Women's views on content and delivery methods for interventions to improve preconception health: a qualitative exploration.

Background: Systematic review evidence suggests preconception health interventions may be effective in improving a range of outcomes. However, few studies have explored women's views on potential content and delivery methods for these interventions. Methods: Participants were purposively sampled from respondents (n = 313) of a survey. Semi-structured, in-depth interviews were conducted to explore their views on seven candidate delivery methods for preconception health interventions: general practitioners (GPs), nurse practitioners, pharmacists, social media, personal texts and emails, pregnancy tests, and health education in schools. Data were analyzed using a data-driven framework analysis. Results: Twenty women were interviewed. Women wanted interventions to be easily accessible but allow them to conceal their pregnancy plans. They preferred to choose to receive preconception interventions but were receptive to health professionals raising preconception health during 'relevant' appointments such as contraceptive counseling and cervical smear tests. They wanted intervention content to provide trustworthy and positively framed information that highlights the benefits of good preconception health and avoids stigmatizing women for their weight and preconception actions. The inclusion of support for preconception mental health and the use of visual media, personalization, simple information, and interesting and unfamiliar facts were viewed favorably. Conclusion: Interventions to improve preconception health should reflect the sensitivities of pregnancy intentions, be easy to access in a way that enables discretion, and be designed to seek consent to receive the intervention. These interventions should ideally be tailored to their target populations and provide trustworthy information from reputable sources. The potential for unintended harmful effects should be explored.

Exploring the associations between adverse childhood experiences (ACEs) and adolescent cancer risk behaviours in the ALSPAC cohort.

BACKGROUND: Some modifiable risk factors for cancer originate during adolescence. While there is evidence indicating relationships between adverse childhood experiences and health risk behaviours generally, little is known about how childhood adversity influences the engagement of adolescents in cancer risk behaviours. This study aimed to determine the relationship between adverse childhood experiences and adolescent cancer risk behaviours. METHODS: Data were collected prospectively from birth to age 18 years on children born to mothers enrolled into the Avon Longitudinal Study of Parents and Children (ALSPAC) cohort study. Multivariable linear regression models assessed relationships of a composite exposure measure comprised of adverse childhood experiences (total number of childhood adversities experienced from early infancy until age 9 years) with multiple cancer risk behaviours. The latter was expressed as a single continuous score for tobacco smoking, alcohol consumption, obesity, unsafe sex, and physical inactivity, at ages 11, 14, 16 and 18 years. Analysis was carried out on the complete case and imputation samples of 1,368 and 7,358 participants respectively. RESULTS: All adolescent cancer risk behaviours increased in prevalence as the adolescents grew older, except for obesity. Each additional adverse childhood experience was associated with a 0.25 unit increase in adolescent cancer risk behaviour (95% CI 0.16-0.34; p < 0.001). Individually, parental substance misuse (ß 0.64, 95% CI 0.25-1.03, p < 0.001) and parental separation (ß 0.56, 95% CI 0.27-0.86, p < 0.001) demonstrated the strongest evidence of association with engagement in adolescent cancer risk behaviour. CONCLUSION: Childhood adversity was associated with a greater degree of engagement in adolescent cancer risk behaviours. This finding demonstrates the need for targeted primary and secondary prevention interventions that reduce engagement across multiple cancer risk behaviours for children and adolescents who have experienced adversity in childhood, such as parental substance misuse and separation, and reduce exposure to adversity.

Women's knowledge, attitudes and views of preconception health and intervention delivery methods: a cross-sectional survey.

