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1.
J Epidemiol Community Health ; 74(3): 269-275, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31822568

RESUMO

BACKGROUND: There is limited evidence that nutritional labelling on food/drinks is changing eating behaviours. Physical activity calorie equivalent (PACE) food labelling aims to provide the public with information about the amount of physical activity required to expend the number of kilocalories in food/drinks (eg, calories in this pizza requires 45 min of running to burn), to encourage healthier food choices and reduce disease. OBJECTIVE: We aimed to systematically search for randomised controlled trials and experimental studies of the effects of PACE food labelling on the selection, purchase or consumption of food/drinks. METHODS: PACE food labelling was compared with any other type of food labelling or no labelling (comparator). Reports were identified by searching electronic databases, websites and social media platforms. Inverse variance meta-analysis was used to summarise evidence. Weighted mean differences (WMD) and 95% CIs were used to describe between-group differences using a random effects model. RESULTS: 15 studies were eligible for inclusion. When PACE labelling was displayed on food/drinks and menus, significantly fewer calories were selected, relative to comparator labelling (WMD=-64.9 kcal, 95% CI -103.2 to -26.6, p=0.009, n=4606). Presenting participants with PACE food labelling results in the consumption of significantly fewer calories (WMD=-80.4 kcal, 95% CI-136.7 to -24.2, p=0.005, n=486) relative to comparator food labelling. CONCLUSION: Based on current evidence PACE food labelling may reduce the number of kilocalories selected from menus and decrease the number of kilocalories/grams of food consumed by the public, compared with other types of food labelling/no labelling. TRIAL REGISTRATION NUMBER: CRD42018088567.


Assuntos
Comportamento do Consumidor , Exercício Físico , Rotulagem de Alimentos/métodos , Valor Nutritivo , Obesidade/prevenção & controle , Ingestão de Energia , Feminino , Preferências Alimentares , Comportamentos Relacionados com a Saúde , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Restaurantes
2.
BMJ Open ; 9(12): e033534, 2019 12 10.
Artigo em Inglês | MEDLINE | ID: mdl-31826896

RESUMO

OBJECTIVE: To assess (1) the feasibility of delivering a culturally adapted weight management programme, Healthy Dads, Healthy Kids United Kingdom (HDHK-UK), for fathers with overweight or obesity and their primary school-aged children, and (2) the feasibility of conducting a definitive randomised controlled trial (RCT). DESIGN: A two-arm, randomised feasibility trial with a mixed-methods process evaluation. SETTING: Socioeconomically disadvantaged, ethnically diverse localities in West Midlands, UK. PARTICIPANTS: Fathers with overweight or obesity and their children aged 4-11 years. INTERVENTION: Participants were randomised in a 1:2 ratio to control (family voucher for a leisure centre) or intervention comprising 9 weekly healthy lifestyle group sessions. OUTCOMES: Feasibility of the intervention and RCT was assessed according to prespecified progression criteria: study recruitment, consent and follow-up, ability to deliver intervention, intervention fidelity, adherence and acceptability, weight loss, using questionnaires and measurements at baseline, 3 and 6 months, and through qualitative interviews. RESULTS: The study recruited 43 men, 48% of the target sample size; the mean body mass index was 30.2 kg/m2 (SD 5.1); 61% were from a minority ethnic group; and 54% were from communities in the most disadvantaged quintile for socioeconomic deprivation. Recruitment was challenging. Retention at follow-up of 3 and 6 months was 63%. Identifying delivery sites and appropriately skilled and trained programme facilitators proved difficult. Four programmes were delivered in leisure centres and community venues. Of the 29 intervention participants, 20 (69%) attended the intervention at least once, of whom 75% attended ≥5 sessions. Sessions were delivered with high fidelity. Participants rated sessions as 'good/very good' and reported lifestyle behavioural change. Weight loss at 6 months in the intervention group (n=17) was 2.9 kg (95% CI -5.1 to -0.6). CONCLUSIONS: The intervention was well received, but there were significant challenges in recruitment, programme delivery and follow-up. The HDHK-UK study was not considered feasible for progression to a full RCT based on prespecified stop-go criteria. TRIAL REGISTRATION NUMBER: ISRCTN16724454.


