To describe the feasibility, acceptability and results of Strong Families Start at Home, a 6-month pilot trial of a home-based food parenting/nutrition intervention.

Pilot randomised controlled trial.

Participants received six visits with a community health worker trained in motivational interviewing (three home visits, three phone calls); an in-home cooking or reading activity; personalised feedback on a recorded family meal or reading activity; text messages and tailored printed materials.

Parents and their 2–5-year-old child were randomised into intervention (responsive food parenting practices/nutrition) or control (reading readiness) groups.

Parents (n 63) were mostly mothers (90 %), Hispanic/Latinx (87 %), born outside the USA (62 %), with household incomes <$25 k (54 %). Despite delivery during COVID-19, 63 % of dyads were retained at 6 months. The intervention was delivered with high fidelity. All parents in the intervention group (n 24) expressed high levels of satisfaction with the intervention, which produced positive treatment effects for whole and total fruit component Healthy Eating Index-2015 scores (point estimate (PE) = 2·14, 95 % CI (0·17, 1·48); PE = 1·71, 95 % CI (0·16, 1·47), respectively) and negative treatment effects for sodium (PE = -2·09, 95 % CI (−1·35, −0·04)). Positive treatment effects also resulted for the following food parenting practices: regular timing of meals and snacks (PE = 1·08, 95 % CI (0·61, 2·00)), reducing distractions during mealtimes (PE = -0·79, 95 % CI (−1·52, −0·19)), using food as a reward (PE = -0·54, 95 % CI (−1·35, −0·04)) and providing a supportive meal environment (PE = 0·73, 95 % CI (0·18, 1·51)).

Given the continued disparities in diet quality among low-income and diverse families, continued efforts to improve child diet quality in fully powered intervention trials are needed.

Aggression is a transdiagnostic indicator of risk and represents one of the most common reasons children are referred for mental health treatment. Theory and research highlight the impact of maternal invalidation on child aggression and suggest that its influence may vary based on differences in child physiological reactivity. Moreover, the interaction between these risk factors may be particularly pronounced among children of mothers with emotion regulation (ER) difficulties. The current study examined the independent and interactive effects of maternal invalidation and child physiological reactivity to frustration on teacher-reported aggression in an at-risk sample of preschool children.

Participants included 77 mothers (Mage = 33.17 years, s.d. = 4.83; 35% racial/ethnic minority) and their children (Mage = 42.48 months; s.d. = 3.78; 56% female; 47% racial/ethnic minority). Groups of mothers with and without clinician-rated ER difficulties reported on maternal invalidation, and child respiratory sinus arrhythmia (RSA) was assessed continuously during a frustration task as an indicator of physiological reactivity. Teachers or daycare providers reported on child aggression.

Results demonstrated positive associations between maternal ER difficulties and both maternal invalidation and child RSA reactivity to frustration. As expected, the interaction between maternal invalidation and child RSA reactivity was significant, such that higher maternal invalidation and greater child RSA reactivity to frustration predicted more aggression in a daycare or preschool setting. Importantly, this effect was demonstrated while controlling for demographic covariates and baseline RSA.

Findings are in line with diathesis–stress and biosocial models of risk and point to multiple targets for prevention and early intervention.

Randomized controlled trials (RCTs) are typically considered the gold standard source of clinical evidence for reimbursement submissions, but they can often be resource-intensive, expensive, and may not always be appropriate. For example, it may be unethical to assign patients to an untreated or undiagnosed control group, or blinding may not be feasible when assessing medical devices. Evidence for medical devices is therefore often limited to nonrandomized studies. We explored the use and value of real-world evidence (RWE) in the reimbursement of medical devices across several health technology assessment (HTA) agencies.

A narrative review was completed to compare the acceptability of RWE for the HTA evaluation of medical devices across a convenience sample of countries. English-language published guidance documents were reviewed, and study design preferences extracted.

