scholarly journals Employer schemes to encourage walking to work: feasibility study incorporating an exploratory randomised controlled trial

2015 ◽  
Vol 3 (4) ◽  
pp. 1-60 ◽  
Author(s):  
Suzanne Audrey ◽  
Sunita Procter ◽  
Ashley Cooper ◽  
Nanette Mutrie ◽  
William Hollingworth ◽  
...  
Keyword(s):  
Public Health ◽  
Physical Activity ◽  
Feasibility Study ◽  
Health Research ◽  
Research Collaboration ◽  
Controlled Trial ◽  
Public Health Research ◽  
Full Scale ◽  
Activity Levels

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.

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 ◽  
...  
Keyword(s):  
Public Health ◽  
Physical Activity ◽  
Health Research ◽  
Delphi Study ◽  
Family Members ◽  
Public Health Research ◽  
Feasibility Trial ◽  
Recruitment Strategies ◽  
Family Based

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.

scholarly journals A peer-led intervention to promote sexual health in secondary schools: the STASH feasibility study

2020 ◽  
Vol 8 (15) ◽  
pp. 1-152
Author(s):  
Kirstin R Mitchell ◽  
Carrie Purcell ◽  
Ross Forsyth ◽  
Sarah Barry ◽  
Rachael Hunter ◽  
...  
Keyword(s):  
Social Media ◽  
Secondary Schools ◽  
Sexual Health ◽  
Feasibility Study ◽  
Health Research ◽  
Public Health Research ◽  
Full Scale ◽  
Programme Theory ◽  
Scale Evaluation

Background Young people report higher levels of unsafe sex and have higher rates of sexually transmitted infections than any other age group. Schools are well placed to facilitate early intervention, but more effective approaches are required. Peer-led approaches can augment school-based education, but often fail to capitalise on mechanisms of social influence. The potential of using social media in sexual health has not been tested in school settings. Objectives Finalise the design of the Sexually Transmitted infections And Sexual Health (STASH) intervention; assess the recruitment and retention of peer supporters, and acceptability to participants and stakeholders; assess the fidelity and reach, in addition to the barriers to and facilitators of, implementation; refine programme theory; understand the potential of social media; determine design parameters for a future randomised controlled trial, including economic evaluation; and establish whether or not progression criteria were met. Design This was a feasibility study comprising intervention development and refinement of the STASH pilot and non-randomised feasibility trial in six schools. Control data were provided by students in the year above the intervention group. Setting Secondary schools in Scotland. Participants Students aged 14–16 years, teachers and intervention delivery partners. Interventions The STASH intervention was adapted from A Stop Smoking In Schools Trial (ASSIST) (an effective peer-led smoking intervention). Based on diffusion of innovation theory, the STASH study involves peer nomination to identify the most influential students, with the aim of recruiting and training 15% of the year group as peer supporters. The peer supporters deliver sexual health messages to friends in their year group via conversations and use of Facebook (www.facebook.com; Facebook, Inc., Menlo Park, CA, USA) to share varied content from a curated set of web-based resources. Peer supporters are given support themselves via follow-up sessions and via trainer membership of Facebook groups. Main outcome measures The primary outcome was whether or not progression criteria were met in relation to intervention acceptability and feasibility. The study also piloted indicative primary outcomes for a full-scale evaluation. Data sources Peer supporter questionnaire; observations of activities; interviews with trainers, teachers, peer supporters and students; monitoring log of peer supporter activities (including on Facebook and meeting attendance); questionnaire to control year group (baseline characteristics, social networks, mediators and sexual health outcomes); baseline and follow-up questionnaire (approximately 6 months later) for intervention year group. Results A total of 104 students were trained as peer supporters (just over half of those nominated for the role by their peers). Role retention was very high (97%). Of 611 students completing the follow-up questionnaire, 58% reported exposure to STASH study activities. Intervention acceptability was high among students and stakeholders. Activities were delivered with good fidelity. The peer supporters were active, representative of their year group and well connected within their social network. Carefully managed social media use by peer supporters augmented conversations. A primary outcome of ‘always safer sex’ was identified, measured as no sex or always condom use for vaginal or anal sex in the last 6 months. The intervention cost £42 per student. Six progression criteria were met. A seventh criterion (regarding uptake of role by peer supporters) was not. Limitations Small feasibility study that cannot comment on effectiveness. Conclusions The STASH intervention is feasible and acceptable within the context of Scottish secondary schools. The results support continuation to a full-scale evaluation. Future work Small-scale improvements to the intervention, refinement to programme theory and funding sought for full-scale evaluation. Trial registration Current Controlled Trials ISRCTN97369178. 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. 8, No. 15. See the NIHR Journals Library website for further project information.