BACKGROUND: Several preconception exposures have been associated with adverse pregnancy, birth and postpartum outcomes. However, few studies have investigated women's knowledge of and attitudes towards preconception health, and the acceptability of potential intervention methods. METHODS: Seven primary care centres in the West of England posted questionnaires to 4330 female patients aged 18 to 48 years. Without providing examples, we asked women to list maternal preconception exposures that might affect infant and maternal outcomes, and assessed their knowledge of nine literature-derived risk factors. Attitudes towards preconception health (interest, intentions, self-efficacy and perceived awareness and importance) and the acceptability of intervention delivery methods were also assessed. Multivariable multilevel regression examined participant characteristics associated with these outcomes. RESULTS: Of those who received questionnaires, 835 (19.3%) responded. Women were most aware of the preconception risk factors of diet (86.0%) and physical activity (79.2%). Few were aware of weight (40.1%), folic acid (32.9%), abuse (6.3%), advanced age (5.9%) and interpregnancy intervals (0.2%), and none mentioned interpregnancy weight change or excess iron intake. After adjusting for demographic and reproductive covariates, women aged 18-24-years (compared to 40-48-year-olds) and nulligravid women were less aware of the benefit of preconception folic acid supplementation (adjusted odds ratios (aOR) for age: 4.30 [2.10-8.80], gravidity: aOR 2.48 [1.70-3.62]). Younger women were more interested in learning more about preconception health (aOR 0.37 [0.21-0.63]) but nulligravid women were less interested in this (aOR 1.79 [1.30-2.46]). Women with the lowest household incomes (versus the highest) were less aware of preconception weight as a risk factor (aOR: 3.11 [1.65-5.84]) and rated the importance of preconception health lower (aOR 3.38 [1.90-6.00]). The most acceptable information delivery methods were websites/apps (99.5%), printed healthcare materials (98.6%), family/partners (96.3%), schools (94.4%), television (91.9%), pregnancy tests (91.0%) and doctors, midwives and nurses (86.8-97.0%). Dentists (23.9%) and hairdressers/beauticians (18.1%) were the least acceptable. CONCLUSIONS: Our findings demonstrate a need to promote awareness of preconception risk factors and motivation for preconception health changes, particularly amongst younger and nulligravid women and women with lower incomes. Interventions to improve preconception health should focus on communication from healthcare professionals, schools, family members, and digital media.

Preconception exposures and adverse pregnancy, birth and postpartum outcomes: Umbrella review of systematic reviews.

BACKGROUND: Preconception exposures have been associated with adverse pregnancy, birth and postpartum outcomes. However, the reports, statements and guidelines of national and international health organisations vary in what they recommend individuals should monitor, avoid, reduce or practise in the preconception period. OBJECTIVES: To synthesise and evaluate the evidence across systematic reviews for associations between exposures before conception and adverse pregnancy, birth and postpartum outcomes. DATA SOURCES: MEDLINE, Embase, Epistemonikos (to May 2020) and reference lists of included reviews, without language or date restrictions. STUDY SELECTION, DATA EXTRACTION AND SYNTHESIS: Systematic literature reviews of observational and/or interventional studies reporting associations between preconception exposures in women and/or men of reproductive age and pregnancy, birth or postpartum health outcomes were included. The methodological quality of reviews and the certainty of the evidence underlying each exposure-outcome association were assessed using AMSTAR 2 and the GRADE approach. RESULTS: We identified 53 eligible reviews reporting 205 unique exposure-outcome associations. Methodological quality was generally low with only two reviews rated as 'high' quality and two as 'moderate'. We found high-certainty, randomised trial evidence that maternal folate supplementation reduces the risk of neural tube defects and anomaly-related terminations. Moderate-certainty, observational evidence was found that maternal physical activity is associated with reduced risk of pre-eclampsia and gestational diabetes, and that paternal age of ≥40 years and maternal body mass index (BMI) and interpregnancy weight gain are associated with increased risk of various adverse pregnancy and birth outcomes. Low- and very low-certainty evidence was found for other associations. CONCLUSIONS: Clinicians and policymakers can be confident that maternal folate supplementation should be encouraged during the preconception period. There is moderate certainty in the evidence base that maternal physical activity, BMI and interpregnancy weight gain and advanced paternal age are important preconception considerations. High-quality research is required to better understand other exposure-outcome associations.

Considerations for Individual-Level Versus Whole-School Physical Activity Interventions: Stakeholder Perspectives.

