scholarly journals Football Fans in Training (FFIT): a randomised controlled trial of a gender-sensitised weight loss and healthy living programme for men – end of study report

2015 ◽  
Vol 3 (2) ◽  
pp. 1-130 ◽  
Author(s):  
Sally Wyke ◽  
Kate Hunt ◽  
Cindy M Gray ◽  
Elisabeth Fenwick ◽  
Christopher Bunn ◽  
...  
Keyword(s):  
Weight Loss ◽  
Cost Effectiveness ◽  
Weight Management ◽  
Health Research ◽  
Controlled Trial ◽  
Cost Effective ◽  
Public Health Research ◽  
Randomised Controlled ◽  
Objectively Measured ◽  
Cost Effectiveness Threshold

BackgroundThe prevalence of male obesity is increasing alongside low uptake of existing weight management programmes by men. Football Fans in Training (FFIT) is a group-based, weight management and healthy living programme delivered by community coaches.ObjectivesTo assess (1) the effectiveness and cost-effectiveness of FFIT, (2) fidelity of delivery and (3) coach and participant experiences of FFIT.DesignA two-arm, pragmatic, randomised controlled trial; associated cost-effectiveness [in terms of incremental cost per quality-adjusted life-year (QALY) within trial and over individuals’ lifetimes]; and process evaluation. Participants were block randomised in a 1 : 1 ratio, stratified by club; the intervention group started FFIT within 3 weeks and the comparison group were put on a 12-month waiting list.SettingThirteen professional football clubs in Scotland, UK.ParticipantsA total of 747 men aged 35–65 years with an objectively measured body mass index (BMI) of ≥ 28 kg/m2.InterventionsFFIT was gender sensitised in context, content and style of delivery. A total of 12 weekly sessions delivered at club stadia combined effective behaviour change techniques with dietary information and physical activity sessions. Men carried out a pedometer-based walking programme. A light-touch maintenance programme included six e-mails and a reunion session at 9 months. At baseline, both groups received a weight management booklet, feedback on their BMI and advice to consult their general practitioner if blood pressure was high.Primary outcomeMean difference in weight loss between groups at 12 months expressed as absolute weight and a percentage. Intention-to-treat analyses used all available data.Data sourcesObjective measurements, questionnaires, observations, focus groups and coach interviews.ResultsA total of 374 men were allocated to the intervention and 333 (89%) completed 12-month assessments; a total of 374 were allocated to the comparator and 355 (95%) completed 12-month assessments. At 12 months, the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4.94 kg [95% confidence interval (CI) 3.95 kg to 5.94 kg]; percentage weight loss, similarly adjusted, was 4.36% (95% CI 3.64% to 5.08%), in favour of the intervention (p < 0.0001). Sensitivity analyses gave similar results. Pre-specified subgroup analyses found no significant predictors of primary outcome. Highly significant differences in favour of the intervention were observed for objectively measured waist, percentage body fat, systolic and diastolic blood pressure, and self-reported physical activity, diet and indicators of well-being and physical aspects of quality of life. Eight serious adverse events were reported, of which two were reported as related to FFIT participation. From the within-trial analysis, FFIT was estimated to cost £862 per additional man maintaining a 5% weight reduction at 12 months and £13,847 per additional QALY, both compared with no intervention. For a cost-effectiveness threshold of £20,000/QALY, the probability that FFIT is cost-effective, compared with no active intervention, is 0.72. This probability rises to 0.89 for a cost-effectiveness threshold of £30,000/QALY. From the longer-term analysis, FFIT was estimated to cost £2535 per life-year gained and £2810 per QALY gained. FFIT was largely delivered as intended. The process evaluation demonstrated the powerful draw of football to attract men at high risk of ill health. FFIT was popular and analyses suggest that it enabled lifestyle change in ways that were congruent with participants’ identities.ConclusionsParticipation in FFIT led to significant reductions in weight at 12 months. It was cost-effective at standard levels employed in the UK, attracted men at high risk of future ill health and was enjoyable. Further research should investigate whether or not participants retained weight loss in the long term, how the programme could be optimised in relation to effectiveness and intensity of delivery and how group-based programmes may operate to enhance weight loss in comparison with individualised approaches.Study registrationCurrent Controlled Trials ISRCTN32677491.FundingScottish Government and The Football Pools funded the delivery of FFIT. National Institute for Health Research Public Health Research programme funded the evaluation and will be published in full inPublic Health Research; Vol. 3, No. 2. See the NIHR Journals Library website for further project information.

