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This article explores the rationales offered in the evaluation literature for studying the processes involved in programme implementation, and their relationship with current arguments about the use of experimental designs to evaluate social interventions. It describes, as a case study, a process evaluation carried out as an integral part of a randomized controlled trial of peer-led sex education. The process evaluation was designed to answer important questions about the implementation of the intervention, the social context of the trial, and the experiences of trial participants. The article describes the methods used to collect process data, and some of the challenges involved. It concludes by arguing that process evaluation is necessarily complex, but essential to the task of understanding why and how interventions and outcomes may be related.

Although widely accepted in medicine and health services research, randomized controlled trials (RCTs) are often viewed with hostility by social scientists, who cite a variety of reasons as to why this approach to evaluation cannot be used to research social interventions. This article discusses the three central themes in these debates, which are those of science, ethics, and feasibility. The article uses three recent U.K. trials of social interventions (day care for preschool children, social support for disadvantaged families, and peer-led sex education for young people) to consider issues relating to the use of random allocation for social intervention evaluation and to suggest some practical strategies for the successful implementation of "social" RCTs. The article argues that the criteria of science, ethics, and feasibility can and should apply to social intervention trials in just the same way as they do to clinical trials.

Although widely accepted in medicine & health vices research, randomized controlled trials (RCTs) are often viewed with hostility by social scientists, who cite a variety of reasons as to why this approach to evaluation cannot be used to research social interventions. This article discusses the three central themes in these debates, which are those of science, ethics, & feasibility. The article uses three recent U.K. trials of social interventions (day care for preschool children, social support for disadvantaged families, & peer-led sex education for young people) to consider issues relating to the use of random allocation for social intervention evaluation & to suggest some practical strategies for the successful implementation of "social" RCTs. The article argues that the criteria of science, ethics, & feasibility can & should apply to social intervention trials in just the same way as they do to clinical trials. [Copyright 2003 Sage Publications, Inc.]

Integration of process with outcome evaluations has been recommended as a way of addressing some of the criticisms of Randomized Controlled Trials (RCTs) for evaluating social interventions. This is the second of two articles (the first was published in issue 10(4) of this journal) discussing the design, implementation and analysis of a process evaluation as an integral part of the RIPPLE (Randomized Intervention of Pupil Peer-Led sex Education) Study. The methods for integrating process and outcome data are outlined and findings are presented to illustrate how integration of process and outcome data enabled exploration of: 1) variation between schools in the extent and quality of the intervention implemented, and any impact of this on outcomes; 2) the processes by which the intervention might affect outcomes; and 3) the extent to which different subgroups of students or schools may have responded differently to the intervention. The article concludes with a discussion of the methodological issues arising from this attempt at integrating process and outcome evaluations within the design of an RCT.

Acknowledgments: We thank the participants of this study, community pharmacists who recruited women for the study, and health-care professionals at the sexual and reproductive health service clinics who assisted with the study implementation. We thank Deirde Sally, Nicola Stewart, and Maria Nunez for the support with study implementation at the local site in London and Kristina Saunders for support with the process evaluation. We also thank Sarah Cameron and Lorna Aucott (senior statistician, the Centre for Healthcare Randomised Trials) for support and Katherine Lewis, Laura Flett, and Judith Parker for trial management support. List of study pharmacies in Edinburgh: Newington Pharmacy, Boots Princes Street, Boots Shandwick Place, Boots Earl Grey Street, Boots Gyle, Boots St Patrick Street, Boots Multrees Walk, Boots Ocean Terminal, Boots Edinburgh Fort Retail Park, Boots Cameron Toll, Boots Craigleith, and Bristo Square Pharmacy. List of study pharmacies in London: Peace Pharmacy, Westbury Chemist, Baba Chemist, Lings Chemist, Streatham Day Lewis, Morrisons—Aylesham Centre, Evergreen Pharmacy, Greenlight Pharmacy, Sandylight Pharmacy, Greenfields, JP Pharmacy, Boots Goodge Street, Boots Tottenham Court Road, and Boots Holborn. Additionally, Asda Pharmacy (Perth), Boots High Street and Boots Perth Road (Dundee). List of sexual and reproductive health clinics: Chalmers Sexual and Reproductive Health Service, NHS Lothian (Edinburgh), Tayside Sexual and Reproductive Health Service, Ninewells Hospital (Dundee), Camberwell Sexual Health Centre, Mortimer Market Centre, the Margaret Pyke Centre, and the Archway Centre (London). Declaration of interests: STC reports grants from the National Institute for Health Research (Health Technology Assessment [NIHR HTA] Programme), during the conduct of the study. AG is a consultant to HRA Pharma. AR reports receiving research grants from Gilead Sciences, Bristol-Myers Squibb, AbbVie, and Roche; honorariums from Gilead Sciences; and personal fees from AbbVie. LM and SP report funding from the UK Medical Research Council and Scottish Government Chief Scientist Office (Central Statistics Office) at the University of Glasgow (MC_UU_12017/11, SPHSU11). PB is a clinical director of the not-for profit community interest company SH:24, that provides online sexual health services in partnership with the UK National Health Service. KC reports being an employee of Boots UK, during the conduct of this study. AleM reports grants from NIHR HTA, during the conduct of this study. AleM is a clinical support bank midwife for SH:24 and a research midwife at Oxford University. JN was a deputy chair of the NIHR HTA General Board Committee (2016–19). All other authors declare no competing interests. This research is funded by the NIHR HTA project 15/113/01. ; Peer reviewed ; Publisher PDF

