Process evaluation is an essential part of designing and testing complex interventions. New MRC guidance provides a framework for conducting and reporting process evaluation studiesAttempts to tackle problems such as smoking and obesity increasingly use complex interventions. These are commonly defined as interventions that comprise multiple interacting components, although additional dimensions of complexity include the difficulty of their implementation and the number of organisational levels they target. 1 Randomised controlled trials are regarded as the gold standard for establishing the effectiveness of interventions, when randomisation is feasible. However, effect sizes do not provide policy makers with information on how an intervention might be replicated in their specific context, or whether trial outcomes will be reproduced. Earlier MRC guidance for evaluating complex interventions focused on randomised trials, making no mention of process evaluation. 2 Updated guidance recognised the value of process evaluation within trials, stating that it "can be used to assess fidelity and quality of implementation, clarify causal mechanisms and identify contextual factors associated with variation in outcomes." 3 However, it did not provide guidance for carrying out process evaluation. Developing guidance for process evaluationIn 2010, a workshop funded by the MRC Population Health Science Research Network discussed the need for guidance on process evaluation. 4 There was consensus that researchers, funders, and reviewers would benefit from guidance. A group of researchers with experience and expertise in evaluating complex interventions was assembled to produce the guidance. In line with the principles followed in developing earlier MRC guidance documents, draft guidance was produced drawing on literature reviews, process evaluation case studies, workshops, and discussions at conferences and seminars. It was then circulated to academic, policy, and practice stakeholders for comment. Around 30 stakeholders provided written comments on the draft structure, while others commented during conference workshops run throughout the development process. A full draft was recirculated for further review, before being revised and approved by key MRC funding panels.Although the aim was to provide guidance on process evaluation of public health interventions, the guidance is highly relevant to complex intervention research in other domains, such as health services and education. The full guidance (www.populationhealthsciences.org/Process-Evaluation-Guidance.html) begins by setting out the need for process evaluation. It then presents a review of influential theories and frameworks which informed its development, before offering practical recommendations, and six detailed case studies. In this article, we provide an overview of the new framework and summarise our practical recommendations using one of the case studies as an example. MRC process evaluation frameworkThe new framework builds on the process evaluation themes descri...

Women with preconceptional psychological distress are more likely to have babies with sleep disturbance during infancy, independent of whether they suffered from postnatal depression.

SUMMARYMany studies have shown that shorter sleep duration in childhood is associated with higher body mass index (BMI), and have proposed that it is due to an effect of sleep on adiposity. There is little evidence about the association of sleep with fat-free mass. This study examined the association between child's sleep duration at age 3 years and fat and fat-free mass at 4 years of age in a prospective cohort study of 302 boys and 285 girls. Study participants were taking part in the Southampton Women's Survey, a longitudinal study of mothers and children from preconception onwards. Total sleep duration at age 3 years was derived from parental report of night sleep and nap duration. Body composition was assessed by Dual-energy X-ray Absorptiometry (DXA) at 4 years. Mean total sleep duration was 11.5 hours. In linear regression analyses, adjusted for potentially confounding factors (maternal educational attainment, prepregnancy BMI, smoking during pregnancy, child's gestational age at birth, age at DXA, sex, age last breastfed, dietary quality at 3 years, TV watching and hours actively on the move and parental social class), shorter sleep in hours was associated with higher BMI (kg/m 2 ) [b: À0.2340, 95% confidence interval (CI): À0.373 to À0.096], a greater fat mass index (kg) (b: À0.1182, 95% CI: À0.218 to À0.018) and a greater fat-free mass index (kg) (b: À0.100, 95% CI: À0.185 to À0.015). Previous research suggested that the association between shorter sleep and higher body mass index is due to an effect on adiposity. Our findings are novel, suggesting that the relationship between sleep and BMI is also determined by an effect on muscle. IN TROD UCTI ON

Background Poor diet and lack of physical activity are strongly linked to non-communicable disease risk, but modifying them is challenging. There is increasing recognition that adolescence is an important time to intervene; habits formed during this period tend to last, and physical and psychological changes during adolescence make it an important time to help individuals form healthier habits. Improving adolescents’ health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children. Building on LifeLab—an existing, purpose-built educational facility at the University of Southampton—we have developed a multi-component intervention for secondary school students called Engaging Adolescents in Changing Behaviour (EACH-B) that aims to motivate and support adolescents to eat better and be more physically active. Methods A cluster randomised controlled trial is being conducted to evaluate the effectiveness of the EACH-B intervention. The primary outcomes of the intervention are self-reported dietary quality and objectively measured physical activity (PA) levels, both assessed at baseline and at 12-month follow-up. The EACH-B intervention consists of three linked elements: professional development for teachers including training in communication skills to support health behaviour change; the LifeLab educational module comprising in-school teaching of nine science lessons linked to the English National Curriculum and a practical day visit to the LifeLab facility; and a personalised digital intervention that involves social support and game features that promote eating better and being more active. Both the taught module and the LifeLab day are designed with a focus on the science behind the messages about positive health behaviours, such as diet and PA, for the adolescents now, in adulthood and their future offspring, with the aim of promoting personal plans for change. The EACH-B research trial aims to recruit approximately 2300 secondary school students aged 12–13 years from 50 schools (the clusters) from Hampshire and neighbouring counties. Participating schools will be randomised to either the control or intervention arm. The intervention will be run during two academic years, with continual recruitment of schools throughout the school year until the sample size is reached. The schools allocated to the control arm will receive normal schooling but will be offered the intervention after data collection for the trial is complete. An economic model will be developed to assess the cost-effectiveness of the EACH-B intervention compared with usual schooling. Discussion Adolescents’ health needs are often ignored and they can be difficult to engage in behaviour change. Building a cheap, sustainable way of engaging them in making healthier choices will benefit their long-term health and that of their future children. Trial registration ISRCTN 74109264. Registered on 30 August 2019. EACH-B is a cluster randomised controlled trial, funded by the National Institute for Health Research (RP-PG-0216-20004).