scholarly journals Results of the First Steps study: a randomised controlled trial and economic evaluation of the Group Family Nurse Partnership (gFNP) programme compared with usual care in improving outcomes for high-risk mothers and their children and preventing abuse

2017 ◽  
Vol 5 (9) ◽  
pp. 1-152 ◽  
Author(s):  
Jacqueline Barnes ◽  
Jane Stuart ◽  
Elizabeth Allen ◽  
Stavros Petrou ◽  
Joanna Sturgess ◽  
...  
Keyword(s):  
Usual Care ◽  
Health Research ◽  
Controlled Trial ◽  
Maternal Sensitivity ◽  
Cost Effective ◽  
Public Health Research ◽  
Expectant Mothers ◽  
Randomised Controlled ◽  
Family Nurse Partnership ◽  
Group Family

BackgroundFamily Nurse Partnership (FNP) is a home-based nurse home-visiting programme to support vulnerable parents. Group Family Nurse Partnership (gFNP) has similar aims and materials and was demonstrated to be feasible in implementation evaluations.ObjectivesTo determine whether or not gFNP, compared with usual care, could reduce risk factors for maltreatment in a vulnerable group and be cost-effective.DesignA multisite randomised controlled parallel-group trial and prospective economic evaluation, with eligible women allocated (minimised by site and maternal age group) to gFNP or usual care.SettingCommunity locations in the UK.ParticipantsExpectant mothers aged < 20 years with one or more previous live births, or expectant mothers aged 20–24 years with no previous live births and with low educational qualifications (defined as General Certificate of Education at grade C or higher in neither mathematics nor English language or, if they had both, no more than four General Certificates of Education at grade C or higher).InterventionForty-four sessions of gFNP (14 during pregnancy and 30 in the first 12 months after birth) were offered to groups of between 8 and 12 women with similar expected delivery dates (the difference between the earliest and latest expected delivery date ranged from 8 to 10 weeks depending on the group) by two family nurses (FNs), one of whom had notified her intention to practise as a midwife.Main outcome measuresParenting was assessed by a self-report measure of parenting opinions, the Adult Adolescent Parenting Inventory Version 2 (AAPI-2), and an objective measure of maternal sensitivity, the CARE-Index. Cost-effectiveness was primarily expressed in terms of incremental cost per quality-adjusted life-year (QALY) gained.Data sourcesInterviews with participants at baseline and when infants were aged 2, 6 and 12 months. Cost information from nurse weekly logs and other service delivery data.ResultsIn total, 166 women were enrolled (99 to the intervention group and 67 to the control group). Adjusting for site and maternal age group, the intention-to-treat analysis found no effect of gFNP on either of the primary outcomes. AAPI-2 total was 7.5/10 [standard error (SE) 0.1] in both arms [difference also adjusted for baseline 0.08, 95% confidence interval (CI) –0.15 to 0.28;p = 0.50]. CARE-Index maternal sensitivity mean: intervention 4.0 (SE 0.3); control 4.7 (SE 0.4) (difference –0.76, 95% CI –1.67 to 0.13;p = 0.21). The sensitivity analyses supported the primary analyses. The probability that the gFNP intervention was cost-effective based on the QALY measure did not exceed 3%. However, in terms ofchangein AAPI-2 score (baseline to 12 months), the probability that gFNP was cost-effective reached 25.1%. A separate discrete choice experiment highlighted the value placed by both pregnant women and members of the general population on non-health outcomes that were not included in the QALY metric.LimitationsSlow recruitment resulted in smaller than ideal group sizes. In some cases, few or no sessions took place owing to low initial group size, and small groups may have contributed to attrition from the intervention. Exposure to gFNP sessions was below maximum for most group members, with only 58 of the 97 intervention participants receiving any sessions; FNs were experienced with FNP but were mainly new to delivering gFNP.ConclusionsThe trial does not support the delivery of gFNP as a means of reducing the risk of child abuse or neglect in this population.Future workA randomised controlled trial with modified eligibility to enable first-time mothers aged < 20 years to be included, and a modified recruitment strategy to enable faster identification of potential participants from antenatal medical records.Trial registrationCurrent Controlled Trials ISRCTN78814904.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. 9. See the NIHR Journals Library website for further project information.

scholarly journals Text messaging and financial incentives to encourage weight loss in men with obesity: the Game of Stones feasibility RCT

