scholarly journals An online family-based self-monitoring and goal-setting intervention to improve children’s physical activity: the FRESH feasibility trial and three-arm pilot RCT

2021 ◽  
Vol 9 (9) ◽  
pp. 1-116
Author(s):  
Esther MF van Sluijs ◽  
Helen E Brown ◽  
Emma Coombes ◽  
Claire Hughes ◽  
Andrew P Jones ◽  
...  

Background Family-based physical activity promotion presents a promising avenue for promoting whole-family physical activity, but high-quality research is lacking. Objectives To assess the feasibility, acceptability and preliminary effectiveness of FRESH (Families Reporting Every Step to Health), a child-led online family-based physical activity intervention; and to identify effective and resource-efficient family recruitment strategies. Design The project consisted of (1) a randomised feasibility trial, (2) a randomised controlled pilot trial and (3) a systematic review and Delphi study. Setting Norfolk/Suffolk counties, UK. Participants Families, recruited from schools, workplaces and community settings, were eligible to participate if one child aged 7–11 years and one adult responsible for their care provided written consent; all family members could participate. Interventions The FRESH intervention, guided by self-determination theory, targeted whole families and was delivered via an online platform. All family members received pedometers and were given website access to select family step challenges to ‘travel’ to target cities around the world, log steps, and track progress as they virtually globetrotted. Families were randomised to FRESH intervention, pedometer-only or control arm. Main outcome measures Physical (e.g. blood pressure), psychosocial (e.g. family functioning) and behavioural (e.g. device-measured family physical activity) measures were collected at baseline and at 8- and 52-week follow-up. A mixed-methods process evaluation assessed the acceptability of the intervention and evaluation. Data sources review Systematic search of four databases (Cochrane Library, PubMed, PsycINFO and SCOPUS). Review methods Articles were screened in duplicate, and data extraction was fully checked. Academic experts participated in the three-round Delphi study. Data were combined to identify effective and resource-efficient family recruitment strategies. Inclusion criteria Included generally healthy school-aged children and at least one adult; intervention attempted to change physical activity, sedentary behaviour, screen use, diet, or prevent overweight/obesity in multiple family members; presented relevant measure of effect in children and adults. Results The feasibility study (12 families, 32 participants; 100% retention at 8 weeks) demonstrated the feasibility and acceptability of FRESH, but highlighted that adaptations were required. Of 41 families recruited in the pilot study (149 participants), 98% and 88% were retained at the 8-week and 52-week follow-up, respectively. More children in the FRESH arm self-reported doing more family physical activity, and they thought that FRESH was fun. There were no notable between-group differences in children’s outcomes. Change in moderate to vigorous physical activity at 8 weeks favoured FRESH intervention adults [vs. control: 9.4 minutes/week (95% confidence interval 0.4 to 18.4) vs. pedometer only: 15.3 (95% confidence interval 6.0 to 24.5)], and was stronger in fathers, but this was not maintained. In 49 included studies, apart from recruitment settings and strategies used (reported in 84% and 73% of the studies, respectively), recruitment details were scarce. School-based recruitment was predominant. The Delphi study identified a wide range of recruitment settings and strategies. Limitations Recruitment was the main limitation of the FRESH studies; generalisability of the proposed recruitment strategies may be limited. Conclusions This study has demonstrated the feasibility and acceptability of the FRESH intervention. However, we failed to recruit the target sample size and were unable to demonstrate a signal of effectiveness. Future research should employ a multifaceted recruitment approach. Future work Further refinements to intervention delivery and recruitment methods should be investigated. Study registration Current Controlled Trials ISRCTN12789422 and PROSPERO CRD42019140042. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 9. See the NIHR Journals Library website for further project information.

2015 ◽  
Vol 3 (4) ◽  
pp. 1-60 ◽  
Author(s):  
Suzanne Audrey ◽  
Sunita Procter ◽  
Ashley Cooper ◽  
Nanette Mutrie ◽  
William Hollingworth ◽  
...  

