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Abstract Background Only limited data are available on the development and feasibility piloting of school-based interventions to prevent and reduce obesity in children. Clear documentation of the rationale, process of development and content of such interventions is essential to enable other researchers to understand why interventions succeed or fail. Methods This paper describes the development of the Healthy Lifestyles Programme (HeLP), a school-based intervention to prevent obesity in children, through the first 4 steps of the Intervention Mapping protocol (IM). The intervention focuses on the following health behaviours, i) reduction of the consumption of sweetened fizzy drinks, ii) increase in the proportion of healthy snacks consumed and iii) reduction of TV viewing and other screen-based activities, within the context of a wider attempt to improve diet and increase physical activity. Results Two phases of pilot work demonstrated that the intervention was acceptable and feasible for schools, children and their families and suggested areas for further refinement. Feedback from the first pilot phase suggested that the 9-10 year olds were both receptive to the messages and more able and willing to translate them into possible behaviour changes than older or younger children and engaged their families to the greatest extent. Performance objectives were mapped onto 3 three broad domains of behaviour change objectives - establish motivation, take action and stay motivated - in order to create an intervention that supports and enables behaviour change. Activities include whole school assemblies, parents evenings, sport/dance workshops, classroom based education lessons, interactive drama workshops and goal setting and runs over three school terms. Conclusion The Intervention Mapping protocol was a useful tool in developing a feasible, theory based intervention aimed at motivating children and their families to make small sustainable changes to their eating and activity behaviours. Although the process was time consuming, this systematic approach ensures that the behaviour change techniques and delivery methods link directly to the Programme's performance objectives and their associated determinants. This in turn provides a clear framework for process analysis and increases the potential of the intervention to realise the desired outcome of preventing and reducing obesity in children.

Abstract Background Over 300 therapies have been proposed for premenstrual syndrome. To date there has been only one survey conducted in the UK of PMS treatments prescribed by GPs, a questionnaire-based study by the National Association of Premenstrual Syndrome in 1989. Since then, selective serotonin re-uptake inhibitors have been licensed for severe PMS/PMDD, and governmental recommendations to reduce the dosage of vitamin B6 (the first choice over-the-counter treatment for many women with PMS) have been made. This study investigates the annual rates of diagnoses and prescribing patterns for premenstrual syndrome (1993–1998) within a computerised general practitioner database. Methods Retrospective survey of prescribing data for premenstrual syndrome between 1993–1998 using the General Practice Research Database for the West Midlands Region which contains information on 282,600 female patients Results Overall the proportion of women with a prescription-linked diagnosis of premenstrual syndrome has halved over the five years. Progestogens including progesterone were the most commonly recorded treatment for premenstrual syndrome during the whole study period accounting for over 40% of all prescriptions. Selective serotonin-reuptake inhibitors accounted for only 2% of the prescriptions in 1993 but rose to over 16% by 1998, becoming the second most commonly recorded treatment. Vitamin B6 accounted for 22% of the prescriptions in 1993 but dropped markedly between 1997 and 1998 to 11%. Conclusions This study shows a yearly decrease in the number of prescriptions linked to diagnoses for premenstrual syndrome. Progestogens including progesterone, is the most widely prescribed treatment for premenstrual syndrome despite the lack of evidence demonstrating their efficacy.

Background: The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9-10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation. Methods: Mixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics. Results: All 16 intervention schools received a complete or near complete programme (94-100%), which was delivered in the spirit in which it had been designed. Of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children's clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher 'buy in', due to the programme's compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners. Conclusion: Our trial shows that it is possible to successfully scale up complex school-based interventions, engage schools and children across the socio-economic spectrum and deliver an intervention as designed. As programme integrity was maintained throughout the HeLP trial, across all intervention schools, we can be confident that the trial findings are a true reflection of the effectiveness of the intervention, enabling policy recommendations to be made. Trial registration: ISRCTN15811706. [ABSTRACT FROM AUTHOR]

Schools are common sites for obesity prevention interventions. Although many theories suggest that the school context influences weight status, there has been little empirical research. The objective of this study was to explore whether features of the school context were consistently and meaningfully associated with pupil weight status (overweight or obese). Exploratory factor analysis of routinely collected data on 319 primary schools in Devon, England, was used to identify possible school-based contextual factors. Repeated cross-sectional multilevel analysis of five years (2006/07-2010/11) of data from the National Child Measurement Programme was then used to test for consistent and meaningful associations. Four school-based contextual factors were derived which ranked schools according to deprivation, location, resource and prioritisation of physical activity. None of which were meaningfully and consistently associated with pupil weight status, across the five years. The lack of consistent associations between the factors and pupil weight status suggests that the school context is not inherently obesogenic. In contrast, incorporating findings from education research indicates that schools may be equalising weight status, and obesity prevention research, policy and practice might need to address what is happening outside schools and particularly during the school holidays. [ABSTRACT FROM AUTHOR]

