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Clinical Trial Summary

This pilot study aims to introduce three interventions directed toward mitigating anemia among women in Ghana, including: 1) multi-sectoral behavior change, 2) strengthening market engagement of fish processors, 3) improving fish smoking technology and practices. These interventions will be implemented among female fish processors, a population that represents a promising focal area for intervention within fisheries value chains, which have been identified as a uniquely promising sector for intervention to mitigate anemia among women. The investigators expect that the findings from this study will inform understanding of how best to design, implement, and evaluate interventions into fisheries and other animal-source food value chains in Ghana and across sub-Saharan Africa to address anemia and other nutritional and health concerns.


Clinical Trial Description

Anemia among women of reproductive age remains an intractable public health problem in many low- and middle-income countries, especially in sub-Saharan Africa (SSA) where more than one-third of women of reproductive age are anemic. The complex etiology of anemia suggests the importance of designing interventions that address both nutritional deficiencies and environmental drivers of anemia risk. This proposed research builds on new knowledge generated from ongoing formative research by our investigator team aimed at understanding the potential for interventions into animal-source food (ASF) value chains to influence anemia among adolescent girls and women in Ghana. The investigators have identified fisheries value chains in Ghana as a uniquely promising sector for intervention to mitigate anemia among women. Specifically, our research indicates that fish processing is the most promising focal area for intervention within fisheries value chains to address anemia among women. Therefore, the overall research objective of this proposed research is to develop, adapt, and pilot test a set of interventions into fisheries value chains in Ghana aimed at mitigating anemia among women. Specifically, the investigators aim to: 1) define the scope, feasibility, and scalability of priority intervention strategies that have been identified through our ongoing formative research, 2) adapt the interventions to the proposed study contexts, and 3) design and pilot test specific implementation strategies, as well as a monitoring and evaluation (M&E) framework for assessing intervention delivery, uptake, impacts, and mechanisms of impact at multiple loci along hypothesized program impact pathways.

Our ongoing formative research and an extended consultation process with stakeholders and community participants have identified priority strategies for intervention within fisheries value chains in Ghana that are feasible, scalable, likely to reduce anemia through multiple mechanisms, and for which there is clear potential for sustainability of impact. The investigators expect that the pilot testing of these interventions and the associated M&E framework will directly inform the design, implementation and evaluation of a full randomized controlled trial (RCT) that will evaluate the effectiveness of these interventions on anemia mitigation among women in Ghana. As such, the design of this pilot research will mimic that of a RCT with three distinct treatments delivered to women in separate study arms, each arm reflecting the priority intervention strategies identified through our ongoing formative research:

- Treatment Arm 1 (TA1): a multi-sectoral anemia behavior change intervention focused on promoting a diversity of anemia-mitigating behaviors including consumption of micronutrient-rich ASFs, malaria and soil-transmitted helminth control practices, and water, sanitation and hygiene best practices (TA1 is also a component of Treatment Arms 2 and 3);

- Treatment Arm 2 (TA2): an intervention aimed at strengthening women fish processors' engagement with markets through a group-based microcredit scheme, providing entrepreneurship training, and facilitating enhanced access to market price information;

- Treatment Arm 3 (TA3): an intervention introducing improved fish smoking technology and practices to women processors aimed both at improving earnings and reducing harmful occupational exposures associated with fish smoking.

The investigators will recruit a total of 120 total participants from 12 communites in two regions of Ghana that represent marine and fresh water small-scale fisheries systems. Participants will be recruited into a nine-month pilot intervention with data collection occurring at baseline prior to the start of the intervention, at the middle point of intervention implementation, and at endline immediately following completion of intervention implementation. The investigators will use survey-based instruments, direct observation, participant diaries, anthropometric and dietary assessment, occupational exposure assessment, as well as analysis of blood and stool specimens to evaluate changes in anemia, micronutrient status, inflammation and infection, as well as changes in participants' knowledge, attitudes, behaviors, and exposures that the investigators hypothesize are linked to intervention exposure. Such an analysis is critical for understanding the relative importance of different mechanisms of impact for each intervention. The investigators will further carry out qualitative, semi-structured interviews with study participants and project implementation staff to understand their perceptions of the interventions, factors that facilitated or prevented successful implementation and uptake of interventions, and their perceptions of positive and negative changes resulting from participation in the project. These insights will be important for addressing our proposed research questions related to defining the scope of the proposed interventions, and assessing the feasibility of intervention uptake and implementation. A final project assessment workshop will also be carried out to internally assess the strengths and limitations of the project's M&E framework.

Smoked fish value chains in Ghana have clear potential to influence anemia risk among women fish smokers via multiple, potentially interconnected and contradictory mechanisms. More broadly, these value chains also have significant potential to affect the nutrition and health status of coastal and lake communities and of consumers across the country whose diets are profoundly shaped by these value chains. The investigators expect that the findings of this research will significantly contribute to understanding how best to design, implement, and evaluate interventions into fisheries and other ASF value chains in Ghana and across SSA to address anemia and related nutrition and health concerns. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03498755
Study type Interventional
Source University of Michigan
Contact
Status Completed
Phase N/A
Start date May 21, 2018
Completion date August 17, 2019

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