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Heterogeneity in blood pressure in UK Bangladeshi, Indian and Pakistani, compared to White, populations: divergence of adults and children.
Battu, HS, Bhopal, R, Agyemang, C
Journal of human hypertension. 2018;32(11):725-744
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Abstract
Blood pressure (BP) and hypertension prevalence differences between UK South Asians (Bangladeshis, Indians and Pakistanis) and White Europeans exist in childhood and adulthood. This meta-analysis sought to quantify these differences. We searched MEDLINE (1946-2017), EMBASE (1974-2017) and GLOBAL HEALTH (1973-2017) for comparative studies and pooled the data with Revman (Cochrane Collaboration). Twenty-two studies were included-fourteen on adults and eight on children. South Asian adults had lower systolic and slightly lower diastolic BP. However, stark heterogeneity existed between South Asian subgroups: Bangladeshis had markedly lower systolic BP (mean difference: -11.7 mmHg in men and women), Indians slightly lower (-2.0 mmHg in men and -4.5 mmHg in women) and Pakistanis intermediately lower (-7.9 mmHg in men and -8.6 mmHg in women), compared to White Europeans. However, South Asian children did not have lower systolic or diastolic BP compared to White children, and their BP was often higher. This intergenerational change in BP difference mirrored the change in body mass index difference, particularly in Bangladeshis. We conclude that ethnicity-related BP differences are heterogeneous and dependent on age, sex and South Asian subgroup. South Asian children do not have lower BP than White Europeans in contrast to their adult counterparts. There is concern that this pattern may continue into adulthood, worsening the already high cardiovascular disease burden in South Asians in future years. Further research is needed to ascertain the causes of this evolving issue.
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Effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6 and 7 year olds: cluster randomised controlled trial (WAVES study).
Adab, P, Pallan, MJ, Lancashire, ER, Hemming, K, Frew, E, Barrett, T, Bhopal, R, Cade, JE, Canaway, A, Clarke, JL, et al
BMJ (Clinical research ed.). 2018;360:k211
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Plain language summary
Excess weight in childhood is a global problem affecting around 41 million children under the age of 5 years. In addition to physical and psychosocial health consequences in these early years, childhood excess weight is an important predictor of obesity in adulthood. The aim of the study is to assess the effectiveness of a school and family based healthy lifestyle programme (WAVES intervention) compared with usual practice, in preventing childhood obesity. The primary outcome for clinical effectiveness was the difference in BMI z scores between arms at 15 and 30 months. The study was a school based, cluster randomised, controlled trial where 200 schools were randomly selected from all state run primary schools within 35miles of the study centre (n=980). 144 eligible schools were approached to achieve the target recruitment of 54 schools. The intervention components were delivered over a period of 12 months and targeted the home and school environment. The results show that there was no overall evidence of improvement in the primary outcomes of reduction in body mass index (BMI) z scores at 15 and 30 months after a childhood obesity prevention programme was delivered through schools and targeting 6 and 7-year olds. The intervention did not have any effects on secondary anthropometric, behavioural, or clinical outcomes. A clinically significant difference in BMI z score in favour of the intervention was seen in the first cohort of schools recruited. However, post hoc analysis suggested that this outcome may have been a cohort effect as no effect was seen in group 2 schools at any time point. Authors conclude that the study intervention did not result in a statistically significant difference in BMI z score overall, and there was no evidence of effect on measured diet or physical activity levels in children. However, the lower cost components of the intervention could be considered by schools to fulfil their mandated responsibilities for education on health and wellbeing.
Abstract
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.
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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.
Adab, P, Barrett, T, Bhopal, R, Cade, JE, Canaway, A, Cheng, KK, Clarke, J, Daley, A, Deeks, J, Duda, J, et al
Health technology assessment (Winchester, England). 2018;(8):1-608
Abstract
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.
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Adiposity and response to an obesity prevention intervention in Pakistani and Bangladeshi primary school boys and girls: a secondary analysis using the BEACHeS feasibility study.