IntroductionThe Healthy Life Trajectories Initiative is an international consortium comprising four harmonised but independently powered trials to evaluate whether an integrated intervention starting preconceptionally will reduce non-communicable disease risk in their children. This paper describes the protocol of the India study.Methods and analysisThe study set in rural Mysore will recruit ~6000 married women over the age of 18 years. The village-based cluster randomised design has three arms (preconception, pregnancy and control; 35 villages per arm). The longitudinal multifaceted intervention package will be delivered by community health workers and comprise: (1) measures to optimise nutrition; (2) a group parenting programme integrated with cognitive–behavioral therapy; (3) a lifestyle behaviour change intervention to support women to achieve a diverse diet, exclusive breast feeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foods, and adopt appropriate hygiene measures; and (4) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance.The primary outcome is adiposity in children at age 5 years, measured by fat mass index. We will report on a host of intermediate and process outcomes. We will collect a range of biospecimens including blood, urine, stool and saliva from the mothers, as well as umbilical cord blood, placenta and specimens from the offspring.An intention-to-treat analysis will be adopted to assess the effect of interventions on outcomes. We will also undertake process and economic evaluations to determine scalability and public health translation.Ethics and disseminationThe study has been approved by the institutional ethics committee of the lead institute. Findings will be published in peer-reviewed journals. We will interact with policy makers at local, national and international agencies to enable translation. We will also share the findings with the participants and local community through community meetings, newsletters and local radio.Trial registration numberISRCTN20161479, CTRI/2020/12/030134; Pre-results.

BackgroundThe nutritional status and health of mothers influence the growth and development of infants during pregnancy and postnatal life. Interventions that focus on improving the nutritional status and lifestyle of mothers have the potential to optimise the development of the fetus as well as improve the health of mothers themselves. Improving the diets of women of childbearing age is likely to require complex interventions that are delivered in a socially and culturally appropriate context. In this study we aim to test the efficacy of two interventions: behaviour change (Healthy Conversation Skills) and vitamin D supplementation, and to explore the efficacy of an intervention that combines both, in improving the diet quality and nutritional status of pregnant women.Methods/designWomen attending the maternity hospital in Southampton are recruited at between 8 and 12 weeks gestation. They are randomised to one of four groups following a factorial design: Healthy Conversation Skills support plus vitamin D supplementation (1000 IU cholecalciferol) (n = 150); Healthy Conversation Skills support plus placebo (n = 150); usual care plus vitamin D supplementation (n = 150); usual care plus placebo (n = 150). Questionnaire data include parity, sunlight exposure, diet assessment allowing assessment of diet quality, cigarette and alcohol consumption, well-being, self-efficacy and food involvement. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH) vitamin D. Maternal diet quality and 25(OH) vitamin D are the primary outcomes. Secondary outcomes are women’s level of self-efficacy at 34 weeks, pregnancy weight gain, women’s self-efficacy and breastfeeding status at one month after birth and neonatal bone mineral content, assessed by DXA within the first 14 days after birth.DiscussionThis trial is evaluating two approaches to improving maternal diet: a behaviour change intervention and vitamin D supplementation. The factorial design of this trial has the advantage of enabling each intervention to be tested separately as well as allowing exploration of the synergistic effect of both interventions on women’s diets and vitamin D levels.Trial registration ISRCTN07227232. Registered on 13 September 2013.

Since the revised MRC guidance on the development and evaluation of complex interventions was published in 2008, much progress has been made in developing and defining good practice, and there is an increasingly detailed and comprehensive set of guidance available to help researchers and funders make the right choices. But progress is patchy, and evidence continues to accumulate of waste in research. Robust approaches are needed, that combine good practice across all stages of the evaluation process, from the initial choice and framing of research questions, through to implementation and translation of evidence. The elements of a robust approach are mostly well-known, but much more rarely are they combined into a coherent package. The talk will consider why this is so, and what can be done to improve matters. This presentation will provide the history of the "Complex Interventions in Health" book. The development of the book took off in the European Academy of Nursing Science (EANS) summer school. For more than 12 years the EANS has gathered doctoral students from all over Europe in a three year programme. The content developed over time, inspired by the critique stating that nursing research was heavily dominated by descriptive, crosssectional or qualitative research not really informing practice. This lead to building a curriculum based on the MRC guidance on complex interventions and the teaching programme became truly successful among students. The road to developing the content for a book was short. Professor Richards and I played around on the black board and after that it has been a success-story. So many authors delivering on time! However, rightfully we have been told that research in health is more than researching complex interventions. I cannot agree more, it is only one step, but a very important one. Health research, as any research with aspirations for informing practice, needs to be carried out systematically and programmatically, using a variety of designs and methods. It is helpful to think of knowledge development as being a stepwise process starting off with discovery and once possible going into the phase of evaluation and once solid knowledge is obtained it is about implementation in practice. In this presentation I will explain what PPI is, what it isn't, and how it differs from engagement, as there is some misunderstanding. There is a range of both ethical and pragmatic reasons for involving members of the public and patients in research, depending on the different values and perspectives of those involved. I will provide practical examples of PPI at different stages of the research cycle: identifying and prioritising research questions; developing research proposals; doing research; analysing research data; disseminating and implementing findings; as well as PPI in systematic reviewing and operational research. Drawing on my own research, I will use the particular example of the Diabetes Intervention for Agenda Trial (DIAT) to illustrate PPI in a trial from start to finish. I will presen...

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