Whole family-based physical activity promotion intervention: the Families Reporting Every Step to Health pilot randomised controlled trial protocol

Introduction : Family-based physical activity (PA) interventions present a promising avenue to promote children’s activity, however, high-quality experimental research is lacking. This paper describes the protocol for the FRESH (Families Reporting Every Step to Health) pilot trial, a child-led family-based PA intervention delivered online.  Methods and analysis : FRESH is a three-armed, parallel-group, randomised controlled pilot trial using a 1:1:1 allocation ratio with follow-up assessments at 8- and 52-weeks post-baseline. Families will be eligible if a minimum of one child in school Years 3-6 (aged 7-11 years) and at least one adult responsible for that child are willing to participate. Family members can take part in the intervention irrespective of their participation in the accompanying evaluation and vice versa. Following baseline assessment, families will be randomly allocated to one of three arms: (1) FRESH, (2) pedometer-only, or (3) no-intervention control. All family members in the pedometer-only and FRESH arms receive pedometers and generic PA promotion information. FRESH families additionally receive access to the intervention website; allowing participants to select step challenges to ‘travel’ to target cities around the world, log steps, and track progress as they virtually globetrot. Control families will receive no treatment. All family members will be eligible to participate in the evaluation with two follow-ups (8 and 52 weeks). Physical (e.g., fitness, blood pressure), psychosocial (e.g., social support), and behavioural (e.g., objectively-measured family PA) measures will be collected each time point. At 8-week follow-up, a mixed-methods process evaluation will be conducted (questionnaires and family focus groups) assessing acceptability of the intervention and evaluation. FRESH families’ website engagement will also be explored.  Ethics and dissemination : This study received ethical approval from the Ethics Committee for the School of the Humanities and Social Sciences at the University of Cambridge. Findings will be disseminated via peer-reviewed publications, conferences, and to participating families

Development and feasibility study of very brief interventions for physical activity in primary care

Abstract Background There is increasing interest in brief and very brief behaviour change interventions for physical activity as they are potentially scalable to the population level. However, few very brief interventions (VBIs) have been published, and evidence is lacking about their feasibility, acceptability and which ‘active ingredients’ (behaviour change techniques) would maximise their effectiveness. The aim of this research was to identify and develop promising VBIs for physical activity and test their feasibility and acceptability in the context of preventive health checks in primary care. Methods The process included two stages, guided by four criteria: effectiveness, feasibility, acceptability, and cost. In Stage 1, we used an iterative approach informed by systematic reviews, a scoping review of BCTs, team discussion, stakeholder consultation, a qualitative study, and cost estimation to guide the development of promising VBIs. In Stage 2, a feasibility study assessed the feasibility and acceptability of the short-listed VBIs, using tape-recordings and interviews with practitioners (n = 4) and patients (n = 68), to decide which VBIs merited further evaluation in a pilot trial. Results Four VBIs were short-listed: Motivational intervention; Action Planning intervention; Pedometer intervention; and Physical Activity Diary intervention. All were deliverable in around five minutes and were feasible and acceptable to participants and practitioners. Based on the results of interviews with practitioners and patients, techniques from the VBIs were combined into three new VBIs for further evaluation in a pilot trial. Conclusions Using a two-stage approach, in which we considered the practicability of VBIs (acceptability, feasibility and cost) alongside potential efficacy from the outset, we developed a short-list of four promising VBIs for physical activity and demonstrated that they were acceptable and feasible as part of a preventive health check in primary care. Trial registration Current Controlled Trials ISRCTN02863077 . Registered 5 October 2012

Fluidity of Equipoise in a Multi-Centred Pilot RCT:Influences on Clinician Decision-Making in Offering Trial Entry

Objectives: The embedded Qualitative Process Evaluation (QPE) within the CSTICH- Pilot RCT explored facilitators and barriers to recruitment within the Pilot. This study reports a secondary analysis of the overarching theme of Fluidity of Equipoise and the influences on individual and community clinical equipoise around the use of Emergency Cervical Cerclage (ECC). Study design: RCT recruitment assumes clinical equipoise and is defined as genuine uncertainty about an intervention. The ability of trial recruiters to convey this equipoise is also key to participant recruitment and fully informed consent. This exploratory qualitative process evaluation used semi-structured interviews with healthcare professionals (HCPs) involved in trial recruitment. Interviews were audio-recorded, transcribed, and analysed using codebook thematic analysis. Results: 23 HCPs were interviewed. Clinical equipoise around the use of ECC was variable and influenced by a multitude of factors including: (1) obstetric history; (2) gestation; (3) standard site practice, and (4) HCPs previous experiences of ECC. We have interpreted this variability as ‘fluidity of equipoise’. Conclusions: Clinical equipoise around complex pregnancy related conditions was fluid and influenced by the complexities of obstetric histories and gestation at presentation. Equipoise of HCPs involved in trial recruitment should be considered carefully as it can impact the nuances of recruitment, particularly in more challenging trials such as CSTICH-2. Study-specific documents and training can be used to increase staff and patient awareness of uncertainty in the evidence base for interventions under investigation. Further research is needed around the potential consequences of equipoise fluidity

Effective and resource-efficient strategies for recruiting families in physical activity, sedentary behavior, nutrition, and obesity prevention research: A systematic review with expert opinion.