Assuntos
Pai , Obesidade/terapia , Programas de Redução de Peso/métodos , Adulto , Criança , Pré-Escolar , Exercício Físico , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desenvolvimento de Programas , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
3.
Health Technol Assess ; 23(33): 1-166, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31293236

RESUMO

BACKGROUND: Excess weight in children is a continuing health issue. Community-based children's weight management programmes have had some effect in promoting weight loss. Families from minority ethnic communities are less likely to complete these programmes but, to date, no programmes have been culturally adapted to address this. OBJECTIVES: We aimed to (1) culturally adapt an existing weight management programme for children aged 4-11 years and their families to make it more suited to Pakistani and Bangladeshi communities but inclusive of all families and (2) evaluate the adapted programme to assess its feasibility and acceptability, as well as the feasibility of methods, for a future full-scale trial. DESIGN: In phase I, a cultural adaptation of a programme that was informed by formative research and guided by two theoretical frameworks was undertaken and in phase II this adapted programme was delivered in a cluster-randomised feasibility study (for which the clusters were the standard and adapted children's weight management programmes). SETTING: Birmingham: a large, ethnically diverse UK city. PARTICIPANTS: In phase I, Pakistani and Bangladeshi parents of children with excess weight, and, in phase II, children aged 4-11 years who have excess weight and their families. INTERVENTIONS: A culturally adapted children's weight management programme, comprising six sessions, which was delivered to children and parents, targeting diet and physical activity and incorporating behaviour change techniques, was developed in phase I and delivered in the intervention arm to 16 groups in phase II. The eight groups in the comparator arm received the standard (unadapted) children's weight management programme. MAIN OUTCOME MEASURES: The primary outcome was the proportion of Pakistani and Bangladeshi families completing (attending ≥ 60% of) the adapted programme. Secondary outcomes included the proportion of all families completing the adapted programme, the feasibility of delivery of the programme, the programme's acceptability to participants, the feasibility of trial processes and the feasibility of collection of outcome and cost data. RESULTS: The proportion of Pakistani and Bangladeshi families and all families completing the adapted programme was 78.8% [95% confidence interval (CI) 64.8% to 88.2%] and 76.3% (95% CI 67.0% to 83.6%), respectively. The programme was feasible to deliver with some refinements and was well received. Ninety-two families participated in outcome data collection. Data collection was mostly feasible, but participant burden was high. Data collection on the cost of programme delivery was feasible, but costs to families were more challenging to capture. There was high attrition over the 6-month follow-up period (35%) and differential attrition in the two study arms (29% and 52% in the intervention and comparator arms, respectively). LIMITATIONS: The study was not designed to address the issue of low participant uptake of children's weight management programmes. The design of a future trial may include individual randomisation and a 'minimal intervention' arm, the acceptability of which has not been evaluated in this study. CONCLUSIONS: The theoretically informed, culturally adapted children's weight management programme was highly acceptable to children and families of all ethnicities. Consideration should be given to a future trial to evaluate clinical effectiveness and cost-effectiveness of the adapted programme, but the design of a future trial would need to address the logistics of data collection, participant burden and study attrition. TRIAL REGISTRATION: Current Controlled Trials ISRCTN81798055. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 33. See the NIHR Journals Library website for further project information. Kate Jolly is part-funded by the Collaboration for Leadership in Applied Health Research and Care West Midlands.


Many programmes have been designed for children with excess weight and their families to help them try and lose weight. Often families start going to these programmes but do not complete them. This has been noted to be an issue in families from ethnic minority communities. We aimed to adapt an existing programme for families of primary school children with excess weight to make it more suitable for Pakistani and Bangladeshi families. We asked parents from these communities who had experience of the existing programme what they thought about it and what they would like to change. We used this information to help us adapt the existing programme. We also aimed to make the programme acceptable to families of all ethnicities. We then aimed to (1) test delivery of the adapted programme, (2) see whether or not it was acceptable to Pakistani and Bangladeshi families and families of other ethnicities and (3) test methods to be used in a future research study to determine whether or not the adapted programme helps children to lose weight and provides value for money. We asked parents and children who attended and the staff delivering the new programme for their views. A panel of Pakistani and Bangladeshi parents helped us to plan our study methods. The programme was successfully delivered and the parents, children and staff all enjoyed it. Overall, 76% of families from all ethnic backgrounds who started attending the programme completed it. This was substantially higher than the 58% of families who completed the standard (unadapted) programme. We identified several issues that we would need to take into account when designing a future study. These include making sure that the families taking part are not overburdened and that we take steps to make sure that as many families as possible are followed up until the end of the study.