scholarly journals A peer-led physical activity intervention in schools for adolescent girls: a feasibility RCT

2019 ◽  
Vol 7 (16) ◽  
pp. 1-178
Author(s):  
Simon J Sebire ◽  
Kathryn Banfield ◽  
Rona Campbell ◽  
Mark J Edwards ◽  
Ruth Kipping ◽  
...  
Keyword(s):  
Public Health ◽  
Physical Activity ◽  
Adolescent Girls ◽  
Health Research ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Public Health Research ◽  
Clinical Trials Unit ◽  
Data Provision ◽  
Randomised Controlled

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.

scholarly journals A workplace-based intervention to increase levels of daily physical activity: the Travel to Work cluster RCT

2019 ◽  
Vol 7 (11) ◽  
pp. 1-128
Author(s):  
Suzanne Audrey ◽  
Harriet Fisher ◽  
Ashley Cooper ◽  
Daisy Gaunt ◽  
Chris Metcalfe ◽  
...  
Keyword(s):  
Physical Activity ◽  
Public Transport ◽  
Health Research ◽  
Intervention Group ◽  
Travel Behaviour ◽  
Public Health Research ◽  
Behavioural Intervention ◽  
Activity Levels ◽  
Physical Activity Levels

Background There may be opportunities for working adults to accumulate recommended physical activity levels (≥ 150 minutes of moderate-intensity physical activity in bouts of ≥ 10 minutes throughout the week) during the commute to work. Systematic reviews of interventions to increase active transport indicate that studies are predominantly of poor quality, rely on self-report and lack robust statistical analyses. Objectives To assess the effectiveness, cost and consequences of a behavioural intervention to increase walking during the commute to work. Design A multicentre, parallel-arm, cluster randomised controlled trial incorporating economic and process evaluations. Physical activity outcomes were measured using accelerometers and GPS (Global Positioning System) receivers at baseline and the 12-month follow-up. Setting Workplaces in seven urban areas in south-west England and south Wales. Participants Employees (n = 654) in 87 workplaces. Interventions Workplace-based Walk to Work promoters were trained to implement a 10-week intervention incorporating key behaviour change techniques. Main outcome measures The primary outcome was the daily number of minutes of moderate to vigorous physical activity (MVPA). Secondary outcomes included MVPA during the commute, overall levels of physical activity and modal shift (from private car to walking). Cost–consequences analysis included employer, employee and health service costs and consequences. Process outcomes included barriers to, and facilitators of, walking during the daily commute. Results There was no evidence of an intervention effect on MVPA at the 12-month follow-up [adjusted difference in means 0.3 minutes, 95% confidence interval (CI) –5.3 to 5.9 minutes]. The intervention cost was on average, £181.97 per workplace and £24.19 per participating employee. In comparison with car users [mean 7.3 minutes, standard deviation (SD) 7.6 minutes], walkers (mean 34.3 minutes, SD 18.6 minutes) and public transport users (mean 25.7 minutes, SD 14.0 minutes) accrued substantially higher levels of daily MVPA during the commute. Participants who walked for ≥ 10 minutes during their commute were more likely to have a shorter commute distance (p < 0.001). No access to a car (p < 0.001) and absence of free workplace car parking (p < 0.01) were independently related to walking to work and using public transport. Higher quality-of-life scores were observed for the intervention group in a repeated-measures analysis (mean 0.018, 95% CI 0.000 to 0.036; scores anchored at 0 indicated ‘no capability’ and scores anchored at 1 indicated ‘full capability’). Conclusions Although this research showed that walking to work and using public transport are important contributors to physical activity levels in a working population, the behavioural intervention was insufficient to change travel behaviour. Broader contextual factors, such as length of journey, commuting options and availability of car parking, may influence the effectiveness of behavioural interventions to change travel behaviour. Further analyses of statistical and qualitative data could focus on physical activity and travel mode and the wider determinants of workplace travel behaviour. Trial registration Current Controlled Trials ISRCTN15009100. 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. 11. See the NIHR Journals Library website for further project information. Living Streets, a UK charity promoting everyday walking, provided funding for the intervention booklets and free pedometers for distribution to participants in the intervention group.

