Credibility at stake: only two-thirds of randomized trials of nutrition interventions are registered and lack transparency in outcome and treatment effect definitions

Mello, Arthur Thives; Kammer, Pedro Vitali; Nascimento, Giovanna M; Lima, Luana Pucci de; Pessini, Júlia; Valmorbida, Aline; Page, Matthew J.; Trindade, Erasmo B. S. M.

doi:10.1016/j.jclinepi.2023.06.021

Cited by 2 publications

(1 citation statement)

References 33 publications

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“…The perspectives offered herein provide some evidence for the desirability, timeliness of a nutrition extension to the existing CONSORT guidelines, and the general acceptability of such guidelines by the nutrition community and respective journal editors. We recognize that many of the deficiencies we identified are not unique to nutrition trials, but a recent review of nutrition trials illustrates the extent of compliance with current CONSORT guidelines [ 38 ]. Of 400 trials reviewed, only 69% were registered and many of these lacked sufficient details of outcomes and treatment effects and information to inform risk of bias assessment, Protocols were available in only 14% of the trials and statistical analysis plans in 3%.…”

Section: Conclusion and Inviting Further Inputmentioning

confidence: 99%

Perspective: Peer Evaluation of Recommendations for CONSORT Guidelines for Randomized Controlled Trials in Nutrition

Weaver,

Ahles,

Murphy

et al. 2024

Advances in Nutrition

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Section: Conclusion and Inviting Further Inputmentioning

confidence: 99%

Perspective: Peer Evaluation of Recommendations for CONSORT Guidelines for Randomized Controlled Trials in Nutrition

Weaver,

Ahles,

Murphy

et al. 2024

Advances in Nutrition

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Exploring how researchers consider nutrition trial design and participant adherence: a theory-based analysis

Worthington,

Coffey,

Gillies

et al. 2024

Front. Nutr.

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IntroductionNutrition trials are important for informing dietary and clinical guidelines. Central to the success of these trials is participant adherence to dietary behaviors. However, trials commonly experience poor adherence. This study seeks to understand if and how researchers consider supporting participant adherence to dietary behaviors and their relationship to using behavior change science when designing trials.MethodsA mapping exercise was undertaken to create matrices that describe the landscape of current nutrition trials. A total of 12 researchers participated in semi-structured, one-on-one interviews. Transcripts were analyzed using (i) the theoretical domains framework (TDF) to identify themes in current practice and beliefs, and (ii) the capability, opportunity, motivation, and behavior model to identify barriers and enablers to using behavior change science in the design of nutrition trials.ResultsTwenty-two belief statements were identified across all 14 TDF domains and were conceptualized as 5 key themes with respect to designing nutrition trials to improve participant adherence: (i) what was done, (ii) how it was done, (iii) why it was done, (iv) adherence challenges, and (v) conflicting beliefs. Regarding using behavior change science when designing trials, some researchers felt this would be beneficial but lacked the knowledge and skills to do so, while others were skeptical of its value over the current experience-based practice.DiscussionResearchers are motivated to encourage participant adherence to dietary behaviors, and, consciously and subconsciously, implement a range of strategies through non-systematic methods in their trials. Future publications would benefit from the explicit documentation of levels of adherence to dietary behaviors and strategies implemented to improve adherence.

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Credibility at stake: only two-thirds of randomized trials of nutrition interventions are registered and lack transparency in outcome and treatment effect definitions

Cited by 2 publications

References 33 publications

Perspective: Peer Evaluation of Recommendations for CONSORT Guidelines for Randomized Controlled Trials in Nutrition

Perspective: Peer Evaluation of Recommendations for CONSORT Guidelines for Randomized Controlled Trials in Nutrition

Exploring how researchers consider nutrition trial design and participant adherence: a theory-based analysis

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