Is it feasible to nest a Trial within a Cohort Study (TwiCS) to evaluate an early years parenting programme? A Born in Bradford's Better Start study protocol.

BACKGROUND: Evaluating the effectiveness of early years parenting interventions provides evidence to improve the development and wellbeing of children. This protocol paper describes a study to explore the feasibility of evaluating the Incredible Years Toddler early life intervention programme, which is offered to parents of 1-3-year-olds via the Better Start Bradford programme. The study aims to use a Trial within a Cohort Study (TwiCS) design that randomly selects individuals participating in a cohort to be offered an intervention. The TwiCS information and consent process is person-centred and aims to replicate real-world practice whereby only those who are offered the intervention are given information about the intervention. The cohort is the Born in Bradford's Better Start (BiBBS) cohort, an interventional birth cohort recruiting expectant parents in three areas of Bradford, UK. The study will assess the feasibility of TwiCS procedures, staged consent, and intervention take-up. METHODS: We will conduct a feasibility TwiCS to test study procedures. We aim to establish the following: (1) whether TwiCS methodology can be implemented to create control and intervention arms, whilst documenting any incidences of contamination within the cohort; (2) whether satisfactory rates of intervention uptake are achieved among participants allocated to the intervention; and (3) whether satisfactory rates of retention of participants in the intervention can be achieved. A Red Amber Green (RAG) rating system has been applied to support the feasibility assessment of each objective: to be rated red (not achieved), amber (partly achieved), and green (achieved). Eligible participants in the BiBBS cohort will be individually randomised 1:1 to the intervention or control arms, with stratification by child age (1 or 2 years old at the time of randomisation) and ethnicity (White British, South Asian, or other). BiBBS researchers will seek consent from participants randomised to the intervention to pass their contact details onto Incredible Years' delivery agents. DISCUSSION: This feasibility study will inform the utility of the TwiCs approach within an experimental birth cohort to evaluate interventions for infants, toddlers, and their families. TRIAL REGISTRATION: The study was prospectively registered on ISRCTN (ISRCTN16150114).

A quasi-experimental effectiveness evaluation of the 'Incredible Years Toddler' parenting programme on children's development aged 5: A study protocol.

Child behavioural and mental health problems have become a public health crisis. The consequences of poor mental health in childhood have large economic costs and consequences for the individual, their families, and for society. Early intervention through parenting programmes can reduce the onset of poor mental health in childhood, hence evaluating the effectiveness of parenting programmes is critical. The 'Incredible Years Toddler' parent programme is an education and training intervention designed to enhance the social and emotional wellbeing of children aged 1-3 years. Whilst previous studies show Incredible Years Toddler to provide promising effects on child outcomes in the short term, the research samples have lacked ethnic diversity and representation from socioeconomically deprived families. This quasi-experimental study is registered on ISRCTN (ISRCTN49991769). We will investigate the effectiveness of Incredible Years Toddler being delivered in three neighbourhoods in inner city Bradford, England. These neighbourhoods contain a socially and ethnically diverse population with 84% living in the poorest decile for England and Wales. Parents with a child aged 1-3 years old who are enrolled in Born in Bradford's Better Start interventional family cohort study are eligible for this study. Intervention participants will be matched to a demographically comparable control group using propensity score matching. This study will use retrospective and prospective data from participants who attended Incredible Years groups between September 2018 and April 2024. The required minimum sample is n = 1336 (ratio 1:3) to detect a small effect (odds = 1.5, d = .20) on the Early Years Foundation Stage profile total score at age 5; a measure of early child development that is routinely collected by teachers. We will also establish whether these effects are moderated by child age at entry to intervention, programme delivery mode, socioeconomic status, and ethnicity. We will also estimate the cost of the intervention and conduct a cost-consequence analysis.

Protocol for the effectiveness evaluation of an antenatal, universally offered, and remotely delivered parenting programme 'Baby Steps' on maternal outcomes: a Born in Bradford's Better Start (BiBBS) study.