BackgroundPhysical inactivity increases the risk of many chronic diseases, including coronary heart disease, type 2 diabetes, obesity and some cancers. Increasing physical activity levels, particularly among the most sedentary, is an important aim of current public health policy in the UK. An opportunity for working adults to increase physical activity levels may be through walking during the daily commute.ObjectivesTo build on existing knowledge and resources to develop an employer-led scheme to increase walking to work; to test the feasibility of implementing and evaluating the intervention; and to explore other requirements of a full-scale trial.DesignFeasibility study incorporating phase 1 resource review, focus groups with employees and interviews with employers in three workplaces (one small, one medium and one large); and phase 2 exploratory cluster randomised controlled trial (RCT) including process and economic evaluations.SettingWorkplaces (eight small, five medium and four large) in Bristol.ParticipantsOne hundred and eighty-seven employees (89 male and 98 female) at baseline.InterventionsWalk to Work promoters were recruited and trained about the health, social, economic and environmental benefits of walking to work and how to identify and promote safe walking routes for employees. They were given resource packs based on nine key behaviour change techniques. The role of the Walk to Work promoter was to encourage participating employees in their workplace to walk to work; to help to identify walking routes; to encourage goal setting; and to provide additional encouragement through four contacts over the following 10 weeks (face to face, e-mail or telephone, as appropriate).Main outcome measuresRecruitment and retention rates; sample size calculation and estimation of the intracluster correlation coefficient (ICC); acceptability of the intervention and evaluation methods; and estimation of costs.ResultsWorkplace and employee recruitment appeared to be restricted by the initial requirement to identify employees living within 2 miles of the workplace. Once recruited, no workplace withdrew from the study between baseline and 1-year follow-up. It proved feasible to recruit and train workplace Walk to Work promoters. The response rate was 132 (71%) at 1-year follow-up. Although the study was not powered to measure effectiveness, accelerometer data suggest that overall physical activity and moderate to vigorous physical activity (MVPA) were higher in the intervention arm than in the control arm at 1-year follow-up. The ICC was estimated at 0.12 (95% confidence interval 0.00 to 0.30). Based on an average cluster size of eight, an ICC of 0.15 and attrition of 25%, a total sample size of 678 would have 80% power with 5% significance to detect a 15% increase in mean MVPA. The average cost of the intervention was estimated at £441 per workplace. Activity levels were similar in the intervention and control arms at baseline.ConclusionsThe intervention and evaluation were feasible, and acceptable to participants. There was sufficient evidence of promise to justify a full-scale trial incorporating lessons learned during the feasibility study. Future work: an application is being submitted for a follow-on full-scale cluster RCT.Trial registrationCurrent Controlled Trials ISRCTN72882329.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 4. See the NIHR Journals Library website for further project information. The work was undertaken with the support of The Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), a UK Clinical Research Collaboration Public Health Research Centre of Excellence. Joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the Welsh Government and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged.


2017 ◽  
Vol 5 (7) ◽  
pp. 1-98 ◽  
Author(s):  
James White ◽  
Jemma Hawkins ◽  
Kim Madden ◽  
Aimee Grant ◽  
Vanessa Er ◽  
...  

BackgroundIllicit drug use increases the risk of poor physical and mental health. There are few effective drug prevention interventions.ObjectiveTo assess the acceptability of implementing and trialling two school-based peer-led drug prevention interventions.DesignStage 1 – adapt ASSIST, an effective peer-led smoking prevention intervention to deliver information from the UK national drug education website [see www.talktofrank.com (accessed 29 August 2017)]. Stage 2 – deliver the two interventions, ASSIST + FRANK (+FRANK) and FRANK friends, examine implementation and refine content. Stage 3 – four-arm pilot cluster randomised control trial (cRCT) of +FRANK, FRANK friends, ASSIST and usual practice, including a process evaluation and an economic assessment.SettingFourteen secondary schools (two in stage 2) in South Wales, UK.ParticipantsUK Year 8 students aged 12–13 years at baseline.Interventions+FRANK is a UK informal peer-led smoking prevention intervention provided in Year 8 followed by a drug prevention adjunct provided in Year 9. FRANK friends is a standalone informal peer-led drug prevention intervention provided in Year 9. These interventions are designed to prevent illicit drug use through training influential students to disseminate information on the risks associated with drugs and minimising harms using content from www.talktofrank.com. Training is provided off site and follow-up visits are made in school.OutcomesStage 1 – +FRANK and FRANK friends intervention manuals and resources. Stage 2 – information on the acceptability and fidelity of delivery of the interventions for refining manuals and resources. Stage 3 – (a) acceptability of the interventions according to prespecified criteria; (b) qualitative data from students, staff, parents and intervention teams on implementation and receipt of the interventions; (c) comparison of the interventions; and (d) recruitment and retention rates, completeness of primary, secondary and intermediate outcome measures and estimation of costs.Results+FRANK and FRANK friends were developed with stakeholders [young people, teachers (school management team and other roles), parents, ASSIST trainers, drug agency staff and a public health commissioner] over an 18-month period. In the stage 2 delivery of +FRANK, 12 out of the 14 peer supporters attended the in-person follow-ups but only one completed the electronic follow-ups. In the pilot cRCT, 12 schools were recruited, randomised and retained. The student response rate at the 18-month follow-up was 93% (1460/1567 students). Over 80% of peer supporters invited were trained and reported conversations on drug use and contact with trainers. +FRANK was perceived less positively than FRANK friends. The prevalence of lifetime illicit drug use was 4.1% at baseline and 11.6% at follow-up, with low numbers of missing data for all outcomes. The estimated cost per school was £1942 for +FRANK and £3041 for FRANK friends. All progression criteria were met.ConclusionsBoth interventions were acceptable to students, teachers and parents, but FRANK friends was preferred to +FRANK. A limitation of the study was that qualitative data were collected on a self-selecting sample. Future work recommendations include progression to a Phase III effectiveness trial of FRANK friends.Trial registrationCurrent Controlled Trials ISRCTN14415936.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 5, No. 7. See the NIHR Journals Library website for further project information. The work was undertaken with the support of the Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer). Joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, the Economic and Social Research Council, the Medical Research Council, the Welsh Government and the Wellcome Trust, under the auspices of the UK CRC, is gratefully acknowledged.


