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

Overview

Journal Contemp Clin Trials

Publisher Elsevier

Date 2024 Oct 16

PMID 39413989

Authors

Cristina Palacios

Julia Leone

Priscilla Clayton

Jacqueline Hernandez

Maria Angelica Trak-Fellermeier

Alison Macchi

Daniela Ramirez-Roggio

Yivani Cobo

Shanelle Bautista

Jeneene Connelly

Malik Elington

Jorge Romero

Rodolfo Galvan

Affiliations

Soon will be listed here.

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.

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