Strategies to address declining physical activity levels among children and adolescents have focused on 'individual-level' approaches which often fail to demonstrate impact. Recent attention has been on an alternative 'whole-school' approach to increasing physical activity that involves promoting physical activity throughout all aspects of the school environment. There is, however, a lack of evidence on how whole-school physical activity approaches could be implemented in the UK. This qualitative study explored perspectives of key stakeholders on potential reasons for the lack of impact of individual-level school-based interventions on children's physical activity, and key considerations for adopting a whole-school approach. Nineteen semi-structured interviews were conducted with a range of stakeholders involved in the implementation of physical activity programmes in UK schools. Data were analysed using an inductive approach. Respondents suggested that individual-level school-based interventions to increase physical activity often failed to consult end users in the design and were typically implemented in environments unsupportive of long-term change. They subsequently outlined specific barriers and key facilitators for the adoption and implementation of whole-school approaches in UK settings and recommended a shift in research foci towards building an evidence base around educational outcomes and whole-school implementation insights.

Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial.

BACKGROUND: Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. METHODS: We conducted a cluster randomised controlled trial with Year 9 (13-14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5-6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. RESULTS: A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was - 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. CONCLUSIONS: This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. TRIAL REGISTRATION: ISRCTN14539759 -31 May, 2018.

Multiple risk behaviour in adolescence is associated with substantial adverse health and social outcomes in early adulthood: Findings from a prospective birth cohort study.

Adolescents' engage in new behaviours such as substance use and change others, such as reducing physical activity. Risks to health from these tend to be considered separately. We examined the association between multiple risk behaviours at age 16 years and outcomes in early adulthood. 5591 young people enrolled in the Avon Longitudinal Study of Parents and Children provided data on at least one of seven adverse outcomes at age ~18 years. We used logistic regression to examine associations between total number of risk behaviours and rates of depression, anxiety, problem gambling, getting into trouble with the police, harmful drinking, obesity and not in education, employment or training (NEET) at age 18 years. We found strong associations between multiple risk behaviours and all seven adverse outcomes. For each additional risk behaviour engaged in the odds of harmful drinking increased by OR = 1.58[95%CI:1.48,1.69], getting into trouble with the police OR = 1.49[95%CI:1.42,1.57], having depression OR = 1.24[95%CI:1.17,1.31], problem gambling OR = 1.20[95%CI:1.13,1.27], NEET OR = 1.19[95%CI:1.11,1.29], anxiety OR = 1.18[95%CI:1.12,1.24] and obesity OR = 1.09[95%CI:1.03,1.15]. Neither adjustment for sex, parental socio-economic position and maternal risk behaviours, nor confining analyses to adolescents with no previous presentation of these adverse outcomes, resulted in any notable reductions in the odds ratios. Investment in interventions and environments that effectively prevent multiple risk behaviour is likely to improve a range of health outcomes in young adults.

Adolescent multiple risk behaviours cluster by number of risks rather than distinct risk profiles in the ALSPAC cohort.

BACKGROUND: Experimentation with new behaviours during adolescence is normal. However, engagement in two or more risk behaviours, termed multiple risk behaviours is associated with socioeconomic disadvantage and poor health and social outcomes. Evidence of how adolescents cluster based on their risk behaviours is mixed. METHODS: Latent Class Analysis was used to study patterns of engagement in 10 self-reported risk behaviours (including substance use, self-harm and sexual health) from the Avon Longitudinal Study of Parents and Children (ALSPAC) cohort at ages 15-16 years. Data was available for 6556 adolescents. Associations between risk profile and sex were explored. RESULTS: A 3-class model for both females and males was deemed to have acceptable fit. Whilst we found evidence of a sex difference in the risk behaviours reported within each class, the sex-specific results were very similar in many respects. For instance, the prevalence of membership of the high-risk class was 8.5% for males and 8.7% for females and both groups had an average of 5.9 behaviours. However, the classes were both statistically dubious, with class separation (entropy) being poor as well as conceptually problematic, because the resulting classes did not provide distinct profiles and varied only by quantity of risk-behaviours. CONCLUSION: Clusters of adolescents were not characterised by distinct risk behaviour profiles, and provide no additional insight for intervention strategies. Given this is a more complicated, software-specific method, we conclude that an equally effective, but more readily replicable approach is to use a count of the number of risk behaviours.

