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Outcomes | SECONDARY | In this post-hoc analysis, patients were grouped by the NED at study drug initiation into low (≤ 0.25 µg/kg/min) and high (> 0.25 µg/kg/min) subgroups. This cut-off was established on the basis of post-marketing observational studies demonstrating that 0.2–0.3 µg/kg/min NED is a common criterion in local hospital protocols for adding AT II [Within each subgroup, we compared the differences in 28-day survival between patients receiving AT II or placebo. The primary outcome was the difference in 28-day survival between the AT II and placebo groups in those with a baseline NED ≤ 0.25 µg/kg/min at the time of study drug initiation. The secondary outcome was the difference in 28-day survival between the two groups in those with a baseline NED > 0.25 µg/kg/min. Other exploratory outcomes included the proportion of patients achieving a MAP response at hour 3, the degree of change in background vasopressors at hour 3, survival at 7 days, and cumulative incidence of discontinuation of renal replacement therapy (RRT) at 7 days. Safety was assessed and reported through 28 days. | PMC10163684 | |
Statistical methods | Categorical data were reported as counts with percentages and analyzed with chi-square or Fisher exact test in univariate analysis, as appropriate. Continuous data were reported as medians with interquartile ranges and analyzed with Wilcoxon rank sum test in univariate analysis. Kaplan–Meier analyses were used to describe time-to-event variables including survival and cumulative incidence of RRT discontinuation. The log-rank test was used to compare the AT II and placebo arms with strata defined by the randomization strata [ | PMC10163684 | ||
Results | PMC10163684 | |||
Renal recovery of patients on RRT | Within the low-NED subgroup, renal recovery (defined as cumulative incidence of discontinuing RRT) at day 7 in patients receiving RRT at randomization in the AT II group was 59% compared to 33% in the placebo group (HR 1.99; 95% CI: 0.55–7.24; | PMC10163684 | ||
Sensitivity analysis | SENSITIVITY | Sensitivity Analysis of the primary outcomes was performed at a NED threshold of 0.2 µg/kg/min and 0.3 µg/kg/min. At a threshold of 0.2 µg/kg/min, there were only 27 patients in the low-NED AT II group and 18 patients in the low-NED placebo group. Overall, with a sample size this low, there was not enough power to detect a difference in 28-day survival between these two groups (HR 0.55; 95% CI 0.19–1.55, | PMC10163684 | |
Discussion | Sepsis, shock, vasoplegic syndrome, hypotension, septic shock | SEPSIS, SHOCK, DISEASE, VASODILATORY SHOCK, SEPTIC SHOCK, DISEASE | This exploratory post-hoc analysis of the phase 3 ATHOS-3 clinical trial was undertaken to determine whether there is a signal for benefit of intervening with AT II at lower doses of other vasopressor agents. While this analysis is only hypothesis-generating in nature, we found a narrow window of low background vasopressor dose at which adding AT II may be associated with better hemodynamic response and increased survival in patients with vasodilatory shock. Specifically, more patients achieved the hemodynamic target with AT II when initiated at low-NED (≤ 0.25 µg/kg/min) compared to high-NED (> 0.25 µg/kg/min). Further, amongst patients with low-NED at the time of study drug initiation, those randomized to AT II were significantly more likely to survive at 7 and 28 days compared to those randomized to placebo, and within the AT II arm, those randomized at low-NED were significantly more likely to survive compared to those randomized at high-NED. Importantly however, this analysis cannot establish the true beneficial window for intervention with AT II, but suggests that it may occur at lower NED, and may also be narrow.Vasodilatory shock is considered a medical emergency that requires hypotension-correcting interventions [While unable to demonstrate any causal relationship, our post-hoc analysis suggests that if started at a lower NED, AT II may be associated with increased survival compared with placebo. Importantly, this analysis demonstrates that there may be a narrow range of NED at which intervention with AT II may be beneficial and above which may be futile. These results are similar to an observational study which found increased hemodynamic benefit with addition of AT II at NED < 0.3 µg/kg/min and even more pronounced benefit when the NED was lower (< 0.2 µg/kg/min) [Reasons for why the addition of AT II at lower NED may be associated with improved outcomes are likely multifactorial but may include NED sparing, RAAS-specific mechanisms, and potentially beneficial interaction between vasopressor agents with differing mechanisms of action. In the ATHOS-3 trial, the addition of AT II lowered the requirement for background vasopressors throughout the majority of the 48-h treatment period [Additionally, RAAS disruption and AT II deficiency have been described to occur in septic shock and vasoplegic syndrome following cardiac surgery and to be significantly associated with adverse outcomes [Finally, while we were unable in this post-hoc analysis to determine whether there is any interaction between vasopressor agents, there may be a potentiating effect of AT II and vasopressin. Such an interaction was suggested in an observational study of AT II, in which pre-existing use of vasopressin at the time of AT II initiation was associated with a significantly higher rate of hemodynamic responsiveness to AT II (OR 6.05, 95% CI 1.98–18.6; The present analysis, although hypothesis-generating in scope, has potentially important clinical implications, as it adds to mounting evidence suggesting that the NED may be an important determinant of outcomes in shock and could be used to guide management strategies. The current Surviving Sepsis Campaign guidelines do not provide specific recommendations regarding timing for initiation of non-catecholamine vasopressors in patients with persistent hypotension, but the guideline authors state that their typical approach is to start vasopressin at a norepinephrine dose of 0.25–0.5 µg/kg/min [The current analysis has several strengths, including the use of data from a prospective randomized trial of patients with vasodilatory shock. Further, the analysis addresses an important clinical question, the most appropriate scenario for intervention with AT II, which is not currently defined. Finally, the present findings are consistent with those from other analyses suggesting that interventions with non-catecholamine agents at lower norepinephrine doses are associated with improved outcomes [We acknowledge several limitations. First, this is a post-hoc observational study of a phase 3 trial with a non-patient-centered primary outcome. Thus, no inferences of causality of AT II on the patient-centered outcomes reported herein can be drawn; the results should be considered exploratory, hypothesis-generating, and the interpretation of the results requires caution. Second, the study design of ATHOS-3 resulted in only one third of patients being enrolled at NED ≤ 0.25 µg/kg/min, limiting the generalizability of these data. Had the ATHOS-3 protocol allowed for earlier enrollment, additional analyses could have been conducted on this population of patients. However, the limited number of patients enrolled in ATHOS-3 below this threshold preclude further analysis of thresholds below 0.25 µg/kg/min. Further, the total number of patients in each subgroup was small and so the findings are subject to type I error. Third, it is possible that low-NED and high-NED do not correlate with early or late stage of disease. Disease trajectory may be such that low-NED may not necessarily be early in the shock state but could potentially be a sign of patient improvement. Therefore, no conclusions regarding timing can be drawn from this analysis. Finally, even within the placebo group, practice may have been variable with regard to vasopressors [ | PMC10163684 |
