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 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 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 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.

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 Cost-effectiveness of PoNDER health visitor training for mothers at lower risk of depression: findings on prevention of postnatal depression from a cluster-randomised controlled trial

2018 ◽  
Vol 49 (08) ◽  
pp. 1324-1334 ◽  
Author(s):  
Catherine Henderson ◽  
Simon Dixon ◽  
Annette Bauer ◽  
Martin Knapp ◽  
C. Jane Morrell ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Postnatal Depression ◽  
Lower Risk ◽  
Controlled Trial ◽  
Cost Effective ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
The Cost

AbstractBackgroundThere is evidence for the cost-effectiveness of health visitor (HV) training to assess postnatal depression (PND) and deliver psychological approaches to women at risk of depression. Whether this approach is cost-effective for lower-risk women is unknown. There is a need to know the cost of HV-delivered universal provision, and how much it might cost to improve health-related quality of life for postnatal women. A sub-study of a cluster-randomised controlled trial in the former Trent region (England) previously investigated the effectiveness of PoNDER HV training in mothers at lower risk of PND. We conducted a parallel cost-effectiveness analysis at 6-months postnatal for all mothers with lower-risk status attributed to an Edinburgh Postnatal Depression Scale (EPDS) score &lt;12 at 6-weeks postnatal.MethodsIntervention HVs were trained in assessment and cognitive behavioural or person-centred psychological support techniques to prevent depression. Outcomes examined: quality-adjusted life-year (QALY) gains over the period between 6 weeks and 6 months derived from SF-6D (from SF-36); risk-of-depression at 6 months (dichotomising 6-month EPDS scores into lower risk (&lt;12) and at-risk (⩾12).ResultsIn lower-risk women, 1474 intervention (63 clusters) and 767 control participants (37 clusters) had valid 6-week and 6-month EPDS scores. Costs and outcomes data were available for 1459 participants. 6-month adjusted costs were £82 lower in intervention than control groups, with 0.002 additional QALY gained. The probability of cost-effectiveness at £20 000 was very high (99%).ConclusionsPoNDER HV training was highly cost-effective in preventing symptoms of PND in a population of lower-risk women and cost-reducing over 6 months.

scholarly journals Cost and cost-effectiveness of a parenting programme to prevent violence against adolescents in South Africa

2019 ◽  
Vol 4 (3) ◽  
pp. e001147 ◽  
Author(s):  
Alice Redfern ◽  
Lucie D Cluver ◽  
Marisa Casale ◽  
Janina I Steinert
Keyword(s):  
South Africa ◽  
Cost Effectiveness ◽  
Low Income ◽  
Emotional Abuse ◽  
Controlled Trial ◽  
Cost Effective ◽  
Cluster Randomised Controlled Trial ◽  
Economic Benefits ◽  
Parenting Programme ◽  
Middle Income

IntroductionThis paper presents the costs and cost-effectiveness of ‘Parenting for Lifelong Health: Sinovuyo Teen’, a non-commercialised parenting programme aimed at preventing violence against adolescents in low-income and middle-income countries.MethodsThe effectiveness of Sinovuyo Teen was evaluated with a cluster randomised controlled trial in 40 villages and peri-urban townships in the Eastern Cape of South Africa from 2015 to 2016. The costs of implementation were calculated retrospectively and models of costs at scale estimated, from the perspective of the programme provider. Cost-effectiveness analysis considers both the cost per incident of abuse averted, and cost per disability-adjusted life year averted. Potential economic benefits from the societal perspective were estimated by developing a framework of possible savings.ResultsThe total implementation cost for Sinovuyo Teen over the duration of the trial was US$135 954, or US$504 per family enrolled. Among the 270 families in the treatment group, an estimated 73 incidents of physical and emotional abuse were averted (95% CI 29 to 118 incidents averted). During the trial, the total cost per incident of physical or emotional abuse averted was US$1837, which is likely to decrease to approximately US$972 if implemented at scale. By comparison, the economic benefits of averting abuse in South Africa are large with an estimated lifetime saving of US$2724 minimum per case.ConclusionParenting programmes are a cost-effective intervention to prevent the abuse of adolescents by their caregivers in South Africa, when compared with existing violence prevention programmes and cost-effectiveness thresholds based on GDP per capita.

