Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06157112 |
Other study ID # |
251771 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 6, 2018 |
Est. completion date |
April 5, 2021 |
Study information
Verified date |
November 2023 |
Source |
Oslo Metropolitan University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
This study aims to assess whether there is an association between students' lifestyle
behaviour, in terms of physical activity level, sleep duration, smoking status, alcohol
consumption and use of cannabis and other illegal drugs, and later health care utilisation
due to musculoskeletal pain. The study will combine data from a national survey in Norway
(SHOT2018), in which all full-time university students in Norway were invited, with data from
a register on health care utilisation in primary health care.
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)