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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
The REFANI Pakistan study--a cluster randomised controlled trial of the effectiveness and cost-effectiveness of
Bridget Fenn1, Ghulam Murtaza Sangrasi2, Chloe Puett3
1Independent consultant for the Emergency Nutrition Network, Oxford, UK. bridget@ennonline.net.
Background:
Cash-based transfer programmes are an emerging strategy in the prevention of wasting in children, especially targeted at vulnerable households during periods of food insecurity or during emergencies. However, the evidence surrounding the use of either cash or voucher transfer programmes in the humanitarian context and on nutritional outcomes is elusive. More evidence is needed not only to inform the global community of practice on best practices in humanitarian settings, but also to help strengthen national mitigation responses.
Methods/Design:
The Research for Food Assistance on Nutrition Impact Pakistan study (REFANI-P) sets out to evaluate the impact of three cash-based interventions on nutritional outcomes in children aged less than five years from poor and very poor households in Dadu District. This four-arm parallel cluster randomised controlled trial is set among Action Against Hunger (ACF) programme villages in Dadu District, Sindh Province. Mothers are the target recipients of either seasonal unconditional cash transfers or fresh food vouchers. A comparison group receives 'standard care' provided by the ACF programme to which all groups have the same access. The primary outcomes are prevalence of wasting and mean weight-for-height Z-score (WHZ) in children. Impact will be assessed at 6 months and at 1 year from baseline. Using a theory-based approach we will determine 'how' the different interventions work by looking at the processes involved and the impact pathways following the theory of change developed for this context. Quantitative and qualitative data are collected on morbidity, health seeking, hygiene and nutrition behaviours, dietary diversity, haemoglobin concentration, women's empowerment, household food security and expenditures and social capital. The direct and indirect costs of each intervention borne by the implementing organisation and their partners as well as by beneficiaries and their communities are also assessed.
Discussion:
The results of this trial will provide robust evidence to help increase knowledge about the predictability of how different modalities of cash-based transfer work best to reduce the risk of child wasting during a season where food insecurity is at its highest. Evidence on costing and cost-effectiveness will further aid decisions on choice of modality in terms of effectiveness and sustainability.
Trial Registration:
Current Controlled Trials ISRCTN10761532 . Registered 26 March 2015.
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