AnemiaNCT03498755
The Invisible Fishers
A study testing Mobile phone audio messaging, Peer-to-peer learning and Conditional cash transfer in people with Anemia, run by University of Michigan at 1 site in Ghana.
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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Mobile phone audio messaging, Peer-to-peer learning and Conditional cash transfer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGhana
- Study dates
- 21 May 2018to 17 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Not pregnant
- Not planning to move from the community during the project period
- Engaged in fish processing as primary livelihood
Who cannot join
- Pregnant
- Planning to move from the community during the project period
- Not engaged in fish processing as primary livelihood
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Invisible Fishers: Empowering and Safeguarding Women in Fisheries Value Chains in Ghana to Reduce Anemia
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.
Read the detailed 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.
- Conditions
- Anemia
- Being tested
- Mobile phone audio messaging, Peer-to-peer learning, Conditional cash transfer, Entrepreneurship training, Market price information
- Keywords
- fisheries, Ghana, sub-Saharan Africa, value chain, fish processing, fish smoking
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone audio messagingBehavioural
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 learningBehavioural
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 transferBehavioural
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 trainingBehavioural
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 informationBehavioural
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 ovensBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-sectoral anemia behavior change | Experimental | Address multiple behavioral determinants of anemia by promoting the identification, knowledge, valuation and practice of four behavioral domains: 1) consumption of micronutrient-rich animal-source foods; 2) malaria and soil-transmitted helminth infection control practices; 3) water, sanitation and hygiene (WASH) best practices; and 4) women's autonomy in decision-making and control of the use of earned income. Receives: Behavioral: Mobile phone audio messaging; Behavioral: Peer-to-peer learning |
| Strengthening market engagement of fish processors | Experimental | Assist women in overcoming limited access to credit, inadequate storage facilities, and insufficient information about market prices, which constrain the timeliness and amount of market-ready product available for sale, through a three-pronged approach that includes: 1) a conditional cash transfer; 2) entrepreneurship training; and 3) enhanced access to market price information. Receives: Behavioral: Mobile phone audio messaging; Behavioral: Peer-to-peer learning; Behavioral: Conditional cash transfer; Behavioral: Entrepreneurship training; Behavioral: Market price information |
| Improving fish smoking technology and practices | Experimental | Introduce and promote a recently developed fish smoking oven known as the Ahotor, which was explicitly designed to reduce emission from biomass fuel combustion, decrease polycyclic aromatic hydrocarbon (PAH) levels of smoked fish, and increase fuel efficiency. Use of this oven will reduce workload, increase earnings, and reduce harmful occupational exposures. Introduction of this improved fish smoking oven will be combined with behavior change education focused on promoting optimal fish smoking and handling practices. Receives: Behavioral: Mobile phone audio messaging; Behavioral: Peer-to-peer learning; Behavioral: Improved smoke ovens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anemia over time
Hemoglobin (Hb) <120 g/L, based on analysis of blood and stool samples
Measured: Change from baseline anemia status over the 9 months of the intervention
Secondary outcomes (18)
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
Measured: Change from baseline knowledge over the 9 months of the intervention
Change in amount of processed fish kept for own consumption
Collected daily using participants' business diaries
Measured: Change from baseline amount of fish over the 9 months of the intervention
Change in animal-source food purchases
Collected using a seven-day animal-source food expenditure questionnaire
Measured: Change from baseline purchases over the 9 months of the intervention
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
Measured: Change from baseline consumption over the 9 months of the intervention
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
Measured: Change from baseline understanding over the 9 months of the intervention
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
Measured: Change from baseline autonomy over the 9 months of the intervention
Change in smoked fish production and processing capacity
Assessed from daily business diaries and participant recall for cross-validation
Measured: Change from baseline production and capacity over the 9 months of the intervention
