Background:Tobacco consumption is a leading cause of death and disease, killing >8 million people each year. Smoking cessation significantly reduces the risk of developing smoking-related diseases. Although combined treatment for addiction is promising, evidence of its effectiveness is still emerging. Currently, there is no published research comparing the effectiveness of blended smoking cessation treatments (BSCTs) with face-to-face (F2F) treatments, where web-based components replace 50% of the F2F components in blended treatment.Objective:The primary objective of this 2-arm noninferiority randomized controlled trial was to determine whether a BSCT is noninferior to an F2F treatment with identical ingredients in achieving abstinence rates.Methods:This study included 344 individuals who smoke (at least 1 cigarette per day) attending an outpatient smoking cessation clinic in the Netherlands. The participants received either a blended 50% F2F and 50% web-based BSCT or only F2F treatment with similar content and intensity. The primary outcome measure was cotinine-validated abstinence rates from all smoking products at 3 and 15 months after treatment initiation. Additional measures included carbon monoxide–validated point prevalence abstinence; self-reported point prevalence abstinence; and self-reported continuous abstinence rates at 3, 6, 9, and 15 months after treatment initiation.Results:None of the 13 outcomes showed statistically confirmed noninferiority of the BSCT, whereas 4 outcomes showed significantly (P<.001) inferior abstinence rates of the BSCT: cotinine-validated point prevalence abstinence rate at 3 months (difference 12.7, 95% CI 6.2-19.4), self-reported point prevalence abstinence rate at 6 months (difference 19.3, 95% CI 11.5-27.0) and at 15 months (difference 11.7, 95% CI 5.8-17.9), and self-reported continuous abstinence rate at 6 months (difference 13.8, 95% CI 6.8-20.8). The remaining 9 outcomes, including the cotinine-validated point prevalence abstinence rate at 15 months, were inconclusive.Conclusions:In this high-intensity outpatient smoking cessation trial, the blended mode was predominantly less effective than the traditional F2F mode. The results contradict the widely assumed potential benefits of blended treatment and suggest that further research is needed to identify the critical factors in the design of blended interventions.Trial Registration:Netherlands Trial Register 27150; https://onderzoekmetmensen.nl/nl/trial/27150
ObjectiveThe Plants for Joints (PFJ) intervention significantly improved pain, stiffness, and physical function, and metabolic outcomes, in people with metabolic syndrome-associated osteoarthritis (MSOA). This secondary analysis investigated its effects on body composition.MethodIn the randomized PFJ study, people with MSOA followed a 16-week intervention based on a whole-food plant-based diet, physical activity, and stress management, or usual care. For this secondary analysis, fat mass, muscle mass, and bone mineral density were measured using dual-energy X-ray absorptiometry (DEXA) for all participants. Additionally, in a subgroup (n = 32), hepatocellular lipid (HCL) content and composition of visceral adipose tissue (VAT) were measured using magnetic resonance spectroscopy (MRS). An intention-to-treat analysis with a linear-mixed model adjusted for baseline values was used to analyse between-group differences.ResultsOf 66 people randomized, 64 (97%) completed the study. The PFJ group experienced significant weight loss (−5.2 kg; 95% CI –6.9, −3.6) compared to controls, primarily from fat mass reduction (−3.9 kg; 95% CI –5.3 to −2.5). No significant differences were found in lean mass, muscle strength, or bone mineral density between groups. In the subgroup who underwent MRI scans, the PFJ group had a greater reduction in HCL (−6.5%; 95% CI –9.9, 3.0) compared to controls, with no observed differences in VAT composition.ConclusionThe PFJ multidisciplinary intervention positively impacted clinical and metabolic outcomes, and appears to significantly reduce body fat, including liver fat, while preserving muscle mass and strength.
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