Using intervention mapping to facilitate and sustain return-to work after breast cancer: protocol for the FASTRACS multicentre randomized controlled trial.

BACKGROUND: Women with breast cancer face many barriers to return to work (RTW) after their cancer. The main objective of the FASTRACS-RCT is to evaluate the impact of the FASTRACS (Facilitate and Sustain Return to Work after Breast Cancer) intervention on the sustainable RTW of breast cancer patients, 12 months after the end of active treatment. METHODS: FASTRACS-RCT is a prospective, national, multicentre, randomized, controlled and open-label study. A total of 420 patients with early breast cancer scheduled for surgery and (neo)adjuvant chemotherapy, will be randomly assigned (1:1 ratio) to: (i) the intervention arm comprising four steps over 6 months : Handing over the intervention tools; transitional medical consultation with the general practitioner (GP); pre-RTW visit with the company's occupational physician (OP); catch-up visit with a hospital-based RTW expert (if sick leave > 10 months) (ii) the control arm to receive usual care. The design of the FASTRACS intervention was informed by intervention mapping for complex interventions in health promotion planning, and involved patients and representatives of relevant stakeholders. Specific tools were developed to bridge the gap between the hospital, the GP, the OP and the workplace: a toolkit for breast cancer patients comprising a theory-based guide; specific checklists for the GP and the OP, respectively; and a theory-based guide for workplace actors (employer, manager, colleagues). The primary endpoint will associate sustainable RTW (full-time or part-time work at 50% or more of working time, for at least 28 consecutive days) and days off work. It will be assessed at 4, 8 and 12 months after the end of active oncological treatment. Secondary endpoints will include quality of life, anxiety, depression, RTW self-efficacy, physical activity, social support, job accommodations, work productivity, job status, and the usefulness and acceptability of the intervention's tools. DISCUSSION: FASTRACS-RCT will be supplemented by a realist evaluation approach aimed at understanding the influence of context in activating the intervention's mechanisms and effects. If the expected impact of the intervention is confirmed, the intervention will be adapted and scaled-up for other cancers and chronic diseases to better integrate healthcare and work disability prevention. TRIAL REGISTRATION: NCT04846972 ; April 15, 2021.

Use of behavior change techniques in physical activity programs and services for older adults: findings from a rapid review.

BACKGROUND: Understanding behavior change techniques (BCTs) used in randomized controlled trials (RCTs) of physical activity programs/services for older adults can help us to guide their implementation in real-world settings. PURPOSE: This study aims to: (a) identify the number and type of BCTs used in physical activity programs/services for older adults evaluated in large, good quality RCTs and (b) explore the impact of different BCTs on different outcome domains. METHODS: This is a secondary data analysis of a WHO-commissioned rapid review of physical activity programs/services for older adults. Fifty-six trials testing 70 interventions were coded for the type and number of BCTs present using a published BCT taxonomy. The proportion of positive effects found from physical activity interventions using the most common BCTs was calculated for the outcomes of physical activity, intrinsic capacity, functional ability, social domain, cognitive and emotional functioning, and well-being and quality of life. RESULTS: Thirty-nine of the 93 possible BCTs were identified in the included trials and 529 BCTs in total (mean 7.6, range 2-17). The most common BCTs were "action planning" (68/70 interventions), "instructions on how to perform a behavior" (60/70), "graded tasks" (53/70), "demonstration of behavior" (44/70), and "behavioral practice/rehearsal" (43/70). Interventions that used any of the most common BCTs showed overwhelmingly positive impacts on physical activity and social domain outcomes. CONCLUSION: Consideration of which BCTs are included in interventions and their impact on outcomes can improve the effectiveness and implementation of future interventions. To enable this, providers can design, implement, and evaluate interventions using a BCT taxonomy.

