Evidence map›Paper›PMID 41315936›Full record

ArticleBMC medical research methodology2025

Quantitative evaluation of recruitment strategies in a cluster-randomized trial: segmented regression and cost analysis from the AOK-Family + study.

Nicola Litke, Michel Wensing, Lina Hermeling, Manuela Bombana

Abstract read
In one paragraph

Article in BMC medical research methodology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

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

4 authors.

Nicola LitkeDepartment of General Practice and Health Services Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany.
Michel WensingDepartment of General Practice and Health Services Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany.
Lina HermelingDepartment for Prevention , AOK Baden-Württemberg, Presselstraße 19, Stuttgart, 70191, Germany.
Manuela BombanaDepartment of General Practice and Health Services Research, University Hospital Heidelberg, Im Neuenheimer Feld 130.3, Heidelberg, 69120, Germany. pddr.manuela.bombana@bw.aok.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecruitment of participants for preventive health intervention studies remains a significant challenge: Approximately 19% of studies are discontinued due to insufficient participant numbers, and one in three extends its recruitment period. This study aimed to examine the impact of recruiting measures on the recruitment rate over time and to describe costs of these strategies to inform future study planning and optimize resource allocation.

methodsA cluster-randomized controlled trial ("AOK-Family+" study) was conducted from April 2023 to June 2024 in southwestern Germany. The intervention focused on reducing lifestyle-related risk factors (LRRFs) among pregnant women and women planning a pregnancy. Analog recruitment strategies included e.g., printed magazines, flyers and digital recruitment strategies included e.g. social media ads, influencer marketing. For 255 interested women, contact details, recruitment source, and participation status were documented and analyzed. A segmented linear regression analysis was used to identify turning points in application trends. Direct costs were calculated based on internal project budget tracking.

resultsThe targeted sample size was not reached despite substantial investment in recruitment measures. The highest number of applications resulted from analog strategies-especially printed AOK magazines (35.5%)-followed by influencer marketing (23.6%). The segmented linear regression analysis identified three significant increases in application rates, the first coinciding with the magazine distribution and the second with the influencer marketing on Instagram. Social media marketing showed a short-lived effect, with application rates dropping immediately after posts ended. Total costs amounted to 99.334 € equaling 389,54€ per application and 534,05€ per actually enrolled participant.

conclusionHealth magazines proved to be the most cost-efficient and sustainable recruitment strategy. Influencer marketing led to high reach and initial spikes in engagement but had limited long-term impact. While digital measures generated many clicks, only a small fraction translated into study participation-indicating a pronounced intention-behavior gap and procedural barriers in the enrolment process. For future studies, a mixed-methods recruitment strategy is recommended combining wide digital outreach with personalized, trust-based communication, ideally through healthcare professionals such as gynecologists and midwives, to reach women in early pregnancy and reduce participation barriers.

trial registrationThe German Clinical Trials Register DRKS00027804. Registered on 2022/01/12.

Indexed as

Patient SelectionRandomized Controlled Trials as TopicAdultCosts and Cost AnalysisFemaleGermanyHumansPregnancySocial MediaBehavior change interventionLifestyle-related risk factorsLinear segmented regression analysisPregnancyRecruitment

Identifiers

PMID41315936
PMCPMC12670862

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Registered trials

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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.