Protocol for a cluster randomised controlled trial of a Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A).

BACKGROUND: Adolescent girls are less physically active than recommended for health, and levels decline further as they approach adulthood. Peers can influence adolescent girls' physical activity. Interventions capitalising on peer support could positively impact physical activity behaviour in this group. Building on promising feasibility work, the purpose of this cluster randomised controlled trial is to assess whether the Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A) increases adolescent girls' physical activity and is cost effective. METHODS: PLAN-A is a two-arm secondary school-based cluster randomised controlled trial, conducted with girls aged 13-14 years from twenty schools in the south west of England. The intervention requires participants to nominate influential girls within their year group to become peer supporters. The top 15% of girls nominated in each school receive three days of training designed to prepare them to support their peers to be more physically active during a ten-week intervention period. Data will be collected at two time points, at baseline (T0) and 5-6 months post-intervention (T1). Schools will be randomly allocated to the intervention (n = 10) or control (n = 10) arm after T0. At each time point, all consenting participants will wear an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity. Multivariable mixed effects linear regression will be used to estimate differences in the primary outcome between the two arms and will be examined on an Intention-to-Treat (ITT) basis. A self-report psychosocial questionnaire will be completed by participants to assess self-esteem and physical activity motivation. Resource use and quality of life will be measured for the purposes of an economic evaluation. A mixed-methods process evaluation will be conducted to explore intervention fidelity, acceptability and sustainability. Analysis of quantitative process evaluation data will be descriptive, and the framework method will be used to analyse qualitative data. DISCUSSION: This paper describes the protocol for the PLAN-A cluster randomised controlled trial, a novel approach to increasing adolescent girls' physical activity levels through peer support. TRIAL REGISTRATION: ISRCTN14539759-31 May, 2018.

Long-term effects of the Active for Life Year 5 (AFLY5) school-based cluster-randomised controlled trial.

OBJECTIVE: To investigate the long-term effectiveness of a school-based intervention to improve physical activity and diet in children. DESIGN: Cluster-randomised controlled trial. SETTING: 60 primary schools in the southwest of England. PARTICIPANTS: Primary school children who were aged 8-9 years at recruitment, 9-10 years during the intervention and 10-11 years at the long-term follow-up assessment. INTERVENTION: Teacher training, provision of lesson and child-parent interactive homework plans and teaching materials. MAIN OUTCOME MEASURES: Primary outcomes were accelerometer-assessed minutes of moderate to vigorous physical activity (MVPA) per day, accelerometer-assessed minutes of sedentary behaviour per day and reported daily consumption of servings of fruit and vegetables. RESULTS: 60 schools with 2221 eligible children were recruited. As in the previously published assessment immediately after the end of the intervention, none of the three primary outcomes differed between children in schools allocated to the intervention, compared with those in control schools at the end of the long-term follow-up (1 year after the end of the intervention). Differences in secondary outcomes were consistent with those at the immediate follow-up, with no evidence that these had diminished over time. Comparing intervention with control schools, the difference in mean child-reported screen viewing at the weekend was -16.03 min (95% CI -32.82 to 0.73), for servings of snacks per day, the difference was -0.11 (95% CI -0.39 to 0.06), in servings of high-energy drinks per day -0.20 (95% CI -0.39 to -0.01) and in servings of high-fat foods per day -0.12 (95% CI -0.39 to 0.00). None of these reached our predefined level of statistical significance, especially after accounting for multiple testing. CONCLUSIONS: School-based curriculum interventions alone are unlikely to have a major public health impact on children's diet and physical activity. TRIAL REGISTRATION NUMBER: ISRCTN50133740, Post-results.

The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial: effect on potential mediators.