Interventions aimed at modifying health-related behaviors, such as physical activity, are often complex, with numerous components. To better understand interventions' "active ingredients," we conducted a secondary analysis of a World Health Organization (WHO)-commissioned rapid review, using a behavior change technique (BCT) taxonomy. We aimed to classify the number and types of BCTs in physical activity programs for older adults, as identified in randomized controlled trials (RCTs), and examine their impact on outcomes, including physical activity, intrinsic capacity, functional ability, social domain, cognitive and emotional functioning, and well-being. Examining 56 trials testing 70 interventions, we identified 39 out of 93 possible BCTs, totaling 529 instances across interventions. Common BCTs included "action planning," "instructions on how to perform a behavior," "graded tasks," "demonstration of behavior," and "behavioral practice/rehearsal." Interventions using the 10 most common BCTs demonstrated overwhelmingly positive impacts on physical activity and social domain outcomes. However, these BCTs were not consistently present in interventions yielding positive outcomes in other domains, with greater variation in effects. Our study highlights the significance of identifying both BCTs and desired outcomes when designing physical activity interventions. We advocate for the use of a taxonomy in designing and implementing future programs to maximize effectiveness.

Nutrition and health effects of pectin: A systematic scoping review of human intervention studies.

Pectin is composed of a group of complex polysaccharides that are naturally found in various plants and are associated with a range of beneficial health effects. Health outcomes from dietary pectin can vary depending on botanical origin, dietary dose and structure of pectin. The objective of this scoping review is to build a comprehensive overview of the current evidence available on intervention studies conducted in humans and to better understand the possible knowledge gaps in terms of structure-function relationships across the different health-related effects. PubMed and Embase databases were searched using PRISMA-ScR guidelines, yielding 141 references (from the initial 3704), representing 134 intervention studies performed between 1961 and 2022 that met inclusion criteria. Studies were divided into six categories, which included gut health, glycaemic response and appetite, fat metabolism, bioavailability of micronutrients, immune response and other topics. Review of these human intervention studies identified a variety of cohort characteristics and populations (life stage, health status, country), sources/types of pectin (i.e. citrus, sugarbeet, apple, other and non-defined), intervention timeframes (from one single intake to 168 d) and doses (0.1-50 g/d) that were tested for health outcomes in people. Gut health, post-prandial glucose regulation and maintenance of blood cholesterol represented the largest categories of studied outcomes. Further research to strengthen the structure-function relationships for pectin with health properties and associated outcomes is warranted and will benefit from a more precise description of physico-chemical characteristics and molecular compositions, such as degree of esterification, weight, degree of branching, viscosity, gel formation and solubility.

Effect of non-pharmacological interventions in people with cognitive frailty: a systematic review and network meta-analysis.

ABSRTACT: OBJECTIVE: To evaluate the effects of various non-pharmacological interventions on patients with cognitive impairment by systematic search and network meta-analysis, and to rank the effects of the included non-pharmacological interventions. METHODS: The databases of PubMed, Cochrane Library, EMbase, Web of Science, CNKI, VIP, WANFANG, and SinoMed were searched by computer. All randomized controlled trials (RCTs) of non-pharmacological interventions for people with cognitive frailty were collected. The search was conducted from 2000 to February 2024. Two reviewers independently screened the studies, extracted data, and assessed the risk of bias of the included studies, and then used Stata15 and R4.3.1 software to conduct network meta-analysis, with physical function and cognitive function as the main outcome indicators. RESULTS: A total of 19 randomized controlled trials involving 1738 patients were included. The results of network meta-analysis showed that among the non-pharmacological interventions, nutritional support had the best effect on improving frailty scores and cognitive function scores in patients with cognitive frailty. Aerobic training combined with resistance training is best for improving grip strength. For improving the patient's motor status, cognitive training had the best effect on improving TUG test scores. High-speed resistance training is best for improving walking speed. CONCLUSION: This review analyses the current study of non-pharmacological interventions to improve physical performance in patients with cognitive frailty. Current evidence suggests that nutritional support is most effective at improving physical frailty and cognitive decline in patients with cognitive frailty, and that exercise and cognitive training interventions significantly improve grip strength and motor ability. TRIAL REGISTRATION: This meta-analysis was prospectively registered with PROSPERO (registration number: CRD42023486881).

Mary Main's contributions to our family systems approach to interventions with parents of young children.

In this paper we describe our Berkeley colleague Mary Main's intellectual contributions to our program of creating and evaluating couples group interventions for parents of young children. The first section presents the theoretical model and the projects at the heart of our research program. The second section illustrates how the Adult Attachment Interview, a Couple Attachment Interview, or a questionnaire describing attachment styles helped us to understand how internal working models of both parent-child and couple relationships added to our observational measures of couple and parenting behavior to provide unique information. In a third section, we conclude that we did not have the kind of impact on Mary's thinking that Mary had on ours, but we are heartened by seeing increasing attempts of some developmental attachment theorists to include fathers in their studies and others who focus on the effects of the quality of relationship between the parents on their children's development.

Development and evaluation of a concise nurse-driven non-pharmacological delirium reduction workflow for hospitalized patients: An interrupted time series study.

We created a concise nurse-driven delirium reduction workflow with the aim of reducing delirium rates and length of stay for hospitalized adults. Our nurse-driven workflow included five evidence-based daytime "sunrise" interventions (patient room lights on, blinds up, mobilization/out-of-bed, water within patient's reach and patient awake) and five nighttime "turndown" interventions (patient room lights off, blinds down, television off, noise reduction and pre-set bedtime). Interventions were also chosen because fidelity could be quickly monitored twice daily without patient interruption from outside the room. To evaluate the workflow, we used an interrupted time series study design between 06/01/17 and 05/30/22 to determine if the workflow significantly reduced the unit's delirium rate and average length of stay. Our workflow is feasible to implement and monitor and initially significantly reduced delirium rates but not length of stay. However, the reduction in delirium rates were not sustained following the emergence of the COVID-19 pandemic.

Recruitment and retention challenges and strategies in randomized controlled trials of psychosocial interventions for children with cancer and their parents: a collective case study.

In pediatric oncology there are few examples of successful recruitment and retention strategies in psychosocial care research. This study aims to summarize experiences, challenges, and strategies for conducting randomized controlled trials (RCTs) of psychosocial intervention studies among children with cancer and their parent(s). We conducted a collective case study. To identify the cases, Pubmed and two trial registries were searched for ongoing and finished RCTs of psychosocial intervention studies for children with cancer and their parents. Online semi-structured expert interviews discussing recruitment and retention challenges and strategies were performed with principal investigators and research staff members of the identified cases. Nine studies were identified. Investigators and staff from seven studies participated, highlighting challenges and strategies within three major themes: eligibility, enrollment and retention. Regarding eligibility, collaborating constructively with healthcare professionals and involving them before the start of the study were essential. Being flexible, training the research staff, enabling alignment with the participants' situation, and providing consistency in contact between the research staff member and the families were important strategies for optimizing enrollment and retention. All studies followed a stepped process in recruitment.  Conclusion: Although recruitment and retention in some selected studies were successful, there is a paucity of evidence on experienced recruitment and retention challenges in pediatric psychosocial research and best practices on optimizing them. The strategies outlined in this study can help researchers optimize their protocol and trial-implementation, and contribute to better psychosocial care for children with cancer and their parents.  Trial Registration: This study is not a clinical trial. What is Known: • Performing RCTs is challenging, particularly in pediatric psychosocial research when both the child and parent are targeted. Recruitment and retention are common concerns. In pediatric oncology, there are few examples of successful recruitment and retention strategies in psychosocial care research. What is New: • Key strategies to collaborate constructively with healthcare professionals were outlined. Being flexible, training the research staff, alignment with the participant's situations and providing consistency in contact between the research staff member and the families were considered as essential strategies.

Effects of Therapeutic Intervention on Spatiotemporal Gait Parameters in Adults With Neurologic Disorder: Systematic Review and Meta-analysis.

OBJECTIVE: This systematic review and meta-analysis aimed to review and quantify the changes in gait parameters after therapeutic intervention in adults with neurologic disorders. DATA SOURCES: A keyword search was performed in 4 databases: PubMed, CINAHL, Scopus, and Web of Science (01/2000-12/2021). We performed the search algorithm including all possible combinations of keywords. Full-text articles were examined further using forward/backward search methods. STUDY SELECTION: Studies were thoroughly screened using the following inclusion criteria: Study design: randomized controlled trial; adults ≥55 years old with a neurologic disorder; therapeutic intervention; spatiotemporal gait characteristics; and language: English. DATA EXTRACTION: A standardized data extraction form was used to collect the following methodological outcome variables from each of the included studies: author, year, population, age, sample size, and spatiotemporal gait parameters such as cadence, step length, step width, or double limb support. A meta-analysis was performed among trials presenting with similar characteristics, including study population and outcome measure. If heterogeneity was >50%, a random plot analysis was used; otherwise, a fixed plot analysis was done. DATA SYNTHESIS: We included 25 out of 34 studies in our meta-analysis that examined gait in adults with neurologic disorders. All analyses used effect sizes and standard error and a P<.05(denoted by *) threshold was considered statistically significant. Overall, we found that sensory (SS) and electrical stimulation (ES) had the most significant effect on step length (SS: z=5.44*, ES: z=2.42*) and gait speed (SS: z=6.19*, ES: z=7.38*) in adults with Parkinson disease (PD). Although balance or physical activity interventions were not found to be effective in modifying step length in adults with PD, they showed a significant effect on gait speed. Further, physical activity had the most significant effect on cadence in adults with PD (z=2.84*) relative to sensory stimulation effect on cadence (z=2.59*). For stroke, conventional physical therapy had the most significant effect on step length (z=3.12*) and cadence (z=3.57*). CONCLUSION: Sensory stimulation such as auditory and somatosensory stimulation while walking had the most significant effect on step length in adults with PD. We also found that conventional physical therapy did improve spatial gait parameters relative to other physical activity interventions in adults with PD and stroke.

Interventions to reduce falls in community-dwelling adults with intellectual disability: a systematic review.

BACKGROUND: People with intellectual disability have a high risk of falls and falls-related injuries. Although people with intellectual disability are at increased risk of falls, there is a need to better understand the efficacy of interventions that can help reduce falls and address risk factors in this population. This systematic review aimed to evaluate the type, nature and effectiveness of interventions undertaken to reduce falls with community-dwelling adults with intellectual disability and the quality of this evidence. METHOD: Four electronic databases were searched: Ovid MEDLINE, PsycINFO, CINAHL Plus and the Cochrane Library. Studies were included if they involved people aged 18 years or over, at least 50% of study participants had intellectual disability, participants were community-dwelling, and the study evaluated any interventions aiming to reduce falls. Study quality was assessed using the National Institutes of Health study quality assessment tools. Reporting of the review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: Seven studies were eligible for review, with a total of 286 participants and mean age of 50.4 years. As only one randomised trial was identified, a narrative synthesis of results was undertaken. Five studies evaluated exercise interventions, one evaluated a falls clinic programme, and one evaluated stretch fabric splinting garments. Methodological quality varied (two studies rated as good, four as fair, and one as poor). Exercise interventions varied in terms of exercise type and dosage, frequency and intensity, and most did not align with recommendations for successful falls prevention exercise interventions reported for older people. While the majority of studies reported reduced falls, they differed in methods of reporting falls, and most did not utilise statistical analyses to evaluate outcomes. CONCLUSION: This review identified a small number of falls prevention intervention studies for people with intellectual disability. Although several studies reported improvements in fall outcomes, ability to draw conclusions about intervention effectiveness is limited by small sample sizes and few studies. Further large-scale research is required to implement and evaluate falls prevention interventions specifically for adults with intellectual disability.

Development of an HIV/STI and partner violence health promotion intervention for abused US Virgin Islands women.

Women in the US Virgin Islands (USVI) experience intimate partner violence (IPV) and human immunodeficiency virus (HIV) at disproportionate rates compared to women on the US mainland. Women in violent relationships report experiencing controlling behaviours that decrease their ability to negotiate for sex using condoms or to prevent unwanted pregnancies. Though several evidence-based interventions exist to prevent either IPV or HIV, few address them through an integrated health promotion approach or attend to particular USVI cultural mores. This article describes the systematic development of a theory based, culturally tailored, integrated health promotion intervention that addresses IPV and HIV among USVI women experiencing abuse. The process included: (i) identifying and integrating evidence-based health promotion interventions, (ii) conducting formative research using focus groups, (iii) synthesizing focus group data to inform intervention development and (iv) developing a culturally and linguistically appropriate intervention specific to the needs and concerns of USVI women. The Empowered Sisters Project: Making Choices Reducing Risks (ESP) was developed through this research. ESP is a three-session health promotion curriculum focussed on enhancing sexual health and safety among women experiencing abuse. The ESP intervention components included promoting condom use, increasing IPV and HIV knowledge and developing a personalized safety plan. Health professionals facilitated individual intervention sessions using culturally tailored visual media and scripts. This program focussed on experiences of women living in the USVI and has implications for utility across the Caribbean diaspora.

Recruitment strategies in couple intervention studies: A systematic review of recruitment methods and sample characteristics in the United States from 2015 to 2020.

Including diverse participants in couple intervention studies is critical for developing an evidence base that informs best practices for all potential clients. Research has shown that subgroups of clients respond differently to different interventions and that interventions that have been adapted to fit the needs of a given population are more effective than non-adapted interventions. Unfortunately, couple intervention samples often exclude participants with marginalized identities and culturally adapted couple intervention research is limited. The lack of information about best practices for diverse client subgroups perpetuates mental and relational health disparities. We conducted a systematic review to examine recruitment strategies and sampling characteristics of diverse races/ethnicities, incomes, ages, and sexual identities. We reviewed articles published between January 2015 and December 2020. Articles were eligible for inclusion in our review if they implemented an intervention with couples in the United States. Of 4054 articles identified, 54 articles were eligible for our review. Findings suggest that couple intervention studies lack diversity across multiple identity domains (i.e., races/ethnicities, incomes, ages, and sexual identities). Further, descriptions of recruitment strategies are often vague, limiting opportunities to better understand methods used to recruit diverse samples.

Preventing railway suicides through level crossing removal: a multiple-arm pre-post study design in Victoria, Australia.

PURPOSE: Rail level crossing removals to improve transport performance across metropolitan Melbourne (state of Victoria) resulted in new rail fencing and grade-separation of tracks from the surrounding environment at several sites. These design changes restricted pedestrian access to the rail tracks, which is a countermeasure known to prevent railway suicide in other settings. We examined whether any such suicide prevention effect followed the removals. METHODS: We used a multiple-arm pre-post design to test whether a decrease in monthly frequency of railway suicides occurred at level crossing removal sites (intervention sites), compared to randomly matched sites where level crossings had not yet been removed (control sites). We used data available in the Victorian Suicide Register covering the period 1st January 2008 to 30th June 2021. RESULTS: The mean monthly number of railway suicides decreased by 68% within a 500 m radius of intervention sites (RR: 0.32; CI 95% 0.11-0.74) and by 61% within a 1000 m radius of intervention sites (RR: 0.39; CI 95% 0.21-0.68). There was no evidence that the mean monthly number of railway suicides changed at the control sites, either within a 500 m radius (RR: 0.88; CI 95% 0.47-1.56) or a 1000 m radius (RR: 0.82; CI 95% 0.52-1.26). CONCLUSION: The reduction in railway suicides at locations where level crossings were removed, demonstrates the suicide prevention benefits that can be derived from a major infrastructure project even if not initially intended. Planning for major infrastructure projects should include consideration of these benefits, with designs incorporating features to maximise suicide prevention impact.