Assuntos
Terapia Comportamental , Competência Cultural , Obesidade Infantil/prevenção & controle , Programas de Redução de Peso/estatística & dados numéricos , Bangladesh/etnologia , Criança , Pré-Escolar , Dieta , Exercício Físico/fisiologia , Estudos de Viabilidade , Feminino , Humanos , Masculino , Paquistão/etnologia , Pais , Reino Unido
4.
BMC Public Health ; 19(1): 848, 2019 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-31253113

RESUMO

BACKGROUND: Childhood obesity prevalence continues to be at high levels in the United Kingdom (UK). South Asian children (mainly Pakistani and Bangladeshi origin) with excess adiposity are at particular risk from the cardiovascular consequences of obesity. Many community-based children's weight management programmes have been delivered in the UK, but none have been adapted for diverse cultural communities. The aim of the Child weigHt mANaGement for Ethnically diverse communities (CHANGE) study, was to culturally adapt an existing children's weight management programme for children aged 4-11 years so that the programme was more able to meet the needs of families from South Asian communities. METHODS: The adaptation process was applied to First Steps, an evidence informed programme being delivered in Birmingham (a large, ethnically diverse city). A qualitative study was undertaken to obtain the views of South Asian parents of children with excess weight, who had fully or partially attended, or who had initially agreed but then declined to attend the First Steps programme. The resulting data were integrated with current research evidence and local programme information as part of a cultural adaptation process that was guided by two theoretical frameworks. RESULTS: Interviews or focus groups with 31 parents in their preferred languages were undertaken. Themes arising from the data included the need for convenient timing of a programme in a close familiar location, support for those who do not speak English, the need to focus on health rather than weight, nutritional content that focuses on traditional and Western diets, more physical activity content, and support with parenting skills. The data were mapped to the Behaviour Change Wheel framework and Typology of Cultural Adaptation to develop an intervention programme outline. The research evidence and local programme information was then used in the detailed planning of the programme sessions. CONCLUSIONS: The process of cultural adaptation of an existing children's weight management programme resulted in a theoretically underpinned programme that is culturally adapted at both the surface and deep structural levels. TRIAL REGISTRATION: ISRCTN81798055 , registered: 13/05/2014.


Assuntos
Povo Asiático/psicologia , Competência Cultural , Diversidade Cultural , Obesidade Infantil/etnologia , Programas de Redução de Peso/organização & administração , Povo Asiático/estatística & dados numéricos , Bangladesh/etnologia , Criança , Pré-Escolar , Feminino , Grupos Focais , Humanos , Masculino , Paquistão/etnologia , Pais/psicologia , Obesidade Infantil/prevenção & controle , Avaliação de Programas e Projetos de Saúde , Pesquisa Qualitativa , Reino Unido
5.
Pilot Feasibility Stud ; 4: 175, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30505457

