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. 2019 Nov 19;2019(11):CD012487. doi: 10.1002/14651858.CD012487.pub2

Healy 2016.

Methods Study design: cluster‐randomised controlled trial
Study duration: 12 months
Dropout: 18% at 12 months (all participants)
Location: 1 government organisation at various work sites in metropolitan and regional Victoria, Australia
Recruitment: sites were identified if they were geographically separate (≥ 1 km apart) from other sites in the same organisation. At each site, a team was formed that included a working group and a line manager; the team met on a regular basis
Participants Population: office workers working in the organisation
Intervention group: 136 participants with 12 to 54 participants with baseline pain in 1 or more body regions
Control group: 95 participants with 4 to 37 participants with baseline pain in 1 or more body regions
Included criteria: required to work at least 0.6 full‐time equivalent; 18 to 65 years of age; ability to speak English; access to telephone, Internet, and dedicated desk at the workplace
Excluded criteria: pregnant, non‐ambulatory, planned absence from work for longer than 2 weeks, planned relocation to another work site within the first 3 months of the intervention
Baseline characteristics: approximately equal proportions of participants in intervention and control groups reported baseline musculoskeletal symptoms
Interventions Intervention
  • Description of intervention: multi‐component intervention drawing on social cognitive theory and an ecological model of sedentary behaviour. Intervention targets were "Stand Up, Sit Less, Move More". Intervention incorporates organisational strategies (workshops with managers, recruitment of team champions to model behaviour, sending 6 emails), environmental strategies (provision of sit‐stand workstation installed for 12 months), and individual strategies (3 months of individual coaching sessions)

  • Duration of intervention: 12 months

  • Intensity of intervention: emails and coaching at weeks 2, 4, 6, 8, and 12


Control
  • Description of intervention: provided with written feedback about their activity and biomarker outcomes at 3 months and 12 months

  • Duration of intervention: 12 months

  • Intensity of intervention: not stated

Outcomes Outcome name, measurement tool, body region
  • Musculoskeletal health

    • Standardised Nordic Questionnaire for 9 body regions ‐ neck, shoulder, upper back, elbow, wrist, lower back, hip, knee, and ankle ‐ over last week and last 3 months

  • Workplace sitting time

    • Work sitting and prolonged sitting measured by activPAL3 accelerometer/inclinometer device

  • Activity outcomes

    • Standing, stepping, stepping at light intensity, stepping at moderate to vigorous intensity measured by activPAL3 accelerometer/inclinometer device

  • Quality of life

    • Australian Quality of Life Survey

  • Job control and productivity

    • Work Limitations Questionniare

Identification  
Notes Sponsorship source: Ergotron Ltd (www.ergotron.com) provided sit‐stand workstations for the present study. Ergotron had no influence on the conduct or findings of the study
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation Unclear risk Quote: "randomization to either the intervention or the control arms of the trial was at the level of the work site via simple cluster randomization. This was achieved by generating a randomization plan for up to 24 clusters in one block (www.randomization.com)"
Judgement comment: although the overall randomisation procedure was low risk, as only a select group of participants with baseline pain were included in the review, randomisation was compromised
Allocation concealment Low risk Quote: "this was achieved by generating a randomization plan for up to 24 clusters in one block (www.randomization.com) by a research staff member not involved in recruitment or data collection"
Blinding of participants and personnel High risk Quote: "participants and study staff were unblinded to group allocation"
Blinding of outcome assessment Unclear risk Judgement comment: in addition, for this study, musculoskeletal outcomes were a secondary outcome, so it is unclear whether the fact that participants were not blinded to the intervention would contribute to bias in self‐reporting of musculoskeletal outcomes
Incomplete outcome data Unclear risk Judgement comment: for the whole cohort ‐ at 3‐month follow‐up, 7/136 in the intervention group were lost to follow‐up and 5/95 in the control group; at 12‐month follow‐up, 22/136 in the intervention group were lost to follow‐up and 20/95 in the intervention group. Attrition was greater in the control group (31%) than in the intervention group (16%). Attrition details for participants with baseline pain were not provided
Selective reporting Low risk Judgement comment: outcomes reported are consistent with the clinical trial registration. However, the full list of outcomes is reported elsewhere (Healy 2017)
Baseline imbalance Low risk Judgement comment: appears to be equal balance of participants with baseline pain in intervention and control groups