scholarly journals Randomised controlled trial with economic and process evaluations of domiciliary welfare rights advice for socioeconomically disadvantaged older people recruited via primary health care (the Do-Well study)

2019 ◽  
Vol 7 (3) ◽  
pp. 1-228
Author(s):  
Catherine Haighton ◽  
Suzanne Moffatt ◽  
Denise Howel ◽  
Mel Steer ◽  
Frauke Becker ◽  
...  
Keyword(s):  
Older People ◽  
Health Research ◽  
Controlled Trial ◽  
Intervention Group ◽  
Public Health Research ◽  
Welfare Rights ◽  
North East ◽  
And Control

BackgroundWelfare rights advice services are effective at maximising previously unclaimed welfare benefits, but their impact on health has not been evaluated.ObjectiveTo establish the acceptability, cost-effectiveness and effect on health of a domiciliary welfare rights advice service targeting older people, compared with usual practice.DesignA pragmatic, individually randomised, parallel-group, single-blinded, wait-list controlled trial, with economic and process evaluations. Data were collected by interview at baseline and 24 months, and by self-completion questionnaire at 12 months. Qualitative interviews were undertaken with purposive samples of 50 trial participants and 17 professionals to explore the intervention’s acceptability and its perceived impacts.SettingParticipants’ homes in North East England, UK.ParticipantsA total of 755 volunteers aged ≥ 60 years, living in their own homes, fluent in English and not terminally ill, recruited from the registers of 17 general practices with an Index of Multiple Deprivation within the most deprived two-fifths of the distribution for England, and with no previous access to welfare rights advice services.InterventionsWelfare rights advice, comprising face-to-face consultations, active assistance with benefit claims and follow-up as required until no longer needed, delivered in participants’ own homes by a qualified welfare rights advisor. Control group participants received usual care until the 24-month follow-up, after which they received the intervention.Main outcome measuresThe primary outcome was health-related quality of life (HRQoL), assessed using the CASP-19 (Control, Autonomy, Self-realisation and Pleasure) score. The secondary outcomes included general health status, health behaviours, independence and hours per week of care, mortality and changes in financial status.ResultsA total of 755 out of 3912 (19%) general practice patients agreed to participate and were randomised (intervention,n = 381; control,n = 374). In the intervention group, 335 participants (88%) received the intervention. A total of 605 (80%) participants completed the 12-month follow-up and 562 (75%) completed the 24-month follow-up. Only 84 (22%) intervention group participants were awarded additional benefits. There was no significant difference in CASP-19 score between the intervention and control groups at 24 months [adjusted mean difference 0.3, 95% confidence interval (CI) –0.8 to 1.5], but a significant increase in hours of home care per week in the intervention group (adjusted difference 26.3 hours/week, 95% CI 0.8 to 56.1 hours/week). Exploratory analyses found a weak positive correlation between CASP-19 score and the amount of time since receipt of the benefit (0.39, 95% CI 0.16 to 0.58). The qualitative data suggest that the intervention was acceptable and that receipt of additional benefits was perceived by participants and professionals as having had a positive impact on health and quality of life. The mean cost was £44 per participant, the incremental mean health gain was 0.009 quality-adjusted life-years (QALYs) (95% CI –0.038 to 0.055 QALYs) and the incremental cost-effectiveness ratio was £1914 per QALY gained.ConclusionsThe trial did not provide sufficient evidence to support domiciliary welfare rights advice as a means of promoting health among older people, but it yielded qualitative findings that suggest important impacts on HRQoL. The intervention needs to be better targeted to those most likely to benefit.Future workFurther follow-up of the trial could identify whether or not outcomes diverge among intervention and control groups over time. Research is needed to better understand how to target welfare rights advice to those most in need.Trial registrationCurrent Controlled Trials ISRCTN37380518.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. 7, No. 3. See the NIHR Journals Library website for further project information. The authors also received a grant of £28,000 from the North East Strategic Health Authority in 2012 to cover the costs of intervention delivery and training as well as other non-research costs of the study.

