- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06157112
Students' Lifestyle Behaviour and Later Health Care Utilization Due to Musculoskeletal Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to determine:
i) whether male and female university students' lifestyle behaviours, in terms of physical activity level, sleep durance, alcohol consumption, smoking and illicit drug use, are associated with future health care utilisation for musculoskeletal pain, back pain or neck pain, and ii) whether the number of adverse lifestyle behaviours is associated with future health care utilisation for musculoskeletal pain, back pain or neck pain.
Study design and setting:
Cohort study, in which data from the Students' Health and Wellbeing study (SHoT) is merged with data from the Norwegian Register of Primary Health Care (NRPHC).
The eligibility criteria:
Inclusion criteria • Participants of the SHoT2018 study (18-35 years of age)
Exclusion criteria
- Participants studying abroad
- Participants above 35 years of age
- Recent health care utilisation for a musculoskeletal pain diagnosis (the last 12 months prior to the exposure assessment)
Primary outcome:
- Health care utilisation for musculoskeletal pain in primary health care, registered in the NRPHC (follow-up period: 3 years after baseline)
Secondary outcome:
- Health care utilisation for back pain, registered in NRPHC (follow-up period: 3 years after baseline)
- Health care utilisation for neck pain, registered in NRPHC (follow-up period: 3 years after baseline)
Exposures:
- Physical activity, obtained from the SHOT-questionnaire, categorised in accordance with recommendations for weekly physical activity
- Sleep duration, obtained from the SHOT-questionnaire, categorised in accordance with recommendations
- Smoking (yes / no)
- Alcohol consumption (assessed with AUDIT)
- Cannabis (categorised in use the last year yes/no)
- Other illegal drug use (categorised in use the last year yes/no)
- Number of adverse lifestyle behaviours (0-5) (low physical activity, short sleep duration, smoking, risky alcohol use, illegal drug use the last year)
Potential confounders:
We will consider to include the following variables as potential confounders in the analyses: age, financial difficulties, physical health complaints, symptoms of depression and anxiety, musculoskeletal pain, other lifestyle behaviours, consultation frequency irrespective of cause, the last year prior baseline (the last will be used as an indicator of health care seeking behaviour)
Statistical analyses:
We will compute the annual incidence rates (with 95% CI) of health utilisation for musculoskeletal pain, back pain and neck pain.
Crude and adjusted associations between each of the lifestyle behaviours and health care utilisation for musculoskeletal pain, back pain and neck pain will be assessed separately. Also, the association between the number of adverse lifestyle behaviours and musculoskeletal pain, back and neck pain will be assessed in crude and adjusted analyses. Logistic regression will be used to analyse the associations with binary outcomes (health care utilisation for musculoskeletal pain yes/no). To asses the associations with an outcome variable reflecting the number of health care visits for musculoskeletal pain, the exact statistical analysis method will be chosen after inspection of the distribution of the outcome data.
The following sensitivity analyses will be considered:
- only including outcome data before 12 March 2020 to assess the associations prior to the Covid 19 restrictions
- excluding participants above 30 years of age to assess the associations in a sample of students withing the "emerging adult" definition (up to 30 years of age)
All analyses will be conducted with STATA statistical software system, version 16 (StataCorp., 2019)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0130
- Oslo Metropolitan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All full-time Norwegian University students aged 18 to 35 years of age
Exclusion Criteria:
- students studying abroad
- students above 35 years of age
- students with health care utilisation due to musculoskeletal pain the last 12 months before baseline
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Norwegian University students
Norwegian fulltime University students
|
Lifestyle behaviour, including physical activity, sleep duration, alcohol consumption, smoking, cannabis and other illegal drugs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health care utilisation due to musculoskeletal pain
Time Frame: 3 years (6 Apr 2018 - 6 Apr 2021)
|
Visiting a primary health care provider (GP, physiotherapist or chiropractor) due to a musculoskeletal pain diagnosis (yes/no and number of visits)
|
3 years (6 Apr 2018 - 6 Apr 2021)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health care utilisation due to back pain
Time Frame: 3 years (6 Apr 2018 - 6 Apr 2021)
|
Visiting a primary health care provider (GP, physiotherapist or chiropractor) due to a back pain diagnosis
|
3 years (6 Apr 2018 - 6 Apr 2021)
|
Health care utilisation due to neck pain
Time Frame: 3 years (6 Apr 2018 - 6 Apr 2018)
|
Visiting a primary health care provider (GP, physiotherapist or chiropractor) due to a neck pain diagnosis
|
3 years (6 Apr 2018 - 6 Apr 2018)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Britt Elin Øiestad, PhD, Oslo Metropolitan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 251771
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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