We assessed the effectiveness of a 6-month healthy lifestyle intervention, on pain intensity in patients with chronic low back pain who were overweight or obese. We conducted a pragmatic randomised controlled trial (RCT), embedded within a cohort multiple RCT of patients on a waiting list for outpatient orthopaedic consultation at a tertiary hospital in NSW, Australia. Eligible patients with chronic low back pain (>3 months in duration) and BMI >= 27kg/m and < 40kg/m were randomly allocated, using a central concealed random allocation process, to receive advice and education and referral to a 6-month telephone-based healthy lifestyle coaching service, or usual care. The primary outcome was pain intensity measured using an 11-point numerical rating scale, at baseline, 2 weeks and monthly for 6 months. Data analysis was by intention-to-treat according to a pre-published analysis plan. Between May 13 and October 27, 2015, 160 patients were randomly assigned in a 1:1 ratio to the intervention or usual care. We found no difference between groups for pain intensity over 6 months (area under the curve, mean difference 6.5, 95%CI -8.0 to 21.0; p = 0.38) or any secondary outcome. In the intervention group 41% (n = 32) of participants reported an adverse event compared with 56% (n = 45) in the control group. Our findings show providing education and advice and telephone-based healthy lifestyle coaching did not benefit patients with low back pain who were overweight or obese, compared to usual care. The intervention did not influence the targeted healthy lifestyle behaviours proposed to improve pain in this patient group.

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