scholarly journals Child-care self-assessment to improve physical activity, oral health and nutrition for 2- to 4-year-olds: a feasibility cluster RCT

2019 ◽  
Vol 7 (13) ◽  
pp. 1-164 ◽  
Author(s):  
Ruth Kipping ◽  
Rebecca Langford ◽  
Rowan Brockman ◽  
Sian Wells ◽  
Chris Metcalfe ◽  
...  
Keyword(s):  
Public Health ◽  
Physical Activity ◽  
Health Research ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Public Health Research ◽  
Post Intervention ◽  
Randomised Controlled ◽  
The Uk ◽  
Food Photography

Background The Nutrition And Physical Activity Self Assessment for Child Care (NAP SACC) intervention has shown evidence of effectiveness in the USA but not been adapted or assessed for effectiveness in the UK. Objectives To evaluate the feasibility and acceptability of implementing NAP SACC in the UK. Design Adaptation and development of NAP SACC and feasibility cluster randomised controlled trial (RCT) including process and economic evaluations. Substudies assessed mediator questionnaire test–retest reliability and feasibility of food photography methods. Setting Nurseries, staff and parents in North Somerset, Cardiff, Gloucestershire and Bristol. Participants Development – 15 early years/public health staff and health visitors, 12 nursery managers and 31 parents. RCT – 12 nurseries and 31 staff, four partners and 168 children/parents. Mediator substudy – 82 parents and 69 nursery staff. Food photography substudy – four nurseries, 18 staff and 51 children. Intervention NAP SACC UK partners supported nurseries to review policies and practices and set goals to improve nutrition, oral health and physical activity (PA) over 5 months. Two workshops were delivered to nursery staff by local experts. A home component [website, short message service (SMS) and e-mails] supported parents. The control arm continued with usual practice. Main outcome measures Feasibility and acceptability of the intervention and methods according to prespecified criteria. Data sources Qualitative data to adapt the intervention. Measurements with children, parents and staff at baseline and post intervention (8–10 months after baseline). Interviews with nursery managers, staff, parents and NAP SACC UK partners; observations of training, workshops and meetings. Nursery environment observation, nursery Review and Reflect score, and resource log. Child height and weight, accelerometer-determined PA and sedentary time, screen time and dietary outcomes using the Child and Diet Evaluation Tool. Staff and parent questionnaires of knowledge, motivation and self-efficacy. Child quality of life and nursery, family and health-care costs. Food photography of everything consumed by individual children and staff questionnaire to assess acceptability. Results Thirty-two per cent (12/38) of nurseries and 35.3% (168/476) of children were recruited; no nurseries withdrew. The intervention was delivered in five out of six nurseries, with high levels of fidelity and acceptability. Partners found it feasible but had concerns about workload. The child loss to follow-up rate was 14.2%. There was suggestion of promise in intervention compared with control nurseries post intervention for snacks, screen time, proportion overweight or obese and accelerometer-measured total PA and moderate to vigorous PA. Many parental and nursery knowledge and motivation mediators improved. The average cost of delivering the intervention was £1184 per nursery excluding partner training, and the average cost per child was £27. Fourteen per cent of parents used the home component and the mediator questionnaire had good internal consistency and test–retest reliability. Photography of food was acceptable and feasible. Limitations Following nursery leavers was difficult. Accelerometer data, diet data and environmental assessment would have been more reliable with 2 days of data. Conclusions The NAP SACC UK intervention and methods were found to be feasible and acceptable to participants, except for the home component. There was sufficient suggestion of promise to justify a definitive trial. Future work A multicentre cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of NAP SACC UK has been funded by NIHR and will start in July 2019 (PHR NIHR 127551). Trial registration Current Controlled Trials ISRCTN16287377. 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. 13. See the NIHR Journals Library website for further project information. Funding was also provided by the North Somerset and Gloucestershire Councils, Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer) (MR/KO232331/1), and the Elizabeth Blackwell Institute.