2020 ◽  
Vol 8 (11) ◽  
pp. 1-224
Author(s):  
Stephan U Dombrowski ◽  
Matthew McDonald ◽  
Marjon van der Pol ◽  
Mark Grindle ◽  
Alison Avenell ◽  
...  
Keyword(s):  
Weight Loss ◽  
Health Research ◽  
Financial Incentives ◽  
Controlled Trial ◽  
Phase 1 ◽  
Qualitative Interviews ◽  
Public Health Research ◽  
Management Intervention ◽  
Randomised Controlled ◽  
Weight Management Intervention

Background In 2016, 26% of UK men were estimated to be obese. Systematic reviews suggest that few men engage in formal weight loss interventions that support weight reduction and improve health. Objective To co-produce, with patient and public involvement, an acceptable and feasible randomised controlled trial design to test a men-only weight management intervention. Design This was a two-phase feasibility study. Phase 1 was the development of intervention components, study procedures and materials including a discrete choice experiment with survey questions. Phase 2 was an individually randomised three-arm feasibility trial over 12 months. Qualitative interviews were conducted at 3 and 12 months. Setting The setting was two sites in Scotland that had disadvantaged urban and rural areas and differed in employment levels and ethnic groups. Participants In phase 1, 1045 men with obesity were recruited by Ipsos MORI (London, UK; www.ipsos.com/ipsos-mori/en-uk) to represent the UK population. In phase 2, 105 men with obesity were recruited in the community or through general practice obesity registers. Qualitative interviews were conducted with 50 men at 3 months and with 33 men at 12 months. Interventions The trial arms were narrative short message service (SMS) for 12 months (SMS only), financial endowment incentive informed by loss aversion and linked to achievement of weight loss targets plus narrative SMS for 12 months (SMS + I), and waiting list control group for 12 months followed by 3 months of an alternative SMS style developed based on feedback from men who had received the narrative SMS (control). Main outcome measures The main outcome measures were acceptability and feasibility of recruitment, retention, engagement, intervention components and trial procedures. Outcomes were assessed by examining procedural, quantitative and qualitative data at 3, 6 and 12 months. Results The most acceptable incentive strategy, based on the discrete choice experiment results, was to verify weight loss of 5% at 3 months, verify weight loss of 10% at 6 months and maintain weight loss of 10% at 12 months. Overall, 105 men with obesity from across the socioeconomic spectrum were successfully recruited to target, 59% of whom lived in more disadvantaged areas. Retention at 12 months was acceptable (74%) and was higher among individuals from disadvantaged areas. Narrative SMS were acceptable to many men, with a minority reporting negative reactions. Incentives were acceptable but were not the primary motivation for behaviour change. Twelve men in the incentive arm (33%) secured at least some money and three (8%) secured the full amount. Both intervention arms lost some weight, with greater weight loss in the arm that received SMS and incentives. The alternative SMS based on men’s feedback received no strong negative reactions. Limitations Fewer participants from the SMS + I arm (64%) completed the study at 12 months than did those in the SMS-only (79%) and control (83%) arms. The reasons for this difference were complex. Conclusions The men-only weight management intervention consisting of narrative SMS and financial incentives was acceptable and feasible, meeting the progression criteria for a full trial. Tailoring of SMS may improve acceptability and retention. Future work Minor refinements to the intervention components based on the study findings will be made prior to testing in a multisite definitive randomised controlled trial. Trial registration ClinicalTrials.gov NCT03040518. 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. 11. See the NIHR Journals Library website for further project information.

scholarly journals Lifestyle information and access to a commercial weight management group to promote maternal postnatal weight management and positive lifestyle behaviour: the SWAN feasibility RCT

2020 ◽  
Vol 8 (9) ◽  
pp. 1-176
Author(s):  
Debra Bick ◽  
Cath Taylor ◽  
Vanita Bhavnani ◽  
Andy Healey ◽  
Paul Seed ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Weight Management ◽  
Body Mass ◽  
Health Research ◽  
Controlled Trial ◽  
Public Health Research ◽  
Normal Body Mass Index ◽  
Lifestyle Behaviour ◽  
Normal Body ◽  
Randomised Controlled