BACKGROUND: Poor perinatal mental health and maternal sensitivity towards a child in the early years can carry a long-term cost to individuals and to society, and result in negative child outcomes such as poor mental health and social emotional issues. Despite the recognition of early intervention and prevention, there is mixed evidence regarding antenatal parenting interventions that aim to enhance perinatal mental health and maternal sensitivity to prevent negative child outcomes. 'Baby Steps' is a relationship-based antenatal and postnatal parenting programme. The service evaluated in this study is delivered in a low-income and ethnically diverse community via Better Start Bradford. This study aims to assess whether the universally, and remotely delivered Baby Steps programme is effective in improving postnatal maternal sensitivity (primary outcome) and postnatal maternal mental health (secondary outcome) when compared to services as usual 6-10 weeks post-birth. It will also assess differences in birth outcomes, and differences in the prevalence of poor perinatal mental ill health through routine data. The feasibility of collecting cost and health related resource use data for a future economic evaluation will be explored. METHODS: The study is a quasi-experimental evaluation in a single centre. All participants are drawn from Born in Bradford's Better Start (BiBBS) interventional family cohort study. Intervention participants will be matched to a demographically comparable control group using propensity score matching. The required minimum sample is n = 130 (ratio 1:1) to detect a medium effect (± 2.35, d = .50) on the primary outcome-maternal-child sensitivity, using the Mothers Object Relations Scale Short Form (MORS-SF). Secondary outcomes include the Patient Health Questionnaire (PHQ-8), Generalised Anxiety Disorder assessment 7 (GAD-7), identification of poor perinatal mental health through routine data, and birth outcomes (delivery method, gestation period, low birth weight). Service delivery costs and health resource use will be gathered from routine data. DISCUSSION: This study will evaluate the effectiveness of Baby Steps for enhancing maternal-child sensitivity and maternal mental health when delivered universally and remotely. The findings regarding programme effectiveness, process, and costs will be relevant for researchers, service commissioners, and service staff. TRIAL REGISTRATION: This study was prospectively registered with ISRCTN (22/04/2022, ISRCTN12196131).

Socioeconomic disadvantage and ethnicity are associated with large differences in children's working memory ability: analysis of a prospective birth cohort study following 13,500 children.

Working memory is a limited capacity system that stores and processes information over short time periods and is essential for learning new information. Some studies have investigated the associations between socioeconomic position and working memory, however none have examined this across potentially dissociable aspects of working memory. Further, there are very few studies about children's working memory differences across and within different ethnic groups. Therefore, there is a need to understand the potential associations between socioeconomic position, ethnicity, and different aspects of children's working memory. We investigated children's working memory (n = 15,154) by socioeconomic group, using a latent class measure of family socioeconomic position, and then by ethnic group. To account for potential problems in applying socioeconomic measures across different ethnic groups, we then examined associations using an ethnic-specific socioeconomic measure within the ethnic majority group (White British) and the largest ethnic minority group (Pakistani). We found a strong association between socioeconomic group at birth and working memory at age 7-10 years, where the difference between the least and most deprived socioeconomic groups was equivalent to at least a 1-year age difference. We also found substantial differences in working memory between nine ethnic groups that varied by working memory task, where the difference between groups was equivalent to an age difference of between 6 and 24 months. Finally, we found evidence for a socioeconomic gradient in working memory for White British children, but this was considerably reduced in Pakistani children. These findings show the importance of separating out different ethnic groups when investigating associations between socioeconomic position and cognitive function, and that researchers need to be mindful when applying socioeconomic measures across ethnic groups. Where possible, ethnic-specific measures of socioeconomic position should be developed and applied for studies like these. Future research considering the possible mechanisms behind associations between ethnicity and working memory, and mechanisms by which socioeconomic position differentially influences working memory performance for different ethnic groups would shed further light on this important topic.

The association between socioeconomic disadvantage and children's working memory abilities: A systematic review and meta-analysis.

