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Evaluating an Intervention to Increase Cereal Fiber Intake in Children: A Randomized Controlled Feasibility Trial.
Donin, AS, Nightingale, CM, Perkin, MR, Ussher, M, Jebb, SA, Landberg, R, Welsh, P, Sattar, N, Adab, P, Owen, CG, et al
The Journal of nutrition. 2021;(2):379-386
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Abstract
BACKGROUND Observational studies have shown that higher cereal fiber intake is associated with reduced type 2 diabetes risk. However, it remains uncertain whether this association is causal. OBJECTIVE This study evaluated the feasibility of an intervention to increase cereal fiber intake in children using breakfast cereals. METHODS The study was a 2-arm parallel group randomized controlled trial in 9-10-y-old children, who received free supplies of high-fiber breakfast cereals (>3.5 g/portion) or low-fiber breakfast cereals (<1.0 g/portion) to eat daily for 1 mo with behavioral support to promote adherence. Children provided baseline and 1-mo fasting blood samples, physical measurements, and 24-h dietary recalls. The primary outcome was the group difference in change in plasma total alkylresorcinol (AR) concentration; secondary outcomes were group differences in nutrient intakes and adiposity indices. Analyses (complete case and multiple imputation) were conducted by regressing the final AR concentration on baseline AR in models adjusted for sex, ethnicity, age, and school (random effect). RESULTS Two-hundred seventy-two children were randomly assigned (137 receiving a low-fiber and 135 a high-fiber diet) and 193 (71%) provided fasting blood samples at baseline and follow-up. Among randomized participants, median (IQR) of baseline AR was 43.1 (24.6-85.5) nmol/L and of cereal fiber intake was 4.5 (2.7-6.4) g; 87% of participants reported consuming the cereal on most or all days. Compared with changes in the low-fiber group, the high-fiber group had greater increases in AR (40.7 nmol/L; 95% CI: 21.7, 59.8 nmol/L, P < 0.0001) and in reported cereal fiber intake (2.9g/d; 95% CI: 2.0, 3.7 g; P < 0.0001). There were no appreciable differences in other secondary outcomes. CONCLUSIONS We have developed a simple and acceptable nutritional intervention that increases markers of daily cereal fiber intake in children. This intervention could be used to test whether increases in cereal fiber intake in children might reduce insulin resistance. This trial was registered at www.isrctn.com as ISRCTN33260236.
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Cost-Effectiveness of a School-and Family-Based Childhood Obesity Prevention Programme in China: The "CHIRPY DRAGON" Cluster-Randomised Controlled Trial.
Zanganeh, M, Adab, P, Li, B, Pallan, M, Liu, WJ, Hemming, K, Lin, R, Liu, W, Martin, J, Cheng, KK, et al
International journal of public health. 2021;:1604025
Abstract
Objectives: Rapid socioeconomic and nutrition transitions in Chinese populations have contributed to the growth in childhood obesity. This study presents a cost-effectiveness analysis of a school- and family-based childhood obesity prevention programme in China. Methods: A trial-based economic evaluation assessed cost-effectiveness at 12 months. Forty schools with 1,641 children were randomised to either receive the multi-component (diet and physical activity) intervention or to continue with usual activities. Both public sector and societal perspectives were adopted. Costs and benefits in the form of quality-adjusted life years (QALYs) were compared and uncertainty was assessed using established UK and US thresholds. Results: The intervention cost was 35.53 Yuan (£7.04/US$10.01) per child from a public sector perspective and 536.95 Yuan (£106/US$151) from a societal perspective. The incremental cost-effectiveness ratio (ICER) was 272.7 Yuan (£54/US$77)/BMI z-score change. The ICER was 8,888 Yuan (£1,760/US$2,502) and 73,831 Yuan (£14,620/US$20,796) per QALY from a public sector and societal perspective, respectively and was cost-effective using UK (£20,000) and US (US$50,000) per QALY thresholds. Conclusion: A multi-component school-based prevention programme is a cost-effective means of preventing childhood obesity in China.
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Effectiveness of school-based interventions to prevent obesity among children aged 4 to 12 years old in middle-income countries: A systematic review and meta-analysis.