Mitigating structural racism to reduce inequities in sepsis outcomes: a mixed methods, longitudinal intervention study.

BACKGROUND: Sepsis affects 1.7 million patients in the US annually, is one of the leading causes of mortality, and is a major driver of US healthcare costs. African American/Black and LatinX populations experience higher rates of sepsis complications, deviations from standard care, and readmissions compared with Non-Hispanic White populations. Despite clear evidence of structural racism in sepsis care and outcomes, there are no prospective interventions to mitigate structural racism in sepsis care, nor are we aware of studies that report reductions in racial inequities in sepsis care as an outcome. Therefore, we will deliver and evaluate a coalition-based intervention to equip health systems and their surrounding communities to mitigate structural racism, driving measurable reductions in inequities in sepsis outcomes. This paper presents the theoretical foundation for the study, summarizes key elements of the intervention, and describes the methodology to evaluate the intervention. METHODS: Our aims are to: (1) deliver a coalition-based leadership intervention in eight U.S. health systems and their surrounding communities; (2) evaluate the impact of the intervention on organizational culture using a longitudinal, convergent mixed methods approach, and (3) evaluate the impact of the intervention on reduction of racial inequities in three clinical outcomes: a) early identification (time to antibiotic), b) clinical management (in-hospital sepsis mortality) and c) standards-based follow up (same-hospital, all-cause sepsis readmissions) using interrupted time series analysis. DISCUSSION: This study is aligned with calls to action by the NIH and the Sepsis Alliance to address inequities in sepsis care and outcomes. It is the first to intervene to mitigate effects of structural racism by developing the domains of organizational culture that are required for anti-racist action, with implications for inequities in complex health outcomes beyond sepsis.

Study Registration for the Field of Prevention Science: Considering Options and Paths Forward.

The practice of prospectively registering the details of intervention studies in a public database or registry is gaining momentum across disciplines as a strategy for increasing the transparency, credibility, and accessibility of study findings. In this article, we consider five registries that may be relevant for registration of intervention studies in the field of prevention science: ClinicalTrials.gov, the American Economic Association Registry of Randomized Controlled Trials (AEA RCT Registry), the Open Science Framework Preregistration (OSF Preregistration), the Registry for International Development Impact Evaluations (RIDIE), and the Registry of Efficacy and Effectiveness Studies (REES). We examine the five registries in terms of substantive focus, study designs, and contents of registry entries. We consider two paths forward for prospective registration of intervention studies in the field of prevention science: Path A: register all studies in ClinicalTrials.gov and Path B: allow individual researchers to select the registry with the "best fit." Lastly, we consider how the field might begin to establish norms around registration.

Transformative learning experience among nursing students with patients acting as teachers: Mixed methods, non-randomized, single-arm study.

AIM: To examine the effects of expert HIV patients acting as teachers to Spanish nursing students both on their HIV-related knowledge, attitudes and practices and on their approach to the care model as well as to explore their learning experience. DESIGN: Non-randomized, single-arm study with quantitative before and after measurements and qualitative data. METHODS: The intervention consisted of five 90-min workshops led by two women living with HIV. Thirty-four nursing students participated, and quantitative and qualitative data were gathered from February to June 2018. We used the Patient-Practitioner Orientation Scale (PPOS) and the KAP questionnaire on HIV/AIDS to collect quantitative data. RESULTS: Statistically significant differences were found in the global score for care orientation and its two dimensions, caring and sharing. About the changes resulting from the workshops, the quantitative results-more patient-centred care perception and better attitudes towards people living with HIV-match the qualitative findings in all the aspects studied, except in sharing. CONCLUSION: Incorporating expert patients as teachers in the nursing bachelor's degree resulted in more patient-centred care and improved knowledge, attitudes and practices. The workshops conducted by qualified expert patients showed transformative learning power, as the participants improved professional and personal aspects.