Change in fish sales and income generation from fish sales
Assessed from daily business diaries and participant recall for cross-validation
Measured: Change from baseline sales over the 9 months of the intervention
Change in fuelwood and other fish processing business-related expenditures
Assessed from daily business diaries and participant recall for cross-validation
Measured: Change from baseline expenditures over the 9 months of the intervention
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
Measured: Change from baseline knowledge and practices over the 9 months of the intervention
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
Measured: Change from baseline perceptions over the 9 months of the intervention
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
Measured: Change from baseline exposure over the 9 months of the intervention
Change in work environments during fish processing including individuals participating in processing activities
Assessed from observation data
Measured: Change from baseline environments over the 9 months of the intervention
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
Measured: Change from baseline knowledge over the 9 months of the intervention
Change in type of fish smoking oven used
Assessed from observational data
Measured: Change from baseline oven used over the 9 months of the intervention
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
Measured: At the end of study (10 months)
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
Measured: At the end of study (10 months)
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
Measured: At the end of study (10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start21 May 2018
- Primary completion17 Aug 2019
- Study completion17 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (129)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two communities in each of two study regions will be assigned to one of the three treatments (i.e., six communities in total per region). Assigning two communities to the same treatment in each region will allow us to assess differential intervention design and implementation needs for communities in similar geographic areas. Ten women in each community will be purposefully selected for participation to ensure intra-community variation on participant age, socioeconomic status, years of experience with fish smoking, and the scale of fish smoking enterprises. Across both regions, 120 women will be recruited from a total of 12 communities. While the interventions will be delivered to individual women, treatment assignment will be carried out at the community-level given the risk of sharing information and inputs within communities that could contaminate intervention exposure and bias observed treatment effects.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ghana, Innovations for Poverty Action, Netherlands Development Organization, Viamo, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Andrew Jones, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498755
- Sponsor's protocol ID
- HUM00138934
- Status last verified
- Aug 2019
- First submitted
- 12 Mar 2018
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
World Health Organization. The global prevalence of anaemia in 2011. Geneva, Switzerland: World Health Organization, 2015.
World Health Organization. Worldwide prevalence of anaemia, 1993-2005. Geneva, Switzerland: World Health Organization, 2008.
International Food Policy Research Institute. Global Nutrition Report 2016: From Promise to Impact: Ending Malnutrition by 2030. Washington, DC: International Food Policy Research Institute, 2016.
Ezzati M, Lopez AD, Rodgers AA, Murray CJL. Comparative quantification of health risks: global and regional burden of disease attributable to selected major risk factors. Geneva, Switzerland: World Health Organization, 2004.
Horton S, Ross J. The economics of iron deficiency. Food Policy. 2003;28(1):51-75.
Klebanoff MA, Shiono PH, Selby JV, Trachtenberg AI, Graubard BI. Anemia and spontaneous preterm birth. Am J Obstet Gynecol. 1991 Jan;164(1 Pt 1):59-63. doi: 10.1016/0002-9378(91)90626-3.
PubMed 1986627Scholl TO, Hediger ML, Bendich A, Schall JI, Smith WK, Krueger PM. Use of multivitamin/mineral prenatal supplements: influence on the outcome of pregnancy. Am J Epidemiol. 1997 Jul 15;146(2):134-41. doi: 10.1093/oxfordjournals.aje.a009244.
PubMed 9230775Zeng L, Dibley MJ, Cheng Y, Dang S, Chang S, Kong L, Yan H. Impact of micronutrient supplementation during pregnancy on birth weight, duration of gestation, and perinatal mortality in rural western China: double blind cluster randomised controlled trial. BMJ. 2008 Nov 7;337:a2001. doi: 10.1136/bmj.a2001.
PubMed 18996930Christian P, Khatry SK, Katz J, Pradhan EK, LeClerq SC, Shrestha SR, Adhikari RK, Sommer A, West KP Jr. Effects of alternative maternal micronutrient supplements on low birth weight in rural Nepal: double blind randomised community trial. BMJ. 2003 Mar 15;326(7389):571. doi: 10.1136/bmj.326.7389.571.
PubMed 12637400Rao R, Georgieff MK. Iron in fetal and neonatal nutrition. Semin Fetal Neonatal Med. 2007 Feb;12(1):54-63. doi: 10.1016/j.siny.2006.10.007. Epub 2006 Dec 6.