We systematically identified effective and resource-efficient strategies for recruiting families into health promoting intervention research. Four databases were searched for reviews. Interventions were extracted from included reviews. Additionally, a Delphi study was conducted with 35 experts in family-based research. We assessed extracted data from our review and Delphi participants' opinions by collating responses into overarching themes based on recruitment setting then recruitment strategies to identify effective and resource-efficient strategies for recruiting families into intervention research. A total of 64 articles (n = 49 studies) were included. Data regarding recruitment duration (33%), target sample size (32%), reach (18%), expressions of interest (33%), and enrollment rate (22%) were scarcely reported. Recruitment settings (84%) and strategies (73%) used were available for most studies. However, the details were vague, particularly regarding who was responsible for recruitment or how recruitment strategies were implemented. The Delphi showed recruitment settings, and strategies fell under six themes: school-based, print/electronic media, community settings-based, primary care-based, employer-based, and referral-based strategies. Underrecruitment in family-based trials is a major issue. Reporting on recruitment can be improved by better adherence to existing guidelines. Our findings suggest a multifaceted recruitment approach targeting adults and children with multiple exposures to study information.This work was supported by the National Institute for Health Research Public Health 16 Research Programme (project number 15/01/19). Funding was also received from the Medical 17 Research Council (project number MC_UU_12015/7) and National Institute for Health Research 18 Biomedical Research Centre Cambridge: Nutrition, Diet, and Lifestyle Research Theme (Grant IS19 BRC-1215-20014)

Erratum to: Development and feasibility study of very brief interventions for physical activity in primary care.

Upon publication of this article [1] it has been noted that due to a technical error the publisher missed to include the Open Access Licence statement in the copyright line. The correct copyright line should have read: © 2015 Pears et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://​creativecommons.​org/​licenses/​by/​4.​0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://​creativecommons.​org/​publicdomain/​zero/​1.​0/​) applies to the data made available in this article, unless otherwise stated

Development and feasibility study of very brief interventions for physical activity in primary care

Abstract Background There is increasing interest in brief and very brief behaviour change interventions for physical activity as they are potentially scalable to the population level. However, few very brief interventions (VBIs) have been published, and evidence is lacking about their feasibility, acceptability and which ‘active ingredients’ (behaviour change techniques) would maximise their effectiveness. The aim of this research was to identify and develop promising VBIs for physical activity and test their feasibility and acceptability in the context of preventive health checks in primary care. Methods The process included two stages, guided by four criteria: effectiveness, feasibility, acceptability, and cost. In Stage 1, we used an iterative approach informed by systematic reviews, a scoping review of BCTs, team discussion, stakeholder consultation, a qualitative study, and cost estimation to guide the development of promising VBIs. In Stage 2, a feasibility study assessed the feasibility and acceptability of the short-listed VBIs, using tape-recordings and interviews with practitioners (n = 4) and patients (n = 68), to decide which VBIs merited further evaluation in a pilot trial. Results Four VBIs were short-listed: Motivational intervention; Action Planning intervention; Pedometer intervention; and Physical Activity Diary intervention. All were deliverable in around five minutes and were feasible and acceptable to participants and practitioners. Based on the results of interviews with practitioners and patients, techniques from the VBIs were combined into three new VBIs for further evaluation in a pilot trial. Conclusions Using a two-stage approach, in which we considered the practicability of VBIs (acceptability, feasibility and cost) alongside potential efficacy from the outset, we developed a short-list of four promising VBIs for physical activity and demonstrated that they were acceptable and feasible as part of a preventive health check in primary care. Trial registration Current Controlled Trials ISRCTN02863077 . Registered 5 October 2012

Project and Research Management: Integrating Systems, Data, and People in Multidisciplinary Work (Vol. 5)

This technical report summarizes the experiential and technical knowledge in project and research management from the Sustainable Corn Coordinated Agricultural Project team. The management infrastructure, processes, outcomes, lessons learned, and insights presented in this report will be particularly relevant to directors and managers of other large teams

Radiofrequency thermal ablation of giant placental chorioangioma complicated with fetal hydrops: a case report and successful outcome

