NDLI: Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions

Content Provider	Springer Nature : BioMed Central
Author	von Klinggraeff, L. Dugger, R. Okely, A. D. Lubans, D. Jago, R. Burkart, S. Weaver, R. G. Armstrong, B. Pfledderer, C. D. Beets, M. W.
Abstract	Background Pilot/feasibility studies play an important role in the development and refinement of behavioral interventions by providing information about feasibility, acceptability, and potential efficacy. Despite their importance and wide-spread use, the approaches taken by behavioral scientists to scale-up early-stage studies to larger-scale trials has received little attention. The aim of our study was to understand the role that pilot studies play in the development and execution of larger-scale trials. Methods We conducted interviews with childhood obesity researchers who had published pilot behavioral interventions and larger-scale trials of the same or similar interventions. Questions were asked about the role of pilot studies in developing larger-scale trials and the challenges encountered when scaling-up an intervention based upon pilot findings. Data were coded and analyzed using an inductive analytic approach to identify themes. Results Twenty-four interventionists (54% women, 37–70 years old, mean 20 years since terminal degree) completed a total of 148 pilot studies across their careers (mean 6.4, range 1–20), of which 59% were scaled-up. Scaling was described as resource intensive and pilot work was considered essential to successfully competing for funding by 63% of the sample (n = 15). When asked to define a high-quality pilot study, interventionists described studies that allowed them to evaluate two independent factors: components of their intervention (e.g., acceptability, feasibility) and study parameters (e.g., sample size, measures). Interventionists expressed that more process implementation measures, different study designs, and additional iterations could improve decisions to scale-up. Most agreed that pilot studies were likely to produce inflated estimates of potential efficacy though only nine interventionists provided potential solutions for decreasing inflated measures of efficacy. Suggested major causes of inflated effects included high levels of oversight in pilot studies (e.g., researcher support), reliance on subjective measures, and utilizing convenience or highly motivated samples. Potential solutions included designing pilots for real-world implementation, only conducting randomized controlled pilot studies, and pre-registering pilot studies. Conclusions Pilot studies purposes are multifaceted and deemed essential to obtaining funding for larger-scale trials. Clarifying the form and function of preliminary, early-stage research may enhance the productive utilization of early-stage studies and reduced drops in efficacy when transitioning to larger scale studies.
Related Links	https://pilotfeasibilitystudies.biomedcentral.com/counter/pdf/10.1186/s40814-022-00991-8.pdf
Ending Page	13
Page Count	13
Starting Page	1
File Format	HTM / HTML
ISSN	20555784
DOI	10.1186/s40814-022-00991-8
Journal	Pilot and Feasibility Studies
Issue Number	1
Volume Number	8
Language	English
Publisher	BioMed Central
Publisher Date	2022-02-07
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Childhood obesity Scalability Intervention Translation Pilot Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Medicine
Journal Impact Factor	1.5/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Correction to: Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions

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Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions

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Correction to: Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions

Small studies, big decisions: the role of pilot/feasibility studies in incremental science and premature scale-up of behavioral interventions

Applying mixed methods to pilot feasibility studies to inform intervention trials

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Early-stage studies to larger-scale trials: investigators’ perspectives on scaling-up childhood obesity interventions