BACKGROUND: Active for life year 5 (AFLY5) is a school-based intervention, based on social cognitive theory, which aims to promote healthy levels of physical activity and healthy eating by improving a child's self-efficacy to make healthy choices, their knowledge of how to make such choices and prompting parents to support their children to make healthy choices. Previously published results showed no effect on the three primary outcomes and beneficial effects on three of nine secondary outcomes (time spent screen-viewing at weekends, consumption of snacks and of high energy drinks). This paper aims to determine the effect of the intervention on potential mediators. METHODS: We conducted a cluster RCT of a school-based intervention, with allocation concealed by use of a remote system. The study was undertaken in the South West of England between 2011 and 2013. Participants were school children who were age 8-9 years at baseline assessment and 9-10 years during the intervention. Potential mediators were assessed at the end of the intervention. The intervention consisted of teacher training, provision of all materials required for lessons and homeworks and written materials for school newsletters and parents. The ten potential mediators were child-reported self-efficacy for physical activity and fruit and vegetable consumption, perceived parental logistic support and modelling for their child's physical activity, parental efforts to limit their child's sedentary behaviour and modelling of healthy fruit and vegetable consumption, together with a knowledge assessment. RESULTS: We successfully recruited 60 schools with over 2,221 children; valid data for the 10 mediators were available for 87 % to 96 % of participants. Three of the ten potential mediators were greater in the intervention, compared with the control group: fruit and vegetable self-efficacy 2.2 units (95 % CI: 0.7 to 3.8), assessed on a scale 26 to 130; child-reported maternal limitation of sedentary behaviour 0.5 (0.1 to 0.8), scale 4 to 16; and knowledge 0.5 (0.2, 0.7) scale 0 to 9. Reported maternal limitation of sedentary behaviour and the child's knowledge explained 23 % of the effect of the intervention on reducing time spent on sedentary behaviour at the weekend. There was no effect on other mediators. CONCLUSIONS: Our findings suggest that the effect of the AFLY5 intervention on reducing screen-viewing at weekends was partially mediated by an effect on mothers limiting their child's time spent sedentary and on increasing the child's knowledge about healthy behaviour. However, overall our findings suggest that theory driven interventions, like AFLY5, can fail to influence most potential mediators and this may explain the failure of the intervention to improve most primary and secondary outcomes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN50133740. Registered 17/03/2011.

Intervention fidelity in a school-based diet and physical activity intervention in the UK: Active for Life Year 5.

BACKGROUND: Active for Life Year 5 (AFLY5) is an educational programme for Year 5 children (aged 9-10) designed to increase children's physical activity, decrease sedentary behaviour and increase fruit and vegetable intake. This paper reports findings from a process evaluation embedded within a randomised controlled trial evaluating the programme's effectiveness. It considers the fidelity of implementation of AFLY5 with a focus on three research questions: 1. To what extent was the intervention delivered as planned? 2. In what ways, if any, did the teachers amend the programme? and 3. What were the reasons for any amendments? METHODS: Mixed methods were used including data collection via observation of the intervention delivery, questionnaire, teacher's intervention delivery log and semi-structured interviews with teachers and parents. Qualitative data were analysed thematically and quantitative data were summarised using descriptive statistics. RESULTS: Following training, 42 of the 43 intervention school teachers/teaching staff (98%) were confident they could deliver the nutrition and physical activity lessons according to plan. The mean number of lessons taught was 12.3 (s.d. 3.7), equating to 77% of the intervention. Reach was high with 95% of children in intervention schools receiving lessons. A mean of 6.2 (s.d. 2.6) out of 10 homeworks were delivered. Median lesson preparation time was 10 min (IQR 10-20) and 28% of lessons were reported as having been amended. Qualitative findings revealed that those who amended the lessons did so to differentiate for student ability, update them for use with new technologies and to enhance teacher and student engagement. Teachers endorsed the aims of the intervention, but some were frustrated with having to adapt the lesson materials. Teachers also a reported tendency to delegate the physical activity lessons to other staff not trained in the intervention. CONCLUSIONS: Fidelity of intervention implementation was good but teachers' enthusiasm for the AFLY5 programme was mixed despite them believing that the messages behind the lessons were important. This may have meant that the intervention messages were not delivered as anticipated and explain why the intervention was found not to be effective. TRIAL REGISTRATION: ISRCTN50133740.