Cezard, G, Bansal, N, Bhopal, R, Pallan, M, Gill, P, Barrett, T, Adab, P
BMJ open. 2016;(2):e007907
Abstract
OBJECTIVES As a secondary analysis of the BEACHeS study, we hypothesised there would be sex differences in Pakistani and Bangladeshi school children when examining adiposity and their response to an obesity intervention. DESIGN The Birmingham healthy Eating and Active lifestyle for CHildren Study (BEACHeS) was designed as a Phase II feasibility study of a complex intervention. SETTING 8 primary schools with predominantly South Asian children in Birmingham, UK PARTICIPANTS 1090 pupils (aged 5-7 years old) from school year 1 and 2 were allocated at school level to receive an intervention. A total of 574 were enrolled in the study with consent. We focused on the 466 children of Pakistani and Bangladeshi origin (50.6% boys). INTERVENTION Delivered between 2007 and 2009, the 1-year obesity prevention intervention targeted school and family-based dietary and physical activities. PRIMARY AND SECONDARY OUTCOME MEASURES AND ANALYSIS Adiposity measures including skinfold thickness were compared by sex at baseline and follow-up. Gains in adiposity measures were compared between control and intervention arms in boys and in girls. Measures were compared using two-sample t tests and Wilcoxon-Mann-Whitney rank sum tests according to normality distribution. RESULTS At baseline, girls had larger skinfold measures at all sites compared to boys although body mass index (BMI) was similar (eg, median subscapular skinfold 6.6 mm vs 5.7 mm; p<0.001). At follow-up, girls in the intervention group gained less weight and adiposity compared to respective controls (p<0.05 for weight, BMI, waist circumference, central and thigh skinfold) with a median total skinfold gain of 7.0 mm in the control group compared to 0.3 mm in the intervention group. CONCLUSIONS Our secondary analysis suggests differences in adiposity in Pakistani and Bangladeshi girls and boys and in the effect of the intervention reducing adiposity in girls. These preliminary findings indicate that including sex differences should be examined in future trials. TRIAL REGISTRATION NUMBER ISRCTN51016370; Post-results.
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Prevalence of vitamin B-12 insufficiency during pregnancy and its effect on offspring birth weight: a systematic review and meta-analysis.
Sukumar, N, Rafnsson, SB, Kandala, NB, Bhopal, R, Yajnik, CS, Saravanan, P
The American journal of clinical nutrition. 2016;(5):1232-51
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BACKGROUND Vitamin B-12 and folate are micronutrients essential for normal embryogenesis. Vitamin B-12 insufficiency in pregnancy is high in certain parts of the world, such as India, and although this has been linked to low birth weight (LBW) in these populations, the relation between vitamin B-12 and birth weight (BW) elsewhere is unknown. OBJECTIVES We performed a systematic review to assess 1) the worldwide prevalence of vitamin B-12 insufficiency in pregnancy and 2) its association with BW. DESIGN A search of 5 electronic databases was performed to identify eligible articles. Random-effects meta-analysis was conducted according to geographic regions and pregnancy trimesters for the prevalence subreview and by categorical measures of BW. RESULTS A total of 57 and 23 articles were included for the prevalence and BW subreviews, respectively. The pooled estimates of vitamin B-12 insufficiency were 21%, 19%, and 29% in the first, second, and third trimesters, respectively, with high rates for the Indian subcontinent and the Eastern Mediterranean. The large heterogeneity between studies was partially addressed by creating a standardized score for each study (mean vitamin B-12 insufficiency ÷ cutoff value), which internally corrected for geographic region, trimester, and assay type. Twelve of the 13 longitudinal studies included showed a decrease in mean or median vitamin B-12 across trimesters. Pooled analysis showed nonsignificantly lower maternal vitamin B-12 concentrations in LBW than in normal-BW infants and higher odds of LBW with lower vitamin B-12 values (adjusted OR: 1.70; 95% CI: 1.16, 2.50), but studies from India largely contributed to the latter. CONCLUSIONS Our review indicates that vitamin B-12 insufficiency during pregnancy is common even in nonvegetarian populations and that concentrations of vitamin B-12 decrease from the first to the third trimester. There is no consistent association between vitamin B-12 insufficiency and LBW. However, given the long-term risks of LBW, this observation warrants further cohort studies and randomized controlled trials.
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Associations between weight change and biomarkers of cardiometabolic risk in South Asians: secondary analyses of the PODOSA trial.
