Background Lateral flow device (LFD) viral antigen immunoassays have been developed around the world as diagnostic tests for SARS-CoV-2 infection. They have been proposed to deliver an infrastructure-light, cost-economical solution giving results within half an hour. Methods LFDs were initially reviewed by a Department of Health and Social Care team, part of the UK government, from which 64 were selected for further evaluation from 1st August to 15th December 2020. Standardised laboratory evaluations, and for those that met the published criteria, field testing in the Falcon-C19 research study and UK pilots were performed (UK COVID-19 testing centres, hospital, schools, armed forces). Findings 4/64 LFDs so far have desirable performance characteristics (orient Gene, Deepblue, Abbott and Innova SARS-CoV-2 Antigen Rapid Qualitative Test). All these LFDs have a viral antigen detection of >90% at 100,000 RNA copies/ml. 8951 Innova LFD tests were performed with a kit failure rate of 5.6% (502/8951, 95% CI: 5.1–6.1), false positive rate of 0.32% (22/6954, 95% CI: 0.20–0.48). Viral antigen detection/sensitivity across the sampling cohort when performed by laboratory scientists was 78.8% (156/198, 95% CI 72.4–84.3). Interpretation Our results suggest LFDs have promising performance characteristics for mass population testing and can be used to identify infectious positive individuals. The Innova LFD shows good viral antigen detection/sensitivity with excellent specificity, although kit failure rates and the impact of training are potential issues. These results support the expanded evaluation of LFDs, and assessment of greater access to testing on COVID-19 transmission. Funding Department of Health and Social Care. University of Oxford. Public Health England Porton Down, Manchester University NHS Foundation Trust, National Institute of Health Research.

BackgroundRapid weight gain during the first three years of life predicts child and adult obesity, and also later cardiovascular and other morbidities. Cross-sectional studies suggest that infant diet, activity and sleep are linked to excessive weight gain. As intervention for overweight children is difficult, the aim of the Prevention of Overweight in Infancy (POI.nz) study is to evaluate two primary prevention strategies during late pregnancy and early childhood that could be delivered separately or together as part of normal health care.Methods/DesignThis four-arm randomised controlled trial is being conducted with 800 families recruited at booking in the only maternity unit in the city of Dunedin, New Zealand. Mothers are randomised during pregnancy to either a usual care group (7 core contacts with a provider of government funded "Well Child" care over 2 years) or to one of three intervention groups given education and support in addition to "Well Child" care: the Food, Activity and Breastfeeding group which receives 8 extra parent contacts over the first 2 years of life; the Sleep group which receives at least 3 extra parent contacts over the first 6 months of life with a focus on prevention of sleep problems and then active intervention if there is a sleep problem from 6 months to 2 years; or the Combination group which receives all extra contacts. The main outcome measures are conditional weight velocity (0-6, 6-12, 12-24 months) and body mass index z-score at 24 months, with secondary outcomes including sleep and physical activity (parent report, accelerometry), duration of breastfeeding, timing of introduction of solids, diet quality, and measures of family function and wellbeing (parental depression, child mindedness, discipline practices, family quality of life and health care use). This study will contribute to a prospective meta-analysis of early life obesity prevention studies in Australasia.DiscussionInfancy is likely to be the most effective time to establish patterns of behaviour around food, activity and sleep that promote healthy child and adult weight. The POI.nz study will determine the extent to which sleep, food and activity interventions in infancy prevent the development of overweight.Trial RegistrationClinical Trials NCT00892983Prospective meta-analysis registered on PROSPERO CRD420111188. Available from http://www.crd.york.ac.uk/PROSPERO

A conventional intervention had unexpected adverse long-term weight outcomes, whereas positive outcomes from a less conventional sleep intervention remained promising at age 5 y. More intensive or extended sleep intervention might have larger or longer-lasting effects and should be investigated. This trial was registered at clinicaltrials.gov as NCT00892983.

