Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000035729
Ethics application status
Approved
Date submitted
25/10/2021
Date registered
17/01/2022
Date last updated
17/01/2022
Date data sharing statement initially provided
17/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A longitudinal study of lifestyle health behaviour in emerging adulthood and risk for later symptoms of depression, anxiety, and stress
Scientific title
A latent class analysis of lifestyle health behaviours amongst emerging adults in the Raine Study and examination of longitudinal associations with outcome mental health at two follow up time points
Secondary ID [1] 305040 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
The current study is a secondary analysis of data collected during the Raine Study (ACTRN12617001599369).

Health condition
Health condition(s) or problem(s) studied:
Depression 323216 0
Anxiety 323217 0
Stress 323218 0
Condition category
Condition code
Mental Health 320797 320797 0 0
Anxiety
Mental Health 320798 320798 0 0
Depression
Mental Health 320799 320799 0 0
Other mental health disorders
Public Health 320800 320800 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The exposure is lifestyle health behaviours (i.e. diet quality, physical activity, sedentary behaviour, alcohol consumption, tobacco smoking, and recreational drug use). Lifestyle health behaviours were assessed when participants were 20-years of age and will be categorised using latent class analysis. Raine study participants completed all questionnaires at ages 20, 22, and 27. However, only lifestyle data at age 20 years will be used as an exposure in the current study and lifestyle data at age 22 and 27 years will NOT be used. Outcome variables (collected at ages 22 and 27 years) will be described in the outcome sections.

Measurement of exposures of interest:
For the purposes of the current study, diet quality was measured by converting Food Frequency Questionnaire (FFQ) data into Dietary Approaches to Stop Hypertension (DASH) diet scores. Physical activity was dichotomised according to whether participants met/didn't meet Australian guidelines. Sedentary behaviour was measured by the average amount of time spent sitting per day and separated into quartiles. Alcohol consumption was based on the average number of standard drinks consumed per day. Recreational drugs were also categorized by frequency of use and participants were classified as either smokers or non-smokers based on whether they currently use tobacco.

Each participant had a single observation at one time point for each exposure variable. Data are pre-existing from the Western Australian Pregnancy Cohort (Raine) Study, which has followed participants longitudinally since birth. The Raine Study commenced recruitment between 1989 and 1991 and is ongoing today. Data collection at age 20-years involved questionnaires and collection of anthropometric data. All data for the current study is sourced directly from the Raine Study (ACTRN12617001599369). Data is preexisting, therefore no additional involvement by participants was required for this study.
Intervention code [1] 322407 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328610 0
Depression symptoms: Depression symptoms were measured via the Depression Subscale of the Depression Anxiety and Stress Scale - Short Form (DASS-21). Scores range from 0 to 21, with higher scores indicative of more severe symptoms.

Timepoint [1] 328610 0
Baseline (age 20 years), follow up 1 (age 22 years) and follow up 2 (age 27 years).
Primary outcome [2] 328611 0
Anxiety symptoms: Anxiety symptoms were measured via the Anxiety Subscale of the Depression Anxiety and Stress Scale - Short Form (DASS-21). Scores range from 0 to 21, with higher scores indicative of more severe symptoms.
Timepoint [2] 328611 0
Baseline (age 20 years), follow up 1 (age 22 years) and follow up 2 (age 27 years).
Primary outcome [3] 328612 0
Stress symptoms: Stress symptoms were measured via the Stress Subscale of the Depression Anxiety and Stress Scale - Short Form (DASS-21). Scores range from 0 to 21, with higher scores indicative of more severe symptoms.
Timepoint [3] 328612 0
Baseline (age 20 years), follow up 1 (age 22 years) and follow up 2 (age 27 years).
Secondary outcome [1] 401567 0
N/A
Timepoint [1] 401567 0
N/A

Eligibility
Key inclusion criteria
Participants were part of the Raine Study (ACTRN12617001599369). Participants had to have complete lifestyle and/or mental health data at baseline (20-years) and/or complete mental health data at both follow-up time points (22- and 27-years).
Minimum age
20 Years
Maximum age
27 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants with a diagnosed eating disorder/weight problems were excluded from the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Participant characteristics will be examined by sex and latent class membership. Differences in participant characteristics between outcome variables will be examined using t-tests (continuous variables) and the chi-square test (categorical variables). Latent class analysis (LCA) will be performed to identify distinct patterns of lifestyle health behaviours amongst emerging adults at age 20-years, using poLCA package in R version 4.0.2.

To find the best model fit, we evaluated a wide range of LCA models following with classes ranging from 1 to 10. We further repeat each model to ensure models find global—rather than just a local—maximum of the log-likelihood function we re-estimate each model 20 times using different values of lass-conditional response probabilities. The model will lowest Akaike Information Criterion (AIC) and with no class with less than 5% of participants in it will be selected as the model of choice.

After reaching the final LCA model, differences in sociodemographic and background characteristics across the classes will be examined using ANOVA and Chi-Square tests. Logistic and linear regression analyses will be performed to assess whether categorical membership to the identified dietary patterns at baseline (20-years) is predictive of categorical and/or continuous indicators of depression, anxiety and/or stress, respectively, at follow up.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/12/2020
Date of last participant enrolment
Anticipated
Actual
7/12/2020
Date of last data collection
Anticipated
Actual
7/12/2020
Sample size
Target
1440
Accrual to date
Final
1440
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20241 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 34974 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 309428 0
Other
Name [1] 309428 0
Raine Study
Country [1] 309428 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Gheringhap Street
Geelong VIC
Australia 3220
Country
Australia
Secondary sponsor category [1] 310401 0
None
Name [1] 310401 0
Address [1] 310401 0
Country [1] 310401 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309230 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 309230 0
Ethics committee country [1] 309230 0
Australia
Date submitted for ethics approval [1] 309230 0
Approval date [1] 309230 0
17/07/2019
Ethics approval number [1] 309230 0
2019-286

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113426 0
Ms Sam Collins
Address 113426 0
Deakin University
1 Gheringhap Street
Geelong VIC
3220
Country 113426 0
Australia
Phone 113426 0
+61 355271100
Fax 113426 0
Email 113426 0
[email protected]
Contact person for public queries
Name 113427 0
Sam Collins
Address 113427 0
Deakin University
1 Gheringhap Street
Geelong VIC
3220
Country 113427 0
Australia
Phone 113427 0
+61 355271100
Fax 113427 0
Email 113427 0
[email protected]
Contact person for scientific queries
Name 113428 0
Sam Collins
Address 113428 0
Deakin University
1 Gheringhap Street
Geelong VIC
3220
Country 113428 0
Australia
Phone 113428 0
+61 355271100
Fax 113428 0
Email 113428 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The Raine Study hold the rights to release this information.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.