Background Increasing numbers of UK women have overweight or obese body mass index scores when they become pregnant, or gain excessive weight in pregnancy, increasing their risk of adverse outcomes. Failure to manage postnatal weight is linked to smoking, non-healthy dietary choices, lack of regular exercise and poorer longer-term health. Women living in areas of higher social deprivation are more likely to experience weight management problems postnatally. Objectives The objectives were to assess the feasibility of conducting a definitive randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of lifestyle information and access to a commercial weight management group focusing on self-monitoring, goal-setting and motivation to achieve dietary change commencing 8–16 weeks postnatally to achieve and maintain weight management and positive lifestyle behaviour. Design The design was a randomised two-arm feasibility trial with a nested mixed-methods process evaluation. Setting The setting was a single centre in an inner city setting in the south of England. Participants Participants were women with body mass index scores of > 25 kg/m2 at antenatal ‘booking’ and women with normal body mass index scores (18.0–24.9 kg/m2) at antenatal booking who developed excessive gestational weight gain as assessed at 36 weeks’ gestation. Main outcome measures Recruitment, retention, acceptability of trial processes and identification of relevant economic data were the feasibility objectives. The proposed primary outcome was difference between groups in weight at 12 months postnatally, expressed as percentage weight change and weight loss from antenatal booking. Other proposed outcomes included assessment of diet, physical activity, smoking, alcohol consumption, body image, maternal esteem, mental health, infant feeding and NHS costs. Results Most objectives were achieved. A total of 193 women were recruited, 98 allocated to the intervention arm and 95 to the control arm. High follow-up rates (> 80%) were achieved to 12 months. There was an 8.8% difference in weight loss at 12 months between women allocated to the intervention arm and women allocated to the control arm (13.0% vs. 4.2%, respectively; p = 0.062); 47% of women in the intervention arm attended at least one weight management session, with low risk of contamination between arms. The greatest benefit was among women who attended ≥ 10 sessions. Barriers to attending sessions included capability, opportunity and motivation issues. Data collection tools were appropriate to support economic evaluation in a definitive trial, and economic modelling is feasible to quantify resource impacts and outcomes not directly measurable within a trial. Limitations The trial recruited from only one site. It was not possible to recruit women with normal body mass index scores who developed excessive pregnancy weight gain. Conclusions It was feasible to recruit and retain women with overweight or obese body mass index scores at antenatal booking to a trial comparing postnatal weight management plus standard care with standard care only and collect relevant data to assess outcomes. Approaches to recruit women with normal body mass index scores who gain excessive gestational weight need to be considered. Commercial weight management groups could support women’s weight management as assessed at 12 months postnatally, with probable greater benefit from attending ≥ 10 sessions. Process evaluation findings highlighted the importance of providing more information about the intervention on trial allocation, extended duration of time to commence sessions following birth and extended number of sessions offered to enhance uptake and retention. Results support the conduct of a future randomised controlled trial. Trial registration Current Controlled Trials ISRCTN39186148. 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. 9. See the NIHR Journals Library website for further project information.

scholarly journals Cluster randomised controlled trial and economic and process evaluation to determine the effectiveness and cost-effectiveness of a novel intervention [Healthy Lifestyles Programme (HeLP)] to prevent obesity in school children

2018 ◽  
Vol 6 (1) ◽  
pp. 1-204 ◽  
Author(s):  
Katrina Wyatt ◽  
Jenny Lloyd ◽  
Siobhan Creanor ◽  
Colin Green ◽  
Sarah G Dean ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Process Evaluation ◽  
Health Research ◽  
Controlled Trial ◽  
Cost Effective ◽  
Cluster Randomised Controlled Trial ◽  
Public Health Research ◽  
Healthy Lifestyles ◽  
Percentage Body Fat

