The usefulness of randomized trials of lifestyle interventions for overweight, obesity, or metabolic syndrome: A systematic review
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Maria Tsirogianni, Androniki; Bouzalmate Hajjaj, Amira; van ’t Hooft, Janneke; Saeed Khan, Khalid; Bueno Cavanillas, Aurora; Cano Ibáñez, NaomiEditorial
Elsevier
Materia
Usefulness Randomized controlled trials Lifestyle
Date
2024-09-06Referencia bibliográfica
Maria Tsirogianni, A. et. al. 63 (2024) 936e943. [https://doi.org/10.1016/j.clnesp.2024.08.026]
Sponsorship
Universidad de Granada / CBUAAbstract
Background: Randomized controlled trials (RCTs) widely considered the gold standard for evidencebased
healthcare may be limited in their clinical usefulness in lifestyle interventions for adults with
overweight, obesity, or metabolic syndrome.
Objective: In this systematic review of lifestyle intervention RCTs we delineated trial usefulness.
Methods: Following prospective registration in PROSPERO (CRD4202347896), we conducted a comprehensive
search across Medline, Scopus, Web of Science, and the Cochrane Library databases, covering the
period from inception to December 2023. RCTs involving dietary interventions, with or without physical
activity, and with or without behavioural support were included. Two reviewers independently performed
study selection and data extraction. Study usefulness was assessed using a multidimensional 14
item questionnaire. Percentage compliance with usefulness items was computed.
Results: Of 1175 records, 30 RCTs (12,841 participants) were included. Among these, 13 (43%) RCTs
complied with half of the usefulness items and only 3 (10%) complied with two-thirds of the items. For
each usefulness item individually: 30 (100%) reported the burden of the problem addressed, 15 (50%)
contextualized the trial through a systematic review, 18 (60%) presented an informative trial with clinically
meaningful outcomes evaluated at a stated statistical power, 17 (57%) had low risk of bias, 2 (7%)
exhibited pragmatic features pertaining to the trial methodologies and outcomes relevant to real-world
application.18 (60%) were patient centred with formal patient involvement, none (0%) demonstrated
value for money, 17 (57%) were completed according to their feasibility assessment achieving at least 90%
of the estimated sample size, and 30 (100%) reported at least one of five transparency or openness
features.
Conclusion: Only one in 10 lifestyle RCTs met two-thirds of the usefulness features. It is imperative to
meet these criteria when devising future trials within the field of nutrition to reduce research waste.