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

A Text-Messaging and Pedometer Program to Promote Physical Activity in People at High Risk of Type 2 Diabetes: The Development of the PROPELS Follow-On Support Program.

BACKGROUND: Mobile technologies for health (mHealth) represent a promising strategy for reducing type 2 diabetes (T2DM) risk. The PROPELS trial investigates whether structured group-based education alone or supplemented with a follow-on support program combining self-monitoring with pedometers and tailored text-messaging is effective in promoting and maintaining physical activity among people at high risk of T2DM. OBJECTIVE: This paper describes the iterative development of the PROPELS follow-on support program and presents evidence on its acceptability and feasibility. METHODS: We used a modified mHealth development framework with four phases: (1) conceptualization of the follow-on support program using theory and evidence, (2) formative research including focus groups (n=15, ages 39-79 years), (3) pre-testing focus groups using a think aloud protocol (n=20, ages 52-78 years), and (4) piloting (n=11). Analysis was informed by the constant comparative approach, with findings from each phase informing subsequent phases. RESULTS: The first three phases informed the structure, nature, and content of the follow-on support program, including the frequency of text messages, the need for tailored content and two-way interaction, the importance of motivational messages based on encouragement and reinforcement of affective benefits (eg, enjoyment) with minimal messages about weight and T2DM risk, and the need for appropriate language. The refined program is personalized and tailored to the individual's perceived confidence, previous activity levels, and physical activity goals. The pilot phase indicated that the program appeared to fit well with everyday routines and was easy to use by older adults. CONCLUSIONS: We developed a feasible and innovative text messaging and pedometer program based on evidence and behavior change theory and grounded in the experiences, views, and needs of people at high diabetes risk. A large scale trial is testing the effectiveness of this 4-year program over and above structured group education alone. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 83465245; http://www.controlled-trials.com/ISRCTN83465245/83465245 (Archived by WebCite at http://www.webcitation.org/6dfSmrVAe)