Multiple risk behaviour in adolescence and socio-economic status: findings from a UK birth cohort.

BACKGROUND: Patterns of risk behaviour during teenage years may vary by socio-economic status (SES). We aimed to examine possible associations between individual and multiple risk behaviours and three measures of SES in mid-adolescence. METHODS: The sample (n = 6406) comprised participants from the Avon Longitudinal Study of Parents and Children, a UK birth cohort. Thirteen risk behaviours spanning sexual health, substance use, self-harm, vehicle-related injury, criminality and physical inactivity were assessed in mid-adolescence (age 15-16 years). Associations between three measures of SES (maternal education, household income and parental social class) and (i) individual risk behaviours and (ii) the total number of risk behaviours were examined. RESULTS: For a one-category reduction in social class, maternal education or income, the odds of having a greater number of multiple risk behaviours increased by 22, 15 and 12%, respectively. At the individual level, there was evidence of a strong relationship with decreasing SES across all three measures of SES and criminality, car passenger risk, TV viewing, scooter risk, early sexual behaviour and weekly tobacco use but insufficient evidence of a relationship for physical inactivity, cycling without a helmet and illicit substance use. There was weak evidence of association between SES and hazardous drinking, self-harm, cannabis use and unprotected sex, but this was not consistent across the SES measures. CONCLUSION: The association between multiple risk behaviours and SES suggests that prevention strategies should apply the principal of proportionate universalism with a focus on more deprived populations, within a population-wide strategy, to prevent widening of social inequalities.

Effect of intervention aimed at increasing physical activity, reducing sedentary behaviour, and increasing fruit and vegetable consumption in children: active for Life Year 5 (AFLY5) school based cluster randomised controlled trial.

OBJECTIVE: To investigate the effectiveness of a school based intervention to increase physical activity, reduce sedentary behaviour, and increase fruit and vegetable consumption in children. DESIGN: Cluster randomised controlled trial. SETTING: 60 primary schools in the south west of England. PARTICIPANTS: Primary school children who were in school year 4 (age 8-9 years) at recruitment and baseline assessment, in year 5 during the intervention, and at the end of year 5 (age 9-10) at follow-up assessment. INTERVENTION: The Active for Life Year 5 (AFLY5) intervention consisted of teacher training, provision of lesson and child-parent interactive homework plans, all materials required for lessons and homework, and written materials for school newsletters and parents. The intervention was delivered when children were in school year 5 (age 9-10 years). Schools allocated to control received standard teaching. MAIN OUTCOME MEASURES: The pre-specified primary outcomes were accelerometer assessed minutes of moderate to vigorous physical activity per day, accelerometer assessed minutes of sedentary behaviour per day, and reported daily consumption of servings of fruit and vegetables. RESULTS: 60 schools with more than 2221 children were recruited; valid data were available for fruit and vegetable consumption for 2121 children, for accelerometer assessed physical activity and sedentary behaviour for 1252 children, and for secondary outcomes for between 1825 and 2212 children for the main analyses. None of the three primary outcomes differed between children in schools allocated to the AFLY5 intervention and those allocated to the control group. The difference in means comparing the intervention group with the control group was -1.35 (95% confidence interval -5.29 to 2.59) minutes per day for moderate to vigorous physical activity, -0.11 (-9.71 to 9.49) minutes per day for sedentary behaviour, and 0.08 (-0.12 to 0.28) servings per day for fruit and vegetable consumption. The intervention was effective for three out of nine of the secondary outcomes after multiple testing was taken into account: self reported time spent in screen viewing at the weekend (-21 (-37 to -4) minutes per day), self reported servings of snacks per day (-0.22 (-0.38 to -0.05)), and servings of high energy drinks per day (-0.26 (-0.43 to -0.10)) were all reduced. Results from a series of sensitivity analyses testing different assumptions about missing data and from per protocol analyses produced similar results. CONCLUSION: The findings suggest that the AFLY5 school based intervention is not effective at increasing levels of physical activity, decreasing sedentary behaviour, and increasing fruit and vegetable consumption in primary school children. Change in these activities may require more intensive behavioural interventions with children or upstream interventions at the family and societal level, as well as at the school environment level. These findings have relevance for researchers, policy makers, public health practitioners, and doctors who are involved in health promotion, policy making, and commissioning services. Trial registration Current Controlled Trials ISRCTN50133740.

