Effectiveness and costs of the recruitment strategies used in the MetA-Bone trial, a randomized clinical trial to test the effects of soluble corn fiber supplementation for 1 year in children
Background: Pediatric recruitment into clinical trials is very challenging. A recruitment plan was designed to recruit healthy children (9–14 years) in a trial testing the 1-year effect of corn soluble fiber supplementation on bone mass. We evaluated the effectiveness and costs of the recruitment st...
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| Veröffentlicht in: | Contemporary clinical trials 2024-12, Vol.147, p.107715, Article 107715 |
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| creator | Palacios, Cristina Leone, Julia Clayton, Priscilla Hernandez, Jacqueline Trak-Fellermeier, María Angélica Macchi, Alison Ramirez-Roggio, Daniela Cobo, Yivani Bautista, Shanelle Connelly, Jeneene Elington, Malik Romero, Jorge Galvan, Rodolfo |
| description | Background: Pediatric recruitment into clinical trials is very challenging. A recruitment plan was designed to recruit healthy children (9–14 years) in a trial testing the 1-year effect of corn soluble fiber supplementation on bone mass. We evaluated the effectiveness and costs of the recruitment strategies used in this trial. Methods: The recruitment plan included “Traditional” (mailings, flyers, posters, visits, snowball, etc.) or “Online” (email campaigns, social media, website, etc.) strategies. All strategies led to the pre-screening online form, which asked how they learned about the study. This analysis includes the number of pre-screenings and enrollment (consents signed), ineligibility, socio-demographics, and costs per strategy. Differences were analyzed using ANOVA or chi-square. Results: 649 individuals completed the pre-screening; 37.1 % came from “Traditional”, 46.7 % from “Online”, 2.6 % from “Other”, and 13.6 % from “Unknown” strategies. The most successful strategies were related to Florida International University (posting flyers around campus and email campaigns). The main reasons for ineligibility were obesity (38.9 %) or outside the age range (22.7 %). A total of 48.4 % of the children enrolled came from “Traditional”, 50.2 % from “Online”, and 1.4 % from “Other” strategies. The cost per screened participant was $1112 for “Traditional” and $512 for “Online” strategies, and the cost per enrolled participant was $2704 for “Traditional” and $1454 for “Online” strategies. The highest costs were staff salary. Conclusion: “Online” strategies were more effective and had a lower implementation cost than “Traditional” strategies, although these were also important in achieving the recruitment goal. Future pediatric trials should consider some of these strategies and their costs.
ClinicalTrials.gov registry number: NCT02916862 |
| doi_str_mv | 10.1016/j.cct.2024.107715 |
| format | Article |
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ClinicalTrials.gov registry number: NCT02916862</description><identifier>ISSN: 1551-7144</identifier><identifier>ISSN: 1559-2030</identifier><identifier>EISSN: 1559-2030</identifier><identifier>DOI: 10.1016/j.cct.2024.107715</identifier><identifier>PMID: 39413989</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Bone ; Bone Density ; Child ; Children ; Dietary Fiber - administration & dosage ; Dietary Fiber - economics ; Dietary Supplements - economics ; Female ; fiber ; Humans ; Intervention ; Male ; Nutrition ; Patient Selection ; Randomized Controlled Trials as Topic ; Recruitment ; Zea mays</subject><ispartof>Contemporary clinical trials, 2024-12, Vol.147, p.107715, Article 107715</ispartof><rights>2024 Elsevier Inc.</rights><rights>Copyright © 2024 Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c235t-da4123bd0be9708a60af7cef0b0f4924549f0a5a5b5623bd5e5c5ed2c8af17d23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1551714424002982$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39413989$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Palacios, Cristina</creatorcontrib><creatorcontrib>Leone, Julia</creatorcontrib><creatorcontrib>Clayton, Priscilla</creatorcontrib><creatorcontrib>Hernandez, Jacqueline</creatorcontrib><creatorcontrib>Trak-Fellermeier, María Angélica</creatorcontrib><creatorcontrib>Macchi, Alison</creatorcontrib><creatorcontrib>Ramirez-Roggio, Daniela</creatorcontrib><creatorcontrib>Cobo, Yivani</creatorcontrib><creatorcontrib>Bautista, Shanelle</creatorcontrib><creatorcontrib>Connelly, Jeneene</creatorcontrib><creatorcontrib>Elington, Malik</creatorcontrib><creatorcontrib>Romero, Jorge</creatorcontrib><creatorcontrib>Galvan, Rodolfo</creatorcontrib><title>Effectiveness and costs of the recruitment strategies used in