2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Z Zins

Abstract The overarching objective of CONSTANCES is to constitute a research infrastructure based on a large population-based cohort to serve as a versatile, high quality and efficient platform for population health research. Constances is designed as a representative sample of 200,000 adults aged 18-69 at inception living in different regions of France. CONSTANCES, which is accessible to the national and international research community, enables the conduct of valid and well-powered studies in a wide range of scientific domains. For each participant, it combines detailed data collection at baseline, englobing lifestyle, environmental, social, and medical history information, with medical examinations, neuropsychological testing with the added advantage of linkage with two major national administrative data bases (SNDS and CNAV). Further, CONSTANCES collects information about changing lifestyles, environments, health behaviors and health conditions on a prospective ongoing basis. A biobank of blood and urine samples is in the process of being constituted. As of April 2018, 85 nested projects designed by French and international teams in many areas of biomedical and public health research were initiated. Constances participates in several French and international consortiums. We established relationships with public health institutions and industrial companies. In the next years, we plan to continue longitudinal follow-up CONSTANCES along the same lines by extending the follow-up of the cohort and by developing innovative new themes prioritizing the strengthening of certain “niches” where CONSTANCES can have international leadership.


BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e030902 ◽  
Author(s):  
Justin M Guagliano ◽  
Helen Elizabeth Brown ◽  
Emma Coombes ◽  
Elizabeth S Haines ◽  
Claire Hughes ◽  
...  

IntroductionFamily-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 analysisFRESH 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 postbaseline. 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 (eg, fitness and blood pressure), psychosocial (eg, social support) and behavioural (eg, objectively measured family PA) measures will be collected at 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 disseminationThis 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.Trial registration numberISRCTN12789422


2021 ◽  
Vol 9 (12) ◽  
pp. 1-138
Author(s):  
Judi Kidger ◽  
Rhiannon Evans ◽  
Sarah Bell ◽  
Harriet Fisher ◽  
Nicholas Turner ◽  
...  

Background Health and Safety Executive data show that teachers are at heightened risk of mental health difficulties, yet few studies have attempted to address this. Poor teacher mental health may impact on the quality of support provided to young people, who also report increased mental health difficulties themselves. Objective To test the effectiveness of an intervention aiming to improve secondary school teachers’ well-being through mental health support and training. Design A cluster randomised controlled trial with embedded process and economic evaluations. Setting Twenty-five mainstream, non-fee-paying secondary schools in the south-west of England and South Wales, stratified by geographical area and free school meal entitlement, randomly allocated to intervention or control groups following collection of baseline measures (n = 12, intervention; n = 13, control) between May and July 2016. Participants All teachers in the study schools at any data collection. All students in year 8 (baseline) and year 10 (final follow-up). Intervention Each intervention school received three elements: (1) a 1-day mental health first aid for schools and colleges training session delivered to 8% of all teachers; (2) a 1-hour mental health session delivered to all teachers; and (3) 8% of staff trained in the 2-day standard mental health first aid training course set up a confidential peer support service for colleagues. Control schools continued with usual practice. Main outcome measures The primary outcome was teacher well-being (using the Warwick–Edinburgh Mental Wellbeing Scale). Secondary outcomes were teacher depression, absence and presenteeism, and student well-being, mental health difficulties, attendance and attainment. Follow-up was at 12 and 24 months. Data were analysed using intention-to-treat mixed-effects repeated-measures models. Economic evaluation A cost–consequence analysis to compare the incremental cost of the intervention against the outcomes measured in the main analysis. Process evaluation A mixed-methods study (i.e. qualitative focus groups and interviews, quantitative surveys, checklists and logs) to examine intervention implementation, activation of the mechanisms of change outlined in the logic model, intervention acceptability and the wider context. Results All 25 schools remained in the study. A total of 1722 teachers were included in the primary analysis. We found no difference in mean teacher well-being between study arms over the course of follow-up (adjusted mean difference –0.90, 95% confidence interval –2.07 to 0.27). There was also no difference in any of the secondary outcomes (p-values 0.203–0.964 in the fully adjusted models). The average cost of the intervention was £9103 (range £5378.97–12,026.73) per intervention school, with the average cost to Welsh schools being higher because of a different delivery model. The training components were delivered with high fidelity, although target dosage was sometimes missed. The peer support service was delivered with variable fidelity, and reported usage by teachers was low (5.9–6.1%). The intervention had high acceptability, but participants reported low support from senior leadership, and minimal impact on school culture. Limitations Participants and the study team were unblinded, self-report for the main outcome measures and inaccurate measurement of peer support service usage. Conclusions The Wellbeing in Secondary Education (WISE) intervention was not effective at improving teacher or student well-being, or reducing mental health difficulties, possibly because of contextual barriers preventing it becoming embedded in school life. Future work Identification of ways in which to achieve system-level change and sustained support from senior leaders is important for future school-based mental health interventions. Trial registration Current Controlled Trials ISRCTN95909211. Funding This project was funded by the National Institute for Health Research Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 12. See the NIHR Journals Library website for further project information. Intervention costs were met by Public Health Wales, Public Health England and Bristol City Council.


2019 ◽  
Vol 7 (16) ◽  
pp. 1-178
Author(s):  
Simon J Sebire ◽  
Kathryn Banfield ◽  
Rona Campbell ◽  
Mark J Edwards ◽  
Ruth Kipping ◽  
...  

Background Girls are less active than boys and few adolescent girls meet physical activity (PA) guidelines. Peers are an important influence on the views and behaviours of adolescent girls, yet many PA interventions involving peers use formal approaches that may not harness the power of peer groups. More informal peer-led PA interventions, which work within proximal peer groups, may hold promise for increasing girls’ PA. Objectives To examine the feasibility, evidence of promise and cost of the Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A), a peer-led PA intervention. Design Phase 1 comprised formative work and a pilot study conducted in one secondary school. Phase 2 was a feasibility study comprising a pilot randomised controlled trial in six secondary schools, including process and economic evaluations. Setting Six secondary schools in South Gloucestershire and Wiltshire, recruited from schools above the median local Pupil Premium (i.e. more deprived). Participants Year 8 girls (aged 12–13 years). Intervention Year 8 girls nominated other girls in their year who are likely to be influential (e.g. who they look up to, are good listeners); the 18% most nominated were invited to be peer supporters (PSs). PSs attended 2 consecutive days of training (plus a top-up day 5 weeks later) outside the school site, led by pairs of PS trainers, to increase their knowledge about PA and their capabilities and confidence to promote PA in their friendship group. Main outcome measures Measures focused on establishing evidence for feasibility and promise: recruitment and retention of Year 8 girls and PSs, data provision rates [accelerometer and questionnaire collected pre randomisation/beginning of Year 8 (T0), end of Year 8 (T1) and beginning of Year 9 (T2)], intervention acceptability, PS training attendance, intervention cost, and the between-arm difference in weekday minutes of moderate to vigorous PA (MVPA). A process evaluation was conducted. Results Six schools were recruited: four PLAN-A (n = 269) and two control (n = 158). In total, 94.7% of Year 8 girls participated. A total of 55 (17–24% of Year 8 girls) PSs were trained (attendance rate 91–100%). Five girls were trained as PS trainers. Questionnaire data provision exceeded 92% at all time points. Accelerometer return rates were > 85% and wear-time criteria were met by 83%, 71% and 62% of participants at T0, T1 and T2, respectively. Mean weekday MVPA did not differ between intervention arms at T1 (1.1 minutes, 95% CI –4.3 to 6.5 minutes) but did at T2 (6.1 minutes, 95% CI 1.4 to 10.8 minutes), favouring PLAN-A. The mean cost of intervention delivery was £2685 per school or £37 per Year 8 girl. Process evaluation identified good fidelity, engagement and enjoyment of the PS training and peer-support strategies. PSs needed more guidance on how to start conversations. Limitations Accelerometer data provision was lowest at T2, suggesting a need for strategies to increase compliance. Conclusions Informal peer-led intervention approaches, such as PLAN-A, hold promise as a means of promoting PA to adolescent girls. Future work A definitive randomised controlled trial of PLAN-A is warranted. Trial registration Current Controlled Trials ISRCTN12543546. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 7, No. 16. See the NIHR Journals Library website for further project information. The work was undertaken with the support of the Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), a UK Clinical Research Collaboration (UKCRC) Public Health Research Centre of Excellence. Joint funding (MR/KO232331/1) from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the Welsh Government and the Wellcome Trust, under the auspices of the UKCRC, is gratefully acknowledged. This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration (BRTC), a UK CRC-registered clinical trials unit in receipt of NIHR clinical trials unit support funding. The intervention costs were jointly funded by South Gloucestershire Council and Wiltshire Council.