In Australia, France, Germany, Ireland, Norway, and Scotland, HTA agencies prefer RCT evidence but accept RWE as supporting data. In England, there is no preferred study design, with directly observed clinical outcomes, evidence syntheses, nonclinical, and modelling studies accepted. Notably, methods and processes for HTA programs are being reviewed and are expected to place a greater emphasis on RWE. In Australia, pseudo-randomized trials, comparative cohort studies, case series, and other study designs are permitted. In France, nonrandomized or nonblinded trials, patient preference cohorts, prospective comparative observational studies, and propensity score matched cohorts are permitted, accompanied by justification. In Scotland, lived experiences, RWE, and systematic reviews are accepted. In Germany, nonrandomized studies are deemed to provide “minimum”, “very low” or “low” certainty of results. In Norway, RWE may be accepted if no RCT data are available, or to support RCTs.

In the assessment of medical devices, where RCTs are unsuitable, RWE can form a feasible alternative. Real-world evidence is increasingly being recognized as a valuable source of evidence for medical interventions and is accepted by a number of HTA agencies. No funding was received for this study.

Individual variability in tonic (resting) and phasic (reactivity) respiratory sinus arrhythmia (RSA) may underlie risk for dysregulated emotion and behavior, two transdiagnostic indicators that permeate most psychological disorders in youth. The interaction between tonic and phasic RSA may specify unique physiological profiles during the transition to adolescence. The current study utilized clinically referred youth (Mage = 12.03; s.d. = 0.92) to examine baseline RSA, RSA reactivity, and their interaction as predictors of dysregulated emotion and behavior in daily life.

Participants were 162 youth (47% female; 60% minority) in psychiatric treatment for any mood or behavior problem. RSA was assessed during three, 2-minute baselines and an 8-minute parent-child conflict discussion task. Dysregulated emotion and behavior were assessed during a 4-day ecological momentary assessment protocol that included 10 time-based prompts over a long weekend.

Greater RSA withdrawal to the conflict was associated with dysregulated basic emotion (sadness, anger, nervousness, stress) in daily life. Two distinct interactions also emerged, such that baseline RSA was related to dysregulated complex emotion (shame, guilt, loneliness, emptiness) and dysregulated behavior as a function of RSA reactivity to conflict. Lower baseline RSA and greater RSA withdrawal were associated with dysregulated complex emotion, while higher baseline RSA and greater RSA withdrawal were associated with dysregulated behavior.

Findings point to physiological profiles that increase the risk of dysregulated emotion and behavior during the transition to adolescence. Excessive RSA withdrawal uniquely, and in combination with baseline RSA, increased risk for dysregulation in daily life, underscoring the role of autonomic stress responding as a risk factor for psychopathology.

Population-based colorectal cancer (CRC) screening programs that use a fecal immunochemical test (FIT) are often faced with a noncompliance issue and its subsequent waiting time (WT) for those FIT positives complying with confirmatory diagnosis. We aimed to identify factors associated with both of the correlated problems in the same model.

A total of 294,469 subjects, either with positive FIT test results or having a family history, collected from 2004 to 2013 were enrolled for analysis. We applied a hurdle Poisson regression model to accommodate the hurdle of compliance and also its related WT for undergoing colonoscopy while assessing factors responsible for the mixture of the two outcomes.

The effect on compliance and WT varied with contextual factors, such as geographic areas, type of screening units, and level of urbanization. The hurdle score, representing the risk score in association with noncompliance, and the WT score, reflecting the rate of taking colonoscopy, were used to classify subjects into each of three groups representing the degree of compliance and the level of health awareness.

Our model was not only successfully applied to evaluating factors associated with the compliance and the WT distribution, but also developed into a useful assessment model for stratifying the risk and predicting whether and when screenees comply with the procedure of receiving confirmatory diagnosis given contextual factors and individual characteristics.

Cerebrovascular reactivity monitoring has been used to identify the lower limit of pressure autoregulation in adult patients with brain injury. We hypothesise that impaired cerebrovascular reactivity and time spent below the lower limit of autoregulation during cardiopulmonary bypass will result in hypoperfusion injuries to the brain detectable by elevation in serum glial fibrillary acidic protein level.

