Clinical trial NCT06183125: Reduce Sedentariness and Enhance Psychological Well-being of Office Workers With TCM-based Intervention
Official title: Reduce Sedentariness and Enhance Physical and Psychological Health of Office Workers With TCM-based Anti-sedentary Intervention: Efficacy and Potential Psychophysiological Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Keywords: sedentary behavior
office worker
Traditional Chinese Medicine
RCT
psychophysiological mechanism
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial will be conducted among 64 office workers with self-reported sitting time of 5.5 hours or longer per workday. They will be randomly assigned to intervention (TCM-based program) and wait-list control groups.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the effects of a TCM-based anti-sedentariness program on workplace sitting time, perceived stress, and cortisol in office workers.The main questions it aims to answer are:

1. Can a Traditional Chinese Medicine (TCM)-based anti-sedentariness program effectively reduce workplace sitting time, perceived stress and cortisol levels among office workers?
2. Whether such anti-sedentary effect works through stress management and enhances when holistic thinking is endorsed.

Participants will engage in a 4 week TCM-based program intervention including 2 weeks of health education and promotion activities (understanding sedentary behaviors, Baduanjin, acupressure, dantian breathing, and mindfulness) and 2 weeks of supported self-practice (daily reminders and tips, regular feedback on sitting time, and individual consultation).

Researchers will compare a group receiving a Traditional Chinese Medicine (TCM)-based intervention with a wait-list control group to determine the effectiveness of the intervention in reducing sitting time and enhancing physical and psychological health.

Detailed description: Introduction:

Sedentary behaviors and their associated physical and mental health risks among adults have received growing concerns among the clinical and research communities. Office workers commonly engage in sedentary behaviors due to their long stationary hours. Evidence has revealed that higher levels of sedentary behaviors were associated with higher perceived stress levels at workplace. However, scarce studies focused on the role of stress management in reducing sedentary behaviors. Traditional Chinese medicine (TCM)-based body works (such as dantian breathing, qigong, and acupressure) are low-cost techniques and found to be primising in addressing stress and sedentary behaviors at workplace. The health benefits of TCM-based bodywork in sedentary office workers may be enhanced when the workers endorse holistic thinking.

The present research aims to test the effects of a TCM-based anti-sedentariness program on workplace sitting time, perceived stress, and cortisol in office workers. Investigators will also explore the psychophysiological mechanism whether such anti-sedentary effect works through stress management and enhances when holistic thinking is endorsed.

Methods:

A systematic review and meta-analysis has been conducted to synthesize the pooled effect of existing anti-sedentariness interventions on office workers' sitting time and compare the effectiveness of different intervention types in reducing sedentary behaviors relative to the control group. The systematic review and meta-analysis set the theoretical foundation of intervention elements for the reduction of sedentary behaviors at workplace and their psychological effects to be applied in the present study.

A randomized controlled trial will be conducted among 92 office workers with self-reported sitting time of 5.5 hours or longer per workday. Participants will be randomly assigned to intervention (TCM-based program) and wait-list control groups. The TCM-based program will last for 4 weeks, with 2 weeks of health education and promotion activities (understanding sedentary behaviors, Baduanjin, acupressure, dantian breathing, and mindfulness) and 2 weeks of supported self-practice (daily reminders and tips, regular feedback on sitting time, website support and individual consultation). Participants' sitting time per workday and perceived stress will be assessed at baseline, post-intervention (4 weeks after baseline), and follow-up (6 weeks after baseline). During the 2-week self-practice, participants in the intervention group will complete a diary of self-practice duration of TCM-based bodywork, perceived stress, and collect saliva samples every two days. Repeated-measures ANOVA will be used to test the group differences in changes in sitting time and perceived stress. Mediating effects of perceived stress and cortisol and moderating effects of holistic thinking will be explored through SPSS marcos.

Significance:

The findings of this study will provide valuable insights into the effectiveness of a TCM-based intervention in reducing sedentary behavior and improving psychological well-being. It is innovative to understand the psychophysiological mechanism of reducing sedentary behavior to explore tailored interventions to enhance the health quality of office workers. Given the easy practice and low cost of the TCM-based body works, the project can put forward a cost-effective intervention that can benefit a large population sustainably.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 or above with a full-time and office-based job
2. Reported \>5.5 hours of sitting per day at work
3. Native Chinese speaker (Cantonese or Mandarin)
4. Be able to give consent

Exclusion Criteria:

1. Have severe or chronic illness and not suitable for physical exercise
2. Be oversensitive to tactile stimulation
3. Have regular practice of qigong, acupressure, or mindfulness-based activities during the 4 weeks prior to recruitment

Primary outcomes:
measure: sedentary behavior- total sitting time/workday
timeFrame: Baseline, week 5, week 9
measure: sedentary behavior- sitting time/9-h working time
timeFrame: Baseline, week 5, week 9
measure: Self-report sedentary behaviors
timeFrame: Baseline, week 5, week 9
measure: psychological stress
timeFrame: Baseline, week 5, week 9
measure: physiological stress
timeFrame: Baseline, week 5, week 9
Secondary outcomes:
measure: Holistic thinking
timeFrame: Baseline
measure: Health-related quality of life
timeFrame: Baseline, week 5, week 9
measure: Sleep quality
timeFrame: Baseline, week 5, week 9
measure: Psychological distress
timeFrame: Baseline, week 5, week 9
measure: Self efficay
timeFrame: Baseline, week 5, week 9
measure: Blood pressures
timeFrame: Baseline, week 5, week 9
measure: Hand grip strength
timeFrame: Baseline, week 5, week 9
measure: IL-6
timeFrame: Baseline, week 5, week 9
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
state: Hong Kong
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Hector Tsang, PhD
role: PRINCIPAL_INVESTIGATOR
References: