PROSPERO International prospective register of systematic reviews

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1 PROSPERO International prospective register of systematic reviews A realist review to explore how low-income pregnant women use food vouchers from the UK s Healthy Start programme. Heather Ohly, Victoria Hall Moran, Nicola Crossland, Nicola Lowe, Fiona Dykes Citation Heather Ohly, Victoria Hall Moran, Nicola Crossland, Nicola Lowe, Fiona Dykes. A realist review to explore how lowincome pregnant women use food vouchers from the UK s Healthy Start programme.. PROSPERO 2014:CRD Available from Review question(s) How does Healthy Start influence the diets of low-income pregnant women, for whom, in what circumstances, and why? Searches Literature searches will be conducted in two overlapping phases: 1. Development of programme theories A scoping search will be conducted to identify documentary sources of information about Healthy Start, including academic studies and grey literature (e.g. policy documents, editorials, opinions pieces). This information will be used to map the intervention (stages and stakeholders) and prioritise review questions. 2. Testing of programme theories A purposive search strategy will be developed in collaboration with Information Specialists in the North West Coast CLAHRC (Collaboration for Leadership in Applied Health Research and Care) to identify empirical evidence relating to Healthy Start and (if needed) other food voucher programmes. Wider searches may also be necessary depending on the volume and richness of the literature. Screening of references will be undertaken by the lead reviewer (HO) and a sample will be double checked by a second reviewer. Any disagreements will be resolved by discussion with a third member of the review team. Types of study to be included Any documents that contribute to theory development will be included. Condition or domain being studied This realist review will complement existing evidence on Healthy Start, by exploring how the programme works (or not), for whom, in what circumstances, and why. Participants/ population Low-income women in OECD countries these are mostly high income economies with high Human Development Index (HDI) and regarded as developed countries. This review will be limited to OECD countries so that CMO configurations identified are more likely to be generalizable between countries. Intervention(s), exposure(s) Healthy Start is a UK government intervention to improve the health of low-income pregnant women and families. Eligibility criteria are based on household income and income-related benefits. All pregnant women under 18 are eligible. Women who have successfully completed the application process receive weekly food vouchers, which can be exchanged in participating shops for plain cow s milk, plain fresh or frozen fruits and vegetables, or infant formula. Page: 1 / 5

2 Women and children also receive coupons for free Healthy Start vitamins, but historically the uptake of vitamins has been very poor. Studies of other food voucher programmes (such as WIC in the US) and other types of financial incentives may also be included if further evidence is needed to test the programme theories. Comparator(s)/ control Some quantitative studies may include a comparison or control group, but this is not a condition of inclusion since relevant information may also be obtained from other types of studies. Context There has been no national evaluation of the impact of Healthy Start on nutritional outcomes, despite repeated calls for a comparative study since its introduction in 2006 (Dyson et al., 2007; Hills, 2006; McFadden et al., 2013). Two recent evaluations commissioned by the Department of Health used predominantly qualitative methods to explore stakeholders views on effectiveness, barriers to success, potential solutions, and made recommendations to improve the intervention (Lucas et al. 2013; McFadden et al. 2013). What is largely absent from these studies is an in-depth examination of how Healthy Start works (or not), for whom, in what circumstances, and why. This realist review aims to explore how low-income pregnant women use their Healthy Start food vouchers - do they increase their consumption of target foods, as the intervention intends, or are there other unintended outcomes? Candidate programme theories will be developed and prioritised using documentary sources and consultations with stakeholders, to elucidate the underlying programme assumptions (intended outcomes) and alternative hypotheses (unintended outcomes). Realist programme theories are constructed as context - mechanism - outcome (CMO) configurations, and abstracted to middle range theories, so that they offer causal explanations for what is actually going on within the programme (Pawson, 2006). Dyson, L., Renfrew, M. J., Jenkins, R., Thomas, J., McCormick, F., et al. (2007). Approaches to evaluating healthy start - a scoping review. Mother and Infant Research Unit, University of York. Hills, D. (2006). Healthy start: Rapid evaluation of early impact on beneficiaries, health professionals, retailers and contractors. London, England: Tavistock Institute/Symbia. Lucas, P. J., Jessiman, T., Cameron, A., Wiggins, M., Hollingworth, K., et al. (2013). Healthy start vouchers study: The views and experiences of parents, professionals and small retailers in England. School for Policy Studies, University of Bristol. McFadden, A., Fox-Rushby, J., Green, J. M., Williams, V., Pokhrel, S., et al. (2013). Healthy start: Understanding the use of vouchers and vitamins. College of Medicine, Dentistry and Nursing, University of Dundee. Pawson, R. (2006). Evidence-based policy: A realist perspective. London: Sage. Outcome(s) Primary outcomes Women s nutritional outcomes, such as consumption of target foods. Intermediate outcomes will also be explored during the development and testing of programme theories. Secondary outcomes None Data extraction, (selection and coding) As with the searches, it is anticipated that the two phases of data extraction will overlap and will be an iterative process throughout the review. 1. Development of programme theories Page: 2 / 5

