TY - JOUR
T1 - Describing the landscape of nutrition- and diet-related randomized controlled trials
T2 - metaresearch study of protocols published between 2012 and 2022
AU - Silva, Flávia Moraes
AU - Amorim Adegboye, Amanda Rodrigues
AU - Naude, Celeste
AU - Curioni, Cintia
AU - Gomes, Fabio S.
AU - Collins, Gary S.
AU - Kac, Gilberto
AU - Anne de Beyer, Jennifer
AU - Cook, Jonathan
AU - Ismail, Leila Cheikh
AU - Page, Matthew J.
AU - Khandpur, Neha
AU - Lamb, Sallie
AU - Hopewell, Sally
AU - Saleh, Shaima
AU - Kirtley, Shona
AU - Bernardes, Simone
AU - Durão, Solange
AU - Vorland, Colby J.
AU - Schlussel, Michael Maia
PY - 2025/1/24
Y1 - 2025/1/24
N2 - Background: Publishing protocols promotes transparency and reproducibility. The scope and methods of protocols for nutrition- and diet-related randomized controlled trials (RCTs) have not been investigated yet. Objectives: This study aims to map the landscape of nutrition- and diet-related interventions research. Methods: We conducted a metaresearch of nutrition-and diet-related RCT protocols published between January 2012 and March 2022, in any language, targeting human participants, evaluating nutrition interventions isolated or combined. A systematic search of the literature was conducted in 6 online databases. Bibliometric information, study characteristics, and research transparency practices data were collected from the included publications. The instructions for authors of journals with publications in our sample were checked for endorsement of reporting guidelines. Mentions to reporting guidelines in the included protocols were also checked. Results: Among the 62,319 records retrieved, 1068 were eligible. The number of published protocols increased annually, with a mean of 103 (range: 32–163) publications/y. Protocols were published in 148 journals, 50 of them (33.8%) endorsed Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), 111 (75.3%) Consolidated Standards of Reporting Trials (CONSORT), and 4 (2.7%) Template for Intervention Description and Replication (TIDieR), whereas 343 (32.1%) protocols mentioned SPIRIT, 297 (27.8%) CONSORT, and 20 (1.9%) TIDieR. Most protocols reported the RCT registration number (n = 1006; 94.2%) and included statements about conflicts of interest (n = 952; 89.1%) and funding (n = 994; 93.2%). About two-thirds of protocols focused on adults or elderly participants (n = 677; 63.4%). Most protocols described 1 isolated nutrition- or diet-related intervention (n = 724; 67.8%), which were most frequently “supplementation, supplements or fortification” (n = 405; 37.9%) or “nutrition education, counseling or coordination of care” (n = 354; 33.1%). The most frequent primary outcomes reported were related to clinical status (n = 308; 28.8%). Conclusions: The number of protocols for nutrition- or diet-related RCTs published is increasing, supporting the raising awareness and the importance of promoting these publications. The support and mention of relevant reporting guidelines by journals and researchers, respectively, remain far from ideal.
AB - Background: Publishing protocols promotes transparency and reproducibility. The scope and methods of protocols for nutrition- and diet-related randomized controlled trials (RCTs) have not been investigated yet. Objectives: This study aims to map the landscape of nutrition- and diet-related interventions research. Methods: We conducted a metaresearch of nutrition-and diet-related RCT protocols published between January 2012 and March 2022, in any language, targeting human participants, evaluating nutrition interventions isolated or combined. A systematic search of the literature was conducted in 6 online databases. Bibliometric information, study characteristics, and research transparency practices data were collected from the included publications. The instructions for authors of journals with publications in our sample were checked for endorsement of reporting guidelines. Mentions to reporting guidelines in the included protocols were also checked. Results: Among the 62,319 records retrieved, 1068 were eligible. The number of published protocols increased annually, with a mean of 103 (range: 32–163) publications/y. Protocols were published in 148 journals, 50 of them (33.8%) endorsed Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), 111 (75.3%) Consolidated Standards of Reporting Trials (CONSORT), and 4 (2.7%) Template for Intervention Description and Replication (TIDieR), whereas 343 (32.1%) protocols mentioned SPIRIT, 297 (27.8%) CONSORT, and 20 (1.9%) TIDieR. Most protocols reported the RCT registration number (n = 1006; 94.2%) and included statements about conflicts of interest (n = 952; 89.1%) and funding (n = 994; 93.2%). About two-thirds of protocols focused on adults or elderly participants (n = 677; 63.4%). Most protocols described 1 isolated nutrition- or diet-related intervention (n = 724; 67.8%), which were most frequently “supplementation, supplements or fortification” (n = 405; 37.9%) or “nutrition education, counseling or coordination of care” (n = 354; 33.1%). The most frequent primary outcomes reported were related to clinical status (n = 308; 28.8%). Conclusions: The number of protocols for nutrition- or diet-related RCTs published is increasing, supporting the raising awareness and the importance of promoting these publications. The support and mention of relevant reporting guidelines by journals and researchers, respectively, remain far from ideal.
KW - interventions
KW - metaresearch
KW - nutrition
KW - protocols
KW - randomized controlled trial
KW - reporting guidelines
KW - research transparency
U2 - 10.1016/j.ajcnut.2025.01.016
DO - 10.1016/j.ajcnut.2025.01.016
M3 - Article
C2 - 39864593
AN - SCOPUS:85217779332
SN - 0002-9165
JO - American Journal of Clinical Nutrition
JF - American Journal of Clinical Nutrition
ER -