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 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 Protocol for a feasibility trial for improving breast feeding initiation and continuation: assets-based infant feeding help before and after birth (ABA)

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019142 ◽  
Author(s):  
Kate Jolly ◽  
Jenny Ingram ◽  
Joanne Clarke ◽  
Debbie Johnson ◽  
Heather Trickey ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Infant Feeding ◽  
Feasibility Study ◽  
Breast Feeding ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Study Results ◽  
Service Staff ◽  
Before And After ◽  
Randomised Controlled

IntroductionBreast feeding improves the health of mothers and infants; the UK has low rates, with marked socioeconomic inequalities. While trials of peer support services have been effective in some settings, UK trials have not improved breast feeding rates. Qualitative research suggests that many women are alienated by the focus on breast feeding. We propose a change from breast feeding-focused interactions to respecting a woman’s feeding choices, inclusion of behaviour change theory and an increased intensity of contacts in the 2 weeks after birth when many women cease to breast feed. This will take place alongside an assets-based approach that focuses on the positive capability of individuals, their social networks and communities.We propose a feasibility study for a multicentre randomised controlled trial of the Assets feeding help Before and After birth (ABA) infant feeding service versus usual care.Methods and analysisA two-arm, non-blinded randomised feasibility study will be conducted in two UK localities. Women expecting their first baby will be eligible, regardless of feeding intention. The ABA infant feeding intervention will apply a proactive, assets-based, woman-centred, non-judgemental approach, delivered antenatally and postnatally tailored through face-to-face contacts, telephone and SMS texts. Outcomes will test the feasibility of delivering the intervention with recommended intensity and duration to disadvantaged women; acceptability to women, feeding helpers and professionals; and feasibility of a future randomised controlled trial (RCT), detailing recruitment rates, willingness to be randomised, follow-up rates at 3 days, 8 weeks and 6 months, and level of outcome completion. Outcomes of the proposed full trial will also be collected. Mixed methods will include qualitative interviews with women/partners, feeding helpers and health service staff; feeding helper logs; and review of audio-recorded helper–women interactions to assess intervention fidelity.Ethics and disseminationStudy results will inform the design of a larger multicentre RCT. The National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN14760978; Pre-results.

scholarly journals Sit–stand desks to reduce sedentary behaviour in 9- to 10-year-olds: the Stand Out in Class pilot cluster RCT

2020 ◽  
Vol 8 (8) ◽  
pp. 1-126
Author(s):  
Stacy A Clemes ◽  
Daniel D Bingham ◽  
Natalie Pearson ◽  
Yu-Ling Chen ◽  
Charlotte Edwardson ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Health Research ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Public Health Research ◽  
Sitting Time ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Randomised Controlled

Background Sedentary behaviour (sitting) is a highly prevalent negative health behaviour, with individuals of all ages exposed to environments that promote prolonged sitting. The school classroom represents an ideal setting for environmental change through the provision of sit–stand desks. Objectives The aim of this study was to undertake a pilot cluster randomised controlled trial of the introduction of sit–stand desks in primary school classrooms, to inform a definitive trial. Objectives included providing information on school and participant recruitment and retention, acceptability of the intervention, and outcome measures. A preliminary estimate of the intervention’s effectiveness on the proposed primary outcome (change in weekday sitting time) for inclusion in a definitive trial was calculated, along with a preliminary assessment of potential cost-effectiveness. A full process evaluation was also undertaken. Design A two-armed pilot cluster randomised controlled trial with economic and qualitative evaluations. Schools were randomised on a 1 : 1 basis to the intervention (n = 4) or control (n = 4) trial arms. Setting Primary schools in Bradford, West Yorkshire, UK. Participants Children in Year 5 (i.e. aged 9–10 years). Intervention Six sit–stand desks replaced three standard desks (sitting six children) in the intervention classrooms for 4.5 months. Teachers were encouraged to ensure that all pupils were exposed to the sit–stand desks for at least 1 hour per day, on average, using a rotation system. Schools assigned to the control arm continued with their usual practice. Main outcome measures Trial feasibility outcomes included school and participant recruitment and attrition, acceptability of the intervention, and acceptability of and compliance with the proposed outcome measures [including weekday sitting measured using activPAL™ (PAL Technologies Ltd, Glasgow, UK) accelerometers, physical activity, adiposity, blood pressure, cognitive function, musculoskeletal comfort, academic progress, engagement and behaviour]. Results Thirty-three per cent of schools approached and 75% (n = 176) of eligible children took part. At the 7-month follow-up, retention rates were 100% for schools and 97% for children. Outcome measure completion rates ranged from 63% to 97%. A preliminary estimate of intervention effectiveness, from a weighted linear regression model (adjusting for baseline sitting time and wear time) revealed a mean difference in change in sitting of –30.6 minutes per day (95% confidence interval –56.42 to –4.84 minutes per day) between the intervention and control trial arms. The process evaluation revealed that the intervention, recruitment and evaluation procedures were acceptable to teachers and children, with the exception of minor issues around activPAL attachment. A preliminary within-trial economic analysis revealed no difference between intervention and control trial arms in health and education resource use or outcomes. Long-term modelling estimated an unadjusted incremental cost-effectiveness ratio of Stand Out in Class of £78,986 per quality-adjusted life-year gained. Conclusion This study has provided evidence of the acceptability and feasibility of the Stand Out in Class intervention and evaluation methods. Preliminary evidence suggests that the intervention may have a positive direction of effect on weekday sitting time, which warrants testing in a full cluster randomised controlled trial. Lessons learnt from this trial will inform the planning of a definitive trial. Trial registration Current Controlled Trials ISRCTN12915848. 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. 8. See the NIHR Journals Library website for further project information.