Conclusions | This exploratory post-hoc analysis of a phase 3 clinical trial suggests that the introduction of AT II therapy at lower doses of vasopressor therapy may be associated with benefit. Prospective randomized trials of AT II infusion in lower NED patients may be both desirable and justified. While the data presented herein should be considered exploratory, hypothesis-generating, and should be interpreted with caution, they may inform selection of an appropriate threshold vasopressor dose below which introduction of AT II could be investigated. | PMC10163684 | ||
Acknowledgements | None. | PMC10163684 | ||
Author contributions | Conception and design of the study: PMW, CRG, TH, JHC. Acquisition of data: All authors. Analysis and interpretation of data: All authors. Drafted or provided critical revisions: All authors. Provided final approval of manuscript: All authors. All authors read and approved the final manuscript. | PMC10163684 | ||
Funding | The primary study and the present post-hoc analysis were supported by La Jolla Pharmaceutical Company. The work is the authors’ own and no payments were made to the authors for participating in or writing the paper. | PMC10163684 | ||
Availability of data and materials | The data supporting the findings of this study are available from La Jolla Pharmaceutical Company. However, restrictions apply to the availability of these data, which were used under license for the current study and so are not publicly available. However, data are available from the authors upon reasonable request and with the permission of La Jolla Pharmaceutical Company. | PMC10163684 | ||
Declarations | PMC10163684 | |||
Ethics approval and consent to participate | ATHOS-3 was sponsored by La Jolla Pharmaceutical Company and conducted under full oversight of site-level or central institutional review boards and ethics committees, per regional requirement. Written informed consent was obtained from all patients or their legal surrogates prior to inclusion. | PMC10163684 | ||
Consent for publication | Not applicable. | PMC10163684 | ||
Competing interests | AMD, Hypertension | HYPERTENSION, SEPTIC SHOCK | RB, KRH, and AMD, report no conflicts of interest. JHC, PMW, AKK, RGW, and DWB have previously served on a scientific advisory board for La Jolla Pharmaceutical Company. JHC, LWB, AKK, and DWB have served on the Speaker’s Bureau for La Jolla Pharmaceutical Company. AZ and JHC have received consultant fees from La Jolla Pharmaceutical Company. AZ has received consultant fees from Paion. AKK received research grant funding from La Jolla Pharmaceutical Company for the ATHOS-3 study and through the Wake Forest Center for Hypertension and Vascular Research for RAAS in septic shock. MO’s institution received research funding from La Jolla Pharmaceutical Company. CRG and TH are employees of La Jolla Pharmaceutical Company. SK was an employee of La Jolla Pharmaceutical Company during the preparation of the manuscript. | PMC10163684 |
References | PMC10163684 | |||
Background | anxiety | DENTAL CARIES, DISEASE | People with dental phobia often present with more active dental caries and fewer teeth. Minimally Intervention oral Healthcare offers a possible solution to address the high care needs of this group. The aim was to determine this patient group’s eligibility and willingness to participate and the effect of MIOC, compared to treatment as usual (TAU), on their oral health outcomes for planning a future randomised controlled trial (RCT). Minimum intervention oral healthcare (MIOC) comprises of four interlinked domains. In the first domain, we identified and diagnosed the disease status and participants’ anxiety status (≥ 19 MDAS). In the second domain, an individualised prevention-based personalised care plan was designed. During this process, patients with dental phobia were exposed to the dental environment in a stepped manner (‘graded exposure’) and had their urgent care provided with conscious sedation. In the 3 | PMC10391962 |
Methods | This two-arm randomised feasibility trial ( | PMC10391962 | ||
Results | Forty-four people diagnosed with dental phobia were allocated randomly to the two study arms. At the six-month recall after completed care, the outcome of each study arm was assessed. It was feasible to conduct a clinical trial (eligibility rate [56%], completion rate [81%], declined to participate [12%]). The intervention group showed improvements in all health care outcomes, and oral health related quality of life. | PMC10391962 | ||
Conclusion | phobia | A clinical trial of MIOC vs TAU in people with dental phobia is feasible. Preliminary findings suggest that patients in the MIOC arm are more likely to successfully complete their course of treatment. The study was ‘retrospectively registered’ on 02/05/2018 (ISRCT15294714) with the International Standard Randomised Controlled Trial (ISRCT). | PMC10391962 | |
Keywords | PMC10391962 | |||
Background | phobia, anxiety, ’, phobic, caries | DENTAL CARIES, INFLAMMATION, DISEASE, CARIES, DISEASES | Dental phobia has been defined “as a persistent fear of situation disproportional to the actual danger posed to the affected person where many will go to great lengths to avoid it. If the feared object or situation cannot be avoided entirely, the affected person will endure it with marked distress and significant interference in social or occupational activities” [There are multiple contributing reasons to poor oral health which is mostly preventable. These include socioeconomic status (being in routine occupations and with lower educational attainment), psychosocial factors (anxiety and fear) and proximal determinants that include biological (inflammation) [Other oral health-related contributing factors can be poor patient treatment choices [Many phobic people (798 [58.5%]) even with an awareness of their dental needs, will wait to seek care and will only attend with painful (infected) symptomatic teeth that exhibit longstanding untreated dental caries [The minimum intervention oral healthcare (MIOC) is the underlying principle of best clinical practice as it takes a holistic approach to provide personalised oral healthcare. The pathway’s first domain involves identification of patients’ problems (detection, risk/ susceptibility assessment of oral diseases), to enable diagnosis and patient-focused care planning. The 2In this programme (MIOC pathway for people with dental phobia), the level of support for prevention and control of disease in MIOC pathway is suitable for this patient group, in particular for caries element because of its chronic and accumulative nature [The learnt skills to combat dental phobia (for example the learnt relaxation techniques) can be used when patients are exposed to trigger factors (e.g., local anaesthetics). In the Minimal Invasive Dentistry (MID) (3The gained knowledge (e.g., dental phobic people’s experiences of dental services) from previous studies [ | PMC10391962 |
Methods | PMC10391962 | |||