Welsh, P, Cezard, G, Gill, JM, Wallia, S, Douglas, A, Sheikh, A, Wild, SH, Tuomilehto, J, McKnight, J, Murray, G, et al
International journal of obesity (2005). 2016;(6):1005-11
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BACKGROUND/OBJECTIVES The association of weight changes with cardiometabolic biomarkers in South Asians has been sparsely studied. SUBJECTS/METHODS We measured cardiometabolic biomarkers at baseline and after 3 years in the Prevention of Diabetes and Obesity in South Asians Trial. We investigated the effect of a lifestyle intervention on biomarkers in the randomized groups. In addition, treating the population as a single cohort, we estimated the association between change in weight and change in biomarkers. RESULTS Complete data were available at baseline and after 3 years in 151 participants. At 3 years, there was an adjusted mean reduction of 1·44 kg (95% confidence interval (95% CI): 0.18-2.71) in weight and 1.59 cm (95% CI: 0.08-3.09) in waist circumference in the intervention arm as compared with the control arm. There was no clear evidence of difference between the intervention and control arms in change of mean value of any biomarker. As a single cohort, every 1 kg weight reduction during follow-up was associated with a reduction in triglycerides (-1.3%, P=0.048), alanine aminotransferase (-2.5%, P=0.032), gamma-glutamyl transferase (-2.2%, P=0.040), leptin (-6.5%, P<0.0001), insulin (-3.7%, P=0.0005), fasting glucose (-0.8%, P=0.0071), 2-h glucose (-2.3%, P=0.0002) and Homeostatic Model Assessment of insulin resistance (HOMA-IR: -4.5%, P=0.0002). There was no evidence of associations with other lipid measures, tissue plasminogen activator, markers of inflammation or blood pressure. CONCLUSIONS We demonstrate that modest weight decrease in SAs is associated with improvements in markers of total and ectopic fat as well as insulin resistance and glycaemia in South Asians at risk of diabetes. Future trials with more intensive weight change are needed to extend these findings.
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Diet and physical activity interventions to prevent or treat obesity in South Asian children and adults: a systematic review and meta-analysis.
Brown, T, Smith, S, Bhopal, R, Kasim, A, Summerbell, C
International journal of environmental research and public health. 2015;(1):566-94
Abstract
BACKGROUND AND AIMS The metabolic risks associated with obesity are greater for South Asian populations compared with White or other ethnic groups, and levels of obesity in childhood are known to track into adulthood. Tackling obesity in South Asians is therefore a high priority. The rationale for this systematic review is the suggestion that there may be differential effectiveness in diet and physical activity interventions in South Asian populations compared with other ethnicities. The research territory of the present review is an emergent, rather than mature, field of enquiry, but is urgently needed. Thus the aim of this systematic review and meta-analysis was to assess the effectiveness of diet and physical activity interventions to prevent or treat obesity in South Asians living in or outside of South Asia and to describe the characteristics of effective interventions. METHODS Systematic review of any type of lifestyle intervention, of any length of follow-up that reported any anthropometric measure for children or adults of South Asian ethnicity. There was no restriction on the type of comparator; randomised controlled trials, controlled clinical trials, and before-after studies were included. A comprehensive search strategy was implemented in five electronic databases: ASSIA, Cochrane Controlled Trials Register, Embase, Medline and Social Sciences Citation Index. The search was limited to English language abstracts published between January 2006 and January 2014. References were screened; data extraction and quality assessment were carried out by two reviewers. RESULTS are presented in narrative synthesis and meta-analysis. RESULTS Twenty-nine studies were included, seven children, 21 adult and one mixed age. No studies in children under six were identified. Sixteen studies were conducted in South Asia, ten in Europe and three in USA. Effective or promising trials include physical activity interventions in South Asian men in Norway and South Asian school-children in the UK. A home-based, family-orientated diet and physical activity intervention improved obesity outcomes in South Asian adults in the UK, when adjusted for baseline differences. Meta-analyses of interventions in children showed no significant difference between intervention and control for body mass index or waist circumference. Meta-analyses of adult interventions showed significant improvement in weight in data from two trials adjusted for baseline differences (mean difference -1.82 kgs, 95% confidence interval -2.48 to -1.16) and in unadjusted data from three trials following sensitivity analysis (mean difference -1.20 kgs, 95% confidence interval -2.23 to -0.17). Meta-analyses showed no significant differences in body mass index and waist circumference for adults. Twenty of 24 intervention groups showed improvements in adult body mass index from baseline to follow-up; average change in high quality studies (n = 7) ranged from 0.31 to -0.8 kg/m2. There was no evidence that interventions were more or less effective according to whether the intervention was set in South Asia or not, or by socio-economic status. CONCLUSIONS Meta-analysis of a limited number of controlled trials found an unclear picture of the effects of interventions on body mass index for South Asian children. Meta-analyses of a limited number of controlled trials showed significant improvement in weight for adults but no significant differences in body mass index and waist circumference. One high quality study in South Asian children found that a school-based physical activity intervention that was delivered within the normal school day which was culturally sensitive, was effective. There is also evidence of culturally appropriate approaches to, and characteristics of, effective interventions in adults which we believe could be transferred and used to develop effective interventions in children.
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A cluster-randomised controlled trial to assess the effectiveness and cost-effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6-7 year old children: the WAVES study protocol.