BackgroundApproximately one-third of children in England leave primary school overweight or obese. There is little evidence of effective obesity prevention programmes for children in this age group.ObjectiveTo determine the effectiveness and cost-effectiveness of a school-based healthy lifestyles programme in preventing obesity in children aged 9–10 years.DesignA cluster randomised controlled trial with an economic and process evaluation.SettingThirty-two primary schools in south-west England.ParticipantsChildren in Year 5 (aged 9–10 years) at recruitment and in Year 7 (aged 11–12 years) at 24 months’ post-baseline follow-up.InterventionThe Healthy Lifestyles Programme (HeLP) ran during the spring and summer terms of Year 5 into the autumn term of Year 6 and included four phases: (1) building a receptive environment, (2) a drama-based healthy lifestyles week, (3) one-to-one goal setting and (4) reinforcement activities.Main outcome measuresThe primary outcome measure was body mass index (BMI) standard deviation score (SDS) at 24 months post baseline measures (12 months post intervention). The secondary outcomes comprised waist circumference SDS, percentage body fat SDS, proportion of children overweight and obese at 18 and 24 months, accelerometer-assessed physical activity and food intake at 18 months, and cost-effectiveness.ResultsWe recruited 32 schools and 1324 children. We had a rate of 94% follow-up for the primary outcome. No difference in BMI SDS was found at 24 months [mean difference –0.02, 95% confidence interval (CI) –0.09 to 0.05] or at 18 months (mean difference –0.02, 95% CI –0.08 to 0.05) between children in the intervention schools and children in the control schools. No difference was found between the intervention and control groups in waist circumference SDS, percentage body fat SDS or physical activity levels. Self-reported dietary behaviours showed that, at 18 months, children in the intervention schools consumed fewer energy-dense snacks and had fewer negative food markers than children in the control schools. The intervention effect on negative food markers was fully mediated by ‘knowledge’ and three composite variables: ‘confidence and motivation’, ‘family approval/behaviours and child attitudes’ and ‘behaviours and strategies’. The intervention effect on energy-dense snacks was partially mediated by ‘knowledge’ and the same composite variables apart from ‘behaviours and strategies’. The cost of implementing the intervention was approximately £210 per child. The intervention was not cost-effective compared with control. The programme was delivered with high fidelity, and it engaged children, schools and families across the socioeconomic spectrum.LimitationsThe rate of response to the parent questionnaire in the process evaluation was low. Although the schools in the HeLP study included a range of levels of socioeconomic deprivation, class sizes and rural and urban settings, the number of children for whom English was an additional language was considerably lower than the national average.ConclusionsHeLP is not effective or cost-effective in preventing overweight or obesity in children aged 9–10 years.Future workOur very high levels of follow-up and fidelity of intervention delivery lead us to conclude that it is unlikely that school-based programmes targeting a single age group can ever be sufficiently intense to affect weight status. New approaches are needed that affect the school, the family and the wider environment to prevent childhood obesity.Trial registrationCurrent Controlled Trials ISRCTN15811706.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. 6, No. 1. 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 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 Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)

2017 ◽  
Vol 21 (24) ◽  
pp. 1-198 ◽  
Author(s):  
Sarah Cockayne ◽  
Sara Rodgers ◽  
Lorraine Green ◽  
Caroline Fairhurst ◽  
Joy Adamson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Incidence Rate ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Falls Prevention ◽  
Randomised Controlled

BackgroundFalls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DesignA pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SettingNine NHS trusts in the UK and one site in Ireland.ParticipantsIn total, 1010 participants aged ≥ 65 years were randomised (intervention,n = 493; usual care,n = 517) via a secure, remote service. Blinding was not possible.InterventionsAll participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.Main outcome measuresThe primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.ResultsThe primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05;p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00;p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LimitationsOwing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.ConclusionsThe intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.Future workFurther research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.Trial registrationCurrent Controlled Trials ISRCTN68240461.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.

scholarly journals Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial

2021 ◽  
pp. 096452842110557
Author(s):  
Trygve Skonnord ◽  
Arne Fetveit ◽  
Holgeir Skjeie ◽  
Mette Brekke ◽  
Margreth Grotle ◽  
...  
Keyword(s):  
Health Care ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Cost Effective ◽  
Cost Effectiveness Analysis ◽  
Effectiveness Analysis ◽  
Randomised Controlled ◽  
Care Costs

Objective: To assess the cost-effectiveness of a single treatment session of acupuncture, when applied in addition to usual care for acute low back pain (ALBP). Methods: Secondary analysis of a multicentre randomised controlled trial in Norwegian general practice. In total, 171 participants with ALBP ⩽14 days were randomised to a control group (CG) receiving usual care or to an acupuncture group (AG) receiving one additional session of Western medical acupuncture alongside usual care. Primary outcome measures for this cost-effectiveness analysis were quality-adjusted life years (QALYs), health care costs and societal costs at days 28 and 365, the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB). The NMB was calculated on the basis of the Norwegian cost-effectiveness threshold of NOK 275,000 (USD 35,628) per QALY gained. Missing data were replaced by multiple chained imputation. Results: Eighty-six participants in the CG and 81 in the AG were included in the analysis. We found no QALY gain at day 28. At day 365, the incremental QALY of 0.035 was statistically significant. The differences in health care costs and societal costs were not statistically significant. Three out of four calculations led to negative ICERs (cost saving) and positive NMBs. For the health care perspective at day 365, the ICER was USD –568 per QALY and the NMB was USD 1265, with 95.9% probability of acupuncture being cost-effective. Conclusion: To our knowledge, this is the first cost-effectiveness analysis of acupuncture for ALBP. The findings indicate that acupuncture may be cost-effective from a 1-year perspective, but more studies are needed. Trial registration number: NCT01439412 (ClinicalTrials.gov).