Fidelity challenges while implementing an intervention aimed at increasing eating performance among nursing home residents with cognitive decline: A multicentre, qualitative descriptive study design.

AIMS AND OBJECTIVES: To increase the knowledge on fidelity challenges in intervention studies promoting eating independence in residents with cognitive decline living in nursing homes (NHs). BACKGROUND: A few studies have documented to date factors affecting fidelity in intervention studies performed in NH settings. Moreover, fidelity issues in intervention studies aimed at promoting eating independence among NH residents with cognitive decline have not been studied to date. DESIGN: A hybrid study design was performed in 2018 and reported here according to the COnsolidated criteria for REporting Qualitative research. METHODS: In a clustered multicentre before/after intervention study design, a nested, multicentre qualitative descriptive design was performed. Four researchers with a nursing background, who received appropriate training, implemented the designed intervention. This consisted in intentional rounds in the dining rooms during lunchtime and was based on supportive, prescriptive and informative prompts delivered to residents with cognitive decline aimed at stimulating eating independence. A momentary assessment method was used, based on daily diary filled in by participant researchers after every session of intervention delivery on the following five dimensions of fidelity: (a) adherence, (b) dose (or exposure), (c) intervention quality, (d) participant responsiveness and (e) programme differentiation. A direct content analysis of the narratives reported on the diaries was performed. RESULTS: Factors increasing or hindering intervention fidelity during its implementation emerged at the NH, staff, family caregivers, resident, researchers and at the intervention itself levels. CONCLUSIONS: Several factors emerged and all reported potentially both positive and negative influences on fidelity while implementing an intervention aimed at promoting eating independence among NH residents. Fidelity challenges should be considered as dynamic in NH intervention studies, where continuous adjustments of the intervention delivered are required. RELEVANCE TO CLINICAL PRACTICE: A calm environment, with staff members showing a caring behaviour, and researchers having achieved good familiarity with the NH setting, the residents, their family carers and the staff members, can all increase intervention fidelity.

The effects of dietary and lifestyle interventions among pregnant women with overweight or obesity on early childhood outcomes: an individual participant data meta-analysis from randomised trials.

BACKGROUND: The impact of maternal obesity extends beyond birth, being independently associated with an increased risk of child obesity. Current evidence demonstrates that women provided with a dietary intervention during pregnancy improve their dietary quality and have a modest reduction in gestational weight gain. However, the effect of this on longer-term childhood obesity-related outcomes is unknown. METHODS: We conducted an individual participant data meta-analysis from RCTs in which women with a singleton, live gestation between 10+0 and 20+0 weeks and body mass index (BMI) ≥ 25 kg/m2 in early pregnancy were randomised to a diet and/or lifestyle intervention or continued standard antenatal care and in which longer-term maternal and child follow-up at 3-5 years of age had been undertaken. The primary childhood outcome was BMI z-score above the 90th percentile. Secondary childhood outcomes included skinfold thickness measurements and body circumferences, fat-free mass, dietary and physical activity patterns, blood pressure, and neurodevelopment. RESULTS: Seven primary trials where follow-up of participants occurred were identified by a systematic literature search within the International Weight Management in Pregnancy (i-WIP) Collaborative Group collaboration, with six providing individual participant data. No additional studies were identified after a systematic literature search. A total of 2529 children and 2383 women contributed data. Approximately 30% of all child participants had a BMI z-score above the 90th percentile, with no significant difference between the intervention and control groups (aRR 0.97; 95% CI 0.87, 1.08; p=0.610). There were no statistically significant differences identified for any of the secondary outcome measures. CONCLUSIONS: In overweight and obese pregnant women, we found no evidence that maternal dietary and/or lifestyle intervention during pregnancy modifies the risk of early childhood obesity. Future research may need to target the pre-conception period in women and early childhood interventions. TRIAL REGISTRATION: PROSPERO, CRD42016047165.

Early Childhood Adversity, Toxic Stress, and the Impacts of Racism on the Foundations of Health.

