{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T17:31:30Z","timestamp":1787160690085,"version":"build-2736575974"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,7,7]],"date-time":"2021-07-07T00:00:00Z","timestamp":1625616000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,7,7]],"date-time":"2021-07-07T00:00:00Z","timestamp":1625616000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill & Melinda Gates Foundation","doi-asserted-by":"publisher","award":["INV 009129"],"award-info":[{"award-number":["INV 009129"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pilot Feasibility Stud"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>This study reports findings from formative research conducted to assess the feasibility and inform the design and implementation of the Addressing Hidden Hunger with Agronomy (AHHA) trial. The AHHA trial was a randomised, controlled trial conducted in rural Malawi, in which participants were given maize flour biofortified with selenium or control flour not biofortified with selenium for a period of 10 weeks, after which blood samples were taken to measure selenium status.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Formative research was conducted in villages near to the AHHA trial study site 1 year before the planned intervention. A short questionnaire with adult women (n = 50), focus group discussions with male (n groups = 3) and female (n groups = 3) community members, and in-depth key informant interviews (n = 7) were conducted to understand community practices and perceptions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Findings<\/jats:title>\n                    <jats:p>Meals were typically cooked and eaten at home in this community, while participants reported that maize flour would be less readily sold than maize grain \u2013 important considerations for the design of the trial. Regarding intervention delivery, we identified potential concerns around effects on fertility, links between blood sampling and witchcraft, and the potential for social stigma if community members considered participants lazy for receiving free flour. Participants reported that involvement of the Malawi government partners including health extension workers would increase trust.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interpretation<\/jats:title>\n                    <jats:p>Following the formative research, the AHHA trial appeared feasible. However, community sensitisation would be essential to address potential fears and concerns; effective sensitisation would support recruitment and treatment adherence, and would protect the safety and wellbeing of participants and researchers. People in positions of authority and trust including village headmen, religious leaders, health and agriculture extension workers, and community care groups should be involved in community sensitisation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s40814-021-00877-1","type":"journal-article","created":{"date-parts":[[2021,7,7]],"date-time":"2021-07-07T05:19:55Z","timestamp":1625635195000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Preparing for a community-based agriculture-to-nutrition trial in rural Malawi: formative research to assess feasibility and inform design and implementation decisions"],"prefix":"10.1186","volume":"7","author":[{"given":"Gabriella","family":"Chiutsi-Phiri","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander A.","family":"Kalimbira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonard","family":"Banda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patson C.","family":"Nalivata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marion","family":"Sanuka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zione","family":"Kalumikiza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Limbanazo","family":"Matandika","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Mfutso-Bengo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Allen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elaine","family":"Ferguson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna","family":"Sturgess","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin R.","family":"Broadley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Langley-Evans","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate","family":"Millar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dawd","family":"Gashu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0106-866X","authenticated-orcid":false,"given":"Edward J. M.","family":"Joy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,7,7]]},"reference":[{"issue":"1","key":"877_CR1","doi-asserted-by":"publisher","first-page":"54","DOI":"10.1111\/nyas.12290","volume":"1308","author":"ME Bentley","year":"2014","unstructured":"Bentley ME, Johnson SL, Wasser H, Creed-Kanashiro H, Shroff M, Fernandez Rao S, et al. Formative research methods for designing culturally appropriate, integrated child nutrition and development interventions: an overview. Ann N Y Acad Sci. 2014;1308(1):54\u201367. https:\/\/doi.org\/10.1111\/nyas.12290.","journal-title":"Ann N Y Acad Sci"},{"key":"877_CR2","doi-asserted-by":"crossref","unstructured":"Brunette W, Sudar S, Sundt M, Larson C, Beorse J, Anderson R. Open Data Kit 2.0: a services-based application framework for disconnected data management. In: Proceedings of the 15th Annual International Conference on Mobile Systems, Applications, and Services June: ACM; 2017. p. 440\u201352.","DOI":"10.1145\/3081333.3081365"},{"issue":"125","key":"877_CR3","doi-asserted-by":"publisher","first-page":"118","DOI":"10.1016\/j.fcr.2011.08.014","volume":"18","author":"ADC Chilimba","year":"2012","unstructured":"Chilimba ADC, Young SD, Black CR, Meacham MC, Lammel J, Broadley MR. Agronomic biofortification of maize with selenium (Se) in Malawi. Field Crop Res. 2012;18(125):118\u201328.","journal-title":"Field Crop Res"},{"key":"877_CR4","unstructured":"Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions. The Medical Research Council. https:\/\/mrc.ukri.org\/documents\/pdf\/complex-interventions-guidance\/. Accessed July 2019."