Background Approximately one third of 10-11 year olds in England are now overweight or obese suggesting that population approaches are urgently required. However, despite the increasing number of school-based interventions to prevent obesity, results continue to be inconsistent and it is still unclear what the necessary conditions are that lead to the sustained behaviour change required to affect weight status. The Healthy Lifestyles Programme is a theoretically informed four phase multi-component intervention which seeks to create supportive school and home environments for healthy behaviours. Methods A process evaluation has run alongside the exploratory trial of the Healthy Lifestyles Programme to ascertain the feasibility and acceptability of; the trial design (including the trial outcomes) and the HeLP Programme and whether it is able to engage schools, children and their families. Data was collected using interviews with teachers (n = 12) and parents (n = 17) and six focus groups with children (n = 47) and a questionnaire for parents of children in the intervention schools. Interview and focus group data relating to the intervention was analysed using framework analysis. Results Four schools and 201 children participated in the exploratory trial. The data showed that the trial design was feasible and acceptable for schools and children. Three themes emerged for the data in relation to the acceptability and feasibility of the HeLP Programme (value, compatibility with the curriculum and enjoyment) and two themes emerged in relation to engagement ('knowledge and awareness' and 'taking messages on board'). The latter could be broken down into 4 subthemes ('initiating discussion with family and friends', 'acceptance of family rules', 'increased responsibility' and 'the importance of the mode and agent of delivery'). The use of highly inclusive and interactive delivery methods where the children were encouraged to identify with and take ownership of the healthy lifestyle messages were identified as important factors in motivating the children to take the messages home, seek parental support and initiate family lifestyle behaviour change. Conclusion The process evaluation of the exploratory trial has not only provided evidence of the feasibility and acceptability of the Programme, it has also allowed an understanding of how HeLP engages schools, children and their families. These findings have informed the process evaluation for the definitive trial. [ABSTRACT FROM AUTHOR]

Background: Over the last three decades there has been a substantial increase in the proportion of children who are overweight or obese. The Healthy Lifestyles Programme (HeLP) is a novel school-based intervention, using highly interactive and creative delivery methods to prevent obesity in children. Methods/Design: We describe a cluster randomised controlled trial to evaluate the effectiveness and cost effectiveness of HeLP. The intervention has been developed using intervention mapping (involving extensive stakeholder involvement) and has been guided by the Information, Motivation, Behavioural Skills model. HeLP includes creating a receptive environment, drama activities, goal setting and reinforcement activities and runs over three school terms. Piloting showed that 9 to 10 year olds were the most receptive and participative. This study aims to recruit 1,300 children from 32 schools (over half of which will have ⩾19% of pupils eligible for free school meals) from the southwest of England. Participating schools will be randomised to intervention or control groups with baseline measures taken prior to randomisation. The primary outcome is change in body mass index standard deviation score (BMI SDS) at 24 months post baseline. Secondary outcomes include, waist circumference and percent body fat SDS and proportion of children classified as overweight or obese at 18 and 24 months and objectively measured physical activity and food intake at 18 months. Between-group comparisons will be made using random effects regression analysis taking into account the hierarchical nature of the study design. An economic evaluation will estimate the incremental cost-effectiveness of HeLP, compared to control, from the perspective of the National Health Service (NHS)/third party payer. An in-depth process evaluation will provide insight into how HeLP works, and whether there is any differential uptake or engagement with the programme. Discussion: The results of the trial will provide evidence on the effectiveness and cost effectiveness of the Healthy Lifestyles Programme in affecting the weight status of children. [ABSTRACT FROM AUTHOR]

Actively involving service users, patients and carers in the creation and development of health research in the UK has recently come under pressure to articulate why involvement is a good use of resources. This has led to a growing interest in creating ways to measure the impact of involving patients, service users and carers in research. However, there is a concern that fundamentally important issues about why we should meaningfully involve service users, patients and carers are missing from the current measurement discourses and activities undertaken in relation to measurement. This paper argues three distinct points, and is based on the experience of the authors working with Folk.us as well as other fields of involvement. Firstly, there should be an open and honest debate about what is meant by the need to measure and assess the effects of involving people in research, addressing issues such as who benefits from the measurement and assessment and why the involvement is being done. Secondly, if at the conclusion of the debate it is deemed necessary to measure and assess, there must be a full and frank discussion about what criteria are appropriate for the proper reporting of involvement activities. This discussion would need to include the less obvious activities that are crucial to active involvement, such as administrative tasks, and where such activities would sit within these criteria. Thirdly, we will consider when such criteria should be applied, at the beginning or end of projects and, indeed, whether one can categorize the 'beginning' or 'end' of involvement. [ABSTRACT FROM AUTHOR]