the MetA-Bone trial, a randomized clinical trial to test the effects of soluble corn fiber supplementation for 1 year in children</title><title>Contemporary clinical trials</title><addtitle>Contemp Clin Trials</addtitle><description>Background: Pediatric recruitment into clinical trials is very challenging. A recruitment plan was designed to recruit healthy children (9–14 years) in a trial testing the 1-year effect of corn soluble fiber supplementation on bone mass. We evaluated the effectiveness and costs of the recruitment strategies used in this trial. Methods: The recruitment plan included “Traditional” (mailings, flyers, posters, visits, snowball, etc.) or “Online” (email campaigns, social media, website, etc.) strategies. All strategies led to the pre-screening online form, which asked how they learned about the study. This analysis includes the number of pre-screenings and enrollment (consents signed), ineligibility, socio-demographics, and costs per strategy. Differences were analyzed using ANOVA or chi-square. Results: 649 individuals completed the pre-screening; 37.1 % came from “Traditional”, 46.7 % from “Online”, 2.6 % from “Other”, and 13.6 % from “Unknown” strategies. The most successful strategies were related to Florida International University (posting flyers around campus and email campaigns). The main reasons for ineligibility were obesity (38.9 %) or outside the age range (22.7 %). A total of 48.4 % of the children enrolled came from “Traditional”, 50.2 % from “Online”, and 1.4 % from “Other” strategies. The cost per screened participant was $1112 for “Traditional” and $512 for “Online” strategies, and the cost per enrolled participant was $2704 for “Traditional” and $1454 for “Online” strategies. The highest costs were staff salary. Conclusion: “Online” strategies were more effective and had a lower implementation cost than “Traditional” strategies, although these were also important in achieving the recruitment goal. Future pediatric trials should consider some of these strategies and their costs.
ClinicalTrials.gov registry number: NCT02916862</description><subject>Adolescent</subject><subject>Bone</subject><subject>Bone Density</subject><subject>Child</subject><subject>Children</subject><subject>Dietary Fiber - administration & dosage</subject><subject>Dietary Fiber - economics</subject><subject>Dietary Supplements - economics</subject><subject>Female</subject><subject>fiber</subject><subject>Humans</subject><subject>Intervention</subject><subject>Male</subject><subject>Nutrition</subject><subject>Patient Selection</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Recruitment</subject><subject>Zea mays</subject><issn>1551-7144</issn><issn>1559-2030</issn><issn>1559-2030</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kcFuFSEYhYnR2Fp9ADeGpQvnCgPM3Imr2rRqUuNG14SBH8sNA1dgmtSn8VGMT1Zmprp0Bfx855z8OQi9pGRHCe3eHnZal11LWl7ffU_FI3RKhRialjDyeL3Tpqecn6BnOR8IYZ3oxFN0wgZO2bAfTtHvS2tBF3cLAXLGKhisYy4ZR4vLDeAEOs2uTBAKziWpAt8dZDxnMNiFFfkM5bx5HwPgkpzyb7DCqfrEyf2skPYuOK389olLxAVyWYWwRq9ROfp59FCzU8DWjZBwno9HD0uwKi7WaUyY_vl1ByotyfrGeZMgPEdPrPIZXjycZ-jb1eXXi4_N9ZcPny7OrxvdMlEaozht2WjICENP9qojyvYaLBmJ5UPLBR8sUUKJUXQLJ0BoAabVe2Vpb1p2hl5vvscUf8x1BTm5rMF7FSDOWTJK-452nLOK0g3VKeacwMpjcpNKd5ISuRQnD7IWJ5fi5FZc1bx6sJ_HCcw_xd-mKvBuA6AueesgyawdBA3G1Y6KNNH9x_4eP8Kt4g</recordid><startdate>202412</startdate><enddate>202412</enddate><creator>Palacios, Cristina</creator><creator>Leone, Julia</creator><creator>Clayton, Priscilla</creator><creator>Hernandez, Jacqueline</creator><creator>Trak-Fellermeier, María Angélica</creator><creator>Macchi, Alison</creator><creator>Ramirez-Roggio, Daniela</creator><creator>Cobo, Yivani</creator><creator>Bautista, Shanelle</creator><creator>Connelly, Jeneene</creator><creator>Elington, Malik</creator><creator>Romero, Jorge</creator><creator>Galvan, Rodolfo</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202412</creationdate><title>Effectiveness and costs of the recruitment strategies used in the MetA-Bone trial, a randomized clinical trial to test the effects of soluble corn fiber supplementation for 1 year in children</title><author>Palacios, Cristina ; Leone, Julia ; Clayton, Priscilla ; Hernandez, Jacqueline ; Trak-Fellermeier, María Angélica ; Macchi, Alison ; Ramirez-Roggio, Daniela ; Cobo, Yivani ; Bautista, Shanelle ; Connelly, Jeneene ; Elington, Malik ; Romero, Jorge ; Galvan, Rodolfo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c235t-da4123bd0be9708a60af7cef0b0f4924549f0a5a5b5623bd5e5c5ed2c8af17d23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adolescent</topic><topic>Bone</topic><topic>Bone Density</topic><topic>Child</topic><topic>Children</topic><topic>Dietary Fiber - administration & dosage</topic><topic>Dietary Fiber - economics</topic><topic>Dietary Supplements - economics</topic><topic>Female</topic><topic>fiber</topic><topic>Humans</topic><topic>Intervention</topic><topic>Male</topic><topic>Nutrition</topic><topic>Patient Selection</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Recruitment</topic><topic>Zea mays</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Palacios, Cristina</creatorcontrib><creatorcontrib>Leone, Julia</creatorcontrib><creatorcontrib>Clayton, Priscilla</creatorcontrib><creatorcontrib>Hernandez, Jacqueline</creatorcontrib><creatorcontrib>Trak-Fellermeier, María Angélica</creatorcontrib><creatorcontrib>Macchi, Alison</creatorcontrib><creatorcontrib>Ramirez-Roggio, Daniela</creatorcontrib><creatorcontrib>Cobo, Yivani</creatorcontrib><creatorcontrib>Bautista, Shanelle</creatorcontrib><creatorcontrib>Connelly, Jeneene</creatorcontrib><creatorcontrib>Elington, Malik</creatorcontrib><creatorcontrib>Romero, Jorge</creatorcontrib><creatorcontrib>Galvan, Rodolfo</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Contemporary clinical trials</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Palacios, Cristina</au><au>Leone, Julia</au><au>Clayton, Priscilla</au><au>Hernandez, Jacqueline</au><au>Trak-Fellermeier, María Angélica</au><au>Macchi, Alison</au><au>Ramirez-Roggio, Daniela</au><au>Cobo, Yivani</au><au>Bautista, Shanelle</au><au>Connelly, Jeneene</au><au>Elington, Malik</au><au>Romero, Jorge</au><au>Galvan, Rodolfo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effectiveness and costs of the recruitment strategies used in the MetA-Bone trial, a randomized clinical trial to test the effects of soluble corn fiber supplementation for 1 year in children</atitle><jtitle>Contemporary clinical trials</jtitle><addtitle>Contemp Clin Trials</addtitle><date>2024-12</date><risdate>2024</risdate><volume>147</volume><spage>107715</spage><pages>107715-</pages><artnum>107715</artnum><issn>1551-7144</issn><issn>1559-2030</issn><eissn>1559-2030</eissn><abstract>Background: Pediatric recruitment into clinical trials is very challenging. A recruitment plan was designed to recruit healthy children (9–14 years) in a trial testing the 1-year effect of corn soluble fiber supplementation on bone mass. We evaluated the effectiveness and costs of the recruitment strategies used in this trial. Methods: The recruitment plan included “Traditional” (mailings, flyers, posters, visits, snowball, etc.) or “Online” (email campaigns, social media, website, etc.) strategies. All strategies led to the pre-screening online form, which asked how they learned about the study. This analysis includes the number of pre-screenings and enrollment (consents signed), ineligibility, socio-demographics, and costs per strategy. Differences were analyzed using ANOVA or chi-square. Results: 649 individuals completed the pre-screening; 37.1 % came from “Traditional”, 46.7 % from “Online”, 2.6 % from “Other”, and 13.6 % from “Unknown” strategies. The most successful strategies were related to Florida International University (posting flyers around campus and email campaigns). The main reasons for ineligibility were obesity (38.9 %) or outside the age range (22.7 %). A total of 48.4 % of the children enrolled came from “Traditional”, 50.2 % from “Online”, and 1.4 % from “Other” strategies. The cost per screened participant was $1112 for “Traditional” and $512 for “Online” strategies, and the cost per enrolled participant was $2704 for “Traditional” and $1454 for “Online” strategies. The highest costs were staff salary. Conclusion: “Online” strategies were more effective and had a lower implementation cost than “Traditional” strategies, although these were also important in achieving the recruitment goal. Future pediatric trials should consider some of these strategies and their costs.
ClinicalTrials.gov registry number: NCT02916862</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>39413989</pmid><doi>10.1016/j.cct.2024.107715</doi></addata></record> |
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| ispartof | Contemporary clinical trials, 2024-12, Vol.147, p.107715, Article 107715 |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adolescent Bone Bone Density Child Children Dietary Fiber - administration & dosage Dietary Fiber - economics Dietary Supplements - economics Female fiber Humans Intervention Male Nutrition Patient Selection Randomized Controlled Trials as Topic Recruitment Zea mays |
| title | Effectiveness and costs of the recruitment strategies used in the MetA-Bone trial, a randomized clinical trial to test the effects of soluble corn fiber supplementation for 1 year in children |
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