scholarly journals All-Wales Licensed Premises Intervention (AWLPI): a randomised controlled trial of an intervention to reduce alcohol-related violence

2015 ◽  
Vol 3 (10) ◽  
pp. 1-152 ◽  
Author(s):  
Simon C Moore ◽  
Mohammed Fasihul Alam ◽  
David Cohen ◽  
Kerenza Hood ◽  
Chao Huang ◽  
...  
Keyword(s):  
Public Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Health Research ◽  
Controlled Trial ◽  
Public Health Research ◽  
Licensed Premises ◽  
Randomised Controlled ◽  
And Control

BackgroundViolence in and around premises licensed for the on-site sale and consumption of alcohol continues to burden the NHS with assault-related injuries.Trial designA randomised controlled trial with licensed premises as the unit of allocation, with additional process and cost-effectiveness evaluations.MethodsPremises were eligible (n = 837) if they were licensed for on-site sale and consumption of alcohol, were within 1 of the 22 local authorities (LAs) in Wales and had previously experienced violence. Data were analysed using Andersen–Gill recurrent event models in an intention-to-treat analysis. An embedded process evaluation examined intervention implementation, reach, fidelity, dose and receipt. An economic evaluation compared costs of the intervention with benefits.InterventionPremises were randomised to receive a violence-reduction intervention, Safety Management in Licensed Environments (SMILE), which was delivered by an environmental health practitioner (EHP; the agent). SMILE consisted of an initial risk audit to identify known risks of violence, a follow-up audit scheduled to enforce change for premises in which serious risks had been identified, structured advice from EHPs on how risks could be addressed in premises and online materials that provided educational videos and related material.ObjectiveTo develop intervention materials that are acceptable and consistent with EHPs’ statutory remit; to determine the effectiveness of the SMILE intervention in reducing violence; to determine reach, fidelity, dose and receipt of the intervention; and to consider intervention cost-effectiveness.OutcomeDifference in police-recorded violence between intervention and control premises over a 455-day follow-up period.RandomisationA minimum sample size of 274 licensed premises per arm was required, rounded up to 300 and randomly selected from the eligible population. Licensed premises were randomly assigned by computer to intervention and control arms in a 1 : 1 ratio. Optimal allocation was used, stratified by LA. Premises opening hours, volume of previous violence and LA EHP capacity were used to balance the randomisation. Premises were dropped from the study if they were closed at the time of audit.ResultsSMILE was delivered with high levels of reach and fidelity but similar levels of dose to all premises, regardless of risk level. Intervention premises (n = 208) showed an increase in police-recorded violence compared with control premises (n = 245), although results are underpowered. An initial risk audit was less effective than normal practice (hazard ratio = 1.34, 95% confidence interval 1.20 to 1.51) and not cost-effective. Almost all eligible intervention premises (98.6%) received the initial risk audit; nearly 40% of intervention practices should have received follow-up visits but fewer than 10% received one. The intervention was acceptable to EHPs and to some premises staff, but less so for smaller independent premises.ConclusionsSMILE was associated with an increase in police-recorded violence in intervention premises, compared with control premises. A lack of follow-up enforcement visits suggests implementation failure for what was seen as a key mechanism of action. There are also concerns as to the robustness of police data for targeting and assessing outcome effectiveness, while intervention premises may have received greater attention from statutory agencies and, therefore, the identification of more violence than control premises. Although SMILE had high reach and was feasible and acceptable to EHPs, it was found to be ineffective and associated with increased levels of violence, compared with normal practice and it requires additional work to promote the implementation of follow-up enforcement visits. Future work will aim to better understand the role of intervention dose on outcomes and seek more objective measures of violence for use in similar trials.Trial registrationCurrent Controlled Trials ISRCTN78924818.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 10. See the NIHR Journals Library website for further project information.

scholarly journals An assets-based intervention before and after birth to improve breastfeeding initiation and continuation: the ABA feasibility RCT