RESUMO

BACKGROUND: Community-based programmes for children with excess weight are widely available, but few have been developed to meet the needs of culturally diverse populations. We adapted an existing children's weight management programme, focusing on Pakistani and Bangladeshi communities. We report the evaluation of this programme to assess feasibility of programme delivery, acceptability of the programme to participants from diverse communities, and feasibility of methods to inform a future trial. METHODS: A cluster-randomised feasibility trial was undertaken in a large UK city. Children's weight management programmes (n = 24) were randomised to be delivered as the adapted or the standard programme (2:1 ratio). Routine data on participant attendance (n = 243) at the sessions were used to estimate the proportion of families completing the adapted and standard programmes (to indicate programme acceptability). Families planning to attend the programmes were recruited to participate in the feasibility study (n = 92). Outcome data were collected from children and parents at baseline, end of programme, and 6 months post-programme. A subsample (n = 24) of those attending the adapted programme participated in interviews to gain their views of the content and delivery and assess programme acceptability. Feasibility of programme delivery was assessed through observation and consultation with facilitators, and data on costs were collected. RESULTS: The proportion of Pakistani and Bangladeshi families and families of all ethnicities completing the adapted programme was similar: 78.8% (95% CI 64.8-88.2%) and 76.3% (95% CI 67.0-83.6%) respectively. OR for completion of adapted vs. standard programme was 2.40 (95% CI 1.32-4.34, p = 0.004). The programme was feasible to deliver with some refinements, and participant interview data showed that the programme was well received. Study participant recruitment was successful, but attrition was high (35% at 6 months). Data collection was mostly feasible, but participant burden was high. Data collection on cost of programme delivery was feasible, but costs to families were more challenging to capture. CONCLUSIONS: This culturally adapted programme was feasible to deliver and highly acceptable to participants, with increased completion rates compared with the standard programme. Consideration should be given to a future trial to evaluate its clinical and cost-effectiveness. TRIAL REGISTRATION: ISRCTN81798055, registered: 13/05/2014.

6.
BMJ ; 360: k211, 2018 02 07.
Artigo em Inglês | MEDLINE | ID: mdl-29437667

RESUMO

OBJECTIVE: To assess the effectiveness of a school and family based healthy lifestyle programme (WAVES intervention) compared with usual practice, in preventing childhood obesity. DESIGN: Cluster randomised controlled trial. SETTING: UK primary schools from the West Midlands. PARTICIPANTS: 200 schools were randomly selected from all state run primary schools within 35 miles of the study centre (n=980), oversampling those with high minority ethnic populations. These schools were randomly ordered and sequentially invited to participate. 144 eligible schools were approached to achieve the target recruitment of 54 schools. After baseline measurements 1467 year 1 pupils aged 5 and 6 years (control: 28 schools, 778 pupils) were randomised, using a blocked balancing algorithm. 53 schools remained in the trial and data on 1287 (87.7%) and 1169 (79.7%) pupils were available at first follow-up (15 month) and second follow-up (30 month), respectively. INTERVENTIONS: The 12 month intervention encouraged healthy eating and physical activity, including a daily additional 30 minute school time physical activity opportunity, a six week interactive skill based programme in conjunction with Aston Villa football club, signposting of local family physical activity opportunities through mail-outs every six months, and termly school led family workshops on healthy cooking skills. MAIN OUTCOME MEASURES: The protocol defined primary outcomes, assessed blind to allocation, were between arm difference in body mass index (BMI) z score at 15 and 30 months. Secondary outcomes were further anthropometric, dietary, physical activity, and psychological measurements, and difference in BMI z score at 39 months in a subset. RESULTS: Data for primary outcome analyses were: baseline, 54 schools: 1392 pupils (732 controls); first follow-up (15 months post-baseline), 53 schools: 1249 pupils (675 controls); second follow-up (30 months post-baseline), 53 schools: 1145 pupils (621 controls). The mean BMI z score was non-significantly lower in the intervention arm compared with the control arm at 15 months (mean difference -0.075 (95% confidence interval -0.183 to 0.033, P=0.18) in the baseline adjusted models. At 30 months the mean difference was -0.027 (-0.137 to 0.083, P=0.63). There was no statistically significant difference between groups for other anthropometric, dietary, physical activity, or psychological measurements (including assessment of harm). CONCLUSIONS: The primary analyses suggest that this experiential focused intervention had no statistically significant effect on BMI z score or on preventing childhood obesity. Schools are unlikely to impact on the childhood obesity epidemic by incorporating such interventions without wider support across multiple sectors and environments. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97000586.