ObjectivesChorioangiomas are the most frequently occurring type of benign tumour of the placenta. However, large chorioangiomas greater than 4 cm are rare and can be more frequently associated with serious complications such as: polyhydramnios, hydrops fetalis, fetal anaemia, intrauterine growth restriction, preterm birth, and an increased risk of perinatal mortality. Importantly timely prenatal diagnosis with close surveillance alongside potential intrauterine intervention can prove impactful on pregnancy outcome and fetal survival.Case presentationWe present a case of a 36-year-old female referred to our tertiary fetal medicine unit at 28 weeks’ gestation with a large chorioangioma measuring 9.4×8.8×5.5 cm and ultrasonographic evidence of severe fetal anaemia and fetal hydrops. The patient underwent an intrauterine transfusion and in utero surgical therapy with radiofrequency ablation (RFA). Immediately following the procedure, the fetus sustained a period of bradycardia, followed by asystole. Delivery was expedited via emergency caesarean section. Careful planning and rapid delivery after fetal intervention within the most appropriate surgical setting mitigated risks for the baby and resulted in a positive outcome. The baby was discharged from the neonatal unit on day 84 of life.ConclusionsLarge placental chorioangiomas are a rare occurrence, however, when associated with fetal complications present a high incidence of adverse perinatal outcomes. In utero interventions require careful planning and surgical expertise to ensure improved fetal and neonatal outcomes. To the best of our knowledge this case is the first recorded instance of a successful postnatal outcome following RFA for a large placental chorioangioma, whereby the fetus was complicated by fetal hydrops

The Application of Transformational Leadership Theory to Parenting: Questionnaire Development and Implications for Adolescent Self-Regulatory Efficacy and Life Satisfaction

We draw upon transformational leadership theory to develop an instrument to measure transformational parenting for use with adolescents. First, potential items were generated that were developmentally appropriate and evidence for content validity was provided through the use of focus groups with parents and adolescents. We subsequently provide evidence for several aspects of construct validity of measures derived from the Transformational Parenting Questionnaire (TPQ). Data were collected from 857 adolescents (Mage = 14.70 years), who rated the behaviors of their mothers and fathers. The results provided support for a second-order measurement model of transformational parenting. In addition, positive relationships between mothers’ and fathers’ transformational parenting behaviors, adolescents’ self-regulatory efficacy for physical activity and healthy eating, and life satisfaction were found. The results of this research support the application of transformational leadership theory to parenting behaviors, as well as the construct validity of measures derived from the TPQ. (AUTHORS' ABSTRACT

School polices, programmes and facilities, and objectively measured sedentary time, LPA and MVPA: associations in secondary school and over the transition from primary to secondary school.

BACKGROUND: There is increasing policy interest in ensuring that the school environment supports healthy behaviours. We examined the cross-sectional and longitudinal associations between schools' policies, programmes and facilities for physical activity (PA) and adolescents' objectively-measured activity intensity during the school day and lunchtime. METHODS: Accelerometer-derived PA (proportion of time spent in sedentary (SED), light PA (LPA) and moderate-to-vigorous PA (MVPA)) during school hours and lunchtime from 325 participants in the SPEEDY study were obtained from baseline measurements (primary school, age 9/10 years) and +4y follow-up (secondary school). School environment characteristics were assessed by teacher questionnaire. Multivariable multi-level linear regression analyses accounting for school and adjusted for sex, age, BMI and family socio-economic status assessed cross-sectional associations with lunchtime and school-day SED, LPA and MVPA; effect modification by sex was investigated. The association of changes in school environment with changes in outcomes was examined using multivariable cross-classified linear regression models. RESULTS: There were significant differences between primary and secondary schools for 6/10 school environment characteristics investigated (including secondary schools reporting shorter breaks, more lunchtime PA opportunities, and higher number of sports facilities). Cross-sectional analyses showed that boys attending secondary schools with longer breaks spent significantly less time in SED and more time in MVPA during the school day. Longitudinally, an increase in break-time duration between primary and secondary school was associated with smaller reductions in MVPA during the school day. Moreover, participants who moved from a primary school that did not provide opportunities for PA at lunchtime to a secondary school that did provide such opportunities exhibited smaller increases in SED and smaller reductions in MVPA at lunchtime. CONCLUSIONS: Schools should consider the potential negative impact of reducing break time duration on students' MVPA and SED during the school day. School-based interventions that combine longer breaks and more PA opportunities during lunchtime may be a fruitful direction for future research. Further research should also explore other factors in the school environment to explain the school-level clustering observed, and study sex differences in the way that the school environment influences activity intensity for adolescent populations.This report is independent research commissioned and funded by the Department of Health Policy Research Programme (Opportunities within the school environment to shift the distribution of activity intensity in adolescents, PR-R5-0213-25001). The views expressed in this publication are those of the author(s) and not necessarily those of the department of health. The SPEEDY study is funded by the National Prevention Research Initiative (http://​www.​npri.​org.​uk), consisting of the following Funding Partners: British Heart Foundation; Cancer Research UK; Department of Health; Diabetes UK; Economic and Social Research Council; Medical Research Council; Health and Social Care Research and Development Office for the Northern Ireland; Chief Scientist Office, Scottish Government Health Directorates; Welsh Assembly Government and World Cancer Research Fund. This work was also supported by the Medical Research Council (Unit Programme numbers MC_UU_12015/7, MC_UU_12015/4, and MC_UU_12015/3) and the Centre for Diet and Activity Research (CEDAR), a UKCRC Public Health Research Centre of Excellence. Funding from the British Heart Foundation, Economic and Social Research Council, Medical Research Council, the National Institute for Health Research, and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged.This is the final version of the article. It first appeared from BioMed Central via http://dx.doi.org/10.1186/s12966-016-0378-