Singhal, J, Herd, C, Adab, P, Pallan, M
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2021;(1):e13105
Abstract
Economic and accompanying nutrition transition in middle-income countries is resulting in rapidly increasing childhood obesity prevalence, exceeding acceleration rates in the West. Previous school-based obesity prevention reviews have mainly included studies from high-income countries. This review aimed to summarize the evidence from randomized controlled trials evaluating the effectiveness of school-based interventions in preventing childhood obesity in middle-income countries. Six electronic databases were searched: MEDLINE, EMBASE, CINAHL Plus, LILACS, IBECS and WPRIM. Eligibility criteria included middle-income country setting, randomized/cluster-randomized controlled trials, children aged 4-12 years and school-based interventions targeting dietary intake and/or physical activity. Twenty-one cluster-randomized controlled trials, conducted in Asia (n = 10), South America (n = 4), North America (n = 4) and the Middle East (n = 3), were included. Fifteen studies reported a significant intervention effect on at least one adiposity-related outcome. Characteristics of effective interventions included combined diet and PA interventions, school teacher-delivery, duration of >8 months, parental involvement, education sessions and school food modifications. The risk of bias in these trials was mixed. The pooled estimate of the odds ratio for obesity in intervention versus control schools (nine studies) was 0.77; 95% CI, 0.63 to 0.94; p = 0.009. In conclusion, there is some evidence to support school-based interventions in preventing childhood obesity in middle-income countries.
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An assessment of the construct validity of the Child Health Utility 9D-CHN instrument in school-aged children: evidence from a Chinese trial.
Zanganeh, M, Adab, P, Li, B, Frew, E
Health and quality of life outcomes. 2021;(1):205
Abstract
BACKGROUND Although there is emerging data regarding the psychometric properties of the Child Health Utility-9D instrument, more evidence is required with respect to its validity for use in different country settings. The aim of this study was to examine the construct validity of the CHU-9D-CHN instrument in Chinese children. METHODS Baseline Health-Related Quality of Life (HRQoL) and demographic data were collected from children recruited to the CHIRPY DRAGON obesity prevention intervention randomised controlled trial in China. HRQoL was measured using the Chinese version of the CHU-9D instrument (CHU-9D-CHN) and the PedsQL instrument. CHU-9D-CHN utility scores were generated using two scoring algorithms [UK and Chinese tariffs]. Discriminant validity, known-group validity and convergent validity were evaluated using non-parametric test for trend, Kruskal-Wallis test and Spearman correlation coefficient analysis respectively. RESULTS Data was available for 1,539 children (mean age 6 years). The CHU-9D-CHN was sensitive to known group differences determined by the median PedsQL total score. Furthermore, the mean CHU-9D-CHN utility values decreased linearly with increasing levels of severity on each dimension of the PedsQL for emotional and social functioning domains. They decreased monotonically with increasing levels of severity on each dimension of the PedsQL for physical and school functioning domains (p < 0.001). Contrary to studies conducted in Western countries, and although not statistically significant, we found an indication that HRQoL, using both the CHU-9D-CHN and the PedsQL, was higher in children whose parents had lower levels of education, compared to those whose parents were university educated. The correlation between the CHU-9D-CHN utility values using UK and Chinese tariffs, and PedsQL total scores showed a statistically significant moderate positive correlation (Spearman's rho = 0.5221, p < 0.001 and Spearman's rho = 0.5316, p < 0.001), respectively. However, each CHU-9D-CHN dimension was either weakly, or very weakly correlated with each of the predetermined PedsQL domain functioning scores. CONCLUSIONS Overall, the findings provide some support for the construct validity of the CHU-9D-CHN within a Chinese population aged 6-7 years. However, some uncertainty remains. We recommend future studies continue to test the validity of the CHU-9D in different country settings. TRIAL REGISTRATION ISRCTN Identifier ISRCTN11867516, Registered on 19/08/2015.
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Effectiveness and cost-effectiveness of The Daily Mile on childhood weight outcomes and wellbeing: a cluster randomised controlled trial.
Breheny, K, Passmore, S, Adab, P, Martin, J, Hemming, K, Lancashire, ER, Frew, E
International journal of obesity (2005). 2020;(4):812-822
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Abstract
BACKGROUND The Daily Mile is designed to increase physical activity levels with children running or walking around school grounds for 15-min daily. It has been adopted by schools worldwide and endorsed as a solution to tackle obesity, despite no robust evidence of its benefits. We conducted a cluster randomised controlled trial to determine its clinical and cost-effectiveness. METHODS Forty schools were randomly assigned (1:1) to either the Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented. The primary outcome was BMI z-score (BMIz) at 12 months follow-up from baseline, with planned subgroup analysis to examine differential effects. Primary economic analysis outcome was incremental cost per Quality-Adjusted-Life-Year (QALY) gained. RESULTS Using a constrained randomisation approach, balanced on school size, baseline BMIz and proportion of pupils eligible for free school meals, 20 schools were allocated to intervention (n = 1,153 participants) and 20 to control (n = 1,127); 3 schools withdrew (2 intervention, 1 control). At 12 months, BMIz data were available for 18 intervention schools (n = 850) and 19 control schools (n = 820 participants). Using intention-to-treat analysis the adjusted mean difference (MD) in BMIz (intervention - control) was -0.036 (95% CI: -0.085 to 0.013, p = 0.146). Pre-specified subgroup analysis showed a significant interaction with sex (p = 0.001) suggesting a moderate size benefit of The Daily Mile in girls (MD -0.097, 95% CI -0.156 to -0.037). This was consistent with the exploratory economic results that showed The Daily Mile to be highly cost-effective in girls (£2,492 per QALY), but not in boys, and overall to have a 76% chance of cost-effectiveness for the whole sample, at the commonly applied UK threshold of £20,000 per QALY. CONCLUSIONS Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.