Objectives: To develop a school-based obesity prevention programme and evaluate the feasibility and acceptability of the intervention and the planned definitive cluster randomised trial. Design: This was a three stage pilot involving six schools (398 children) in South West England, including an exploratory randomised controlled trial and qualitative interviews and focus groups with teachers, parents and children. Intervention: The Healthy Lifestyle Programme uses a range of school-based activities including lessons, assemblies, parents' evenings, interactive drama workshops and goal setting to engage schools, children and their families. Results: Of the 398 eligible children in the three pilot phases, only four opted out and a further three withdrew from the exploratory trial. In the exploratory trial, baseline measurements (anthropometric and behavioural) were obtained for 202/204 eligible children in four schools and both 18- and 24-month outcome measurements for 193/204 and 187/204 participants, respectively. Qualitative data show that delivery of the intervention is feasible within schools and acceptable to teachers, children and families. In the exploratory trial, 18/80 children (24%) in the intervention schools and 31/122 (26%) in the control schools were overweight or obese at baseline, increasing, at 18-month follow-up, to 38/119 (32%) in the control schools compared with 18/74 (24%) in the intervention schools. At 24 months the proportion of overweight and obese children in the control schools remained at 32% (36/114), whereas the proportion in the intervention schools decreased slightly to 22% (16/73). Conclusion: The Healthy Lifestyle Programme is feasible to deliver and acceptable to schools, children and their families. We recruited, retained and obtained outcome measurements from 92% of eligible children in the exploratory trial, including measurements taken after transition to secondary school, suggesting that a definitive trial is likely to be deliverable. [ABSTRACT FROM AUTHOR]

To determine the effectiveness of gonadotrophin-releasing hormone analogues (GnRHa) with and without hormonal add-back therapy in the management of premenstrual syndrome.Randomised controlled trials were identified by searching multiple databases.Exeter and North Devon Research and Development Support Unit and Keele University Academic Unit of Obstetrics and Gynaecology.Women with pre-diagnosed premenstrual syndrome and/or premenstrual dysphoric disorder.A meta-analysis of published randomised placebo-controlled trials assessing the use of GnRHa in the management of premenstrual syndrome. The standardised mean difference for each individual study and subsequently an overall standardised mean difference were calculated after demonstrating the consistency or homogeneity of the study results.Overall improvement in premenstrual symptomatology and effectiveness of GnRHa with additional hormonal add-back therapy were the main outcome measures assessed in this analysis. A secondary analysis was performed to assess the effectiveness of GnRHa in treating physical and emotional symptoms.Overall standardised mean difference for all trials that assessed the efficacy of GnRHa was−1.19 (95% confidence interval [CI]−1.88 to−0.51). The equivalent odds ratio was 8.66 (95% CI 2.52 to 30.26) in favour of GnRHa. GnRHa were more efficacious for physical than behavioural symptoms, although the difference was not statistically significant. The addition of hormonal add-back therapy to GnRHa did not appear to reduce the efficacy of GnRHa alone; standardised mean difference 0.12 (95% CI−0.35 to 0.58).GnRHa appear to be an effective treatment in the management of premenstrual syndrome. The addition of hormonal add-back therapy to reduce side effects does not reduce efficacy. [ABSTRACT FROM AUTHOR]

Objective: To validate a menstrual symptometrics device that can quantify menstrual blood loss, dysmenorrhea, and the premenstrual syndrome against traditional methods of collecting data on symptoms.Design: Validation study.Setting: Academic research clinic for menstrual cycle disorders.Participant(s): Women 18-50 years of age who presented with menstrual cycle disorders. Controls were recruited from lists of patients requesting sterilization and from hospital staff.Intervention(s): Participants were asked to complete the menstrual symptometrics device and to record pain, blood loss, and premenstrual symptoms by using traditional methods (paper-based scales and the alkaline hematin method) for two cycles.Main Outcome Measure(s): Agreement between traditional methods of quantifying menstrual cycle disorders and data obtained from the menstrual symptometrics device, and acceptability of the latter technique to patients.Result(s): A high level of agreement was observed between the traditional methods and the menstrual symptometrics device in quantifying and diagnosing menorrhagia, dysmenorrhea, and the premenstrual syndrome. Most patients preferred the menstrual symptometrics device as a data collection tool.Conclusion(s): The menstrual symptometrics device is a rapid and accurate method of quantifying blood loss, pain, and premenstrual symptoms. It has a high level of patient acceptability and can provide instant pictorial feedback on symptoms for patients and clinicians. [ABSTRACT FROM AUTHOR]