Assuntos
Avaliação de Processos e Resultados em Cuidados de Saúde , Obesidade Infantil/prevenção & controle , Serviços de Saúde Escolar/organização & administração , Índice de Massa Corporal , Criança , Inglaterra , Feminino , Humanos , Masculino
7.
Health Technol Assess ; 22(8): 1-608, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29436364

RESUMO

BACKGROUND: Systematic reviews suggest that school-based interventions can be effective in preventing childhood obesity, but better-designed trials are needed that consider costs, process, equity, potential harms and longer-term outcomes. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) study intervention, compared with usual practice, in preventing obesity among primary school children. DESIGN: A cluster randomised controlled trial, split across two groups, which were randomised using a blocked balancing algorithm. Schools/participants could not be blinded to trial arm. Measurement staff were blind to allocation arm as far as possible. SETTING: Primary schools, West Midlands, UK. PARTICIPANTS: Schools within a 35-mile radius of the study centre and all year 1 pupils (aged 5-6 years) were eligible. Schools with a higher proportion of pupils from minority ethnic populations were oversampled to enable subgroup analyses. INTERVENTIONS: The 12-month intervention encouraged healthy eating/physical activity (PA) by (1) helping teachers to provide 30 minutes of additional daily PA, (2) promoting 'Villa Vitality' (interactive healthy lifestyles learning, in an inspirational setting), (3) running school-based healthy cooking skills/education workshops for parents and children and (4) highlighting information to families with regard to local PA opportunities. MAIN OUTCOME MEASURES: The primary outcomes were the difference in body mass index z-scores (BMI-zs) between arms (adjusted for baseline body mass index) at 3 and 18 months post intervention (clinical outcome), and cost per quality-adjusted life-year (QALY) (cost-effectiveness outcome). The secondary outcomes were further anthropometric, dietary, PA and psychological measurements, and the difference in BMI-z between arms at 27 months post intervention in a subset of schools. RESULTS: Two groups of schools were randomised: 27 in 2011 (n = 650 pupils) [group 1 (G1)] and another 27 in 2012 (n = 817 pupils) [group 2 (G2)]. Primary outcome data were available at first follow-up (n = 1249 pupils) and second follow-up (n = 1145 pupils) from 53 schools. The mean difference (MD) in BMI-z between the control and intervention arms was -0.075 [95% confidence interval (CI) -0.183 to 0.033] and -0.027 (95% CI -0.137 to 0.083) at 3 and 18 months post intervention, respectively. The main analyses showed no evidence of between-arm differences for any secondary outcomes. Third follow-up included data on 467 pupils from 27 G1 schools, and showed a statistically significant difference in BMI-z (MD -0.20, 95% CI -0.40 to -0.01). The mean cost of the intervention was £266.35 per consented child (£155.53 per child receiving the intervention). The incremental cost-effectiveness ratio associated with the base case was £46,083 per QALY (best case £26,804 per QALY), suggesting that the intervention was not cost-effective. LIMITATIONS: The presence of baseline primary outcome imbalance between the arms, and interschool variation in fidelity of intervention delivery. CONCLUSIONS: The primary analyses show no evidence of clinical effectiveness or cost-effectiveness of the WAVES study intervention. A post hoc analysis, driven by findings at third follow-up, suggests a possible intervention effect, which could have been attenuated by baseline imbalances. There was no evidence of an intervention effect on measures of diet or PA and no evidence of harm. FUTURE WORK: A realist evidence synthesis could provide insights into contextual factors and strategies for future interventions. School-based interventions need to be integrated within a wider societal framework and supported by upstream interventions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97000586. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 8. See the NIHR Journals Library website for further project information.


Assuntos
Dieta Saudável , Exercício Físico , Promoção da Saúde/organização & administração , Obesidade Infantil/prevenção & controle , Serviços de Saúde Escolar/organização & administração , Índice de Massa Corporal , Criança , Análise Custo-Benefício , Feminino , Promoção da Saúde/economia , Humanos , Estilo de Vida , Masculino , Avaliação de Programas e Projetos de Saúde , Anos de Vida Ajustados por Qualidade de Vida , Serviços de Saúde Escolar/economia , Resultado do Tratamento , Reino Unido
8.
Artigo em Inglês | MEDLINE | ID: mdl-27965865