scholarly journals Evaluation of teaching an integrated case formulation approach on the quality of case formulations: randomised controlled trial

2012 ◽  
Vol 36 (4) ◽  
pp. 140-145 ◽  
Author(s):  
Mohammed Abbas ◽  
Ruth Walton ◽  
Allan Johnston ◽  
Millicent Chikoore
Keyword(s):  
Randomised Controlled Trial ◽  
Rating Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Case Formulation ◽  
New Approach ◽  
Before And After ◽  
Randomised Controlled

Aims and methodThis paper introduces a new approach to producing case formulations, the integrated case formulation (ICF) approach, and a rating scale, the Case Formulation Scale (CFS). Twenty-four psychiatrists participated in a single-blind randomised controlled trial to evaluate the effectiveness of teaching using this new approach. The intervention group (n = 12) received teaching about using ICF, whereas the control group (n = 12) received teaching as usual. The scores on the CFS were compared before and after teaching.ResultsPrior to teaching, psychiatric trainees had poor scores on the CFS. The CFS score for the group taught the ICF approach improved five times more than the control group.Clinical implicationsThis study demonstrates that case formulation skills can be taught. With further improvements, the ICF approach might be useful in the teaching of case formulation.

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 One-to-one volunteer befriending to reduce symptoms of depression in people with intellectual disability: a feasibility RCT

2021 ◽  
Vol 9 (10) ◽  
pp. 1-80
Author(s):  
Afia Ali ◽  
Emma Mckenzie ◽  
Zara Rasoul ◽  
Angela Hassiotis ◽  
Stefan Priebe ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Intellectual Disability ◽  
Depressive Symptoms ◽  
Health Research ◽  
Controlled Trial ◽  
Intervention Group ◽  
Depression Scale ◽  
Public Health Research ◽  
Randomised Controlled

Background Little is known about the effectiveness of befriending for people with intellectual disability and whether or not befriending improves depressive symptoms and social outcomes. Objective This pilot trial aimed to assess the feasibility and acceptability of conducting a future full-scale randomised controlled trial of one-to-one befriending for people with intellectual disability who had depressive symptoms. Design This was a parallel-group, two-armed randomised controlled trial incorporating an exploratory economic analysis and a mixed-methods process evaluation. Outcome assessments were conducted at baseline and at 6 months post randomisation by a research assistant who was blind to allocation. We aimed to approach 50 participants, with a view to recruiting 40. Setting Participants with intellectual disability were recruited from one NHS trust and from referrals to two community befriending services. The intervention was delivered by community befriending services. Participants Adults with mild or moderate intellectual disability with a score on the Glasgow Depression Scale for people with a Learning Disability of ≥ 5 were included. Those attending a day service/college for ≥ 3 days a week were excluded. Volunteers were aged ≥ 18 years and had no history of prior convictions. Intervention Participants in the intervention group were matched with a volunteer befriender and were expected to meet once per week for 1 hour, over 6 months. Volunteers recorded activities in a logbook. Volunteers received training and regular supervision. Both groups received usual care and a resource booklet of local activities. Main outcome measures The feasibility outcomes and progression criteria were recruitment of at least 70% of participants approached; matching of at least 70% of participants in the intervention group to a volunteer; a dropout rate of < 30% of participants and volunteers; adherence to the intervention (10 meetings between pairs); acceptability of the intervention; and feasibility of collecting data on costs and resource use for an economic evaluation. Changes in depressive symptoms (primary clinical outcome: Glasgow Depression Scale) and self-esteem, quality of life, social participation, social support, health-related quality of life and service use were recorded at 6 months. Outcomes in volunteers were also assessed. Results We recruited only 16 participants with intellectual disability (40% of target) and 10 volunteers. Six of the eight (75%) participants in the intervention group were matched with a befriender and there was good adherence (mean number of meetings attended 11.8; range 1–21 meetings). Going to a cafe/restaurant and having a conversation were the most frequent activities. All participants were retained at follow-up, but two volunteers dropped out. Trial procedures and the intervention might be acceptable, but modifications were suggested. Data on costs and resource use were obtained, but there were discrepancies in the health-related quality-of-life data. Limitations Delays to the study prevented the use of alternative recruitment strategies and the planned 12-month follow-up could not be completed. Conclusions Recruitment was not feasible, but other feasibility outcomes were more positive. Future work Evaluating befriending for people with intellectual disability could be explored through alternative study designs, such as observational studies. Trial registration Current Controlled Trials ISRCTN63779614. 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. 10. See the NIHR Journals Library website for further project information.