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Relationship between primary school healthy eating and physical activity promoting environments and children's dietary intake, physical activity and weight status: a longitudinal study in the West Midlands, UK.
Garden, EM, Pallan, M, Clarke, J, Griffin, T, Hurley, K, Lancashire, E, Sitch, AJ, Passmore, S, Adab, P
BMJ open. 2020;(12):e040833
Abstract
OBJECTIVE We aimed to examine the association between food and physical activity environments in primary schools and child anthropometric, healthy eating and physical activity measures. DESIGN Observational longitudinal study using data from a childhood obesity prevention trial. SETTING State primary schools in the West Midlands region, UK. PARTICIPANTS 1392 pupils who participated in the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) childhood obesity prevention trial (2011-2015). PRIMARY AND SECONDARY OUTCOME MEASURES School environment (exposure) was categorised according to questionnaire responses indicating their support for healthy eating and/or physical activity. Child outcome measures, undertaken at three time points (ages 5-6, 7-8 and 8-9 years), included body mass index z-scores, dietary intake (using a 24-hour food ticklist) and physical activity (using an Actiheart monitor over 5 days). Associations between school food and physical activity environment categories and outcomes were explored through multilevel models. RESULTS Data were available for 1304 children (94% of the study sample). At age 8-9 years, children in 10 schools with healthy eating and physical activity-supportive environments had a higher physical activity energy expenditure than those in 22 schools with less supportive healthy eating/physical activity environments (mean difference=5.3 kJ/kg body weight/24 hours; p=0.05). Children in schools with supportive physical activity environments (n=8) had a lower body mass index z-score than those in schools with less supportive healthy eating/physical activity environments (n=22; mean difference=-0.17, p=0.02). School food and physical activity promoting environments were not significantly associated with dietary outcomes. CONCLUSIONS School environments that support healthy food and physical activity behaviours may positively influence physical activity and childhood obesity. TRIAL REGISTRATION NUMBER ISRCTN97000586.
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Economic evaluation of a childhood obesity prevention programme for children: Results from the WAVES cluster randomised controlled trial conducted in schools.
Canaway, A, Frew, E, Lancashire, E, Pallan, M, Hemming, K, Adab, P, ,
PloS one. 2019;(7):e0219500
Abstract
BACKGROUND Childhood obesity is a serious public health challenge and schools have been identified as an ideal place to implement prevention interventions. The aim of this study was to measure the cost-effectiveness of a multi-faceted school-based obesity prevention intervention targeting children aged 6-7 years when compared to 'usual activities'. METHODS A cluster randomised controlled trial in 54 schools across the West Midlands (UK) was conducted. The 12-month intervention aimed to increase physical activity by 30 minutes per day and encourage healthy eating. Costs were captured from a public sector perspective and utility-based health related outcomes measured using the CHU-9D. Multiple imputation using chained equations was used to address missing data. The cost effectiveness was measured at 30 months from baseline using a hierarchical net-benefit regression framework, that controlled for clustering and prespecified covariates. Any uncertainty in the results was characterised using cost-effectiveness acceptability curves. RESULTS At 30 months, the total adjusted incremental mean cost of the intervention was £155 (95% confidence interval [CI]: £139, £171), and the incremental mean QALYs gained was 0.006 (95% CI: -0.024, 0.036), per child. The incremental cost-effectiveness at 30 months was £26,815 per QALY and using a standard willingness to pay threshold of £30,000 per QALY, there was a 52% chance that the intervention was cost-effective. CONCLUSIONS The cost-effectiveness of the school-based WAVES intervention was subject to substantial uncertainty. We therefore recommend more research to explore obesity prevention within schools as part of a wider systems approach to obesity prevention. TRIAL REGISTRATION This paper uses data collected by the WAVES trial: Controlled trials ISRCTN97000586 (registered May 2010).
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Cultural adaptation of an existing children's weight management programme: the CHANGE intervention and feasibility RCT.
Pallan, M, Griffin, T, Hurley, KL, Lancashire, E, Blissett, J, Frew, E, Griffith, L, Hemming, K, Jolly, K, McGee, E, et al
Health technology assessment (Winchester, England). 2019;(33):1-166
Abstract
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.