3 Each document will be read thoroughly and any information that contributes to theory development will be extracted in the form of note-taking, annotation and conceptualisation. A mind map or theoretical framework will be used to record programme theories and possible interrelationships. 2. Testing of programme theories Relevant data will be extracted from included studies into a bespoke database, which will be piloted to ensure that it captures the information needed to test the programme theories. This stage of the review will involve critical discussions between reviewers and the review advisory group, to ensure that we begin to develop a line of argument that feeds into the final synthesis stage. Further theorising by the reviewers will be documented at this stage. Data extraction in phases 1 and 2 will be undertaken by the lead reviewer (HO) and a sample will be double checked by a second reviewer for inconsistencies, errors and omissions. Any disagreements will be resolved by discussion with a third member of the review team. Risk of bias (quality) assessment In realist synthesis, studies are assessed based on two criteria: Relevance whether they contribute to the development or testing of programme theories Rigour whether the methods used are credible and trustworthy Studies will be assessed under the criteria of relevance and rigour as described in the RAMESES quality standards for realist reviews: Strategy for data synthesis An evidence-based programme theory will be iteratively developed throughout the review. The synthesis of evidence will be guided by the following realist principles: questioning programme integrity; adjudicating between rival programme theories; considering the same theory in different contexts; comparing official expectations with actual practice (Pawson, 2006). Therefore, the evidence will be used to support, contradict, modify and reinterpret the programme theory, and to highlight areas for future research where the existing evidence is insufficient. The type of data extracted will determine the precise synthesis methods to be used. Data analysis and synthesis will be undertaken by the lead reviewer (HO) with regular discussions with the review team and in consultation with the review advisory group. The guidance provided by the RAMESES project will be used throughout this process. Analysis of subgroups or subsets The CMO analysis will be sensitive to potential differences between subgroups of low-income pregnant women, such as women of different ages, ethnic groups and those living in urban/rural areas. This is the main purpose of the realist approach, to examine what works, for whom, in what circumstances and why. Dissemination plans The review will be submitted for publication in an academic journal in the fields of public health or maternal and child nutrition. Contact details for further information Mrs Ohly HOhly@uclan.ac.uk Organisational affiliation of the review School of Health, University of Central Lancashire Review team Page: 3 / 5

4 Mrs Heather Ohly, University of Central Lancashire Dr Victoria Hall Moran, University of Central Lancashire Dr Nicola Crossland, University of Central Lancashire Professor Nicola Lowe, University of Central Lancashire Professor Fiona Dykes, University of Central Lancashire Anticipated or actual start date 01 November 2014 Anticipated completion date 31 March 2016 Funding sources/sponsors CLAHRC North West Coast PhD Studentship ( ) Conflicts of interest None known Language English Country England Subject index terms status Subject indexing assigned by CRD Subject index terms Female; Food Assistance; Humans; Poverty Stage of review Completed and published Date of registration in PROSPERO 20 November 2014 Date of publication of this revision 28 April 2017 Details of final report/publication(s) Ohly H, Crossland N, Dykes F, et al. A realist review to explore how low-income pregnant women use food vouchers from the UK s Healthy Start programme. BMJ Open 2017;7:e doi: /bmjopen DOI /CRD Stage of review at time of this submission Started Completed Preliminary searches Yes Yes Piloting of the study selection process Yes Yes Formal screening of search results against eligibility criteria Yes Yes Data extraction Yes Yes Risk of bias (quality) assessment Yes Yes Page: 4 / 5

5 Powered by TCPDF ( Data analysis Yes Yes PROSPERO International prospective register of systematic reviews The information in this record has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Page: 5 / 5