scholarly journals Brief mindfulness-based intervention of ‘STOP (Stop, Take a Breath, Observe, Proceed) touching your face’: a study protocol of a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e041364
Author(s):  
Yanhui Liao ◽  
Ling Wang ◽  
Tao Luo ◽  
Shiyou Wu ◽  
Zhenzhen Wu ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Intervention Group ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Psychological Traits ◽  
Study Results ◽  
Before And After ◽  
Randomised Controlled

IntroductionFace-touching behaviour often happens frequently and automatically, and poses potential risk for spreading infectious disease. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of behaviour disorders. This study aims to evaluate an online mindfulness-based brief intervention skill named ‘STOP (Stop, Take a Breath, Observe, Proceed) touching your face’ in reducing face-touching behaviour.Methods and analysisThis will be an online-based, randomised, controlled, trial. We will recruit 1000 participants, and will randomise and allocate participants 1:1 to the ‘STOP touching your face’ (both 750-word text and 5 min audio description by online) intervention group (n=500) and the wait-list control group (n=500). All participants will be asked to monitor and record their face-touching behaviour during a 60 min period before and after the intervention. Primary outcome will be the efficacy of short-term mindfulness-based ‘STOP touching your face’ intervention for reducing the frequency of face-touching. The secondary outcomes will be percentage of participants touching their faces; the correlation between the psychological traits of mindfulness and face-touching behaviour; and the differences of face-touching behaviour between left-handers and right-handers. Analysis of covariance, regression analysis, χ2 test, t-test, Pearson’s correlations will be applied in data analysis. We will recruit 1000 participants from April to July 2020 or until the recruitment process is complete. The follow-up will be completed in July 2020. We expect all trial results to be available by the end of July 2020.Ethics and disseminationThe study protocol has been approved by the Ethics Committee of Sir Run Run Shaw Hospital, an affiliate of Zhejiang University, Medical College (No. 20200401-32). Study results will be disseminated via social media and peer-reviewed publications.Trial registration numberNCT04330352.

scholarly journals Can a documentary increase help-seeking intentions in men? A randomised controlled trial

2017 ◽  
Vol 72 (1) ◽  
pp. 92-98 ◽  
Author(s):  
Kylie Elizabeth King ◽  
Marisa Schlichthorst ◽  
Matthew J Spittal ◽  
Andrea Phelps ◽  
Jane Pirkis
Keyword(s):  
Public Health ◽  
Randomised Controlled Trial ◽  
Help Seeking ◽  
Controlled Trial ◽  
Linear Regression Analysis ◽  
Intervention Group ◽  
Public Health Intervention ◽  
Well Being ◽  
Control Group ◽  
Randomised Controlled

BackgroundWe investigated whether a public health intervention—a three-part documentary called Man Up which explored the relationship between masculinity and mental health, well-being and suicidality—could increase men’s intentions to seek help for personal and emotional problems.MethodsWe recruited men aged 18 years or over who were not at risk of suicide to participate in a double-blind randomised controlled trial. Participants were randomly assigned (1:1) via computer randomisation to view Man Up (the intervention) or a control documentary. We hypothesised that 4 weeks after viewing Man Up participants would report higher levels of intention to seek help than those who viewed the control documentary. Our primary outcome was assessed using the General Help Seeking Questionnaire, and was analysed for all participants. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616001169437, Universal Trial Number: U1111-1186-1459) and was funded by the Movember Foundation.ResultsThree hundred and fifty-four men were assessed for eligibility for the trial and randomised to view Man Up or the control documentary. Of these, 337 completed all stages (nine participants were lost to follow-up in the intervention group and eight in the control group). Linear regression analysis showed a significant increase in intentions to seek help in the intervention group, but not in the control group (coef.=2.06, 95% CI 0.48 to 3.63, P=0.01).ConclusionsOur trial demonstrates the potential for men’s health outcomes to be positively impacted by novel, media-based public health interventions that focus on traditional masculinity.Trial registration numberACTRN12616001169437, Results.

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 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.

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