ObjectiveTo evaluate the effectiveness of sleep education delivered antenatally and at 3 weeks postpartum to prevent infant sleep problems at 6 months of age.DesignSleep intervention within a randomised controlled trial for the Prevention of Overweight in Infancy (POI) study.Participants802 families were randomly allocated to one of four groups: usual care (control), sleep intervention (sleep), food, activity and breastfeeding intervention (FAB), and combined group receiving both interventions (combination).InterventionsAll groups received standard Well Child care. The sleep intervention groups (sleep and combination) received an antenatal group education session (all mothers and most partners) emphasising infant self-settling and safe sleeping, and a home visit at 3 weeks reinforcing the antenatal sleep education. FAB and combination groups received four contacts providing education and support on breast feeding, food and activity up to 4 months postpartum.Outcome measuresHere we report secondary sleep outcomes from the POI study: the prevalence of parent-reported infant sleep problems and night waking, and differences in sleep duration. Additional outcomes reported include differences in infant self-settling, safe sleep practices, and maternal and partner reports of their own sleep, fatigue and depression symptoms.ResultsLinear or mixed linear regression models found no significant intervention effects on sleep outcomes, with 19.1% of mothers and 16.6% of partners reporting their infant’s sleep a problem at 6 months. Actigraphy estimated the number of night wakings to be significantly reduced (8%) and the duration of daytime sleep increased (6 min) in those groups receiving the sleep intervention compared with those who did not. However, these small differences were not clinically significant and not observed in 24 hours infant sleep diary data. No other differences were observed.ConclusionA strategy delivering infant sleep education antenatally and at 3 weeks postpartum was not effective in preventing the development of parent-reported infant sleep problems.

The few existing early-life obesity prevention initiatives have concentrated on nutrition and physical activity, with little examination of sleep. METHODS:This community-based, randomized controlled trial allocated 802 pregnant women (≥16 years, <34 weeks' gestation) to: control, FAB (food, activity, and breastfeeding), sleep, or combination (both interventions) groups. All groups received standard well-child care. FAB participants received additional support (8 contacts) promoting breastfeeding, healthy eating, and physical activity (antenatal-18 months). Sleep participants received 2 sessions (antenatal, 3 weeks) targeting prevention of sleep problems, as well as a sleep treatment program if requested (6-24 months). Combination participants received both interventions (9 contacts). BMI was measured at 24 months by researchers blinded to group allocation, and secondary outcomes (diet, physical activity, sleep) were assessed by using a questionnaire or accelerometry at multiple time points. RESULTS:At 2 years, 686 women remained in the study (86%). No significant intervention effect was observed for BMI at 24 months (P = .086), but there was an overall group effect for the prevalence of obesity (P = .027). Exploratory analyses found a protective effect for obesity among those receiving the "sleep intervention" (sleep and combination compared with FAB and control: odds ratio, 0.54 [95% confidence interval, 0.35-0.82]). No effect was observed for the "FAB intervention" (FAB and combination compared with sleep and control: odds ratio, 1.20 [95% confidence interval, 0.80-1.81]). CONCLUSIONS:A well-developed food and activity intervention did not seem to affect children's weight status. However, further research on more intensive or longer running sleep interventions is warranted. Departments of a the Dean, Dunedin School of Medicine, b Preventive and Social Medicine, c Women's and Children's Health, d Human Nutrition, and e Medicine, University of Otago, Dunedin, New ZealandProf B Taylor is the co-principal investigator of the Prevention of Overweight in Infancy (POI) study, contributed to study design, co-led the sleep intervention, co-wrote the manuscript, and directed the statistical analyses; Mr Gray contributed to study design, designed and completed all statistical analyses, and wrote the relevant sections of the manuscript; Dr Galland contributed to study design, co-led the sleep intervention, and reviewed and revised the manuscript; Dr Heath contributed to study design, co-led the FAB (food, activity, and breastfeeding) intervention, and reviewed and revised the manuscript; Dr Lawrence contributed to study design, coordinated and led the management of the study, and reviewed and revised the manuscript; Ms Sayers delivered the sleep intervention, and reviewed and revised the manuscript; Drs Cameron, Hanna, and Dale contributed to data collection, and reviewed and revised the manuscript; Dr Coppell contributed to study design, and reviewed and revised the manuscript; and Prof R Taylor is the co-principal inves...