The nutritional status of both women and men before conception has profound implications for the growth, development, and long-term health of their offspring. Evidence of the effectiveness of preconception interventions for improving outcomes for mothers and babies is scarce. However, given the large potential health return, and relatively low costs and risk of harm, research into potential interventions is warranted. We identified three promising strategies for intervention that are likely to be scalable and have positive effects on a range of health outcomes: supplementation and fortification; cash transfers and incentives; and behaviour change interventions. On the basis of these strategies, we suggest a model specifying pathways to effect. Pathways are incorporated into a life-course framework using individual motivation and receptiveness at different preconception action phases, to guide design and targeting of preconception interventions. Interventions for individuals not planning immediate pregnancy take advantage of settings and implementation platforms outside the maternal and child health arena, since this group is unlikely to be engaged with maternal health services. Interventions to improve women's nutritional status and health behaviours at all preconception action phases should consider social and environmental determinants, to avoid exacerbating health and gender inequalities, and be underpinned by a social movement that touches the whole population. We propose a dual strategy that targets specific groups actively planning a pregnancy, while improving the health of the population more broadly. Modern marketing techniques could be used to promote a social movement based on an emotional and symbolic connection between improved preconception maternal health and nutrition, and offspring health. We suggest that speedy and scalable benefits to public health might be achieved through strategic engagement with the private sector. Political theory supports the development of an advocacy coalition of groups interested in preconception health, to harness the political will and leadership necessary to turn high-level policy into effective coordinated action.

The nutritional status of women and men before conception has profound implications for the growth, development and long-term health of their offspring. Evidence of the effectiveness of preconception interventions in improving outcomes for mothers or babies is scarce, though given the large potential health return, relatively low costs and risk of harm, intervention is still warranted. We identify three promising strategies for intervention that are likely to be scalable and to have positive effects on a range of health outcomes: supplementation and fortification; cash transfers; and behaviour change interventions. Based on this, we suggest a model specifying pathways to effect. Pathways are incorporated into a lifecourse framework using individual motivation and receptiveness at different 'preconception action phases' to guide design and targeting of preconception interventions. Interventions with those not planning immediate pregnancy take advantage of settings and implementation platforms outside the maternal and child health arena, since this group is unlikely to be engaged with maternal health services. Interventions to improve women's nutritional status and health behaviours at all preconception action phases need to take account of social and environmental determinants to avoid exacerbating health and gender inequalities, and should be underpinned by a social movement that touches the whole population. A dual strategy that targets specific groups actively planning a pregnancy, while improving the health of the population more broadly, is proposed. The engagement of modern marketing techniques points to a social movement based on an emotional and symbolic connection between improved maternal nutrition and health prior to conception and offspring health. We suggest that speedy and scalable public health benefit might be achieved through strategic engagement with the private sector. Political theory supports the development of an advocacy coalition of groups interested in preconception health, to harness the ...