RESUMO

BACKGROUND: Group-based children's weight management programmes are widely available in the UK and evidence shows that these are effective in the short-term. No programmes have been specifically developed to meet the cultural requirements of UK minority ethnic communities. South Asian children are a high-risk group for obesity and its consequences; therefore, the study aim is to adapt an existing weight management programme for children aged 4-11 years and their families to ensure cultural relevance to Pakistani and Bangladeshi communities, and undertake a feasibility study of the adapted programme. METHODS/DESIGN: Pakistani and Bangladeshi families of overweight children who have been offered the existing children's weight management programme in Birmingham, UK, will be invited to interviews and focus groups to explore their experiences and views of the programme. These data, together with existing literature and service provider information, will inform adaptation of the programme to be more culturally relevant to these families. The feasibility study will employ a cluster-randomised design, and will assess success of programme adaptation and feasibility of programme delivery. Planned programmes will be randomised to be delivered as the adapted programme (intervention) or the standard programme (comparator) with a 2:1 ratio. The primary outcome will be the proportion of Pakistani and Bangladeshi families completing the adapted programme. To assess recruitment, retention and data collection methods to inform a future trial, we aim to recruit 80 participants. A range of assessments will be undertaken with participants pre-, post- and 6-months post-intervention. DISCUSSION: This study addresses the identified need to provide children's weight management programmes that are suitable for minority ethnic communities. Whilst the focus of the intervention adaptation is on Pakistani and Bangladeshi communities, the programme will be developed to be flexibly delivered to meet the cultural needs of communities of all ethnic compositions. The feasibility study will directly compare the adapted and existing weight management programmes, and will enable a comprehensive evaluation of the success of the adaptation. Essential information will also be gathered to inform the design and sample size calculation of a future trial to evaluate intervention effectiveness. TRIAL REGISTRATION: ISRCTN81798055, registered: 13/05/2014.

9.
J Contin Educ Health Prof ; 36(4): 300-306, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-28350313

RESUMO

INTRODUCTION: Diabetes affects upward of 30% of South Bronx residents. The Centers for Disease Control and Prevention's National Diabetes Prevention Program (NDPP) reduces risk of progression to diabetes, yet implementation has been elusive within health disparities populations. METHODS: This community-based, collaborative project piloted the NDPP in the South Bronx and evaluated implementation challenges and enablers. The New York State training group prepared community peer lifestyle coaches recruited by a community organization. A professional society trained academic detailers from local faculty. An interview process evaluated community needs and public health officials' beliefs. A portal managed by the New York State training group collected demographic and biometric data from the community participants and facilitated online registration. Data from interviews and observations were coded systematically using a thematic analysis framework. RESULTS: We were successful at recruiting and training 14 lifestyle coaches and 7 academic detailers, as well as recruiting members of the health disparities population in the South Bronx into the program. Fifty-two individuals completed the first 6 months of the yearlong program, attending an average of 12.7 of 16 sessions. By week 16, weight loss averaged 7.4 lbs and many had doubled their minutes of physical activity. Local electronic referral and feedback systems were developed. DISCUSSION: Health professionals, their teams, public health centers, and communities can work together to prevent diabetes by enhancing the reach of the NDPP to health disparities populations. Peer education using lifestyle coaches can provide a trustworthy process for crossing the boundaries between health teams and community support groups.


Assuntos
Comportamento Cooperativo , Diabetes Mellitus/prevenção & controle , Disparidades em Assistência à Saúde/tendências , Desenvolvimento de Programas/métodos , Parcerias Público-Privadas , Humanos , Avaliação das Necessidades , Cidade de Nova Iorque , Projetos Piloto
10.
BMC Public Health ; 15: 488, 2015 May 13.
Artigo em Inglês | MEDLINE | ID: mdl-25968599

