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 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 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 Preschoolers in the Playground: a pilot cluster randomised controlled trial of a physical activity intervention for children aged 18 months to 4 years

2015 ◽  
Vol 3 (5) ◽  
pp. 1-210 ◽  
Author(s):  
Sally E Barber ◽  
Shaheen Akhtar ◽  
Cath Jackson ◽  
Daniel D Bingham ◽  
Catherine Hewitt ◽  
...  
Keyword(s):  
Physical Activity ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Public Health Research ◽  
Early Years ◽  
Cluster Rct ◽  
Initiation Phase ◽  
Randomised Controlled ◽  
Full Trial

BackgroundThe preschool years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood and establishing habitual physical activity early in life is therefore vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school-aged children. There are few preschool, playground-based interventions and these have given inconclusive results. A report published by the UK’s Chief Medical Officer (CMO) highlighted the need for new interventions to promote movement in the early years (0–5 years).ObjectivesThis study aimed to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged from 18 months to 4 years (Preschoolers in the Playground or PiP) and to assess the feasibility of conducting a full-scale cluster RCT.DesignThe study was a two-armed pilot cluster RCT with economic and qualitative evaluations. Participants were randomised on a 1 : 1 basis to the PiP intervention (n = 83) or usual practice (control;n = 81).SettingBradford, West Yorkshire, UK.ParticipantsChildren aged from 18 months to 4 years.InterventionThe PiP intervention is grounded in behavioural theory (social cognitive theory) and is in accordance with CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents. The intervention was delivered in primary school playgrounds. Six 30-minute PiP sessions per week were available for 30 weeks; families were encouraged to come to three a week. The 10-week initiation phase was facilitated by a member of school staff and the maintenance phase was unsupervised.Main outcome measuresRecruitment and retention of schools and families to the trial were the main outcome measures. The acceptability of trial procedures and the intervention, the feasibility of collecting health outcome data and the fidelity of the implementation of the intervention were also evaluated. A preliminary assessment of cost-effectiveness and a sample size calculation for a full trial were conducted.ResultsIn total, 37% of schools and 48% of parents approached agreed to take part. Levels of retention were good at 10 and 52 weeks’ follow-up (82.3% and 83.5% respectively). Both the trial procedures and the intervention were acceptable. However, attendance was low during the autumn and winter/spring initiation phases but somewhat better in the summer initiation phase. Attendance was poor throughout all maintenance phases. The accelerometry protocol for measuring physical activity requires modification. The fidelity of intervention implementation was good (81% adherence). The intervention was borderline cost-effective. A sample size of 600 children from 38 schools is required for a full trial.ConclusionA full RCT of the PiP intervention is feasible. The PiP intervention requires some modification, for example running the intervention during the summer term only, but was found to be acceptable to schools and families.Trial registrationCurrent Controlled Trials ISRCTN54165860.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 5. See the NIHR Journals Library website for further project information.

scholarly journals Bristol Girls Dance Project: a cluster randomised controlled trial of an after-school dance programme to increase physical activity among 11- to 12-year-old girls

2016 ◽  
Vol 4 (6) ◽  
pp. 1-176 ◽  
Author(s):  
Russell Jago ◽  
Mark J Edwards ◽  
Simon J Sebire ◽  
Emma L Bird ◽  
Keeley Tomkinson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Adolescent Girls ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Self Determination Theory ◽  
Self Determination ◽  
After School ◽  
Cluster Randomised ◽  
Clinical Trials Unit ◽  
Randomised Controlled

BackgroundMany children do not meet UK physical activity (PA) guidelines. Girls are less active than boys, and the age-related decline in activity is steeper for girls. Dance is the favourite form of PA among adolescent girls in the UK. Participation in after-school dance classes could significantly contribute to girls’ PA. Therefore, after-school dance may be effective for increasing PA levels.ObjectivesTo determine the effectiveness and cost-effectiveness of a dance-based intervention to increase the objectively assessed mean weekday minutes of moderate- to vigorous-intensity physical activity (MVPA) of Year 7 girls (11- and 12-year olds) 1 year after baseline measurement.DesignTwo-arm cluster randomised controlled trial and economic evaluation. Year 7 girls in participant schools received a ‘taster’ session and were invited to participate. Up to 33 girls per school were able to participate. Schools were randomly assigned (equal numbers) to intervention or control arms.SettingA total of 18 mainstream secondary schools across greater Bristol.ParticipantsYear 7 girls in participating schools who could participate in physical education.InterventionNine intervention schools received an after-school dance intervention (40 × 75-minute sessions) underpinned by self-determination theory, which attempts to improve intrinsic motivation for being active, and delivered by external dance instructors. Control schools continued as normal.Main outcome measuresThe main outcome was accelerometer-assessed mean minutes of MVPA at T2. Measures were assessed at baseline (T0), the end of the intervention (T1) and at T0 + 52 weeks (T2).ResultsBaseline MVPA levels were high. A total of 508 girls were included in the primary analysis, which found no difference in weekday MVPA between trial arms. There was no effect on secondary accelerometer outcomes. Data were subjected to a per-protocol analysis and no effect was found. However, at T1, girls who attended dance classes had 4.61 minutes more of MVPA and 14.27 minutes more of light-intensity activity between 15.00 and 17.00 on the days on which they attended intervention sessions. The intervention was inexpensive at £73 per participant (£63 when excluding dance instructor travel) but was not cost-effective owing to the ineffectiveness of the intervention. The European Quality of Life-5 Dimensions Youth survey data were unresponsive to changes in the sample. The process evaluation reported that girls in attendance enjoyed the sessions, that exertion levels were low during sessions and that attendance was low and declined. Fidelity to the session-plan manual was low but theoretical fidelity (to self-determination theory) was good. Qualitative information provides information for improving future interventions.ConclusionsThe intervention was enjoyed by participants. However, there was no difference in the MVPA levels (which were high at baseline) of girls allocated to receive dance compared with girls receiving the control. High baseline MVPA levels indicate that the study appealed to an already active cohort and, therefore, may not have targeted those most in need of an intervention. Dance is an enjoyable activity for adolescent girls and could be further trialled as a means by which to increase PA. Research might consider the impact of dividing the intervention period into smaller blocks.Trial RegistrationCurrent Controlled Trials ISRCTN52882523.FundingThe National Institute for Health Research Public Health Research programme. The work was also 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) PHR 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, a UKCRC Registered Clinical Trials Unit in receipt of NIHR Clinical Trials Unit support funding. All intervention costs were funded by the respective councils to which the participant schools were affiliated, namely North Somerset Council, Bristol City Council, and Bath and North East Somerset Council.

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 Steps Towards Alcohol Misuse Prevention Programme (STAMPP): a school- and community-based cluster randomised controlled trial

2017 ◽  
Vol 5 (2) ◽  
pp. 1-154 ◽  
Author(s):  
Harry Sumnall ◽  
Ashley Agus ◽  
Jon Cole ◽  
Paul Doherty ◽  
David Foxcroft ◽  
...  
Keyword(s):  
Public Health ◽  
Health Research ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Public Health Research ◽  
Study Condition ◽  
School Year ◽  
Intervention Costs ◽  
Randomised Controlled ◽  
Mean Cost

BackgroundAlcohol use in young people remains a public health concern, with adverse impacts on outcomes such as health, well-being, education and relationships.ObjectivesTo assess the effectiveness and cost-effectiveness of a combined classroom curriculum and parental intervention on self-reported alcohol use [heavy episodic drinking (HED)] and alcohol-related harms (indicators such as getting into fights after drinking, poorer school performance and trouble with friends and family).DesignA two-arm, cluster randomised controlled trial with schools as the unit of randomisation.SettingA total of 105 post-primary schools in Northern Ireland (NI) and Glasgow/Inverclyde Educational Authority areas.ParticipantsA total of 12,738 male and female secondary school students (intervention delivered when students were in school year 9 in NI or S2 in Scotland in the academic year 2012–13 and aged 12–13 years) were randomised. Randomisation and baseline (T0) surveys took place when children were in school year 8 or S1. Schools were randomised (1 : 1) by an independent statistician to the Steps Towards Alcohol Misuse Prevention Programme (STAMPP) or to education as normal (EAN). All schools were stratified by free school meal provision. Schools in NI were also stratified by school type (male/female/coeducational).InterventionsSTAMPP combined a school-based alcohol harm reduction curriculum [an adapted version of the School Health and Alcohol Harm Reduction Project (SHAHRP)] and a brief parental intervention designed to support parents in setting family rules around drinking. The classroom component comprised two phases delivered over 2 years, and the parental component comprised a standardised presentation delivered by a trained facilitator at specially arranged parent evenings on school premises. This was followed up a few weeks later by an information leaflet mailed to all intervention pupils’ parents highlighting the main points of the evening.Main outcome measures(1) Self-reported HED (defined as self-reported consumption of ≥ 6 units in a single episode in the previous 30 days for male students and ≥ 4.5 units for female students) assessed at 33 months from baseline (T3); and (2) the number of self-reported harms (harms caused by own drinking) assessed at T3.Data sourcesSelf-completed pupil questionnaires.ResultsAt final follow-up (T3), data were available for 5160 intervention and 5073 control pupils for the HED outcome, and for 5234 intervention and 5146 control pupils for the self-reported harms outcome. The intervention reduced self-reported HED compared with EAN (p < 0.001), but did not reduce self-reported harms associated with own drinking. The odds ratio for the intervention effect on HED was 0.596 (standard error 0.0596, 95% confidence interval 0.490 to 0.725). The mean cost of delivery per school was £818 and the mean cost per individual was £15. There were no clear cost savings in terms of service utilisation associated with the intervention. The process evaluation showed that the classroom component engaged and was enjoyed by pupils, and was valued by teachers. Schools, students, intervention trainers and delivery staff (teachers) were not blind to study condition. Data collection was undertaken by a team of researchers that included the trial manager and research assistants, some of whom were not blinded to study condition. Data analysis of primary and secondary outcomes was undertaken by the trial statistician, who was blinded to the study condition.LimitationsAlthough the classroom component was largely delivered as intended, there was very low attendance at the parent/carer event; however, all intervention pupils’ parents/carers received an intervention leaflet.ConclusionsThe results of this trial provide some support for the effectiveness and cost-effectiveness of STAMPP in reducing heavy episodic (binge) drinking, but not in reducing self-reported alcohol-related harms, in young people over a 33-month follow-up period. As there was low uptake of the parental component, it is uncertain whether or not the intervention effect was accounted for by the classroom component alone.Trial registrationCurrent Controlled Trials ISRCTN47028486.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. 2. See the NIHR Journals Library website for further project information. The Public Health Agency of NI and Education Boards of Glasgow/Inverclyde provided some intervention costs. Diageo provided funds to print some workbooks. The remaining intervention costs were internally funded.

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 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.

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