Inequalities in health outcomes impose substantial human and economic costs on all societies-and the relation between early adversity and lifelong well-being presents a rich scientific framework for fresh thinking about health promotion and disease prevention broadly, augmented by a deeper focus on how racism influences disparities more specifically. This review begins with an overview of advances in the biology of adversity and resilience through an early childhood lens, followed by an overview of the unique effects of racism on health and a selective review of findings from related intervention research. This article presents a framework for addressing multiple dimensions of the public health challenge-including institutional/structural racism, cultural racism, and interpersonal discrimination-and concludes with the compelling need to protect the developing brain and other biological systems from the physiological disruptions of toxic stress that can undermine the building blocks of optimal health and development in the early childhood period.

The use of the mannitol test as an outcome measure in asthma intervention studies: a review and practical recommendations.

BACKGROUND: The mannitol test is an indirect bronchial challenge test widely used in diagnosing asthma. Response to the mannitol test correlates with the level of eosinophilic and mast cell airway inflammation, and a positive mannitol test is highly predictive of a response to anti-inflammatory treatment with inhaled corticosteroids. The response to mannitol is a physiological biomarker that may, therefore, be used to assess the response to other anti-inflammatory treatments and may be of particular interest in early phase studies that require surrogate markers to predict a clinical response. The main objectives of this review were to assess the practical aspects of using mannitol as an endpoint in clinical trials and provide the clinical researcher and respiratory physician with recommendations when designing early clinical trials. METHODS: The aim of this review was to summarise previous uses of the mannitol test as an outcome measure in clinical intervention studies. The PubMed database was searched using a combination of MeSH and keywords. Eligible studies included intervention or repeatability studies using the standard mannitol test, at multiple timepoints, reporting the use of PD15 as a measure, and published in English. RESULTS: Of the 193 papers identified, 12 studies met the inclusion criteria and data from these are discussed in detail. Data on the mode of action, correlation with airway inflammation, its diagnostic properties, and repeatability have been summarised, and suggestions for the reporting of test results provided. Worked examples of power calculations for dimensioning study populations are presented for different types of study designs. Finally, interpretation and reporting of the change in the response to the mannitol test are discussed. CONCLUSIONS: The mechanistic and practical features of the mannitol test make it a useful marker of disease, not only in clinical diagnoses, but also as an outcome measure in intervention trials. Measuring airway hyperresponsiveness to mannitol provides a novel and reproducible test for assessing efficacy in intervention trials, and importantly, utilises a test that links directly to underlying drivers of disease.

A randomized trial of a one-time pest intervention: impact on childhood asthma outcomes.

Objectives: To evaluate the effects of a one-time, apartment-level Integrated Pest Management (IPM) intervention on healthcare utilization and asthma symptoms among children with persistent asthma living in households with a pest infestation.Study design: In a randomized controlled trial of 384 children aged 5-12 years with persistent asthma, we assigned 183 to receive IPM and 197 to usual care (UC). The primary outcome was healthcare utilization from hospital and Medicaid claims records. Secondary outcomes included caregiver-reported asthma symptoms, pest infestation levels, missed days of school due to asthma, and rescue medication use.Results: The entire cohort improved over the study period, with significant but equivalent declines in mean healthcare utilization in both groups. IPM group had fewer days with reduced activity due to asthma (p = 0.04) and larger declines that fell short of statistical significance in asthma symptom days (p = 0.22), severe symptoms (p = 0.16), missed school (p = 0.27) and rescue medication use (p = 0.27). Both roach (p = 0.001) and mice (p = 0.11) infestations decreased much more in the IPM group than the UC group.Conclusions: After a one-time, apartment-level IPM intervention, we found no difference in health care utilization, but fewer days of reduced activity and consistent suggestive evidence of clinically meaningful improvements relative to usual care across other secondary outcomes. Coupled with the established effectiveness of IPM in reducing allergens and scientific consensus on pest-related allergens as asthma triggers, these findings support adding home pest control to traditional medical management of children with severe asthma.