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.

Autor: Palacios C; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America. Electronic address: cristina.palacios@fiu.edu., Leone J; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America., Clayton P; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America., Hernandez J; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America., Trak-Fellermeier MA; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America., Macchi A; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America., Ramirez-Roggio D; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America., Cobo Y; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America., Bautista S; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America., Connelly J; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America., Elington M; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America., Romero J; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America., Galvan R; Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2024 Dec; Vol. 147, pp. 107715. Date of Electronic Publication: 2024 Oct 15.
DOI: 10.1016/j.cct.2024.107715
Abstrakt: 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.
Competing Interests: Declaration of competing interest None.
(Copyright © 2024 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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