Increasing physical activity and reducing sedentary behaviour among office-workers in order to improve mental health and cognition

• Register: ISRCTN
• Last refreshed on: 22 January 2024
• Main ID: ISRCTN92968402
• Date of registration: 09/04/2018
• Prospective Registration: No
• Primary sponsor: The Swedish School of Sport and Health Sciences, GIH
• Public title: Increasing physical activity and reducing sedentary behaviour among office-workers in order to improve mental health and cognition
• Scientific title: Improving office workers’ mental health and cognition: a three-arm cluster randomized controlled trial targeting physical activity and sedentary behaviour in multi-component interventions
• Date of first enrolment: 15/03/2018
• Target sample size: 330
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN92968402
• Study type: Interventional
• Study design: Single-blinded three-arm clustered randomized controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Carla Nooijen

Key inclusion & exclusion criteria

Inclusion criteria: 1. Between 18-70 years of age
2. Have the capability of standing and exercising
Exclusion criteria: 1. Not be working for the full duration of the first 6 months of the study (i.e. retirement, maternity leave)
2. Very high physical activity level: more than 30 min/day in prolonged bouts (=10 min) moderate to vigorous physical activity. This exclusion criteria will be checked by assessing physical activity with accelerometers. Note that because we have found that almost all office-workers working at the involved companies have high levels of sedentary behavior, sedentary behavior will not be used as an exclusion criterion

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Sedentary office workers
Not Applicable

Intervention(s)

Two multicomponent interventions of 6 months will be studied. The interventions are both based on ecological frameworks suggesting that behaviour can be influenced on multiple levels including individual, social, organizational, environmental and policy. All participants will be randomized into receiving one of the two interventions, or to a waiting list control group. The waiting list group will start one of the interventions 6 months later to compare the effects of the interventions to a group receiving no intervention during that period. In order to control contamination and to limit interaction between the different groups, randomisation will be done on a cluster level. The aim is to have 24 clusters (8 clusters per arm), 10 at Company A and 14 at Company B. Clusters will be composed while considering: 1) having a team or line manager, 2) having regular group meetings, 3) limited regular meetings with other teams. Block randomisation will be performed using a computer-generated random number list prepared by an investigator with no clinical involvement in the trial. Groups will be randomly allocated (1:1) with stratification for company and cluster size (large vs small).

The physical activity intervention aims to promote physical activity of moderate to vigorous intensity and includes:
1. Individual: motivational counselling towards improving their time spent in moderate to vigorous physical activity, based on cognitive behavioral therapy (CBT). Counselling consists of 3 individual and 2 group sessions and focuses on both work and leisure time. The counselling includes feedback on individual moderate to vigorous physical activity
2. Environmental: access to a commercial gym (6 months) with possibility to go during working hours, as well as organized exercise sessi

Primary Outcome(s)

Physical activity patterns, including sedentary behaviour, objectively measured with accelerometers (Actigraph) and inclinometers (ActivPAL) at baseline and after the 6-month intervention

Secondary Outcome(s)

This 24-month study includes 5 measurement timepoints, with measurements every 6 months

Proximal outcomes:
1. Physical activity patterns, including sedentary behaviour, objectively measured with accelerometers (Actigraph) and inclinometers (ActivPAL), at long-term follow-up

Distal outcomes (all measured at all specified timepoints):
1. Mental health: including self-reported measures of anxiety and depression (The Hospital Anxiety and Depression Scale, stress (single-item), recovery (self-rating of recovery from work), burnout (Shirom and Melamed burnout measure), general mental health (single-item), life satisfaction (WHO-5 and single-item), and sickness absence
2. Cognition: a comprehensive cognitive test battery assessing the following cognitive domains: processing speed (Digit symbol), attention (Trail Making Test-A), working memory (Capacity: Automated Operation Span; Backward Digit Span), executive functions (Trail Making Test-B, Stroop, n-back), episodic memory (free recall; recognition), semantic memory (SRB:1), and visuospatial ability (Form Board Test). Additionally, self-reported subjective memory complaints (Cognitive Dysfunction Questionnaire) will be assessed.

Secondary outcomes (all measured at all specified timepoints, unless otherwise stated):
1. Cardiovascular fitness: participants undergo a submaximal cycle ergometer test. Heart rate response to a submaximal rate of work will be used to estimate maximal oxygen consumption
2. Body composition: body mass index calculated from measured weight and height. Waist circumference (WC) measured in duplicate with participants standing dressed in underwear and exhaled. WC measured at the minimum circumference between the iliac crest and the rib cage
3. Sleep: during night time, participants wear the accelerometer on the non-dominant wrist and additionally self-reported sleep will be assessed (Karolinska Sleep Questionnaire)
4. Self-reported data for physical activity (including active transport) and sedentary behaviour (Workforce Sitting Questionnaire)
5. Other health habits: including smoking, drinking and diet (national guidelines)
6. Physical health: self-reported physical health (single-item) and self-reported health conditions
7. Feasibility and acceptability of the intervention (only measured after intervention)

Working mechanisms (all measured at all specified timepoints, unless otherwise stated):
1. Blood analyses: per measurement point, three blood samples (each 5 ml) will be drawn to determine blood glucose, plasma and serum levels of inflammatory markers, BDNF, VEGF, and IGF-1, as well as genetic profiling of BDNF genes (baseline only)
2. Self-reported: including self-efficacy (Exercise Self-Efficacy Scale), motivation and self-regulation (BREQ-4)

Secondary ID(s)

2017/2409-31/1

Source(s) of Monetary Support

Stiftelsen för Kunskaps- och Kompetensutveckling, ICA-gruppen, Intrum, SATS Elixia, Monark Exercise, Itrim Sweden

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Regionala Etikprövningsnämnden i Stockholm, 02/02/2018, ref: 2017/2409-31/1

Results

• Results available: Yes
• Date Completed: 31/12/2020