Trial design | A two-arm feasibility trial (Fig. Flow diagram for the feasibility study according to CONSORT 2010The following three feasibility outcomes: the proportion of patients presenting for treatment who met the eligibility criteria (Table
Dentist adherence to intervention.Patient adherence with behaviour required by intervention and completion of personalised care plans.Proportion of participants captured at recall and patient satisfaction. Other outcome measures were estimates of means and standard deviations.The inclusion and exclusion criteria for the feasibility trialApproval was obtained from East of Scotland Research Ethics Service (EoSRES) and Health Research Authority (REC:17/ES/0067). The study was also registered with the International Standard Randomised Controlled Trial (ISRCTN15294714) with a link to the protocol. All methods were carried out in accordance with relevant guidelines and regulations. Informed consent was obtained from all participants for all forms of personally identifiable data including clinical, and biometric data. | PMC10391962 | ||
Setting and location | The department of Sedation and Special Care Dentistry (SSCD) is based in Guy's Dental Hospital as part of Faculty of Dentistry, Oral & Craniofacial Sciences, King’s College London (KCL) and Guy's and St Thomas' Hospitals Foundation Trust (GSTT). Patients are referred from primary care for treatment by specialists when care cannot be carried out in a primary care setting. | PMC10391962 | ||
Randomisations | Patients were allocated to condition at random, following a simple random allocation sequence created independently of the treating clinician. The allocation sequence was concealed in an opaque envelop, opened after the participant consented. | PMC10391962 | ||
Intervention (T3) | The intervention group was treated according to the MIOC patient management pathway [ | PMC10391962 | ||
Description of treatment as usual arm (TAU) | Participants in the standard (control, TAU) care arm were offered conventional treatment. Upon completion of dental care, at the recall appointment that marked the end of the study, participants’ oral health outcome was documented by SSCD staff (Table The trial’s data collection information | PMC10391962 | ||
Validation of the intervention | In order to validate the independent variable (testing if MIOC was delivered as per protocol design), one of the authors (AB) reviewed 11 randomised patients’ records to assess if treatment was provided per feasibility and MIOC protocol. | PMC10391962 | ||
Measures | Information was collected (Table | PMC10391962 | ||
Screening measures | Anxiety, anxiety, tooth, depression, Depression | Participants completed a questionnaire set comprising Demographic data, Modified Dental Anxiety Score (MDAS) and Hospital Anxiety & Depression Scale (HADS) information. MDAS consists of five-items related to the dentist’s waiting room, tooth drilling and scaling in addition to local anaesthetic injection. The 5-point scale responses can vary from: Not Anxious (score of 1) to Extremely Anxious (score of 5). The sum can produce a total score ranging from 5 to 25 with cut-off value of 19 (score The general anxiety and depression were measured using HADS, a 14-item questionnaire that produces two scales, one for anxiety (HADS–A) and one for depression (HADS–D), with scores of | PMC10391962 | |
Measures for eligible patients | OHR | The eligible participants filled in the questionnaire (part A and part B). Part B of the questionnaire (with questions based on ADHS, 2009) [At the recall appointment, in the post completion of care (≥ 6 months), in addition to part A of the questionnaire (patients’ demographic, MDAS and HADS), part B (patients’ OHR behaviours based on ADHS, 2009 and adherence with behaviour modification required by MIOC intervention) and part C (we sought participants’ views in the adapted version of Treatment Evaluation Inventory [TEI]) by Newton & Sturmey 2004. The questionnaire was disturbed to all feasibility study’s participants (Table The TEI measures acceptability of treatment interventions and has a 19-item questionnaire with answers on a seven-point Likert scale with higher scores indicating more perceived acceptability [ | PMC10391962 | |
Outcome measures (baseline and completed care) | PLAQUE | The clinical data compromised of collecting data on total number of teeth present, DMFS, BPE and plaque scores based on the UK ADHS 2009 methodology [ | PMC10391962 | |
Statistics | For outcome measures, the statistical analysis consisted of descriptive statistics (means, proportions, standard deviations [SD]). No changes to the trial protocol or trial measures were made after the commencement of the trial. | PMC10391962 | ||
Results | Figure In addition, the study sought to determine a preliminary estimate of the following potential outcome variables (e.g., patient satisfaction with care provided) (Table The data form the trial’s data collection information | PMC10391962 | ||
Validation of the intervention | One of the authors (AB) reviewed independently a random sample of 11 participants case records in the intervention arm and was satisfied that dentist (EH) had adhered to the defined specific behaviours in the MIOC pathway. | PMC10391962 | ||
Patient’s demographic | OHR, ’ | Most of the respondents were female (32, 72%) and between the ages of 45 to 54 (13, 30%). The average age for completing full-time education was 16 and 18 in the experimental respective control arm at the baseline. Majority of the respondents (33, 75%) only attended when they had trouble with their teeth/dentures.In MIOC, the patients’ adherence to OHR behaviour (follow the individual tailored prevention regime in 2The demographic and oral health-related behaviours of study participants | PMC10391962 | |
Recall rates within the trial | In the MIOC (intervention arm) group, there were 4 dropouts whilst in the TAU group, the number was 19 (Fig. | PMC10391962 | ||
Discussion | phobic, OHR, phobia, caries | SECONDARY, RECRUITMENT, CARIES, DECAYED TEETH | This feasibility study highlighted that a trial seeking to determine the effects of providing MIOC to patients with dental phobia is possible within a secondary care setting that is a major national provider of conscious sedation and CBT services. The recruitment process to identify eligible patients and acceptability of MIOC pathway by patients was successful as shown in the relatively low declining participating rates in the eligible participants (only 12% at the screening appointment and 17% at the care planning session). These factors indicate a possibility to conduct a future prospective MIOC randomised control trial (RCT) for people with dental phobia. The dentist fully adhered to the intervention (MIOC) protocol. The results from valid and reliable measures (MDAS, HADS, OHIP, caries diagnosis) also aided the comparison to other studies’ data.The participants’ background (such as age, gender and educational levels) was similar to a published general population with phobia [This study’s high number of decayed teeth [Previous studies [Although the rate of the intervention (MIOC) groups’ follow up could be improved (a dropout rate of 4 people), the participants who completed the MIOC approach reported high satisfaction rates and expressed improved OHR QoL. The drop out rates in particular in TAU can partly been explained by participants’ phobic status (only people with MDAS scores of 19 and above were invited to take part). The lower drop out rate for the intervention arm may reflect the greater person-centred nature of the MIOC