PubMed 17157088Stevens GA, Finucane MM, De-Regil LM, Paciorek CJ, Flaxman SR, Branca F, Pena-Rosas JP, Bhutta ZA, Ezzati M; Nutrition Impact Model Study Group (Anaemia). Global, regional, and national trends in haemoglobin concentration and prevalence of total and severe anaemia in children and pregnant and non-pregnant women for 1995-2011: a systematic analysis of population-representative data. Lancet Glob Health. 2013 Jul;1(1):e16-25. doi: 10.1016/S2214-109X(13)70001-9. Epub 2013 Jun 25.
PubMed 25103581Petry N, Olofin I, Hurrell RF, Boy E, Wirth JP, Moursi M, Donahue Angel M, Rohner F. The Proportion of Anemia Associated with Iron Deficiency in Low, Medium, and High Human Development Index Countries: A Systematic Analysis of National Surveys. Nutrients. 2016 Nov 2;8(11):693. doi: 10.3390/nu8110693.
PubMed 27827838Balarajan Y, Ramakrishnan U, Ozaltin E, Shankar AH, Subramanian SV. Anaemia in low-income and middle-income countries. Lancet. 2011 Dec 17;378(9809):2123-35. doi: 10.1016/S0140-6736(10)62304-5. Epub 2011 Aug 1.
PubMed 21813172Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
PubMed 15758012Schumann K, Solomons NW. Perspective: What Makes It So Difficult to Mitigate Worldwide Anemia Prevalence? Adv Nutr. 2017 May 15;8(3):401-408. doi: 10.3945/an.116.013847. Print 2017 May.
PubMed 28507005
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Invisible Fishers: Empowering and Safeguarding Women in Fisheries Value Chains in Ghana to Reduce Anemia
- ClinicalTrials.gov ID
- NCT03498755
- Acronym / sponsor ID
- HUM00138934
- Conditions
- Anemia
- Keywords
- fisheries, Ghana, sub-Saharan Africa, value chain, fish processing, fish smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Ghana, Innovations for Poverty Action, Netherlands Development Organization, Viamo, Bill and Melinda Gates Foundation
- Study start
- 21 May 2018 (actual)
- Primary completion
- 17 Aug 2019 (actual)
- Study completion
- 17 Aug 2019 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Two communities in each of two study regions will be assigned to one of the three treatments (i.e., six communities in total per region). Assigning two communities to the same treatment in each region will allow us to assess differential intervention design and implementation needs for communities in similar geographic areas. Ten women in each community will be purposefully selected for participation to ensure intra-community variation on participant age, socioeconomic status, years of experience with fish smoking, and the scale of fish smoking enterprises. Across both regions, 120 women will be recruited from a total of 12 communities. While the interventions will be delivered to individual women, treatment assignment will be carried out at the community-level given the risk of sharing information and inputs within communities that could contaminate intervention exposure and bias observed treatment effects.