scholarly journals Cost-effectiveness of habit-based advice for weight control versus usual care in general practice in the Ten Top Tips (10TT) trial: economic evaluation based on a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e017511 ◽  
Author(s):  
Nishma Patel ◽  
Rebecca J Beeken ◽  
Baptiste Leurent ◽  
Rumana Z Omar ◽  
Irwin Nazareth ◽  
...  
Keyword(s):  
General Practice ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Health Service ◽  
Usual Care ◽  
Controlled Trial ◽  
Cost Effective ◽  
The Mean ◽  
Randomised Controlled

ObjectiveTen Top Tips (10TT) is a primary care-led behavioural intervention which aims to help adults reduce and manage their weight by following 10 weight loss tips. The intervention promotes habit formation to encourage long-term behavioural changes. The aim of this study was to estimate the cost-effectiveness of 10TT in general practice from the perspective of the UK National Health Service.DesignAn economic evaluation was conducted alongside an individually randomised controlled trial.Setting14 general practitioner practices in England.ParticipantsAll patients were aged ≥18 years, with body mass index ≥30 kg/m2. A total of 537 patients were recruited; 270 received the usual care offered by their practices and 267 received the 10TT intervention.Outcomes measuresHealth service use and quality-adjusted life years (QALYs) were measured over 2 years. Analysis was conducted in terms of incremental net monetary benefits (NMBs), using non-parametric bootstrapping and multiple imputation.ResultsOver a 2-year time horizon, the mean costs and QALYs per patient in the 10TT group were £1889 (95% CI £1522 to £2566) and 1.51 (95% CI 1.44 to 1.58). The mean costs and QALYs for usual care were £1925 (95% CI £1599 to £2251) and 1.51 (95% CI 1.45 to 1.57), respectively. This generated a mean cost difference of −£36 (95% CI −£512 to £441) and a mean QALY difference of 0.001 (95% CI −0.080 to 0.082). The incremental NMB for 10TT versus usual care was £49 (95% CI −£1709 to £1800) at a maximum willingness to pay for a QALY of £20 000. 10TT had a 52% probability of being cost-effective at this threshold.ConclusionsCosts and QALYs for 10TT were not significantly different from usual care and therefore 10TT is as cost-effective as usual care. There was no evidence to recommend nor advice against offering 10TT to obese patients in general practices based on cost-effectiveness considerations.Trial registration numberISRCTN16347068; Post-results.

scholarly journals Economic evaluation of the Good School Toolkit: an intervention for reducing violence in primary schools in Uganda

2018 ◽  
Vol 3 (2) ◽  
pp. e000526 ◽  
Author(s):  
Giulia Greco ◽  
Louise Knight ◽  
Willington Ssekadde ◽  
Sophie Namy ◽  
Dipak Naker ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Primary Schools ◽  
Physical Violence ◽  
Controlled Trial ◽  
Cost Effective ◽  
Cluster Randomised Controlled Trial ◽  
Total Cost ◽  
Good School ◽  
Randomised Controlled ◽  
The Cost

IntroductionThis paper presents the cost and cost-effectiveness of the Good School Toolkit (GST), a programme aimed at reducing physical violence perpetrated by school staff to students in Uganda.MethodsThe effectiveness of the Toolkit was tested with a cluster randomised controlled trial in 42 primary schools in Luwero District, Uganda. A full economic costing evaluation and cost-effectiveness analysis were conducted alongside the trial. Both financial and economic costs were collected retrospectively from the provider’s perspective to estimate total and unit costs.ResultsThe total cost of setting up and running the Toolkit over the 18-month trial period is estimated at US$397 233, excluding process monitor (M&E) activities. The cost to run the intervention is US$7429 per school annually, or US$15 per primary school pupil annually, in the trial intervention schools. It is estimated that the intervention has averted 1620 cases of past-week physical violence during the 18-month implementation period. The total cost per case of violence averted is US$244, and the annual implementation cost is US$96 per case averted during the trial.ConclusionsThe GST is a cost-effective intervention for reducing violence against pupils in primary schools in Uganda. It compares favourably against other violence reduction interventions in the region.

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