2020 ◽  
Author(s):  
Carpio-Arias Tannia Valeria ◽  
Álvarez-Dardet Carlos ◽  
Ruiz-Cantero María Teresa ◽  
Ortíz Rocío

Las políticas públicas son los proyectos que gestiona el gobierno con el fin de satisfacer una necesidad en la sociedad. Objetivo: Analizar la situación de las políticas públicas de investigación en salud en Ecuador. Métodos: Se realizó un estudio FODA (fortalezas, oportunidades, debilidades y amenazas) más un estudio Delphi a 20 informantes clave (sector público y privado) sobre su percepción de los aspectos positivos y negativos de las políticas públicas de investigación en salud del Ecuador en los últimos 8 años (2007-2014). Realización del estudio: Marzo, 2014 a febrero, 2015. Fuente de información: encuesta online. Posteriormente, los participantes ordenaron las tres estrategias más nombradas en cada componente del FODA según su importancia. Tras calcular la mediana, rangos inter cuartil y valores mínimo y máximo, los expertos llegaron al consenso final. Resultados: Los 4 componentes FODA más frecuentes fueron: Fortaleza: Apoyo gubernamental mediante Becas del Gobierno; Oportunidades: Coordinación Interinstitucional y redes de investigación. Debilidades: Trámites burocráticos, especialmente para obtención de fondos económicos para investigación, y evaluaciones de proyectos por profesionales con poca experiencia. Amenazas: Cambios de políticas inesperados, legislación confusa, disminución en los presupuestos. Conclusiones: La investigación y producción científica en el Ecuador presenta cambios importantes, se recomienda aprovechar el apoyo gubernamental, la coordinación y financiamiento institucional, fortaleciendo los recursos destinados para la investigación y evitando los trámites burocráticos y reglamentos confusos. Public policies are the projects that the government manages in order to satisfy a need in society. Objective: To analyze the situation of public health research policies in Ecuador. Methods: A SWOT study (strengths, opportunities, weaknesses and threats) plus a Delphi study was conducted on 20 key informants (public and private sector) on their perception of the positive and negative aspects of Ecuador’s public health research policies in the last 8 years (2007-2014). Conduct of the study: March 2014 to February 2015. Source of information: online survey. Subsequently, the participants ordered the three most-named strategies in each SWOT component according to their importance. After calculating the mean, median and minimum and maximum values, the experts reached the final consensus. Results: The 4 most frequent SWOT components were: Strength: Government support through Government Scholarships; Opportunities: Inter-institutional coordination and research networks. Weaknesses: Bureaucratic procedures, especially to obtain economic funds for research, and project evaluations by professionals with little experience. Threats: Unexpected policy changes, confusing legislation, decrease in budgets. Conclusions: Research and scientific production in Ecuador presents important changes, it is recommended to take advantage of government support, institutional coordination and financing, strengthening the resources allocated for research and avoiding bureaucratic procedures and confusing regulations. Palabras claves: Políticas públicas, Investigación en salud, Ecuador, Delfos. Key words: Public policies, Health research, Ecuador, Delphi.


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