scholarly journals Randomised controlled trial evaluating the effectiveness and cost-effectiveness of ‘Families for Health’, a family-based childhood obesity treatment intervention delivered in a community setting for ages 6 to 11 years

2017 ◽  
Vol 21 (1) ◽  
pp. 1-180 ◽  
Author(s):  
Wendy Robertson ◽  
Joanna Fleming ◽  
Atiya Kamal ◽  
Thomas Hamborg ◽  
Kamran A Khan ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Process Evaluation ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Cost Effective ◽  
Z Score ◽  
Clinically Significant ◽  
Family Based ◽  
Randomised Controlled

BackgroundEffective programmes to help children manage their weight are required. ‘Families for Health’ focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health version 1 showed sustained reductions in mean body mass index (BMI) z-score after 2 years in a pilot project.ObjectiveThe aim was to evaluate its effectiveness and cost-effectiveness in a randomised controlled trial (RCT).DesignThe trial was a multicentre, investigator-blind RCT, with a parallel economic and process evaluation, with follow-up at 3 and 12 months. Randomisation was by family unit, using a 1 : 1 allocation by telephone registration, stratified by three sites, with a target of 120 families.SettingThree sites in the West Midlands, England, UK.ParticipantsChildren aged 6–11 years who were overweight (≥ 91st centile BMI) or obese (≥ 98th centile BMI), and their parents/carers. Recruitment was via referral or self-referral.InterventionsFamilies for Health version 2 is a 10-week, family-based community programme with parallel groups for parents and children, addressing parenting, lifestyle, social and emotional development. Usual care was the treatment for childhood obesity provided within each locality.Main outcome measuresJoint primary outcome measures were change in children’s BMI z-score and incremental cost per quality-adjusted life-year (QALY) gained at 12 months’ follow-up (QALYs were calculated using the European Quality of Life-5 Dimensions Youth version). Secondary outcome measures included changes in children’s waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. Parents’ BMI and mental well-being, family eating/activity, parent–child relationships and parenting style were also assessed. The process evaluation documented recruitment, reach, dose delivered, dose received and fidelity, using mixed methods.ResultsThe study recruited 115 families (128 children; 63 boys and 65 girls), with 56 families randomised to the Families for Health arm and 59 to the ‘usual-care’ control arm. There was 80% retention of families at 3 months (Families for Health, 46 families; usual care, 46 families) and 72% retention at 12 months (Families for Health, 44 families; usual care, 39 families). The change in BMI z-score at 12 months was not significantly different in the Families for Health arm and the usual-care arm [0.114, 95% confidence interval (CI) –0.001 to 0.229;p = 0.053]. However, within-group analysis showed that the BMI z-score was significantly reduced in the usual-care arm (–0.118, 95% CI –0.203 to –0.034;p = 0.007), but not in the Families for Health arm (–0.005, 95% CI –0.085 to 0.078;p = 0.907). There was only one significant difference between groups for secondary outcomes. The economic evaluation, taking a NHS and Personal Social Services perspective, showed that mean costs 12 months post randomisation were significantly higher for Families for Health than for usual care (£998 vs. £548;p < 0.001). The mean incremental cost-effectiveness of Families for Health was estimated at £552,175 per QALY gained. The probability that the Families for Health programme is cost-effective did not exceed 40% across a range of thresholds. The process evaluation demonstrated that the programme was implemented, as planned, to the intended population and any adjustments did not deviate widely from the handbook. Many families waited more than 3 months to receive the intervention. Facilitators’, parents’ and children’s experiences of Families for Health were largely positive and there were no adverse events. Further analysis could explore why some children show a clinically significant benefit while others have a worse outcome.ConclusionsFamilies for Health was neither effective nor cost-effective for the management of obesity in children aged 6–11 years, in comparison with usual care. Further exploration of the wide range of responses in BMI z-score in children following the Families for Health and usual-care interventions is warranted, focusing on children who had a clinically significant benefit and those who showed a worse outcome with treatment. Further research could focus on the role of parents in the prevention of obesity, rather than treatment.Trial registrationCurrent Controlled Trials ISRCTN45032201.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. 1. See the NIHR Journals Library website for further project information.

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