The Invisible Fishers

Anemia Clinical Trial

Official title:

The Invisible Fishers: Empowering and Safeguarding Women in Fisheries Value Chains in Ghana to Reduce Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498755
• Other study ID #: HUM00138934
• Status: Completed
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: August 17, 2019

Study information

• Verified date: August 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 17, 2019
• Est. primary completion date: August 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• Not pregnant

• Not planning to move from the community during the project period

• Engaged in fish processing as primary livelihood

Exclusion Criteria:

• Pregnant

• Planning to move from the community during the project period

• Not engaged in fish processing as primary livelihood

Related Conditions & MeSH terms

• Anemia

Intervention

Behavioral:
• Mobile phone audio messaging
Audio messages will be "pushed" to participants' mobile phones twice weekly on a set schedule in discrete modules that include basic information related to each of the four behavioral domains followed by an integration of the information across behaviors through relatable, character-driven narratives that enable message recipients to engage with the content through a real-world context.
• Peer-to-peer learning
Women participants in each community will meet twice monthly for peer-to-peer learning sessions to reinforce the content of audio messages. These sessions will further use women's empowerment approaches including critical examination of gender dynamics, and discussions of solutions for equitable decision-making and control of resources within households. These discussions will be facilitated with male household members and grandmothers in separate learning sessions that will be held three times throughout the intervention period.
• Conditional cash transfer
Participants will receive a conditional cash transfer to support their fish smoking business. The payment will be conditional on their participation in entrepreneurship trainings and the use of the investment into their fish smoking business.
• Entrepreneurship training
Entrepreneurship training will focus on commonly lacking business knowledge, with an emphasis on establishing fundamental entrepreneurial skills (i.e., customer care, accounting), sound business management and decision-making, building strong and sustainable business relationships, and encouraging the use of loans for their intended purposes. This training will be introduced during the credit and savings group (CSG) meetings that will occur twice per month.
• Market price information
Average market prices for fresh and processed fish at community, district, and regional markets will be disseminated via audio message calls (using Viamo's Infoline platform) to the mobile phones of women with the price information in their preferred language. These market prices will be collected twice weekly by Viamo field enumerators and sent to regional coordinators for validation. A second, independent validation will be carried out to ensure that there are no discrepancies.
• Improved smoke ovens
Local private sector artisans will construct and serve as suppliers of the new ovens. The promotion, uptake and impact of these improved Ahotor ovens will be tested among study participants. Awareness-raising workshops held in each community will promote the Ahotor in concert with a public retrofitting of a Chorkor stove. Immediately following this event, one month later, and three months later, study participants will receive additional one-on-one counseling to provide further support on the proper use of the smoke oven, as well as on optimal handling and smoking practices to enhance product quality.

Locations

Country	Name	City	State
Ghana	University of Ghana, Legon	Accra

Sponsors (6)

Lead Sponsor	Collaborator
University of Michigan	Bill and Melinda Gates Foundation, Innovations for Poverty Action, Netherlands Development Organization, University of Ghana, Viamo

Country where clinical trial is conducted

Ghana, 

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* Note: There are 129 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anemia over time	Hemoglobin (Hb) <120 g/L, based on analysis of blood and stool samples	Change from baseline anemia status over the 9 months of the intervention
Secondary	Change in knowledge and value of animal-source foods for health over time	Evaluated from participants' responses to assessment related to content of audio messages and peer-to-peer learning	Change from baseline knowledge over the 9 months of the intervention
Secondary	Change in amount of processed fish kept for own consumption	Collected daily using participants' business diaries	Change from baseline amount of fish over the 9 months of the intervention
Secondary	Change in animal-source food purchases	Collected using a seven-day animal-source food expenditure questionnaire	Change from baseline purchases over the 9 months of the intervention
Secondary	Change in consumption of animal-source food	Collected using a 24-hour dietary recall questionnaire on three non-consecutive days in a one-week period	Change from baseline consumption over the 9 months of the intervention
Secondary	Change in understanding and valuation of the importance of specific practices for improving environmental and personal hygiene and minimizing risk of infection	Participant recall and observation of use of insecticide-treated bed nets for sleeping, recent anti-malaria indoor residual spraying of household, frequency and location of barefoot travel, handwashing with soap, safe disposal of stool, treatment of drinking water, safe food and storage preparation practices, and personal hygiene	Change from baseline understanding over the 9 months of the intervention
Secondary	Change in women's autonomy in decision-making and control over earned income	Measure of women's access to productive capital and the role of women in household decision-making related to agricultural production and income generation, as assessed by a questionnaire of the Women's Empowerment in Agriculture Index	Change from baseline autonomy over the 9 months of the intervention
Secondary	Change in smoked fish production and processing capacity	Assessed from daily business diaries and participant recall for cross-validation	Change from baseline production and capacity over the 9 months of the intervention
Secondary	Change in fish sales and income generation from fish sales	Assessed from daily business diaries and participant recall for cross-validation	Change from baseline sales over the 9 months of the intervention
Secondary	Change in fuelwood and other fish processing business-related expenditures	Assessed from daily business diaries and participant recall for cross-validation	Change from baseline expenditures over the 9 months of the intervention
Secondary	Change in knowledge of entrepreneurial skills and best business practices	Examined using assessment tool that evaluates knowledge of customer care, calculating profits, managing inventory, and accounting	Change from baseline knowledge and practices over the 9 months of the intervention
Secondary	Change in perceptions of positive and negative changes resulting from participation in interventions	Measured from extent to which women used market price information that was disseminated via mobile phones, changes in women's business practices, and women's perceptions of the reasons for changes in fish processing, sales, and/or income from fish sales	Change from baseline perceptions over the 9 months of the intervention
Secondary	Change in exposure to PM2.5 (particulate matter less than 2.5 microns in aerodynamic diameter) and CO (carbon monoxide)	Primary exposure will be calculated as the mean of recorded concentrations during fish smoking activities (determined by participant time use diaries and corroborated with observational data). Secondary exposure will be calculated as the mean of recorded concentrations during the full 48-hour exposure measurement period	Change from baseline exposure over the 9 months of the intervention
Secondary	Change in work environments during fish processing including individuals participating in processing activities	Assessed from observation data	Change from baseline environments over the 9 months of the intervention
Secondary	Change in knowledge of optimal fish handling and smoking practices for enhancing product quality	Assessed using custom tool based on the content of community promotional activities and one-on-one counseling sessions	Change from baseline knowledge over the 9 months of the intervention
Secondary	Change in type of fish smoking oven used	Assessed from observational data	Change from baseline oven used over the 9 months of the intervention
Secondary	Women's perceptions of the ease of use of Ahotor oven relative to their prior stoves	Assessed using a semi-structured interview guide through in-person interview with subsample of participants in treatment arm 3	At the end of study (10 months)
Secondary	Women's perceptions of the functionality of the new oven	Assessed using a semi-structured interview guide through in-person interview with subsample of participants in treatment arm 3	At the end of study (10 months)
Secondary	Differences in home cooking patterns following adoption of new ovens	Assessed using a semi-structured interview guide through in-person interview with subsample of participants in treatment arm 3	At the end of study (10 months)

External Links

•   International Food Policy Research Institute. Women's Empowerment in Agriculture Index.
•   Netherlands Development Organization. Introducing the Ahotor oven in the Volta region of Ghana. 2017.
•   World Bank. Adwoa Adezawa: The Young Woman and the Sea.