BACKGROUND AND OBJECTIVE: Working memory is an essential cognitive skill for storing and processing limited amounts of information over short time periods. Researchers disagree about the extent to which socioeconomic position affects children's working memory, yet no study has systematically synthesised the literature regarding this topic. The current review therefore aimed to investigate the relationship between socioeconomic position and working memory in children, regarding both the magnitude and the variability of the association. METHODS: The review protocol was registered on PROSPERO and the PRISMA checklist was followed. Embase, Psycinfo and MEDLINE were comprehensively searched via Ovid from database inception until 3rd June 2021. Studies were screened by two reviewers at all stages. Studies were eligible if they included typically developing children aged 0-18 years old, with a quantitative association reported between any indicator of socioeconomic position and children's working memory task performance. Studies were synthesised using two data-synthesis methods: random effects meta-analyses and a Harvest plot. KEY FINDINGS: The systematic review included 64 eligible studies with 37,737 individual children (aged 2 months to 18 years). Meta-analyses of 36 of these studies indicated that socioeconomic disadvantage was associated with significantly lower scores working memory measures; a finding that held across different working memory tasks, including those that predominantly tap into storage (d = 0.45; 95% CI 0.27 to 0.62) as well as those that require processing of information (d = 0.52; 0.31 to 0.72). A Harvest plot of 28 studies ineligible for meta-analyses further confirmed these findings. Finally, meta-regression analyses revealed that the association between socioeconomic position and working memory was not moderated by task modality, risk of bias, socioeconomic indicator, mean age in years, or the type of effect size. CONCLUSION: This is the first systematic review to investigate the association between socioeconomic position and working memory in children. Socioeconomic disadvantage was associated with lower working memory ability in children, and that this association was similar across different working memory tasks. Given the strong association between working memory, learning, and academic attainment, there is a clear need to share these findings with practitioners working with children, and investigate ways to support children with difficulties in working memory.

Leucine-enriched whey protein supplementation, resistance-based exercise, and cardiometabolic health in older adults: a randomized controlled trial.

BACKGROUND: Increasing protein intake (above the Recommended Dietary Amount) alone or with resistance-based exercise is suggested to improve cardiometabolic health; however, randomized controlled trials (RCTs) are needed to confirm this. METHODS: The Liverpool Hope University-Sarcopenia Aging Trial (LHU-SAT) was a 16 week RCT (ClinicalTrials.gov Identifier: NCT02912130) of 100 community-dwelling older adults [mean age: 68.73 ± 5.80 years, body mass index: 27.06 ± 5.18 kg/m2 (52% women)] who were randomized to four independent groups [Control (C), Exercise (E), Exercise + Protein (EP), Protein (P)]. E and EP completed supervised and progressive resistance-based exercise (resistance exercise: two times per week, functional circuit exercise: once per week), while EP and P were supplemented with a leucine-enriched whey protein drink (three times per day) based on individual body weight (0.50 g/kg/meal, 1.50 g/kg/day). Outcome measures including arterial stiffness (pulse wave velocity), fasting plasma/serum biomarkers [glucose/glycated haemoglobin, total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein, insulin, resistin, leptin, adiponectin, C-reactive protein, tumour necrosis factor-alpha, interleukin-6, cystatin-C, & ferritin], insulin resistance (HOMA-IR), and kidney function (eGFR) were measured before and after intervention. RESULTS: Total protein intake (habitual diet plus supplementation) increased to 1.55 ± 0.69 g/kg/day in EP and to 1.93 ± 0.72 g/kg/day in P, and remained significantly lower (P < 0.001) in unsupplemented groups (E: 1.08 ± 0.33 g/kg/day, C: 1.00 ± 0.26 g/kg/day). At 16 weeks, there was a group-by-time interaction whereby absolute changes in LDL-cholesterol were lower in EP [mean difference: -0.79 mmol/L, 95% confidence interval (CI): -1.29, -0.28, P = 0.002] and P (mean difference: -0.76 mmol/L, 95% CI: -1.26, -0.26, P = 0.003) vs. C. Serum insulin also showed group-by-time interactions at 16 weeks whereby fold changes were lower in EP (mean difference: -0.40, 95% CI: -0.65, -0.16, P = 0.001) and P (mean difference: -0.32, 95% CI: -0.56, -0.08, P = 0.009) vs. C, and fold changes in HOMA-IR improved in EP (mean difference: -0.37, 95% CI: -0.64, -0.10, P = 0.007) and P (mean difference: -0.27, 95% CI: -0.53, -0.00, P = 0.048) vs. C. Serum resistin declined in P only (group-by-time interaction at 16 weeks: P = 0.009). No other interactions were observed in outcome measures (P > 0.05), and kidney function (eGFR) remained unaltered. CONCLUSIONS: Sixteen weeks of leucine-enriched whey protein supplementation alone and combined with resistance-based exercise improved cardiometabolic health markers in older adults.