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The CHIRPY DRAGON intervention in preventing obesity in Chinese primary-school--aged children: A cluster-randomised controlled trial.
Li, B, Pallan, M, Liu, WJ, Hemming, K, Frew, E, Lin, R, Liu, W, Martin, J, Zanganeh, M, Hurley, K, et al
PLoS medicine. 2019;(11):e1002971
Abstract
BACKGROUND In countries undergoing rapid economic transition such as China, rates of increase in childhood obesity exceed that in the West. However, prevention trials in these countries are inadequate in both quantity and methodological quality. In high-income countries, recent reviews have demonstrated that school-based prevention interventions are moderately effective but have some methodological limitations. To address these issues, this study evaluated clinical- and cost- effectiveness of the Chinese Primary School Children Physical Activity and Dietary Behaviour Changes Intervention (CHIRPY DRAGON) developed using the United Kingdom Medical Research Council complex intervention framework to prevent obesity in Chinese primary-school-aged children. METHODS AND FINDINGS In this cluster-randomised controlled trial, we recruited 40 state-funded primary schools from urban districts of Guangzhou, China. A total of 1,641 year-one children with parent/guardian consent took part in baseline assessments prior to stratified randomisation of schools (intervention arm, 20 schools, n = 832, mean age = 6.15 years, 55.6% boys; control arm n = 809, mean age = 6.14 years, 53.3% boys). The 12-month intervention programme included 4 school- and family-based components delivered by 5 dedicated project staff. We promoted physical activity and healthy eating behaviours through educational and practical workshops, family activities, and supporting the school to improve physical activity and food provision. The primary outcome, assessed blind to allocation, was between-arm difference in body mass index (BMI) z score at completion of the intervention. A range of prespecified, secondary anthropometric, behavioural, and psychosocial outcomes were also measured. We estimated cost effectiveness based on quality-adjusted life years (QALYs), taking a public sector perspective. Attrition was low with 55 children lost to follow up (3.4%) and no school dropout. Implementation adherence was high. Using intention to treat analysis, the mean difference (MD) in BMI z scores (intervention - control) was -0.13 (-0.26 to 0.00, p = 0.048), with the effect being greater in girls (MD = -0.18, -0.32 to -0.05, p = 0.007, p for interaction = 0.015) and in children with overweight or obesity at baseline (MD = -0.49, -0.73 to -0.25, p < 0.001, p for interaction < 0.001). Significant beneficial intervention effects were also observed on consumption of fruit and vegetables, sugar-sweetened beverages and unhealthy snacks, screen-based sedentary behaviour, and physical activity in the intervention group. Cost effectiveness was estimated at £1,760 per QALY, with the probability of the intervention being cost effective compared with usual care being at least 95% at a willingness to pay threshold of £20,000 to 30,000 per QALY. There was no evidence of adverse effects or harms. The main limitations of this study were the use of dietary assessment tools not yet validated for Chinese children and the use of the UK value set to estimate QALYS. CONCLUSIONS This school- and family-based obesity prevention programme was effective and highly cost effective in reducing BMI z scores in primary-school-aged children in China. Future research should identify strategies to enhance beneficial effects among boys and investigate the transferability of the intervention to other provinces in China and countries that share the same language and cultures. TRIAL REGISTRATION ISRCTN Identifier ISRCTN11867516.
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A scoping review and systematic mapping of health promotion interventions associated with obesity in Islamic religious settings in the UK.
Rai, KK, Dogra, SA, Barber, S, Adab, P, Summerbell, C, ,
Obesity reviews : an official journal of the International Association for the Study of Obesity. 2019;(9):1231-1261
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Abstract
Islamic religious settings (IRS) may be useful places to implement obesity interventions for Muslims. However, little is known about the level and nature of such activity in these settings. We searched bibliographic databases and grey literature, and requested grey information from Muslim organizations, local councils, and mosques in 13 selected areas in the United Kingdom. Thirty-five interventions were identified; most were poorly described and not evaluated. Twenty-seven interventions focused on physical activity behaviours, four on diet behaviours, one on both behaviours, and seven addressed long-term conditions associated with obesity. Most interventions were led by volunteers from the congregation/faith leaders and were funded through donations from congregants or charity organizations. The evidence suggests that health promotion interventions in IRS have a relatively high reach. Obesity interventions are commonly delivered in UK IRS. Most target physical activity behaviours, are instigated and led by volunteers from the congregation or faith leaders, receive no public funding, and are only recorded in people's memories. High-quality evaluations of well-specified interventions in this context are needed. We suggest that the methods used in this review, including the learning around positionality of researchers, could be adopted by other researchers as a way to locate opportunities for effective community-level interventions.