Evidence map›Paper›PMID 39413989›Full record

ArticleContemporary clinical trials2024

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.

Cristina Palacios, Julia Leone, Priscilla Clayton, Jacqueline Hernandez, María Angélica Trak-Fellermeier, Alison Macchi, Daniela Ramirez-Roggio, Yivani Cobo, Shanelle Bautista, Jeneene Connelly and 3 more

Registry-linked trialAbstract read
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02916862 (Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02916862 phase2completednot on this map

Effect of Soluble Corn Fiber Supplementation for 1 Year on Bone Metabolism in Adolescents

TypeinterventionalSponsorFlorida International UniversityRan2020 to 2025Enrolled177ConditionsOsteoporosisArmsSoluble Corn Fiber (SCF) without Calcium, Soluble Corn Fiber (SCF) + Calcium, Placebo, Placebo + calcium
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Cristina PalaciosDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America. Electronic address: cristina.palacios@fiu.edu.
Julia LeoneDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.
Priscilla ClaytonDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.
Jacqueline HernandezDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.
María Angélica Trak-FellermeierDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.
Alison MacchiDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.
Daniela Ramirez-RoggioDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.
Yivani CoboDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.
Shanelle BautistaDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.
Jeneene ConnellyDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.
Malik ElingtonDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.
Jorge RomeroDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.
Rodolfo GalvanDietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, United States of America.

Funding

Effect of Soluble Corn Fiber supplementation for 1 year on bone metabolism in adolescents (MetA-Bone Trial)R01HD098589 · NICHD · FLORIDA INTERNATIONAL UNIVERSITY · PI PALACIOS, CRISTINA · 2019 to 2023
$3.2M
NICHD NIH HHS R01 HD098589
6 · The paper itself

Abstract

backgroundPediatric 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.

methodsThe 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.

results649 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.

Indexed as

Dietary FiberPatient SelectionZea maysAdolescentBone DensityChildDietary SupplementsFemaleHumansMaleRandomized Controlled Trials as TopicDietary FiberBoneChildrenfiberInterventionNutritionRecruitment

Identifiers

PMID39413989
PMCPMC11620906

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.