Characteristics associated with requested and required accelerometer wear in children.

OBJECTIVE: To investigate characteristics associated with wearing an accelerometer for the required and requested time among 8-year-old to 10-year-old children. DESIGN: Cross-sectional. SETTING: 60 Bristol and North Somerset primary schools taking part in the 'Active for Life Year 5' randomised controlled trial (RCT) in 2011. PARTICIPANTS: 2048 children, aged 8-10 years, invited to wear an accelerometer for 5 days of recording. PRIMARY OUTCOME MEASURE: Numbers meeting required wear-time for inclusion in main RCT analysis (≥8 h/day ≥3 days) and numbers meeting requested wear-time (≥8 h/day for all 5 days). RESULTS: 817 (40%) of the children wore the accelerometer for the requested time and 1629 (80%) for the required time. In adjusted multivariable analyses the odds of wearing the accelerometer for the required time were greater in females as compared with males (OR 1.76 (1.42-2.18)), those with higher scores for reporting their mother restricted time on sedentary behaviours (1.26 (1.04-1.52) per increase of 1 on a 1-4 scale) and in children from schools with larger year group sizes (1.01 (1.00-1.02) per additional child). Living in a neighbourhood with higher levels of deprivation (0.49 (0.33-0.72) comparing highest to lowest third of the deprivation score) or reporting higher levels of weekday outdoor play (0.97 (0.94, 1.00) per 30 min more) were associated with reduced odds of meeting required time. Results were essentially the same for requested wear-time. Other characteristics, including child body mass index, were not associated with required or requested wear-time. CONCLUSIONS: Only 40% of children wore the accelerometer for the requested time but 80% fulfilled the required criteria to be included in the main study analyses. Knowing which characteristics are associated with accelerometer wear could help target interventions to increase wear-time.

The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan.

BACKGROUND: The Active For Life Year 5 (AFLY5) randomised controlled trial protocol was published in this journal in 2011. It provided a summary analysis plan. This publication is an update of that protocol and provides a detailed analysis plan. UPDATE: This update provides a detailed analysis plan of the effectiveness and cost-effectiveness of the AFLY5 intervention. The plan includes details of how variables will be quality control checked and the criteria used to define derived variables. Details of four key analyses are provided: (a) effectiveness analysis 1 (the effect of the AFLY5 intervention on primary and secondary outcomes at the end of the school year in which the intervention is delivered); (b) mediation analyses (secondary analyses examining the extent to which any effects of the intervention are mediated via self-efficacy, parental support and knowledge, through which the intervention is theoretically believed to act); (c) effectiveness analysis 2 (the effect of the AFLY5 intervention on primary and secondary outcomes 12 months after the end of the intervention) and (d) cost effectiveness analysis (the cost-effectiveness of the AFLY5 intervention). The details include how the intention to treat and per-protocol analyses were defined and planned sensitivity analyses for dealing with missing data. A set of dummy tables are provided in Additional file 1. DISCUSSION: This detailed analysis plan was written prior to any analyst having access to any data and was approved by the AFLY5 Trial Steering Committee. Its publication will ensure that analyses are in accordance with an a priori plan related to the trial objectives and not driven by knowledge of the data. TRIAL REGISTRATION: ISRCTN50133740.

Weight loss from three commercial providers of NHS primary care slimming on referral in North Somerset: service evaluation.