Adab, P, Pallan, MJ, Lancashire, ER, Hemming, K, Frew, E, Griffin, T, Barrett, T, Bhopal, R, Cade, JE, Daley, A, et al
BMC public health. 2015;:488
Abstract
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).
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Effect of a lifestyle intervention on weight change in south Asian individuals in the UK at high risk of type 2 diabetes: a family-cluster randomised controlled trial.
Bhopal, RS, Douglas, A, Wallia, S, Forbes, JF, Lean, ME, Gill, JM, McKnight, JA, Sattar, N, Sheikh, A, Wild, SH, et al
The lancet. Diabetes & endocrinology. 2014;(3):218-27
Abstract
BACKGROUND The susceptibility to type 2 diabetes of people of south Asian descent is established, but there is little trial-based evidence for interventions to tackle this problem. We assessed a weight control and physical activity intervention in south Asian individuals in the UK. METHODS We did this non-blinded trial in two National Health Service (NHS) regions in Scotland (UK). Between July 1, 2007, and Oct 31, 2009, we recruited men and women of Indian and Pakistani origin, aged 35 years or older, with waist circumference 90 cm or greater in men or 80 cm or greater in women, and with impaired glucose tolerance or impaired fasting glucose determined by oral glucose tolerance test. Families were randomised (using a random number generator program, with permuted blocks of random size, stratified by location [Edinburgh or Glasgow], ethnic group [Indian or Pakistani], and number of participants in the family [one vs more than one]) to intervention or control. Participants in the same family were not randomised separately. The intervention group received 15 visits from a dietitian over 3 years and the control group received four visits in the same period. The primary outcome was weight change at 3 years. Analysis was by modified intention to treat, excluding participants who died or were lost to follow-up. We used linear regression models to provide mean differences in baseline-adjusted weight at 3 years. This trial is registered, number ISRCTN25729565. FINDINGS Of 1319 people who were screened with an oral glucose tolerance test, 196 (15%) had impaired glucose tolerance or impaired fasting glucose and 171 entered the trial. Participants were in 156 family clusters that were randomised (78 families with 85 participants were allocated to intervention; 78 families with 86 participants were allocated to control). 167 (98%) participants in 152 families completed the trial. Mean weight loss in the intervention group was 1.13 kg (SD 4.12), compared with a mean weight gain of 0.51 kg (3.65) in the control group, an adjusted mean difference of -1.64 kg (95% CI -2.83 to -0.44). INTERPRETATION Modest, medium-term changes in weight are achievable as a component of lifestyle-change strategies, which might control or prevent adiposity-related diseases. FUNDING National Prevention Research Initiative, NHS Research and Development; NHS National Services Scotland; NHS Health Scotland.
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Preventing childhood obesity, phase II feasibility study focusing on South Asians: BEACHeS.
Adab, P, Pallan, MJ, Cade, J, Ekelund, U, Barrett, T, Daley, A, Deeks, J, Duda, J, Gill, P, Parry, J, et al
BMJ open. 2014;(4):e004579
Abstract
OBJECTIVE To assess feasibility and acceptability of a multifaceted, culturally appropriate intervention for preventing obesity in South Asian children, and to obtain data to inform sample size for a definitive trial. DESIGN Phase II feasibility study of a complex intervention. SETTING 8 primary schools in inner city Birmingham, UK, within populations that are predominantly South Asian. PARTICIPANTS 1090 children aged 6-8 years took part in the intervention. 571 (85.9% from South Asian background) underwent baseline measures. 85.5% (n=488) were followed up 2 years later. INTERVENTIONS The 1-year intervention consisted of school-based and family-based activities, targeting dietary and physical activity behaviours. The intervention was modified and refined throughout the period of delivery. MAIN OUTCOME MEASURES Acceptability and feasibility of the intervention and of measurements required to assess outcomes in a definitive trial. The difference in body mass index (BMI) z-score between arms was used to inform sample size calculations for a definitive trial. RESULTS Some intervention components (increasing school physical activity opportunities, family cooking skills workshops, signposting of local leisure facilities and attending day event at a football club) were feasible and acceptable. Other components were acceptable, but not feasible. Promoting walking groups was neither acceptable nor feasible. At follow-up, children in the intervention compared with the control group were less likely to be obese (OR 0.41; 0.19 to 0.89), and had lower adjusted BMI z-score (-0.15 kg/m(2); 95% CI -0.27 to -0.03). CONCLUSIONS The feasibility study informed components for an intervention programme. The favourable direction of outcome for weight status in the intervention group supports the need for a definitive trial. A cluster randomised controlled trial is now underway to assess the clinical and cost-effectiveness of the intervention. TRIAL REGISTRATION NUMBER ISRCTN51016370.