Background: Over 300 therapies have been proposed for premenstrual syndrome. To date there has been only one survey conducted in the UK of PMS treatments prescribed by GPs, a questionnaire-based study by the National Association of Premenstrual Syndrome in 1989. Since then, selective serotonin re-uptake inhibitors have been licensed for severe PMS/PMDD, and governmental recommendations to reduce the dosage of vitamin B6 (the first choice over-thecounter treatment for many women with PMS) have been made. This study investigates the annual rates of diagnoses and prescribing patterns for premenstrual syndrome (1993-1998) within a computerised general practitioner database. Methods: Retrospective survey of prescribing data for premenstrual syndrome between 1993-1998 using the General Practice Research Database for the West Midlands Region which contains information on 282,600 female patients Results: Overall the proportion of women with a prescription-linked diagnosis of premenstrual syndrome has halved over the five years. Progestogens including progesterone were the most commonly recorded treatment for premenstrual syndrome during the whole study period accounting for over 40% of all prescriptions. Selective serotonin-reuptake inhibitors accounted for only 2% of the prescriptions in 1993 but rose to over 16% by 1998, becoming the second most commonly recorded treatment. Vitamin B6 accounted for 22% of the prescriptions in 1993 but dropped markedly between 1997 and 1998 to 11%. Conclusions: This study shows a yearly decrease in the number of prescriptions linked to diagnoses for premenstrual syndrome. Progestogens including progesterone, is the most widely prescribed treatment for premenstrual syndrome despite the lack of evidence demonstrating their efficacy. [ABSTRACT FROM AUTHOR]

Objectives: To assess the behavioural and weight status outcomes in English children in a feasibility study of a novel primary school-based obesity prevention programme., Design: Exploratory cluster randomised controlled trial of the Healthy Lifestyles Programme., Setting: Four city primary schools (two control and two intervention) in the South West of England., Participants: 202 children aged 9-10 years, of whom 193 and 188 were followed up at 18 and 24 months, respectively. No child was excluded from the study; however, to be eligible, schools were required to have at least one single Year 5 class., Intervention: Four-phase multicomponent programme using a range of school-based activities including lessons, assemblies, parents' evenings, interactive drama workshops and goal setting to engage and support schools, children and their families in healthy lifestyle behaviours. It runs over the spring and summer term of Year 5 and the autumn term of Year 6., Primary and Secondary Outcomes: Weight status outcomes were body mass index, waist circumference and body fat standard deviation scores (SDS) at 18 and 24 months, and behavioural outcomes were physical activity, television (TV) viewing/screen time and food intake at 18 months., Results: At 18 months of follow-up, intervention children consumed less energy-dense snacks and more healthy snacks; had less 'negative food markers', more 'positive food markers', lower mean TV/screen time and spent more time doing moderate-vigorous physical activity each day than those in the control schools. Intervention children had lower anthropometric measures at 18 and 24 months than control children, with larger differences at 24 months than at 18 months for nearly all measures., Conclusions: Results from this exploratory trial show consistent positive changes in favour of the intervention across all targeted behaviours, which, in turn, appear to affect weight status and body shape. A definitive trial is now justified.

Background: Only limited data are available on the development and feasibility piloting of school-based interventions to prevent and reduce obesity in children. Clear documentation of the rationale, process of development and content of such interventions is essential to enable other researchers to understand why interventions succeed or fail., Methods: This paper describes the development of the Healthy Lifestyles Programme (HeLP), a school-based intervention to prevent obesity in children, through the first 4 steps of the Intervention Mapping protocol (IM). The intervention focuses on the following health behaviours, i) reduction of the consumption of sweetened fizzy drinks, ii) increase in the proportion of healthy snacks consumed and iii) reduction of TV viewing and other screen-based activities, within the context of a wider attempt to improve diet and increase physical activity., Results: Two phases of pilot work demonstrated that the intervention was acceptable and feasible for schools, children and their families and suggested areas for further refinement. Feedback from the first pilot phase suggested that the 9-10 year olds were both receptive to the messages and more able and willing to translate them into possible behaviour changes than older or younger children and engaged their families to the greatest extent. Performance objectives were mapped onto 3 three broad domains of behaviour change objectives--establish motivation, take action and stay motivated--in order to create an intervention that supports and enables behaviour change. Activities include whole school assemblies, parents evenings, sport/dance workshops, classroom based education lessons, interactive drama workshops and goal setting and runs over three school terms., Conclusion: The Intervention Mapping protocol was a useful tool in developing a feasible, theory based intervention aimed at motivating children and their families to make small sustainable changes to their eating and activity behaviours. Although the process was time consuming, this systematic approach ensures that the behaviour change techniques and delivery methods link directly to the Programme's performance objectives and their associated determinants. This in turn provides a clear framework for process analysis and increases the potential of the intervention to realise the desired outcome of preventing and reducing obesity in children.