| Arm | Type | Receives |
|---|---|---|
| Multi-sectoral anemia behavior change | Experimental | Behavioral: Mobile phone audio messaging, Behavioral: Peer-to-peer learningAddress multiple behavioral determinants of anemia by promoting the identification, knowledge, valuation and practice of four behavioral domains: 1) consumption of micronutrient-rich animal-source foods; 2) malaria and soil-transmitted helminth infection control practices; 3) water, sanitation and hygiene (WASH) best practices; and 4) women's autonomy in decision-making and control of the use of earned income. |
| Strengthening market engagement of fish processors | Experimental | Behavioral: Mobile phone audio messaging, Behavioral: Peer-to-peer learning, Behavioral: Conditional cash transfer, Behavioral: Entrepreneurship training, Behavioral: Market price informationAssist women in overcoming limited access to credit, inadequate storage facilities, and insufficient information about market prices, which constrain the timeliness and amount of market-ready product available for sale, through a three-pronged approach that includes: 1) a conditional cash transfer; 2) entrepreneurship training; and 3) enhanced access to market price information. |
| Improving fish smoking technology and practices | Experimental | Behavioral: Mobile phone audio messaging, Behavioral: Peer-to-peer learning, Behavioral: Improved smoke ovensIntroduce and promote a recently developed fish smoking oven known as the Ahotor, which was explicitly designed to reduce emission from biomass fuel combustion, decrease polycyclic aromatic hydrocarbon (PAH) levels of smoked fish, and increase fuel efficiency. Use of this oven will reduce workload, increase earnings, and reduce harmful occupational exposures. Introduction of this improved fish smoking oven will be combined with behavior change education focused on promoting optimal fish smoking and handling practices. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Not pregnant
- Not planning to move from the community during the project period
- Engaged in fish processing as primary livelihood
Key exclusion criteria (3 listed)
- Pregnant
- Planning to move from the community during the project period
- Not engaged in fish processing as primary livelihood
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile phone audio messagingAudio 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. | Behavioural | Improving fish smoking technology and practices, Multi-sectoral anemia behavior change, Strengthening market engagement of fish processors |
| Peer-to-peer learningWomen 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. | Behavioural | Improving fish smoking technology and practices, Multi-sectoral anemia behavior change, Strengthening market engagement of fish processors |
| Conditional cash transferParticipants 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. | Behavioural | Strengthening market engagement of fish processors |
| Entrepreneurship trainingEntrepreneurship 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. | Behavioural | Strengthening market engagement of fish processors |
| Market price informationAverage 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. | Behavioural | Strengthening market engagement of fish processors |
| Improved smoke ovensLocal 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. | Behavioural | Improving fish smoking technology and practices |
Primary outcome
Change in anemia over time
Time frame: Change from baseline anemia status over the 9 months of the intervention
Hemoglobin (Hb) <120 g/L, based on analysis of blood and stool samples
18 secondary outcomes
Change in knowledge and value of animal-source foods for health over time
Time frame: Change from baseline knowledge over the 9 months of the intervention
Change in amount of processed fish kept for own consumption
Time frame: Change from baseline amount of fish over the 9 months of the intervention
Change in animal-source food purchases
Time frame: Change from baseline purchases over the 9 months of the intervention
Change in consumption of animal-source food
Time frame: Change from baseline consumption over the 9 months of the intervention
Change in understanding and valuation of the importance of specific practices for improving environmental and personal hygiene and minimizing risk of infection
Time frame: Change from baseline understanding over the 9 months of the intervention
Change in women's autonomy in decision-making and control over earned income
Time frame: Change from baseline autonomy over the 9 months of the intervention
Change in smoked fish production and processing capacity
Time frame: Change from baseline production and capacity over the 9 months of the intervention
Change in fish sales and income generation from fish sales
Time frame: Change from baseline sales over the 9 months of the intervention
Change in fuelwood and other fish processing business-related expenditures
Time frame: Change from baseline expenditures over the 9 months of the intervention
Change in knowledge of entrepreneurial skills and best business practices
Time frame: Change from baseline knowledge and practices over the 9 months of the intervention
Change in perceptions of positive and negative changes resulting from participation in interventions
Time frame: Change from baseline perceptions over the 9 months of the intervention
Change in exposure to PM2.5 (particulate matter less than 2.5 microns in aerodynamic diameter) and CO (carbon monoxide)
Time frame: Change from baseline exposure over the 9 months of the intervention
Change in work environments during fish processing including individuals participating in processing activities
Time frame: Change from baseline environments over the 9 months of the intervention
Change in knowledge of optimal fish handling and smoking practices for enhancing product quality
Time frame: Change from baseline knowledge over the 9 months of the intervention
Change in type of fish smoking oven used
Time frame: Change from baseline oven used over the 9 months of the intervention
Women's perceptions of the ease of use of Ahotor oven relative to their prior stoves
Time frame: At the end of study (10 months)
Women's perceptions of the functionality of the new oven
Time frame: At the end of study (10 months)
Differences in home cooking patterns following adoption of new ovens
Time frame: At the end of study (10 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- BackgroundWorld Health Organization. The global prevalence of anaemia in 2011. Geneva, Switzerland: World Health Organization, 2015.