approach, especially if this was combined with CBT.Although some anxious individuals report regular dental attendance [As a feasibility study, the population is a convenience sample with a fixed recall period that cannot give powerful statistical results [The lack of time was the reason for not collecting participants’ character and the reasons for refusals (rate of 48, [22%]), however, the refusal rate is comparable to a similar centre [The use of minimally invasive operative approaches (the third clinical domain of MIOC) to improve prognosis of treated teeth was welcomed by participants in this study unlike in the Schwendicke et al. (2016) [This study bias was limited by using simple randomization with concealed allocation numbers and randomly reviewing researcher’s adherence to intervention. The introduced self-reported OHR behavioural changes can be a consequence of study participation, however, currently there are no evidence of a single effect [A single examiner can be beneficial to provide a consistent care but there is a need to report intra-examiner reliability. The relatively short follow-up time might have overestimated the reported clinical effectiveness [ | PMC10391962 |
Acknowledgements | The authors would like to thank all the participants for taking part in this research, the department of Sedation and Special Care Dentistry and Faculty of Dentistry, Oral & Craniofacial Sciences (FoDOCS) for the support for this study. | PMC10391962 | ||
Authors’ contributions | The correspondence author has contributed in all following mentioned elements (the conception, design of the work, the acquisition, analysis interpretation of data, have drafted the work, revised it and approved the submitted version). The other authors (TN and AB) have contributed to all mentioned elements (the conception, design of the work, analysis/interpretation of data, revised it and approved the submitted version). | PMC10391962 | ||
Funding | “Not applicable”. | PMC10391962 | ||
Availability of data and materials | All data generated or analysed during this study are included in this published article. | PMC10391962 | ||
Declarations | PMC10391962 | |||
Ethics approval and consent to participate | Approval was obtained from East of Scotland Research Ethics Service (EoSRES) and Health Research Authority (REC:17/ES/0067).All methods were carried out in accordance with relevant guidelines and regulations. Informed consent was obtained from all participants for all forms of personally identifiable data including clinical, and biometric data. | PMC10391962 | ||
Consent for publication | “Not applicable”. | PMC10391962 | ||
Competing interests | The authors declare no competing interests. | PMC10391962 | ||
References | PMC10391962 | |||
Background | inflammation, infections | INFLAMMATION, INFECTIONS | Preterm children with their aberrant gut microbiota and susceptibility to infections and inflammation constitute a considerable target group for probiotic therapy to generate the age-appropriate healthy microbiota. | PMC10589095 |
Methods | 68 preterm neonates were randomized into five intervention groups: Beginning from the median age of 3 days, 13 children received | PMC10589095 | ||
Results | The gut microbiota compositions of the children directly receiving the probiotic combination (LGG + Bb12) were significantly different from those of the children receiving the other intervention modes or placebo ( | PMC10589095 | ||
Conclusion | DISEASES | The connection between aberrant primary gut microbiota and a heightened risk of infectious and non-communicable diseases invites effective microbiota modulation. We show that the direct, early, and brief probiotic intervention of LGG + Bb12 10 | PMC10589095 | |
Impact | breast milk |
Preterm children have a higher risk of several health problems partly due to their aberrant gut microbiota.More research is needed to find a safe probiotic intervention to modify the gut microbiota of preterm children. The maternal administration route via breast milk might be safer for the newborn.In our study, the early and direct administration of the probiotic combination Lactobacillus rhamnosus GG with Bifidobacterium lactis Bb-12 increased the proportion of bifidobacteria in the preterm children’s gut at the age of 7 days, but the maternal administration route was not as effective. | PMC10589095 | |
Introduction | prematurity, breast-fed | NECROTIZING ENTEROCOLITIS, SEQUELAE | The gut microbiota of healthy term vaginally delivered breast-fed children is rich in bifidobacteria.The establishment of the gut microbiota guides the maturation of key regulatory systems during the critical period of developmental plasticity.The use of specific probiotics has received considerable attention, particularly in the attempt to fight the acute sequelae of prematurity. A Cochrane meta-analysis with more than 10,000 preterm neonates determined that administering specific probiotics may prevent necrotizing enterocolitis, although they expressed the need for more studies to be carried out.Probiotics, by definition, are live microorganismsThe data on how the microbiota of a preterm child responds to probiotic intervention, directly administered to the child as compared to the administration via mother, are lacking. Consequently, we compare these modes of intervention, and secondly, seek probiotic strain combinations that give the optimal microbiota modulation for this vulnerable population. | PMC10589095 |
Methods | SEVERE BIRTH ASPHYXIA | A randomized, double-blind, placebo-controlled clinical trial recruited preterm neonates and their mothers at the Turku University Central Hospital from April 2014 to March 2018. The trial was registered in October 2011 (ClinicalTrials.gov Identifier NCT01454661). Children born during a 25–35-week gestational period, younger than 3 days of age, admitted in the Neonatal Intensive Care Unit (NICU), and those who were able to provide a faecal sample at the age of 7 days were eligible for the study. The exclusion criteria were severe birth asphyxia and significant anomalies in the gastrointestinal tract. In total, 68 mother-child pairs were accepted into this study (Fig. | PMC10589095 | |
The progress of the study. | MP | -11, DISEASE, ADVERSE EVENT, LYSIS | Initially, 65 mothers with their 79 newborn children were randomized into five intervention groups. Eventually, 68 mother-child pairs were eligible for the study. The abbreviations of the intervention groups are described in figure.The intervention strains were -Placebo: both the mother and the child received placebo-C-LGG: The mothers received placebo, the children were administered LGG.