},{"issue":"7","key":"877_CR5","doi-asserted-by":"publisher","first-page":"1337","DOI":"10.1089\/ars.2010.3275","volume":"14","author":"SJ Fairweather-Tait","year":"2011","unstructured":"Fairweather-Tait SJ, Bao Y, Broadley MR, Collings R, Ford D, Hesketh JE, et al. Selenium in human health and disease. Antioxid Redox Signal. 2011;14(7):1337\u201383. https:\/\/doi.org\/10.1089\/ars.2010.3275.","journal-title":"Antioxid Redox Signal"},{"key":"877_CR6","doi-asserted-by":"crossref","unstructured":"Garcia-Casal MN, Pe\u00f1a-Rosas JP, Pach\u00f3n H, De-Regil LM, Tablante EC, Flores-Urrutia MC. Staple crops biofortified with increased micronutrient content: effects on vitamin and mineral status, as well as health and cognitive function in the general population. Cochrane Database Syst Rev. 2016;8.","DOI":"10.1002\/14651858.CD012311"},{"issue":"1","key":"877_CR7","doi-asserted-by":"publisher","first-page":"38","DOI":"10.1186\/s12937-016-0155-z","volume":"15","author":"D Gashu","year":"2015","unstructured":"Gashu D, Stoecker BJ, Bougma K, Adish A, Haki GD, Marquis GS. Stunting, selenium deficiency and anemia are associated with poor cognitive performance in preschool children from rural Ethiopia. Nutr J. 2015;15(1):38. https:\/\/doi.org\/10.1186\/s12937-016-0155-z.","journal-title":"Nutr J"},{"issue":"9","key":"877_CR8","doi-asserted-by":"publisher","first-page":"788","DOI":"10.1136\/jech.2003.014415","volume":"58","author":"P Hawe","year":"2004","unstructured":"Hawe P, Shiell A, Riley T, Gold L. Methods for exploring intervention variation and local context within a cluster randomised community intervention trial. J Epidemiol Commun H. 2004;58(9):788\u201393. https:\/\/doi.org\/10.1136\/jech.2003.014415.","journal-title":"J Epidemiol Commun H"},{"key":"877_CR9","volume-title":"Panel on Dietary Antioxidants and Related Compounds. Dietary reference intakes for vitamin C, vitamin E, selenium, and carotenoids","author":"Institute of Medicine (US)","year":"2000","unstructured":"Institute of Medicine (US). Panel on Dietary Antioxidants and Related Compounds. Dietary reference intakes for vitamin C, vitamin E, selenium, and carotenoids. Washington (DC): National Academies Press (US); 2000."},{"issue":"1","key":"877_CR10","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s13063-019-3894-2","volume":"20","author":"EJM Joy","year":"2019","unstructured":"Joy EJM, Kalimbira AA, Gashu D, Ferguson EL, Sturgess J, Dangour AD, et al. Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial. Trials. 2019;20(1):1\u20139.","journal-title":"Trials."},{"issue":"1","key":"877_CR11","doi-asserted-by":"publisher","first-page":"42","DOI":"10.1186\/s40795-015-0036-4","volume":"1","author":"EJM Joy","year":"2015","unstructured":"Joy EJM, Kumssa DB, Broadley MR, Watts MJ, Young SD, Chilimba ADC, et al. Dietary mineral supplies in Malawi: spatial and socioeconomic assessment. BMC Nutr. 2015;1(1):42. https:\/\/doi.org\/10.1186\/s40795-015-0036-4.","journal-title":"BMC Nutr"},{"issue":"1","key":"877_CR12","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s40814-020-00664-4","volume":"6","author":"U Mahboob","year":"2020","unstructured":"Mahboob U, Ohly H, EJM J, Moran V, Zaman M, Lowe NM. Exploring community perceptions in preparation for a randomised controlled trial of biofortified flour in Pakistan. Pilot and Feasibility Studies. 2020;6(1):1.","journal-title":"Pilot and Feasibility Studies"},{"issue":"4","key":"877_CR13","first-page":"96","volume":"25","author":"L Manda-Taylor","year":"2013","unstructured":"Manda-Taylor L. Establishing community advisory boards for clinical trial research in Malawi: engendering ethical conduct in research. Malawi Med J. 2013;25(4):96\u2013100.","journal-title":"Malawi Med J"},{"key":"877_CR14","first-page":"1(1)","volume":"2015","author":"A O\u2019Cathain","year":"2015","unstructured":"O\u2019Cathain A, Hoddinott P, Lewin S, Thomas KJ, Young B, Adamson J, et al. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers. 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New Phytol. 2009;182(1):49\u201384. https:\/\/doi.org\/10.1111\/j.1469-8137.2008.02738.x.","journal-title":"New Phytol"},{"key":"877_CR17","volume-title":"Vitamin and mineral requirements in human nutrition","author":"World Health Organization\/Food and Agricultural Organization of the United Nations","year":"2004","unstructured":"World Health Organization\/Food and Agricultural Organization of the United Nations. Vitamin and mineral requirements in human nutrition. 2nd ed. Geneva, Switzerland: World Health Organization; 2004.","edition":"2"}],"container-title":["Pilot and Feasibility Studies"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s40814-021-00877-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s40814-021-00877-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s40814-021-00877-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,7,7]],"date-time":"2021-07-07T05:21:46Z","timestamp":1625635306000},"score":1,"resource":{"primary":{"URL":"https:\/\/pilotfeasibilitystudies.biomedcentral.com\/articles\/10.1186\/s40814-021-00877-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,7,7]]},"references-count":17,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["877"],"URL":"https:\/\/doi.org\/10.1186\/s40814-021-00877-1","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-407197\/v1","asserted-by":"object"}]},"ISSN":["2055-5784"],"issn-type":[{"value":"2055-5784","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,7,7]]},"assertion":[{"value":"13 March 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 June 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 July 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Written informed consent was obtained from all participants prior to recruitment. Ethical approval for this study was approved by research ethics committees at the College of Medicine, University of Malawi (reference P.05\/18\/2393) and the London School of Hygiene & Tropical Medicine, United Kingdom (reference 15730).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"141"}}