Effects of exercise and whey protein on muscle mass, fat mass, myoelectrical muscle fatigue and health-related quality of life in older adults: a secondary analysis of the Liverpool Hope University-Sarcopenia Ageing Trial (LHU-SAT).

PURPOSE: To investigate the effects of exercise in combination with, or without, a leucine-enriched whey protein supplement on muscle mass, fat mass, myoelectrical muscle fatigue and health-related quality of life (HR-QOL) in older adults. METHODS: 100 community-dwelling older adults [52% women, age: 69 ± 6 years (mean ± SD)] were randomised to four [Control (C); Exercise (E); Exercise + Protein (EP); Protein (P)] independent groups. E and EP groups completed 16 weeks of exercise [resistance (2 times/week) and functional (1 time/week]. EP and P groups were also administered a leucine-enriched whey protein supplement (3 times/day) based on body weight (1.5 g/kg/day). Muscle and fat mass (bioelectrical impedance analysis), myoelectrical muscle fatigue (surface electromyography) and HR-QOL (WHOQOL-BREF) were measured pre- and post-intervention. RESULTS: At post-intervention, the rectus femoris (E: - 4.8%/min, p = 0.007, ES = 0.86; EP: - 3.3%/min, p = 0.045, ES = 0.58) and bicep femoris (E: - 3.9%/min, p < 0.001, ES = 1.46; EP: - 4.3%/min, p < 0.001, ES = 1.58) muscles became more resistant to fatigue in the E and EP groups, respectively (p < 0.05 versus C). HR-QOL improved in the E group only. Muscle and fat mass did not change (p > 0.05). CONCLUSION: Physical exercise is a potent method to improve myoelectrical muscle fatigue and HR-QOL in older adults. However, leucine-enriched whey protein did not augment this response in those already consuming sufficient quantities of protein at trial enrolment.

Exercise and Dietary-Protein as a Countermeasure to Skeletal Muscle Weakness: Liverpool Hope University - Sarcopenia Aging Trial (LHU-SAT).

