Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001245189
Ethics application status
Not required
Date submitted
23/08/2019
Date registered
9/09/2019
Date last updated
9/09/2019
Date data sharing statement initially provided
9/09/2019
Date results information initially provided
9/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mental health in childhood, adolescent depressive symptoms and health risk behaviours among young people in the UK
Scientific title
An analysis of parent-reported mental health in childhood, adolescent depressive symptoms and health risk behaviours in a UK-representative population cohort
Secondary ID [1] 299102 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet 314149 0
Physical activity 314150 0
Sleep 314151 0
Social media use 314152 0
Mental health 314153 0
Condition category
Condition code
Mental Health 312523 312523 0 0
Depression
Public Health 312597 312597 0 0
Other public health
Mental Health 312598 312598 0 0
Other mental health disorders
Neurological 312599 312599 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Parent-reported mental health problems at 7 years measured by the Strengths and Difficulties Questionnaire (average completion time 5 minutes) and self-reported depressive symptoms at 14 years (average completion time 5 minutes) using the Short Mood and Feelings Questionnaire. each participant had one observation at age 7 years, and again at age 14 years, making the total observation per participant 7 years. Data are pre-exsisting from the UK Millennium Cohort Study and data collection occurred during 2008 and 2015. This is a retrospectively study.
Intervention code [1] 315368 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321152 0
Diet: Fruit, vegetable and soft drink consumption, and social media use were all self-reported. Fruit and vegetable consumption was measured by the following item; ‘how often do you eat at least 2 portions of (fruit/vegetables)?’, with responses ‘never’, ‘some days, but not all days’, and ‘every day’. Soft drink consumption was measured by the question ‘How often do you drink sweetened drinks?’ with responses classified into ‘less often than once per week’, ‘1-2 days a week’, ‘3-6 days a week’ and ‘everyday’. The three diet variables (fruit, vegetables, soft drink) were dichotomised into consumers and non-consumers.
Timepoint [1] 321152 0
Diet was assessed at 14 year follow-up
Primary outcome [2] 321153 0
Physical activity: Physical activity levels were monitored using wrist worn GENEActiv. Participants wore accelerometers on two randomly selected 24 hour days (one weekday and one weekend day). The total time spent in physical activity was calculated as the time spent with acceleration (Euclidean Norm Minus One, ENMO) with a value above 100mg (referred to as mean physical activity in minutes). This cut-off was based on a comparison between measured energy expenditure and wrist worn accelerometer output for children walking at 3km per hour. Epochs were based on 5 second intervals. The second activity variable was indicated by the mean acceleration score (ENMO, mg) during the two days combined and averaged (referred to as mean acceleration).
Timepoint [2] 321153 0
Physical activity was measured at 14 year follow-up
Primary outcome [3] 321154 0
Sleep: Sleep was estimated in hours based on response to the following two items; ‘What time do you typically go to bed on a school night?’ and ‘What time do you typically wake on a school morning?’. Responses were converted into hours and categorised into whether participants met or did not meet age-specific sleep recommendations of 9 hours sleep a night.
Timepoint [3] 321154 0
Sleep was measured at 14 year follow-up
Secondary outcome [1] 374135 0
Social media use: Social media was measured by asking participants ‘how many hours per week do you spend on social networking sites?’ with responses ‘less than half an hour’, ‘half hour to less than 1 hour’, ‘1 hour to less than 2 hours’, ‘2 hours to less than 3 hours’, ‘3 hours to less than 5 hours’, and ‘5 hours to less than 7 hours’, or ‘7 hours or more’ and the variable was treated as continuous.
Timepoint [1] 374135 0
Social media use was measured at 14 year follow-up

