A three arm cluster randomised controlled trial to test the effectiveness and cost-effectiveness of the SMART Work & Life intervention for reducing daily sitting time in office workers: study protocol

Abstract

BackgroundOffice-based workers typically spend 70–85% of working hours, and a large proportion of leisure time, sitting. High levels of sitting have been linked to poor health. There is a need for fully powered randomised controlled trials (RCTs) with long-term follow-up to test the effectiveness of interventions to reduce sitting. This paper describes the methodology of a three-arm cluster RCT designed to determine the effectiveness and cost-effectiveness of the SMART Work & Life intervention, delivered with and without a height-adjustable desk, for reducing daily sitting.Methods/designA three-arm cluster RCT of 33 clusters (660 council workers) will be conducted in three areas in England (Leicester; Manchester; Liverpool). Office groups (clusters) will be randomised to the SMART Work & Life intervention delivered with (group 1) or without (group 2) a height-adjustable desk or a control group (group 3). SMART Work & Life includes organisational (e.g., management buy-in, provision/support for standing meetings), environmental (e.g., relocating waste bins, printers), and group/individual (education, action planning, goal setting, addressing barriers, coaching, self-monitoring, social support) level behaviour change strategies, with strategies driven by workplace champions. Baseline, 3, 12 and 24 month measures will be taken. Primary outcome: Objectively measured daily sitting time (activPAL3). Secondary outcomes: objectively measured sitting, standing, stepping, prolonged sitting and moderate-to-vigorous physical activity time and number of steps at work and daily; objectively measured sleep (wrist accelerometry). Adiposity, blood pressure, fasting glucose, glycated haemoglobin, cholesterol (total, HDL, LDL) and triglycerides will be assessed from capillary blood samples. Questionnaires will examine dietary intake, fatigue, musculoskeletal issues, job performance and satisfaction, work engagement, occupational and general fatigue, stress, presenteeism, anxiety and depression and sickness absence (organisational records). Quality of life and resources used (e.g. GP visits, outpatient attendances) will also be assessed. We will conduct a full process evaluation and cost-effectiveness analysis.DiscussionThe results of this RCT will 1) help to understand how effective an important simple, yet relatively expensive environmental change is for reducing sitting, 2) provide evidence on changing behaviour across all waking hours, and 3) provide evidence for policy guidelines around population and workplace health and well-being.Trial registrationISRCTN11618007. Registered on 21 January 2018.

A randomised-controlled feasibility study of the REgulate your SItting Time (RESIT) intervention for reducing sitting time in individuals with type 2 diabetes: study protocol

“…After randomisation, all intervention participants will be provided with an online education programme. This is an adapted version of the one used in the SMART Work and Life intervention [ 40 ], content of which was based on the face-to-face education used in the SMArT Work multicomponent intervention that led to significant reductions in workplace sitting after 12 months [ 20 ]. The online programme includes numerous interactive modules that cover information on the health consequences of excessive sitting, the benefits of reducing sitting, awareness of own sitting time, goal setting and action planning for reducing sitting, addressing potential barriers to sitting less and the importance of self-monitoring and using prompts.…”

Adverse event recording failed to reflect potential harms: a review of trial protocols of behavioral, lifestyle and psychological therapy interventions

“…Psychosocial intervention [41] Asylum seekers and refugees Stated it can be reasonably assumed that no physical AEs will be related to the intervention. For SAEs, eight protocols restricted recording serious AEs to only those which were treatment-related [26][27][28][29][30][31][32][33] and four protocols restricted to unexpected and treatment-related SAEs [ 18 , 34-36 ]. Five protocols excluded specific events as AEs, see Table 3 .…”

Design and analysis of three‐arm parallel cluster randomized trials with small numbers of clusters

“…One recent major trial enrolled over 700 clusters into seven trial arms to evaluate the effects of different combinations of water, sanitation, hygiene, and nutrition interventions on the risk of childhood diarrhoeal and respiratory illness in Bangladesh where the presence of disease was recorded post‐intervention 10,11 . Smaller examples include a three‐arm trial with 11 clusters per arm of an intervention to reduce time spent sitting at work with baseline and post‐treatment measures of sitting time 12 . We have conducted a four‐arm trial of different levels of incentives for small businesses to follow a healthy workplace initiative that included both continuous and binary outcomes measured pre‐ and post‐intervention 13 .…”