2020 ◽  
Vol 8 (7) ◽  
pp. 1-156
Author(s):  
Joanne L Clarke ◽  
Jenny Ingram ◽  
Debbie Johnson ◽  
Gill Thomson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Public Health ◽  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Health Research ◽  
Controlled Trial ◽  
Intervention Group ◽  
Public Health Research ◽  
Breastfeeding Initiation ◽  
Before And After ◽  
Randomised Controlled

Background The UK has low levels of breastfeeding initiation and continuation, with evident socioeconomic disparities. To be inclusive, peer-support interventions should be woman-centred rather than breastfeeding-centred. Assets-based approaches to public health focus on the positive capabilities of individuals and communities, rather than their deficits and problems. The Assets-based feeding help Before and After birth (ABA) intervention offers an assets-based approach based on behaviour change theory. Objective To investigate the feasibility of delivering the ABA infant feeding intervention in a randomised controlled trial. Design This was an individually randomised controlled feasibility trial; women were randomised in a 1 : 1 ratio to either the intervention group or the comparator (usual care) group. Setting Two separate English sites were selected because they had an existing breastfeeding peer support service, relatively high levels of socioeconomic disadvantage and low rates of breastfeeding. Participants Women aged ≥ 16 years who were pregnant with their first child, irrespective of feeding intention (n = 103), were recruited by researchers in antenatal clinics. Interventions Proactive, woman-centred support, using an assets-based approach and including behaviour change techniques, was provided by an infant-feeding helper (a breastfeeding peer supporter trained in the ABA intervention) and delivered through face-to-face contact, telephone conversations and text messages. The intervention commenced at around 30 weeks’ gestation and could continue until 5 months postnatally. Main outcome measures The main outcome measures were feasibility of intervention delivery with the requisite intensity and duration; acceptability to women, infant-feeding helpers and maternity services; and feasibility of a future randomised controlled trial. Outcomes included recruitment rates and follow-up rates at 3 days, 8 weeks and 6 months postnatally, and outcomes for a future full trial were collected via participant questionnaires. A mixed-methods process evaluation included qualitative interviews with women, infant-feeding helpers and maternity services; infant-feeding helper logs; and audio-recordings of antenatal contacts to check intervention fidelity. Results Of the 135 eligible women approached, 103 (76.3%) agreed to participate. The study was successful in recruiting teenagers (8.7%) and women living in areas of socioeconomic disadvantage (37.3% resided in the most deprived 40% of small areas in England). Postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3 days, 8 weeks and 6 months, respectively. Feeding status at 8 weeks was obtained for 95.1% of participants. Recruitment took place from February 2017 until August 2017. It was possible to recruit and train existing peer supporters to the infant-feeding helper role. The intervention was delivered to most women with relatively high fidelity. Among the 50 women in the intervention group, 39 received antenatal visits and 40 received postnatal support. Qualitative data showed that the intervention was acceptable. There was no evidence of intervention-related harms. Limitations Birth notification delays resulted in delays in the collection of postnatal feeding status data and in the offer of postnatal support. In addition, the intervention needs to better consider all infant-feeding types and did not adequately accommodate women who delivered prematurely. Conclusion It is feasible to deliver the intervention and trial. Future work The intervention should be tested in a fully powered randomised controlled trial. Trial registration Current Controlled Trials ISRCTN14760978. 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. 8, No. 7. See the NIHR Journals Library website for further project information.

scholarly journals Adapting the ASSIST model of informal peer-led intervention delivery to the Talk to FRANK drug prevention programme in UK secondary schools (ASSIST + FRANK): intervention development, refinement and a pilot cluster randomised controlled trial

2017 ◽  
Vol 5 (7) ◽  
pp. 1-98 ◽  
Author(s):  
James White ◽  
Jemma Hawkins ◽  
Kim Madden ◽  
Aimee Grant ◽  
Vanessa Er ◽  
...  
Keyword(s):  
Public Health ◽  
Drug Use ◽  
Health Research ◽  
Illicit Drug ◽  
Illicit Drug Use ◽  
Public Health Research ◽  
Drug Prevention ◽  
Smoking Prevention ◽  
Prevention Intervention

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.

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