BACKGROUND: The aim of this study was to analyse the effect of provider, gender and obesity class on outcomes of National Health Service (NHS) slimming on referral. METHODS: Service evaluation in 12 UK general practices. Obese patients aged ≥16 were referred for 12 sessions to one of three commercial providers. Outcomes at 12 weeks were attendance, BMI, total and percentage weight loss, 5% and 5 kg weight loss and comparison across providers. Linear and multiple regression analyses were used, adjusting for confounders. RESULTS: One thousand four hundred and forty patients were referred; 1047 receiving vouchers and 880 attending at least one session. The mean weight change was -4.8 kg (95% CI: -5.1 to -4.5) and the percentage bodyweight loss was -4.6% (standard deviation: 3.7). Weight Watchers patients lost more weight [-1.15 kg (95% confidence interval, CI: -1.25, -1.04), P < 0.001] and were more likely to lose 5% bodyweight [odds ratio: 1.81 (95% CI: 1.78, 1.83), P < 0.001] than those attending the provider with the least weight loss. CONCLUSIONS: NHS slimming on referral can successfully achieve short-term weight loss. Patients attending Weight Watchers were most likely to lose weight than those attendingother providers.

The Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial: study protocol for a randomized controlled trial.

BACKGROUND: Low levels of physical activity, high levels of sedentary behaviour and low levels of fruit and vegetable consumption are common in children and are associated with adverse health outcomes. The aim of this paper is to describe the protocol for a cluster randomised controlled trial (RCT) designed to evaluate a school-based intervention that aims to increase levels of physical activity, decrease sedentary behaviour and increase consumption of fruit and vegetables in school children. METHODS/DESIGN: The Active for Life Year 5 (AFLY5) study is a school-based, cluster RCT that targets school children in Year 5 (age 9-10 years). All state junior/primary schools in the area covered by Bristol City and North Somerset Council are invited to participate; special schools are excluded. Eligible schools are randomised to one of two arms: intervention arm (receive the intervention 2011-2012) and control arm (receive the intervention after the final follow-up assessment, 2013-2014). The primary outcomes of the trial are levels of accelerometer assessed physical activity and sedentary behaviour and questionnaire assessed fruit and vegetable consumption. A number of secondary outcomes will also be measured, including body mass index, waist circumference and overweight/obesity. Outcomes will be assessed at baseline (prior to intervention when the children are in Year 4), at the end of intervention 'immediate follow-up' and '12 months long-term' follow-up. We will use random effects linear and logistic regression models to compare outcomes by randomised arm. The economic evaluation from a societal perspective will take the form of a cost consequence analysis. Data from focus groups and interviews with pupils, parents and teachers will be used to increase understanding of how the intervention has any effect and is integrated into normal school activity. DISCUSSION: The results of the trial will provide information about the public health effectiveness of a school-based intervention aimed at improving levels of physical activity, sedentary behaviour and diet in children. TRIAL REGISTRATION: ISRCTN50133740.

Diet outcomes of a pilot school-based randomised controlled obesity prevention study with 9-10 year olds in England.

OBJECTIVES: To assess the effect of a US obesity prevention intervention on dietary outcomes in English 9-10 year old children in 2006. METHODS: A pilot cluster randomised controlled trial in 19 schools with children aged 9 to 10 with lessons taught by teachers. Diet was assessed at baseline and 5 months later using questionnaires. Full intention-to-treat analysis (n=506) and analyses using only those with complete baseline and follow-up data (n=393). RESULTS: 8.5% of children ate 5 or more portions of fruit and vegetables per day. The odds of eating healthy amounts of fruit and vegetables (OR 1.39 (95%CI: 0.69, 2.80)) and snacks (OR 1.22 (95%CI: 0.68, 2.21)) were greater in children from the intervention compared to control schools. Point estimates were less than one for consumption of no portions of high fat food and one or zero high energy drinks. A full-scale trial would require 2640 children (106 schools) with 80% power to detect an odds ratio of at least 1.30 for healthy levels of consumption for the four dietary outcomes, with an alpha level of 0.01. CONCLUSIONS: The US intervention can be transferred to England and it might be effective in increasing fruit and vegetable consumption and decreasing snacks.