-C-LGG + Bb12: mother: placebo, child: LGG + Bb12-M-LGG: mother: LGG, child: placebo-M-LGG + Bb12: mother: LGG + Bb12, child: placeboRandom permuted block randomisation was performed by an independent statistician and the randomisation code was generated by SAS, version 9.3 for Windows. The allocation concealment was ensured using sequentially numbered containers. The University laboratory and the Hospital pharmacy held the emergency envelope to be opened in case of serious adverse event or disease in a study subject. Clinical research nurses recruited the patients and gave the intervention products in numerical order.The children received the intervention substances as probiotic capsules the contents of which were dispersed with a small amount of breastmilk and administered with their morning feed throughout their stay in the NICU. The mothers received the probiotics as capsules. The daily doses of the probiotics were 10The age of the children (days) when the administration of the intervention product was begun (median and range) by intervention group.The gut microbiota compositions of the study subjects (68 children) were assessed using faecal samples obtained 7 days after birth. The samples were stored in RNAlater solution at −80 °C. The gut microbiota compositions were assessed by analyzing the DNA isolated from faecal samples and utilizing 16S rRNA sequencing. The DNA was extracted by homogenizing 100–125 mg of faeces in the lysis buffer via bead beating with FastPrep-24 (MP Biomedicals, Irvine, CA). Then, commercial kit InviMag Stool DNA Kit (Stratec Molecular, Berlin, Germany) was used with the automated KingFisher DNA System (Thermo Fisher Scientific Oy, Vantaa, Finland). The manufacturer’s protocol was followed, and it included nucleic acid binding on magnetic beads, five-step washing, and elution. A Qubit® 2.0 Fluorometer (Life Technology, Carlsbad, CA) was used to measure the total DNA consentration. V3–V4 region of the 16S rRNA gene was amplified following the 16S rDNA gene Metagenomic Sequencing Library Preparation Illumina protocol (Cod. 15044223 Rev. A). The multiplexing was completed by using Nextera XT Index Kit (FC-131–2001). One microliter of the PCR product was run on a Bioanalyzer DNA 1000 chip to verify the size; the expected size being ca. 550 bp on a Bioanalyzer trace. The sequencing was made by utilising a 2 × 300 bp paired-end run (MiSeq Reagent Kit v3) on a MiSeq-Illumina platform following the manufacturer’s protocol. Both positive and negative sequencing controls were used to exclude contamination and batch effects. These sequencing results are available from the corresponding author as Fastq files upon reasonable request. In 16S rRNA sequencing method, the 16S rRNA gene, which codes the small subunit of procaryotic ribosome, is copied. Subsequently, these copies are grouped into coherent Amplicon Sequence Variants (ASVs) and mapped to a reference database for downstream compositional data analysis at the higher taxonomic levels. In our study, the QIIME2 (version 2019-07 and 2020-11) pipeline was used to analyze the raw sequences. Phred33-importing tool for paired-end data was used to import the data and DADA2 software package to correct Illumina-sequenced amplicon errors.CONSORT 2010 Checklist is included in the supplementary files (Supplementary File | PMC10589095 |
Statistics | The data was stored as a TreeSummarizedExperiment | PMC10589095 | ||
Results | The clinical characteristics of the study population are summarized in Table Characteristics of the children at birth by intervention group. Median with range or number with percentage. | PMC10589095 | ||
A heatmap of the gut microbiota of the preterm children receiving placebo. | breast milk | The counts of the bacterial groups have been converted into relative abundances, then CLR-transformed for the samples, and Z-transformed for the features (taxa) so that the heatmap is distributed around 0. The The effect of possible confounding factors on the gut microbiota.The R2 values that describe to what extent the gestational age, delivery mode, and sex of the child explain the variance in different bacterial taxonomic levels in the gut microbiota. In brackets, the All children received their own mothers’ breastmilk. On average, they started to receive it at the age of 1.3 days. All but one child (in group M -LGG + Bb12) received additionally donor breast milk, commonly starting on the day they were born, except for one child who was given donor milk at the age of 3 days (in group C -LGG + Bb12). Five children received formula at discharge, but this happened after the faecal samples were obtained at the age of 7 days. These were subjects from groups C -LGG, Placebo (3 children), and C -LGG + Bb12. According to the hospital guideline, all children with birth weight below 1800 g received breast milk fortifier until their weight was ca. 3500 g.The children and their mothers received antibiotics if needed according to the hospital’s protocol, which are well in line with the current clinical practice. Consequently, only 3 of 68 children (in groups C -LGG, M -LGG, and Placebo) did not receive any antibiotics during the study. The children usually received benzylpenicillin with gentamicin. The mothers of 43 children received intrapartum antibiotics, the most common reason being prophylaxis (usually benzylpenicillin or cefuroxime with or without azithromycin) due to caesarean section. The number of the children whose mothers received intrapartum antibiotics in each group were: C -LGG: 7/13 children, M -LGG + Bb12: 8/10 children, M -LGG: 10/17 children, Placebo: 8/14 children, C -LGG + Bb12: 10/14 children.The choice of the probiotic strain and the route of administration had a definite effect on the children’s gut microbiota. The gut microbiota compositions of the children directly receiving the probiotic combination (LGG + Bb12), in particular, were significantly different from those of the children receiving the other intervention modes or placebo ( | PMC10589095 | |
Discussion | breast-fed | ACUTE INFECTIONS, ADVERSE EFFECTS | In early life, the profile of the gut microbiota of a full-term, vaginally delivered, breast-fed infant is considered the gold standard.Our study has a number of limitations. The intervention groups were small because several different interventions were included. Nevertheless, our study is of importance for future research on the administration routes of probiotics as no similar studies have been carried out before. The children started to receive the supplementation at the median age of 3 days and the faecal samples were collected at the age of 7 days. The short time interval between the commencement of the intervention and sample collection may not reveal the full extent of the effect of the probiotic supplementation. Albeit, the short and early intervention was sufficient to modulate the gut microbiota of the preterm infant when administered directly but not through the mother. The adequate dosage of probiotics is not yet known.The results of this study bespeak differences in early gut microbiota in preterm and full-term children. Our results, in agreement with those of previous studies,Taken previous studies - mostly in full-term children – into account, it appears that specifically a greater number of bifidobacteria among the early gut microbiota is associated with a lower risk and shorter duration of acute infections,Specific probiotic bacteria have been shown to stabilize the gut microbial environment and the permeability barrier of the intestine, and to enhance systemic and mucosal IgA responses.No adverse effects were observed in our study even if preterm neonates were directly administered living bacteria. This observation is strengthened by previous findings of the safe prophylactic use of LGG in preterm infants over a 12-year period. | PMC10589095 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41390-023-02560-y. | PMC10589095 | ||
Acknowledgements | We warmly thank Prof. Maria Carmen Collado (Institute of Agrochemistry and Food Technology, Valencia, Spain) for the sequencing analyses of the faecal samples and Ms Satu Tölkkö (Functional Foods Forum, University of Turku, Finland) for processing these samples. | PMC10589095 | ||
