The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6–7 years
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-effe...
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| Format: | Article |
| Language: | English |
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NIHR Journals Library
2018-02-01
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| Series: | Health Technology Assessment |
| Subjects: | |
| Online Access: | https://doi.org/10.3310/hta22080 |
| _version_ | 1818522338433433600 |
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| author | Peymane Adab Timothy Barrett Raj Bhopal Janet E Cade Alastair Canaway Kar Keung Cheng Joanne Clarke Amanda Daley Jonathan Deeks Joan Duda Ulf Ekelund Emma Frew Paramjit Gill Tania Griffin Karla Hemming Kiya Hurley Emma R Lancashire James Martin Eleanor McGee Miranda J Pallan Jayne Parry Sandra Passmore |
| author_facet | Peymane Adab Timothy Barrett Raj Bhopal Janet E Cade Alastair Canaway Kar Keung Cheng Joanne Clarke Amanda Daley Jonathan Deeks Joan Duda Ulf Ekelund Emma Frew Paramjit Gill Tania Griffin Karla Hemming Kiya Hurley Emma R Lancashire James Martin Eleanor McGee Miranda J Pallan Jayne Parry Sandra Passmore |
| author_sort | Peymane Adab |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-11T05:31:58Z |
| format | Article |
| id | doaj.art-f60da931b36a47a6a2badb3e583cb833 |
| institution | Directory Open Access Journal |
| issn | 1366-5278 2046-4924 |
| language | English |
| last_indexed | 2024-12-11T05:31:58Z |
| publishDate | 2018-02-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Health Technology Assessment |
| spelling | doaj.art-f60da931b36a47a6a2badb3e583cb8332022-12-22T01:19:24ZengNIHR Journals LibraryHealth Technology Assessment1366-52782046-49242018-02-0122810.3310/hta2208006-85-11The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6–7 yearsPeymane Adab0Timothy Barrett1Raj Bhopal2Janet E Cade3Alastair Canaway4Kar Keung Cheng5Joanne Clarke6Amanda Daley7Jonathan Deeks8Joan Duda9Ulf Ekelund10Emma Frew11Paramjit Gill12Tania Griffin13Karla Hemming14Kiya Hurley15Emma R Lancashire16James Martin17Eleanor McGee18Miranda J Pallan19Jayne Parry20Sandra Passmore21Institute of Applied Health Research, University of Birmingham, Birmingham, UKInstitute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UKEdinburgh Migration, Ethnicity and Health Research Group, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UKFaculty of Mathematics and Physical Sciences, School of Food Science and Nutrition, University of Leeds, Leeds, UKClinical Trials Unit, University of Warwick, Warwick, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKSchool of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UKMedical Research Council (MRC) Epidemiology Unit, Cambridge, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKBirmingham Community Healthcare NHS Trust, Birmingham, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKInstitute of Applied Health Research, University of Birmingham, Birmingham, UKServices for Education, Birmingham, UKBackground: 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.https://doi.org/10.3310/hta22080childhood obesitypreventioncluster randomised trialcomplex interventioneconomic evaluation |
| spellingShingle | Peymane Adab Timothy Barrett Raj Bhopal Janet E Cade Alastair Canaway Kar Keung Cheng Joanne Clarke Amanda Daley Jonathan Deeks Joan Duda Ulf Ekelund Emma Frew Paramjit Gill Tania Griffin Karla Hemming Kiya Hurley Emma R Lancashire James Martin Eleanor McGee Miranda J Pallan Jayne Parry Sandra Passmore The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6–7 years Health Technology Assessment childhood obesity prevention cluster randomised trial complex intervention economic evaluation |
| title | The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6–7 years |
| title_full | The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6–7 years |
| title_fullStr | The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6–7 years |
| title_full_unstemmed | The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6–7 years |
| title_short | The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6–7 years |
| title_sort | west midlands active lifestyle and healthy eating in school children waves study a cluster randomised controlled trial testing the clinical effectiveness and cost effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6 7 years |
| topic | childhood obesity prevention cluster randomised trial complex intervention economic evaluation |
| url | https://doi.org/10.3310/hta22080 |
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