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Background: These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method: These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions: A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to. [ABSTRACT FROM AUTHOR]

Background: Sitting time questionnaires have largely been validated in small convenience samples. The validity of this multi-context sitting questionnaire against an accurate measure of sitting time is reported in a large demographically diverse sample allowing assessment of validity in varied demographic subgroups. Methods: A subgroup of participants of the third wave of the Australian Diabetes, Obesity, and Lifestyle (AusDiab3) study wore activPAL3™ monitors (7 days, 24 hours/day protocol) and reported their sitting time for work, travel, television viewing, leisure computer use and "other" purposes, on weekdays and weekend days (n = 700, age 36-89 years, 45 % men). Correlations (Pearson's r; Spearman's p) of the self-report measures (the composite total, contextual measures and items) with monitor-assessed sitting time were assessed in the whole sample and separately in socio-demographic subgroups. Agreement was assessed using Bland-Altman plots. Results: The composite total had a correlation with monitor-assessed sitting time of r = 0.46 (95 % confidence interval [CI]: 0.40, 0.52); this correlation did not vary significantly between demographic subgroups (all >0.4). The contextual measure most strongly correlated with monitor-assessed sitting time was work (p = 0.25, 95 % CI: 0.17, 0.31), followed by television viewing (p = 0.16, 95 % CI: 0.09, 0.24). Agreement of the composite total with monitored sitting time was poor, with a positive bias (B = 0.53, SE 0.04, p < 0.001) and wide limits of agreement (±4.32 h). Conclusions: This multi-context questionnaire provides a total sitting time measure that ranks participants well for the purposes of assessing health associations but has limited accuracy relative to activPAL-assessed sitting time. Findings did not differ in demographic subgroups. [ABSTRACT FROM AUTHOR]