Author contributions | S.R. designed the study. H.H. performed the microbiological analyses. The statistical analyses were performed by C.R. and L.L. All authors participated in analyzing and interpreting the data. The first draft of the manuscript was written by E.-N.R.; all authors contributed to writing and revising the manuscript, have seen and approved the submission of the final version of the manuscript, and take full responsibility for the manuscript. | PMC10589095 | ||
Funding | This trial was partly financed by the Finnish Foundation for Paediatric Research and The Academy of Finland, project 26081142. Open Access funding provided by University of Turku (UTU) including Turku University Central Hospital. | PMC10589095 | ||
Data availability | The datasets generated and analysed during the current study are available from the corresponding author on reasonable request. Source code for the analyses is available online [10.5281/zenodo.6674816]. | PMC10589095 | ||
Competing interests | The authors declare no competing interests. | PMC10589095 | ||
Informed consent | Written informed consent was obtained from the children’s parents. | PMC10589095 | ||
References | PMC10589095 | |||
1. Introduction | metabolic syndrome, MetS, premature death, T2DM | EVENT, SECONDARY, METABOLIC SYNDROME, TYPE 2 DIABETES, TYPE 2 DIABETES MELLITUS, METABOLIC SYNDROME, COMPLICATIONS | There is a high prevalence of metabolic syndrome (MetS) among people with type 2 diabetes mellitus (T2DM). Physical activity has the potential to improve health outcomes for individuals with type 2 diabetes. Our study aim was to determine the effect of a 12-week culturally appropriate home-based physical activity program on metabolic syndrome markers and quality of life in Ghanaian adults with T2DM. A secondary objective was to examine the feasibility of implementing the PA program. A feasibility randomised controlled trial (RCT) was conducted. A purposive sample of 87 adults with T2DM at the Korle-Bu Teaching Hospital, Ghana, were randomized into either the control group (CG) (Metabolic syndrome (MetS) is a condition closely associated with type 2 diabetes (T2DM) [Evidence suggests that about 90% of Ghanaians with T2DM have MetS [Research has identified that physical activity (PA) improves MetS, reducing a person’s risk for future cardiovascular event and premature death [Despite the purported benefits of PA, the specific component of PA needed to achieve these improvements remains unclear. Additionally, people with T2DM generally are also identified as physically inactive [Context-specific evidence of the spectrum of T2DM is needed in prioritising and designing relevant health interventions to address the challenges associated with T2DM complications [ | PMC10138586 |
2. Materials and Methods | PMC10138586 | |||
2.1. Study Design | MAY, RECRUITMENT | This study is a single-site parallel feasibility randomised controlled trial (RCT). The study design has the potential to provide information on intervention compliance, retention, adherence, recruitment, and safety [Ethics approvals were obtained in May 2022 from the Deakin University Human Research Ethics Committee (Project Number 2022-041) and Institutional Review Board of the Korle-Bu Teaching Hospital (protocol ID number: KBTH-IRB/00011/2022). The study protocol was also registered with the Australian New Zealand Clinical Trials Registry (registration number: ACTRN12622000323729p). The conduct and reporting of this trial align with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Individuals provided written consent to participate in this study.There was no a priori sample size calculation as PA programs had not been undertaken previously in Ghana. This project was guided by evidence that feasibility RCTs have a median sample size of 72 (36 per arm) [ | PMC10138586 | |
2.2. Participants | abdominal obesity, MetS, Diabetes, T2DM, Metabolic syndrome | RECRUITMENT, RECRUITMENT, METABOLIC SYNDROME, DIABETES | Between June and August 2022, 134 patients with T2DM and MetS who routinely reported to the National Diabetes Management and Research Centre (NDMRC) of the Korle-Bu Teaching Hospital (KBTH) were screened for possible recruitment into the study. A diagnosis of T2DM was confirmed by an NDMRC nurse or physician based on documentation in participant’s medical record. Metabolic syndrome was determined according to the definition of The National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III which requires the presence of any three of the following five cardiovascular risk factors: abdominal obesity, raised triglycerides, low HDL, raised BP, high FBG [Participants were included in this trial if they: (a) had a diagnosis of T2DM and met the criteria of MetS, (b) received medical clearance from their physician to take part in the PA program, (c) were sedentary (not achieving 600 metabolic equivalent of task—minutes/week, based on the International Physical Activity Questionnaire—short form (IPAQ-SF) assessment [Participants were randomly allocated using a computer-generated excel program in a 1:1 ratio to either the IG or the CG. A researcher independent to the research program, who had no relationship with participants, conducted the randomisation. Recruitment and data collection were undertaken by blinded assessors—research assistants and a biomedical scientist. Participants and physical therapists were not blinded to group allocation due to the nature of the intervention. | PMC10138586 |
2.3. Study Interventions | PMC10138586 | |||
2.3.1. Control Group (Usual Diabetes Care in Ghana) | diabetes | DIABETES | Usual diabetes care in Ghana involves routine follow-up visits to the diabetes clinic. Depending on the patient’s glycaemic control, this visit may occur every 1 to 6 months. During these visits, the patient undergoes routine medical assessment (e.g., weight, BP, urine analysis, and blood tests such as Hb1Ac, FBG, and lipid profile). Patients may also be referred for dietary management, and eye or foot care. Nurses also deliver a 30–45-min group education session to all clients of the clinic on self-care practices including exercise, medication adherence, dietary modification, foot care, and the need for follow-up visits. There is no structured PA program as part of the usual diabetes care. However, group exercise advice is delivered by general nurses to patients during clinic wait times. | PMC10138586 |
2.3.2. Intervention Group (PA Program) | diabetes | DIABETES | Participants engaged in a structured 12-week PA program in addition to their usual diabetes care. In total, participants engaged in 36 exercise sessions, involving three sessions per week with no more than two days without exercise. With each session lasting 45 min, participants performed three minutes of stretching exercise, 10 min of resistance training using a resistance band, 30 min of walking (brisk pace, 5.2–5.6 km/h), and 2 min of cool-down exercises. Participants attended a weekly individual session at the physiotherapy department of the KBTH, under the supervision of a physical therapist (PT). All other sessions were self-delivered at home. Participants attended a 45-min group exercise education session prior to exercise sessions. The PT gave advice on the PA program, including its importance in controlling diabetes. Participants maintained an exercise diary and a PT followed individuals on a weekly basis to encourage and document exercise participation. All participants in the IG received a brochure, a resistance band, and videos that displayed the prescribed exercise. | PMC10138586 |
