP) was 1.31 (0.63-2.72) (p = 0.600). The mean change (follow-up minus baseline) in SBP was significantly higher in the intervention than in the usual care (-18.7 mmHg vs. -11.2 mmHg, p = 0.041). Such mean change of DBP was also higher in the intervention (-10.95 mmHg vs. -5.53 mmHg, p = 0.065). The knowledge score on hypertension improved by 2.38 (SD 2.4) in the intervention arm, which was significantly different from that of the control group, 0.13 (1.8) (p<0.001).ConclusionsMultiple health education sessions complemented by frequent household visits by health volunteers can effectively improve knowledge on hypertension and reduce blood pressure among uncontrolled hypertensive patients at the community level in Nepal.Trial registrationClinicalTrial.gov: NCT02981251.

Dataset Information

Home- and community-based growth monitoring to reduce early life growth faltering: an open-label, cluster-randomized controlled trial.

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Home- and community-based growth monitoring to reduce early life growth faltering: an open-label, cluster-randomized controlled trial.

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