Randomised controlled trials – the gold standard for effectiveness research

Hariton, Eduardo; Locascio, Joseph J.

doi:10.1111/1471-0528.15199

Cited by 862 publications

(648 citation statements)

References 2 publications

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“…Despite several limitations of the study there are many strengths to be considered in the design and methods used. Firstly, randomized controlled trials are considered to be the gold standard in human research investigating relationships between an intervention and outcome [70]. Secondly, the food packs provided to the IER group were fortified eliminating the risk of confounding effects of reduced micronutrient intake during fasting.…”

Section: Discussionmentioning

confidence: 99%

Energy Restriction Enhances Adult Hippocampal Neurogenesis-Associated Memory after Four Weeks in an Adult Human Population with Central Obesity; a Randomized Controlled Trial

et al. 2020

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Adult neurogenesis, the generation of new neurons throughout life, occurs in the subventricular zone of the dentate gyrus in the human hippocampal formation. It has been shown in rodents that adult hippocampal neurogenesis is needed for pattern separation, the ability to differentially encode small changes derived from similar inputs, and recognition memory, as well as the ability to recognize previously encountered stimuli. Improved hippocampus-dependent cognition and cellular readouts of adult hippocampal neurogenesis have been reported in daily energy restricted and intermittent fasting adult mice. Evidence that nutrition can significantly affect brain structure and function is increasing substantially. This randomized intervention study investigated the effects of intermittent and continuous energy restriction on human hippocampal neurogenesis-related cognition, which has not been reported previously. Pattern separation and recognition memory were measured in 43 individuals with central obesity aged 35–75 years, before and after a four-week dietary intervention using the mnemonic similarity task. Both groups significantly improved pattern separation (P = 0.0005), but only the intermittent energy restriction group had a significant deterioration in recognition memory. There were no significant differences in cognitive improvement between the two diets. This is the first human study to investigate the association between energy restriction with neurogenesis-associated cognitive function. Energy restriction may enhance hippocampus-dependent memory and could benefit those in an ageing population with declining cognition. This study was registered on ClinicalTrials.gov (NCT02679989) on 11 February 2016.

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Section: Discussionmentioning

confidence: 99%

Energy Restriction Enhances Adult Hippocampal Neurogenesis-Associated Memory after Four Weeks in an Adult Human Population with Central Obesity; a Randomized Controlled Trial

et al. 2020

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“…Studies that employed a randomized design (within or between subjects) were included, thereby excluding natural experiments, observational studies, or pre-post evaluations. We included only randomized experiments because they are the gold standard for demonstrating the causal impact of new interventions [56], including warning labels.…”

Section: Search Strategymentioning

confidence: 99%

Experimental Studies of Front-of-Package Nutrient Warning Labels on Sugar-Sweetened Beverages and Ultra-Processed Foods: A Scoping Review

et al. 2020

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Policies that require front-of-package (FoP) nutrient warnings are becoming increasingly common across the globe as a strategy to discourage excess consumption of sugary drinks and ultra-processed food. However, a better understanding of the pathway through which FoP nutrient warnings work, as well as a review of how outcomes being measured in recent studies map onto this pathway, are needed in order to inform policy on the most effective FoP label design for reducing purchases of ultra-processed foods. This scoping review describes a conceptual model for how FoP nutrient warnings affect consumer behavior, examines which of these outcomes are currently being measured, and summarizes evidence from randomized controlled experiments. Twenty-two studies which experimentally tested nutrient warnings against a control label or other labeling systems were included for full-text review. Our conceptual model includes attention; comprehension, cognitive elaboration, and message acceptance; negative affect and risk perception; behavioral intentions, and behavioral response, along with other elements such as external factors and interpersonal communications. We found that many studies focused on outcomes such as attention, comprehension, and behavioral intentions, but considerable gaps in the evidence remain, particularly for intermediary steps on the pathway to behavioral change, such as negative affect and social interactions. FoP nutrient warnings were visually attended to by consumers, easy to understand, helped consumers identify products high in nutrients of concern, and discouraged them from purchasing these products, although other labeling systems were perceived as containing more information and performed better at helping consumers rank the healthfulness of products. More research is needed to understand whether and how nutrient warnings work in the real world to discourage consumer purchases of sugary drinks and ultra-processed food.

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“…The current study includes different municipalities with their own organisation and policies that may affect how and under which conditions regulatory tools lead to compliance with OSH regulation. Nevertheless, the randomisation will balance both observed and unobserved characteristics between the groups of municipalities and thereby minimise the risk of confounding factors influencing the results 44…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of the Labour Inspection Authority’s regulatory tools for work environment and employee health: study protocol for a cluster-randomised controlled trial among Norwegian home-care workers

et al. 2019

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IntroductionThere is a need to evaluate whether, and to what degree, labour inspections or other regulatory tools have the desired effects on psychosocial, organisational and mechanical work environment, and employee health. The Norwegian Labour Inspection Authority (NLIA) uses different tools and strategies to enforce compliance with occupational safety and health (OSH) legislation. The aim of the present study is to evaluate the effects of labour inspections and other regulatory tools employed by the NLIA. The home-care service is one of the fastest growing occupations and a prioritised area for the NLIA, hence the present study will investigate regulatory tools in this sector.Methods and analysisThe research project has been designed as a longitudinal, cluster-randomised, controlled trial and will be conducted among Norwegian home-care workers. The objective of the research project is to evaluate the effects of the NLIA’s regulatory tools (inspection and guidance) on: (1) compliance with OSH legislation and regulation; (2) psychosocial, organisational and mechanical work environment; (3) employee health in terms of musculoskeletal and mental health complaints; and (4) sickness absence. Public home-care services have been randomised to three intervention groups and one control group. Home-care services in the intervention groups will receive one of three intervention activities from the NLIA: (1) inspection from the Labour Inspection Authority; (2) guidance through an online interactive risk-assessment tool; and (3) guidance on psychosocial, organisational and mechanical work environment through workshops. The interventions will be performed at the organisational level (home-care service), and the effects of the interventions on the working environment and health complaints will be measured at the individual level (home-care employees).Ethics and disseminationThis project has been approved by the Regional Committees for Medical and Health Research Ethics (REC) in Norway (REC South East) (2018/2003/REK sør-øst C), the Norwegian Center for Research Data (566128), and will be conducted in accordance with the World Medical Association Declaration of Helsinki. The results will be reported in international peer-reviewed journals.Trial registration number NCT03855163.

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Randomised controlled trials – the gold standard for effectiveness research

Cited by 862 publications

References 2 publications

Energy Restriction Enhances Adult Hippocampal Neurogenesis-Associated Memory after Four Weeks in an Adult Human Population with Central Obesity; a Randomized Controlled Trial

Energy Restriction Enhances Adult Hippocampal Neurogenesis-Associated Memory after Four Weeks in an Adult Human Population with Central Obesity; a Randomized Controlled Trial

Experimental Studies of Front-of-Package Nutrient Warning Labels on Sugar-Sweetened Beverages and Ultra-Processed Foods: A Scoping Review

Effectiveness of the Labour Inspection Authority’s regulatory tools for work environment and employee health: study protocol for a cluster-randomised controlled trial among Norwegian home-care workers

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