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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)


Recruitment information / eligibility

Status Completed
Enrollment 50054
Est. completion date April 5, 2021
Est. primary completion date April 5, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Lifestyle behaviour (exposure in a observational study)
Lifestyle behaviour, including physical activity, sleep duration, alcohol consumption, smoking, cannabis and other illegal drugs

Locations

Country Name City State
Norway Oslo Metropolitan University Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo Metropolitan University

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health care utilisation due to musculoskeletal pain 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 Health care utilisation due to back pain Visiting a primary health care provider (GP, physiotherapist or chiropractor) due to a back pain diagnosis 3 years (6 Apr 2018 - 6 Apr 2021)
Secondary Health care utilisation due to neck pain Visiting a primary health care provider (GP, physiotherapist or chiropractor) due to a neck pain diagnosis 3 years (6 Apr 2018 - 6 Apr 2018)
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