RESUMO

BACKGROUND: There is some evidence that school-based interventions are effective in preventing childhood obesity. However, longer term outcomes, equity of effects and cost-effectiveness of interventions have not been assessed. The aim of this trial is to assess the clinical and cost-effectiveness of a multi-component intervention programme targeting the school and family environment through primary schools, in preventing obesity in 6-7 year old children, compared to usual practice. METHODS: This cluster randomised controlled trial is set in 54 primary schools within the West Midlands, UK, including a multi-ethnic, socioeconomically diverse population of children aged 6-7 years. The 12-month intervention consists of healthy diet and physical activity promotion. These include: activities to increase time spent doing physical activity within the school day, participation in the 'Villa Vitality' programme (a programme that is delivered by an iconic sporting institution (Aston Villa Football Club), which provides interactive learning opportunities for physical activity and healthy eating), healthy cooking skills workshops in school time for parents and children, and provision of information to families signposting local leisure opportunities. The primary (clinical) outcome is the difference in body mass index (BMI) z-scores between arms at 3 and 18 months post-intervention completion. Cost per Quality Adjusted Life Year (QALY) will also be assessed. The sample size estimate (1000 children split across 50 schools at follow-up) is based on 90% power to detect differences in BMI z-score of 0.25 (estimated ICC ≤ 0.04), assuming a correlation between baseline and follow-up BMI z-score of 0.9. Treatment effects will be examined using mixed model ANCOVA. Primary analysis will adjust for baseline BMI z-score, and secondary analysis will adjust for pre-specified baseline school and child level covariates. DISCUSSION: The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study is the first trial that will examine the cost-effectiveness and long term outcomes of a childhood obesity prevention programme in a multi-ethnic population, with a sufficient sample size to detect clinically important differences in adiposity. The intervention was developed using the Medical Research Council framework for complex interventions, and outcomes are measured objectively, together with a comprehensive process evaluation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97000586 (registered May 2010).


Assuntos
Análise Custo-Benefício , Promoção da Saúde/economia , Promoção da Saúde/normas , Avaliação de Resultados em Cuidados de Saúde , Obesidade Infantil/prevenção & controle , Adiposidade , Adolescente , Índice de Massa Corporal , Criança , Feminino , Humanos , Estilo de Vida , Masculino , Anos de Vida Ajustados por Qualidade de Vida , Serviços de Saúde Escolar/economia , Instituições Acadêmicas/economia , Reino Unido
11.
Arch Dis Child ; 97(11): 952-4, 2012 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-22913973

RESUMO

BACKGROUND: In response to a resurgence of symptomatic cases of vitamin D deficiency in a high-risk predominantly ethnic minority population, a programme of universal rather than targeted vitamin D supplementation was begun with a public awareness campaign about the importance of vitamin D. OBJECTIVE: To evaluate the effectiveness of this programme in reducing case numbers. METHODS: Cases of symptomatic vitamin D deficiency in children under 5 years resident in a primary care trust catchment area presenting at local hospitals were identified through laboratory records of low vitamin D levels which were cross-checked against medical records to confirm the diagnosis. Comparisons were made of the case incidence rate, level of public knowledge and vitamin supplement uptake rate at the onset of the programme in 2005 and 4 years later. RESULTS: The number of cases of symptomatic vitamin D deficiency in those under 5 years fell by 59% (case incidence rate falling from 120/100 000 to 49/100 000) despite the supplement uptake rate rising only to 17%. Public awareness of vitamin D deficiency rose to near universal levels. CONCLUSIONS: A programme of universal rather than targeted Healthy Start vitamin D supplementation for pregnant and lactating women and young children has led to a substantial decrease in cases of symptomatic vitamin D deficiency in a high-risk population. Supplementation was also started at a younger age than in the national programme. This approach has implications for the delivery of vitamin D supplementation programmes in similar populations.


Assuntos
Suplementos Nutricionais , Assistência Alimentar , Saúde Pública/métodos , Raquitismo/prevenção & controle , Deficiência de Vitamina D/prevenção & controle , Vitamina D/uso terapêutico , Vitaminas/uso terapêutico , Pré-Escolar , Inglaterra , Feminino , Humanos , Incidência , Lactente , Recém-Nascido , Lactação , Gravidez , Avaliação de Programas e Projetos de Saúde , Raquitismo/epidemiologia , Deficiência de Vitamina D/epidemiologia , Deficiência de Vitamina D/etnologia
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