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Table 1 Trial Measures

From: A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight or obese: study protocol

Outcome Domain Measures Time point (weeks)
Primary Pain intensity Pain intensity over the previous week as measured by the 0–10 Numerical Rating Scale (NRS) [26] 0, 2, 6, 10, 14, 18, 22, 26
Secondary Disability Roland Morris Disability Questionnaire (RMDQ) [28] 0, 6, 26
  Self-reported weight Self-reported weight (kg) 0, 6, 26
  Objective weight Measured to the nearest 0.1 kg [29] 0a, 26
  BMI Calculated as weight/height squared (kg/m2) 0a, 26
  Waist circumference Measured to the nearest 0.1 cm [29] 26
  Quality of life Short Form 12 version 2 (SF12.v2) [30] 0, 6, 26
  Perceived change in condition Global Perceived Effect Scale [43] 6, 26
  Psychological distress Depression, Anxiety and Stress Scale-21 (DASS-21) [31] 0, 26
  Sleep quality Item 6 of the Pittsburgh sleep quality index [32] 0, 6, 26
  Health behaviours Physical Activity measured using the Active Australia Survey [33] 0, 6, 26
   Dietary intake measured using a short food frequency questionnaire [34] 0, 6, 26
   Alcohol Consumption measured using the alcohol use disorders identification test (AUDIT) [35] 0, 6, 26
   Self-reported smoking status [36] 0, 6, 26
  Health care utilisation Medication use for low back pain 0, 6, 26
Visits for low back pain – type and number of sessions 0, 6, 26
Attended orthopaedic consultation, received surgery 26
  Pain attitudes Survey of Pain Attitudes (SOPA) [38] 0, 6, 26
  Fear Avoidance Fear Avoidance Beliefs Questionnaire (FABQ) [39] 0, 26
  Economic Quality of life (SF12.v2) 0, 6, 26
Health care utilisation (including estimated out of pocket cost)
Absenteeism (days off normal work due to lower back pain in the past 6 weeks)
  1. GHS: Get Healthy Information and Coaching Service; aIntervention group only