2.4. Outcome Measures | TG, pain | ADVERSE EVENTS, SECONDARY, BLOOD, PATHOLOGY, CREST | The primary outcome measure was a change in MetS markers (BP, TG, WC, FBG, and HDL) in the IG, compared to those in the CG. Secondary outcomes included: (1) a change in QoL in the IG, compared to the CG; and (2) feasibility of implementing the PA program determined by measures of participation and safety. Except for measures of participation and safety which were assessed each week, the primary and other secondary outcomes were assessed at baseline and 12-week follow-up.A demographic data questionnaire was used to collect personal information including age, sex, and marital, educational and employment status. For pathology measures, participants fasted for 8 h overnight, and a blood sample (5 mL) was collected by a biomedical scientist for the following measures: TG, HDL, and FBG. Waist circumstance was measured by one nurse, independent of the research team, measuring the mid-point between the lower costal margin and iliac crest. Blood pressure measurement was taken after the individual had rested for 10 min, in a seated position. Three consecutive readings with 5-min intervals were collected using a calibrated sphygmomanometer, and the average of the last two readings were used for analysis.Guided by the formula by Johnson et al. [Quality of life was assessed using the Short Form Health Survey—version 2 (SF-12V2). The 12-item tool was used to measure eight specific health domains: physical functioning, role limitation related to physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The items on the scale were scored from 0 to 100, where 100 indicates high quality of life [Measures of participation were assessed using the exercise diary, by recording the proportion of exercise sessions that participants completed. The exercise diary was developed by the authors, and its face validity was verified by the research team which included an endocrinologist, nurse, and PT. The diary was used to document the type, length, intensity, and frequency of exercise performed by participants each week. During the weekly visit to the physiotherapy department at KBTH, the PT asked participants about the exercise they performed during the week. A participation rate of more than 70% of the scheduled sessions (36 in total) was considered as high participation. Reasons for missing a session were also documented. Measures of safety were determined by participants’ subjective reports of any adverse events from the exercise sessions. | PMC10138586 |
2.5. Data Analysis | Data were analysed using STATA (version 17). Continuous data are reported as means +/− SD and categorical data are reported using frequencies and percentages. Baseline comparisons between the control group and the intervention group were analysed using two sample t-tests or chi-squared tests for continuous and categorical variables, respectively. A Fisher’s exact test was used if there were small samples (i.e., frequencies less than 5). To compare the groups in this study, statistical analyses were performed with linear mixed models. Linear mixed models were used because in all methods, an adjustment should be made for the dependency of the repeated observations within the individual (i.e., at baseline and at follow-up). The effect size was calculated using Cohen’s d, which is the follow-up mean minus the baseline mean, divided by the pooled standard deviation. In all instances, a | PMC10138586 | ||
3. Results | PMC10138586 | |||
3.1. Sample Characteristics | ±, T2DM | RECRUITMENT | A total of 87 out of 134 patients screened for eligibility were included in the study, indicating a recruitment rate of 64.9%. Reasons for exclusion included poor ECG results (Forty-four patients were randomly allocated to the IG (mean age 56.2 ± 8.3 years) and 43 were assigned to the CG (mean age 56.5 ± 8.5 years). More females participated in the study (65.5%). On average, patients had been diagnosed with T2DM for 6.1 ± 2.7 years. Most participants were taking oral glycaemic agents (89.40%); an additional 11.4% participants were prescribed insulin. All participants met the diagnostic criteria for MetS. There were no significant differences between the two groups for baseline characteristics, as shown in | PMC10138586 |
3.2. Physical Activity Program Participation | Thirty-two (72.7%) participants in the IG completed the 12-week program (all 36 sessions at home and facility) and the remaining eleven (25%) participants completed 80% of the exercise sessions. The average number of sessions completed was 29 ± 5.4 (mean ± SD) out of 36 sessions. This indicates high feasibility. Reasons for missing sessions included high work demands, social commitments, not feeling well, and long travel hours for the weekly facility exercise sessions.Eight participants (IG = 1, CG = 7) did not complete the program. One participant from the IG withdrew from the study due to hospital admission for medical reasons not related to the PA program. Seven participants in the CG were lost to follow-up due to: travel away from home ( | PMC10138586 | ||
3.3. Effect of Physical Activity on Metabolic Syndrome Markers | Following the 12-week PA program, participants in the IG had significant improvement (Correlation analyses showed no significant difference between groups for oral glycaemic medication use and insulin use ( | PMC10138586 | ||
3.4. Effect of Physical Activity on Quality of Life | Comparing the IG to the CG, our results show that QoL generally improved in some dimensions of the SF-12, in favour of the IG, as shown in | PMC10138586 | ||
4. Discussion | MetS, T2DM, diabetes | ADVERSE EVENTS, PATHOLOGY, RECRUITMENT, DIABETES | The findings of this study show that the culturally appropriate 12-week PA program designed specifically for Ghanaian adults with T2DM improved three MetS markers (FBG, SBP, and WC). This is likely to have contributed to the reclassification of 48.8% of participants in the IG as no longer having MetS after completion of the PA program. Further, there was high engagement in the program. Except for one participant who dropped out of the program, all participants in the IG completed at least 80% of the exercise sessions, with no exercise-related adverse events recorded during the study period.The exercise program trialled in this study involved a combination of aerobic and resistance exercises, with our study results showing a positive impact on MetS severity score among the IG compared to the CG. This finding is consistent with guidelines from the American College of Sports Medicine, suggesting that combined exercise in people with T2DM produced more beneficial outcome compared to aerobics or resistance exercise alone [The overall improvement in MetS severity score following exercise intervention cannot be overemphasised. It is recommended that studies investigating the role of exercise in reducing MetS markers should highlight whether participants still meet the MetS criteria after receiving an intervention [Wewege et al. [Our analysis of changes in QoL following the PA intervention program revealed significant improvement in two dimensions: physical function and vitality. Few studies have examined the effect of PA on QoL in adults with T2DM, and there has been inconsistency in their findings. Using SF-36 to examine the impact of resistance training on the mental health status of Puerto Rico adults with T2DM, Lincoln et al. [Our study had a high participation rate. Previous studies in Ghana have reported low PA participation (21.4%) among the Ghanaian population living with T2DM [A major strength of this study is that there were no