Eligibility
Key inclusion criteria
Complete health behavioural (physical activity, dietary, sleep and social media use), mental health (parent-reported at 7 years and self-reported at 14 years) and demographic (sex, country of birth, household income and body fat percentage) data. Parents of participants provided mental health measures of their children at 7 years and this data was also required for inclusion.
Minimum age
7 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Retrospective
Statistical methods / analysis
The data will be weighted to account for the unequal selection probability and non-response. The clustering of the sample in terms of region of recruitment will be taken into account by using the svy command. Participant characteristics will be calculated in raw (unweighted) values and weighted proportions for categorical variables, or as weighted means and standard deviations for continuous variables as appropriate. Regression models will be calculated for each lifestyle variable, with linear regression used for continuous variables (physical activity, social media use) and logistic regression for dichotomous variables (sleep, fruit, vegetable, soft drink consumption). All models will include the stratum design variable as a dummy variable as per data guidelines to account for sampling stratification methods. Models will be conducted separately for each predictor with the participants’ sex, body fat percentage at 14 years, and household income included as covariates. Supplementary analyses will be conducted with each model adjusted for all other lifestyle variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
1/01/2015
Date of last data collection
Anticipated
Actual
30/04/2016
Sample size
Target
15415
Accrual to date
Final
11726
Recruitment outside Australia
Country [1] 21805 0
United Kingdom
State/province [1] 21805 0

Funding & Sponsors
Funding source category [1] 303640 0
Government body
Name [1] 303640 0
Economic and Social Research Council, UK Government
Country [1] 303640 0
United Kingdom
Primary sponsor type
University
Name
Deakin University
Address
Gheringhap Street
Geelong VIC
Australia 3220
Country
Australia
Secondary sponsor category [1] 303730 0
None
Name [1] 303730 0
Address [1] 303730 0
Country [1] 303730 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 304165 0
Ethics committee address [1] 304165 0
Ethics committee country [1] 304165 0
Date submitted for ethics approval [1] 304165 0
Approval date [1] 304165 0
Ethics approval number [1] 304165 0

Summary
Brief summary
This study is a secondary analysis of the UK Millennium Cohort Study (MCS), a longitudinal study of young people led by the Centre for Longitudinal Research. Ethics for the MCS has previously been obtained and detailed below. Data will be obtained from the UK Millennium Cohort Study data custodians at the Centre for Longitudinal Research. Additional ethics approval is not required due to the data being pre-existing and non-identifiable.
The aim of this study is to investigate the relationships between mental health during childhood and adolescence as an exposure of interest, and subsequent physical activity, diet, sleep and social media use behaviours at 14 years as outcomes of interest, among a large, nationally representative cohort of young people in the United Kingdom. it is hypothesised that mental health problems early in life and in adolescence will predict sub-optimal lifestyle behaviours in adolescence.
Trial website
https://cls.ucl.ac.uk/cls-studies/millennium-cohort-study/
Trial related presentations / publications
Public notes
Ethics for the the data included in this study was previously obtained from the Northern and Yorkshire Multi-Centre Research Ethics Committee of the UK National Health Survey. Informed consent was provided from all participating families. Data will be accessed with permission of the data custodians and the data used in this study are pre-existing and de-identified.

Contacts
Principal investigator
Name 96018 0
Dr Erin Hoare
Address 96018 0
Deakin University
Kitchener House
Ryrie Street
Geelong VIC
AUSTRALIA
3220
Country 96018 0
Australia
Phone 96018 0
+61 3 5227 2333
Fax 96018 0
Email 96018 0
[email protected]
Contact person for public queries
Name 96019 0
Dr Erin Hoare
Address 96019 0
Deakin University
Kitchener House
Ryrie Street
Geelong VIC
AUSTRALIA
3220
Country 96019 0
Australia
Phone 96019 0
+61 3 5227 2333
Fax 96019 0
Email 96019 0
[email protected]
Contact person for scientific queries
Name 96020 0
Dr Erin Hoare
Address 96020 0
Deakin University
Kitchener House
Ryrie Street
Geelong VIC
AUSTRALIA
3220
Country 96020 0
Australia
Phone 96020 0
+61 3 5227 2333
Fax 96020 0
Email 96020 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
Permission for sharing IPD lies with data custodians at the Centre for Longitudinal Studies.


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.