We designed a multicentre observational pilot study combining concurrent cerebrovascular reactivity and biomarker monitoring during cardiopulmonary bypass. All children undergoing bypass for CHD were eligible. Autoregulation was monitored with the haemoglobin volume index, a moving correlation coefficient between the mean arterial blood pressure and the near-infrared spectroscopy-based trend of cerebral blood volume. Both haemoglobin volume index and glial fibrillary acidic protein data were analysed by phases of bypass. Each patient’s autoregulation curve was analysed to identify the lower limit of autoregulation and optimal arterial blood pressure.

A total of 57 children had autoregulation and biomarker data for all phases of bypass. The mean baseline haemoglobin volume index was 0.084. Haemoglobin volume index increased with lowering of pressure with 82% demonstrating a lower limit of autoregulation (41±9 mmHg), whereas 100% demonstrated optimal blood pressure (48±11 mmHg). There was a significant association between an individual’s peak autoregulation and biomarker values (p=0.01).

Individual, dynamic non-invasive cerebrovascular reactivity monitoring demonstrated transient periods of impairment related to possible silent brain injury. The association between an impaired autoregulation burden and elevation in the serum brain biomarker may identify brain perfusion risk that could result in injury.

To examine the differences in dietary intakes of children consuming school meals and packed lunches, the contribution of lunchtime intake to overall dietary intake, and how lunchtime intake relates to current food-based recommendations for school meals.

Cross-sectional analysis of overall intake of macronutrients and food choice from 4 d food diaries and school lunchtime intake from the two diary days completed while at school.

Norfolk, UK.

One thousand six hundred and twenty-six children (aged 9–10 years) attending ninety Norfolk primary schools.

At school, lunchtime school meal eaters consumed more vegetables, sweet snacks, chips, starchy foods and milk, and less squash/cordial, fruit, bread, confectionery and savoury snacks than packed lunch eaters. These differences were also reflected in the overall diet. On average school meal eaters met the School Food Trust (SFT) food-based standards, while food choices among packed lunch eaters were less healthy. The contribution of food consumed at school lunchtime to overall diet varied by food and lunch type, ranging from 0·8 % (milk intake in packed lunches) to 74·4 % (savoury snack intake in packed lunches).

There were significant differences in the foods consumed by school meal and packed lunch eaters, with food choices among school meal eaters generally in line with SFT standards. The food choices made at school lunchtime make a significant contribution to overall diet.

To examine the association between breakfast consumption and physical activity in a well-characterised sample of English children.

Cross-sectional study using food diaries to record breakfast consumption and accelerometry to assess physical activity.

Norfolk county, England.

Children (n 1697) aged 9–10 years from the SPEEDY (Sport, Physical Activity and Eating behaviour: Environmental Determinants in Young people) study.

Boys who consumed a poor-quality breakfast based on dairy product, cereal and fruit intakes spent approximately 7 min more time in moderate-to-vigorous physical activity (MVPA) during weekday afternoons and evenings compared with those who did not consume breakfast (P < 0·05). On weekend days, boys who consumed a poor- or good-quality breakfast spent approximately 6 and 5 min less time respectively being sedentary during the mornings compared with breakfast non-consumers (P < 0·05). Boys who consumed a good-quality breakfast spent almost 3 min more in MVPA during the morning on weekend days compared with non-consumers, and boys who consumed a poor- or good-quality breakfast were 22 % and 16 % more active overall respectively than breakfast non-consumers (P < 0·05). During the rest of the day, boys who consumed a good-quality breakfast spent about 11 min less time being sedentary (P < 0·05) and 7 min more time in MVPA (P < 0·01).

Although some associations between breakfast consumption and physical activity were detected for boys, the present study does not provide strong evidence that failing to consume breakfast, or having a low energy intake at breakfast time, is detrimental to children's physical activity levels.