- BackgroundWorld Health Organization. Worldwide prevalence of anaemia, 1993-2005. Geneva, Switzerland: World Health Organization, 2008.
- BackgroundInternational Food Policy Research Institute. Global Nutrition Report 2016: From Promise to Impact: Ending Malnutrition by 2030. Washington, DC: International Food Policy Research Institute, 2016.
- BackgroundEzzati M, Lopez AD, Rodgers AA, Murray CJL. Comparative quantification of health risks: global and regional burden of disease attributable to selected major risk factors. Geneva, Switzerland: World Health Organization, 2004.
- BackgroundHorton S, Ross J. The economics of iron deficiency. Food Policy. 2003;28(1):51-75.
- Background: PubMed 1986627Klebanoff MA, Shiono PH, Selby JV, Trachtenberg AI, Graubard BI. Anemia and spontaneous preterm birth. Am J Obstet Gynecol. 1991 Jan;164(1 Pt 1):59-63. doi: 10.1016/0002-9378(91)90626-3.
- Background: PubMed 9230775Scholl TO, Hediger ML, Bendich A, Schall JI, Smith WK, Krueger PM. Use of multivitamin/mineral prenatal supplements: influence on the outcome of pregnancy. Am J Epidemiol. 1997 Jul 15;146(2):134-41. doi: 10.1093/oxfordjournals.aje.a009244.
- Background: PubMed 18996930Zeng L, Dibley MJ, Cheng Y, Dang S, Chang S, Kong L, Yan H. Impact of micronutrient supplementation during pregnancy on birth weight, duration of gestation, and perinatal mortality in rural western China: double blind cluster randomised controlled trial. BMJ. 2008 Nov 7;337:a2001. doi: 10.1136/bmj.a2001.
- Background: PubMed 12637400Christian P, Khatry SK, Katz J, Pradhan EK, LeClerq SC, Shrestha SR, Adhikari RK, Sommer A, West KP Jr. Effects of alternative maternal micronutrient supplements on low birth weight in rural Nepal: double blind randomised community trial. BMJ. 2003 Mar 15;326(7389):571. doi: 10.1136/bmj.326.7389.571.
- Background: PubMed 17157088Rao R, Georgieff MK. Iron in fetal and neonatal nutrition. Semin Fetal Neonatal Med. 2007 Feb;12(1):54-63. doi: 10.1016/j.siny.2006.10.007. Epub 2006 Dec 6.
- Background: PubMed 25103581Stevens GA, Finucane MM, De-Regil LM, Paciorek CJ, Flaxman SR, Branca F, Pena-Rosas JP, Bhutta ZA, Ezzati M; Nutrition Impact Model Study Group (Anaemia). Global, regional, and national trends in haemoglobin concentration and prevalence of total and severe anaemia in children and pregnant and non-pregnant women for 1995-2011: a systematic analysis of population-representative data. Lancet Glob Health. 2013 Jul;1(1):e16-25. doi: 10.1016/S2214-109X(13)70001-9. Epub 2013 Jun 25.
- Background: PubMed 27827838Petry N, Olofin I, Hurrell RF, Boy E, Wirth JP, Moursi M, Donahue Angel M, Rohner F. The Proportion of Anemia Associated with Iron Deficiency in Low, Medium, and High Human Development Index Countries: A Systematic Analysis of National Surveys. Nutrients. 2016 Nov 2;8(11):693. doi: 10.3390/nu8110693.
- International Food Policy Research Institute. Women's Empowerment in Agriculture Index.Link provided by the sponsor.
- Netherlands Development Organization. Introducing the Ahotor oven in the Volta region of Ghana. 2017.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone audio messaging, Peer-to-peer learning and Conditional cash transfer in people with Anemia, run by University of Michigan at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anemia over time (time frame: Change from baseline anemia status over the 9 months of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03498755, which also lists 129 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019; AzTrials last refreshed its copy on 30 Oct 2026.