OBJECTIVE: To investigate the effects of a 16-week concurrent exercise regimen [resistance exercise (RE) + functional exercise (FE)] in combination with, or without, a leucine-enriched whey protein isolate supplement on muscle strength, physical functioning, aerobic capacity, and cardiometabolic health in older adults (≥60 years). Physical activity levels were also evaluated 6 months post-cessation of the intervention. METHODS: Forty-six, community-dwelling, previously untrained males, and females [age: 68 ± 5 years (mean ± SD); BMI: 27.8 ± 6.2 kg/m2] who completed the trial were initially randomized to one of two independent arms [Exercise n = 24 (E); Exercise+Protein n = 22 (EP)]. Both arms completed 16 weeks of RE (performed to fatigue) (2 times/week) with FE (1 time/week) on non-consecutive days. Additionally, EP were administered a leucine-enriched whey protein supplement (3 times/day) for 16 weeks based on individual body-weight (1.5 g/kg/day). RESULTS: As a result of dietary supplementation, protein intake increased in EP (∼1.2 ± 0.4 to 1.5 ± 0.7 g/kg/day) during the intervention. Maximal strength (1RM) values for leg press (E: +39 ± 7 kg, p = 0.006; EP: +63 ± 7 kg, p < 0.001), chest press (E: +22 ± 4 kg, p < 0.001; EP: +21 ± 6 kg, p < 0.001), and bicep curl (E: +7 ± 0 kg, p = 0.002; EP: +6 ± 1 kg, p = 0.008) significantly increased in E and EP respectively, with no differences between arms (p > 0.05). Physical functioning in the obstacle course (E: -5.1 ± 6.8 s, p < 0.001; EP: -2.8 ± 0.8 s, p < 0.001) and short-physical performance battery scores (E: +0.5 ± 0.5, p = <0.001; EP: +0.4 ± 0.5, p = 0.038), and aerobic capacity in the 6-min walk test (E: +37 ± 24 m, p = 0.014; EP: +36 ± 3 m, p = 0.005) improved in E and EP respectively, with no differences between arms (p > 0.05). No significant change was observed for markers of cardiometabolic health (glycaemic control or blood pressure) (p > 0.05). At follow-up, 86% of older adults reported to performing physical activity ≥1 per week. Of those, 61% were still participating in strength- and cardiovascular- based exercise. CONCLUSION: Concurrent exercise (RE + FE) offers a potent method to combat age-related muscle weakness, and our results suggest a high proportion of older adults may continue to exercise unsupervised. However, leucine-enriched whey protein isolate supplementation did not confer any additional benefit in those already consuming ample amounts of dietary protein at trial enrolment. Future trials should utilize a whole-foods approach and investigate the effects in frail and non-frail older adults habitually consuming the RDA of protein, to assess if a higher intake of protein is needed to delay the onset of muscle weakness. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02912130.

Recovery Curves for Pediatric Burn Survivors: Advances in Patient-Oriented Outcomes.

IMPORTANCE: Patient-reported outcomes serving as benchmarks for recovery of pediatric burn survivors are lacking, and new approaches using longitudinal cohorts for monitoring their expected recovery based on statistical models are needed for patient management during the early years following the burn. OBJECTIVE: To describe multidimensional patient-reported outcomes among pediatric burn survivors younger than 5 years to establish benchmarks using recovery curve methods. DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort study of pediatric burn survivors younger than 5 years at 12 burn centers. Age-matched nonburned reference groups were studied to define expected results in normal growth and development. The Burn Outcomes Questionnaire for children aged 0 to 5 years (BOQ0-5) was administered to parents of children who had burns and were younger than 5 years. Mixed models were used to generate 48-month recovery curves for each of the 10 BOQ0-5 domains. The study was conducted between January 1999 and December 2008. MAIN OUTCOMES AND MEASURES: The 10 BOQ0-5 domains including play, language, fine motor skills, gross motor skills, emotional behavior, family functioning, pain/itching, appearance, satisfaction with care, and worry/concern up to 48 months after burn injury. RESULTS: A total of 336 pediatric burn survivors younger than 5 years (mean [SD] age, 2.0 [1.2] years; 58.4% male; 60.2% white, 18.6% black, and 12.0% Hispanic) and 285 age-matched nonburned controls (mean [SD] age, 2.4 [1.3] years; 51.1% male; 67.1% white, 8.9% black, and 15.0% Hispanic) completed the study. Predicted scores improved exponentially over time for 5 of the BOQ0-5 domains (predicted scores at 1 month vs 24 months: play, 48.6 vs 52.1 [P = .03]; language, 49.2 vs 54.4 [P < .001]; gross motor skills, 48.7 vs 53.0 [P = .002]; pain/itching, 15.8 vs 33.5 [P < .001]; and worry/concern, 31.6 vs 44.9 [P < .001]). Pediatric burn survivors had higher scores in language, emotional behavior, and family functioning domains compared with healthy children in later months. CONCLUSIONS AND RELEVANCE: This study demonstrates significant deficits in multiple functional domains across pediatric burn survivors compared with controls. Recovery curves can be used to recognize deviation from the expected course and tailor care to patient needs.

Impact of hand burns on health-related quality of life in children younger than 5 years.