significant differences between the two groups at baseline. Moreover, participants received weekly follow-up with a PT. In the first week, all exercise sessions were supervised by a PT at the physiotherapy department to ensure that exercises were performed correctly and within safety limits. Furthermore, the study was conducted in the largest diabetes clinic in Ghana, where patients are from diverse socio-economic and cultural backgrounds.A limitation of this study is the subjective report of participants’ weekly PA, which could possibly lead to under or over reporting. There is some evidence of a fair agreement between self-reported and objectively measured PA, despite evidence that about 59% of patients over-report their PA levels [People who volunteer in PA programs may have high self-motivation; therefore, this might have accounted for the high participation rate. A plausible reason for the successful recruitment and retention of participants may also be related to the tests performed as part of enrolment in this study. (e.g., pathology tests, ECG). The costs for these tests were covered by the funds available for this research, which is self-funded. These expenses pose a financial burden for patients, hence may have contributed to their decision to participate. Lastly, the sample size was small, and it was a single-site study. However, a feasibility study was conducted within the constraints of limited funding and PhD timelines. | PMC10138586 |
5. Conclusions | MetS, T2DM, diabetes | DIABETES | Overall, our findings suggest that the PA program implemented in this study has the potential to improve MetS and QoL in Ghanaian adults with T2DM. Further, the PA program was feasible and safe. With a signification proportion of Ghanaians with T2DM resorting to alternative diabetes treatment, coupled with barriers to diabetes self-care, HCPs in Ghana have a responsibility to promote positive lifestyle behaviours. Further multi-centre studies involving a larger sample size are warranted. | PMC10138586 |
Author Contributions | Conceptualization, M.A.; methodology, M.A., D.K., Y.A., M.M.S. and A.D.; software, M.A. and M.M.S.; validation, M.A., D.K., Y.A. and A.D.; formal analysis, M.A., D.K. and A.D.; investigation, M.A., Y.A. and M.M.S.; resources, M.A., D.K., Y.A., M.M.S. and A.D.; data curation, M.A. and M.M.S.; writing—original draft preparation, M.A.; writing—review and editing, M.A., D.K., Y.A., M.M.S. and A.D.; visualization, M.A., D.K., Y.A., M.M.S. and A.D.; supervision, D.K., Y.A. and A.D.; project administration, M.A., D.K., Y.A., M.M.S. and A.D. All authors have read and agreed to the published version of the manuscript. | PMC10138586 | ||
Institutional Review Board Statement | MAY | The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Korle-Bu Teaching Hospital (protocol code KBTH-IRB/00011/2022; date of approval 24 May 2022) and the Deakin University Human Research Ethics Committee (protocol code 2022-041; date of approval 13 May 2022). The study protocol was also registered with the Australian New Zealand Clinical Trials Registry (registration number: ACTRN12622000323729p, date of approval 21 February 2022). | PMC10138586 | |
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10138586 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC10138586 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10138586 | ||
Objective: | To evaluate the impact of a menu box delivery service tailored to the long-day care (LDC) setting on improving menu compliance with recommendations, children’s diet quality and dietary intake while in care. | PMC10755420 | ||
Design: | A cluster randomised controlled trial in LDC centres randomly assigned to an intervention (menu box delivery) or comparison (menu planning training) group. The primary outcome was child food provision and dietary intake. Secondary outcomes include menu compliance and process evaluation, including acceptability, fidelity and menu cost (per child, per day). | PMC10755420 | ||
Setting: | South Australian LDC centres. | PMC10755420 | ||
Participants: | Eight LDC centres ( | PMC10755420 | ||
Results: | No differences were observed in serves/d between intervention and comparison centres, for provision (intervention, 0·9 inter-quartile range (IQR) 0·7–1·2; comparison, 0·8 IQR 0·5–1·3) or consumption (intervention, 0·5 IQR 0·2–0·8; comparison, 0·5 IQR 0·3–0·9) of vegetables. Child food provision and dietary intake were similar across both groups for all food groups ( | PMC10755420 | ||
Conclusions: | Menu compliance can be improved via a menu delivery service, delivering equivalent impacts on child food provision and dietary intake compared with an online training programme. Further exploration of cooks acceptability and cost is essential before scaling up to implementation. | PMC10755420 | ||
Keywords | chronic disease | DISEASE, SECONDARY, CHRONIC DISEASE | A nutritious diet supports health, growth and development. Diet is a modifiable risk factor for chronic disease and can prevent the burden of disease later in life. Early intervention is key to developing healthy habits, especially as behaviours developed in childhood often carry through to adolescence and adulthoodIn Australia, over half of children under 5 years old attend ECEC servicesWithin Australian LDC centres that provide meals onsite, centre cooks are typically responsible for menu planning, food purchasing and food preparation. While centre cooks are not required to undertake formal nutrition training, they are expected to provide a healthy, nutritious menu to children in careAnalysis of childcare menus both in Australia and internationally shows that centres typically do not meet menu guidelines, particularly for vegetablesMeal kit subscription services have been growing in popularity across many countries including Australia and the United States of AmericaTherefore, the aim of this study was to evaluate the impact of a meal kit-style intervention tailored to the LDC setting, compared with standard practice, on child food provision and dietary intake of the five food groups (vegetables and legumes; fruit; cereals and breads; dairy and alternatives; meat and alternatives) for preschool children, particularly vegetables, while in LDC. The secondary aim of this study was to evaluate the impact of the intervention on menu compliance with menu planning guidelines. Centre cook, director acceptability and cost were also assessed. | PMC10755420 |
Methods | PMC10755420 | |||
Study design | A cluster randomised controlled trial design in South Australian LDC centres. Centres were randomly allocated to one of two study groups over the 12-week study period. Intervention centres received a weekly menu box delivery service to provide a predetermined menu compliant with the Victorian Menu Planning Guidelines, designed by dietitians experienced in the LDC setting for the purpose of the present studyComparison centres were asked to utilise an online menu assessment tool and an online cook training tool to support cooks to develop and deliver a menu that was compliant with the Victorian Menu Planning Guidelines reflective of recommended practice in LDC | PMC10755420 | ||
Study participants | Study participants are reported in detail in the published protocol paper | PMC10755420 | ||
Recruitment | As detailed in the protocol paper, eligible centres were recruited in partnership with a local childcare service provider and stratified by socio-economic status | PMC10755420 |
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