BACKGROUND: The purpose of this multicenter study was to evaluate the impact of hand burn injury in preschool children younger than 5 years on health-related quality of life, including both physical and psychosocial function, in the 5 years after burn injury. METHODS: This prospective case series assessed children younger than 5 years admitted to four pediatric burn centers. Each child's family completed the American Burn Association/Shriners Hospitals for Children Burn Outcome Questionnaire (BOQ), a validated and reliable assessment tool, which measures the physical and psychosocial functioning of the child with burn injury ages 0 year to 5 years, at baseline, 3, 6, 12, 18, 24, 36, and 48 months after discharge. Multivariate models controlling for sociodemographic and clinical characteristics were developed, and recovery curves were generated for the time since burn using generalized estimating equations with random effects. RESULTS: A cohort of 438 patients was followed up prospectively. Mean (SD) patient age was 2.2 (1.2) years, mean (SD) total body surface area (TBSA) was 28% (22.4%), and 19% had inhalation injury. Children with hand burns had lower scores in most of the areas tested, with the most pronounced and significant differences were in fine motor function, gross motor function, and appearance. These findings applied to both small (<20% TBSA) and large (≥20% TBSA) burns. The most profound impact of hand burns was noted in fine and gross motor function during the 4 years of follow-up. CONCLUSION: Children with hand burns have significantly worse outcomes than do children with burns in other areas.

The effect of hand burns on quality of life in children.

There is limited data regarding the long-term outcomes for children with hand burns. The objective of this study was to prospectively document recovery after burn injury using a validated health outcomes burn questionnaire for infants, children, and adolescents. A single center prospective study was conducted on consecutive children aged 0 to 4 years and 5 to 18 years comparing outcomes between children with and without hand burns. Age specific American Burn Association/Shriners Hospitals for Children Burn Outcomes Questionnaires were administered at admission, first clinic after discharge, 3, 6, 12, 18, and 24 months after injury. One hundred eighty-one consecutive patients were enrolled in the study. Demographic, injury, and survey outcome data were available for 145 patients for at least 24 months after injury. Children with hand burns had significantly longer hospitalization, intensive care unit days, ventilator days, and TBSA burns. Initial Burn Outcomes Questionnaire scores for children with hand burns were significantly lower than controls and children with burns not involving the hand. For ages 0 to 4 years and 5 to 18 years, only the domain specific to upper extremity function was significantly decreased between the groups over the entire study period. Despite severe injury, children with hand burns have continued improvement in quality of life for at least 2 years after injury. The presence of a hand burn in the context of large TBSA burn is a marker of more severe acute illness and predicts increased resource utilization. Rehabilitative efforts after upper extremity injury should continue to target both physical function and the psychosocial impact of burn injury.

Effects of skin grafting on successful prosthetic use in children with lower extremity amputation.

The use of skin grafts after lower extremity amputation in pediatric patients remains a controversial decision. A skin graft may help to preserve residual limb length and knee joint function; however, the literature suggests that it may make the patient more susceptible to complications. Directly contrasting children with and without skin grafts on their residual limbs will provide important data for the clinician making this decision. This study compares amputation characteristics, complications, and functional outcomes of these two populations. A retrospective chart analysis was performed on 45 pediatric patients who underwent lower extremity amputation between 1997 and 2006. Patients were divided into two groups: the graft group had skin grafts on their residual lower extremity limb(s) and the no graft group had no skin grafts present on the residual lower extremity limb(s). The mean time from amputation to follow-up was 4.5 years in the graft group and 7.0 years in the no graft group (P = .07). The average age at amputation for the graft group was 9.4 +/- 1.4 years and 5.9 +/- 1.1 years for the no graft group (P = .04). The graft group had a significantly longer hospital stay with 91 inpatient days vs 31 inpatient days in the no graft group (P = .03). There was no increased incidence of surgical revisions or reported problems with prosthetic wear in the graft group. Both groups achieved comparable levels of independence with ambulation. The presence of skin grafts on a child's amputated limb does not adversely affect functional outcome and does not lead to greater prosthetic complications for the child.