Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001430123
Ethics application status
Approved
Date submitted
24/09/2019
Date registered
16/10/2019
Date last updated
18/09/2023
Date data sharing statement initially provided
16/10/2019
Date results provided
20/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
ARIA: Annual rhythms in adults' lifestyle and health
Scientific title
Annual rhythms in weight gain, activity and diet compositions in parents – identifying opportunities to prevent cycles of weight gain
Secondary ID [1] 298854 0
Nil
Universal Trial Number (UTN)
Trial acronym
ARIA (Annual Rhythms in Adults)
Linked study record
Participants are parents of children in ACTRN12618002008202.

Health condition
Health condition(s) or problem(s) studied:
Overweight 313808 0
Physical inactivity 313809 0
Inadequate diet 313810 0
Condition category
Condition code
Public Health 312219 312219 0 0
Epidemiology
Diet and Nutrition 313010 313010 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to examine
(1) annual rhythms in weight, activity and diet in adults;
(2) associations between changes in adults’ weight, activity and diet;
(3) how adults' weight, activity and diet are associated with their children’s weight, activity and diet; and
(4) associations between parental factors (holiday/vacation status, home environment, and parenting style) and children’s weight.

This observational cohort study will observe weight, activity and diet over 1 year in parents or guardians of children enrolled in the existing cohort study “Life on Holidays” (ACTRN12618002008202). Specifically, weight (measured using Fitbit Aria 2 scales), and 24 h movement data (minutes of sleep, sedentary behaviour, light physical activity, and moderate-to-vigorous physical activity; measured using Fitbit Charge 3 activity trackers) will be measured daily. Diet (measured using the Cancer Council Victoria’s Dietary Questionnaire for Epidemiological Studies) and holiday/vacation status will be measured on 8 occasions. Home environment (measured using items from the ISCOLE study parent survey) and parenting style (measured using the parental warmth and control scales from the Longitudinal Study of Australian Children) will be measured at baseline (survey will take approx 15 minutes). Recruitment and data collection will occur in three waves: wave 1 (cohort 1) assessments will occur from December 2019 (baseline) through to December 2020; wave 2 (cohort 2) assessments will occur from December 2020 to December 2021; wave 3 (cohort 3) assessments will occur from December 2020 to December 2021. Wave 3 will differ from waves 1 and 2, in that parents from the general public will be recruited, rather than from the Life on Holidays study. Data from parents in waves 1 and 2 will be matched with weight, activity and diet data from their child(ren) enrolled in the existing cohort study, Life on Holidays. Data from parents in wave 3 will not be linked to any children's data, and will therefore answer to aims (1) and (2) only.
Intervention code [1] 315121 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320860 0
Body weight (kgs) will be assessed remotely using Fitbit Aria 2 Wi-Fi scales.
Timepoint [1] 320860 0
Participants will weigh themselves daily for 12 months between the following months:
Wave 1: Dec 2019 – Dec 2020
Wave 2: Dec 2020 – Dec 2021
Wave 3: Dec 2020 – Dec 2021
Primary outcome [2] 320861 0
Daily activity composition (minutes spent in sleep, sedentary behaviour, light physical activity, and moderate-to-vigorous physical activity) will be assessed remotely using Fitbit Charge 3 activity trackers.
Timepoint [2] 320861 0
Participants will wear their activity tracker continuously for 12 months between the following months:
Wave 1: Dec 2019 – Dec 2020
Wave 2: Dec 2020 – Dec 2021
Wave 3: Dec 2020 – Dec 2021
Primary outcome [3] 320862 0
Diet will be assessed using the online Dietary Questionnaire for Epidemiological Studies (DQES v3.2; developed by Cancer Council Victoria), modified to reflect diet over the previous month.
Timepoint [3] 320862 0
Wave 1 baseline assessment (Dec 2019) and 7 follow-up assessments (Jan, Mar, Apr, June, Aug, Oct and Dec 2020).
Wave 2 baseline assessment (December 2020) and 7 follow-up assessments (Jan, Mar, Apr, June, Aug, Oct and Dec 2021).
Wave 3 baseline assessment (December 2020) and 7 follow-up assessments (Jan, Mar, Apr, June, Aug, Oct and Dec 2021).
Secondary outcome [1] 373113 0
Holiday/vacations status (did the participant have holidays at home or a vacation away) in the last month (baseline) or since the previous assessment (follow-up timepoints) will be assessed via purpose-designed survey item.
Timepoint [1] 373113 0
Wave 1 baseline assessment (Dec 2019) and 7 follow-up assessments (Jan, Mar, Apr, June, Aug, Oct and Dec 2020).
Wave 2 baseline assessment (December 2020) and 7 follow-up assessments (Jan, Mar, Apr, June, Aug, Oct and Dec 2021).
Wave 3 baseline assessment (December 2020) and 7 follow-up assessments (Jan, Mar, Apr, June, Aug, Oct and Dec 2021).
Secondary outcome [2] 373114 0
Parenting style will be assessed using the parenting style survey from the Longitudinal Study of Australian Children. For waves 1 and 2, parenting style for the child enrolled in Life on Holidays will be assessed. For wave 3, parenting style of the child closest in age to 10 years will be assessed.
Timepoint [2] 373114 0
Baseline assessment
Secondary outcome [3] 373115 0
Home environment (e.g. motor vehicles, TV/computer/video games) will be assessed using items from the International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) questionnaire. For waves 1 and 2, any child-specific questions will relate to the child enrolled in Life on Holidays. For wave 3, any child-specific questions will relate to the child aged closest to 10 years.
Timepoint [3] 373115 0
Baseline assessment

Eligibility
Key inclusion criteria
Participants in waves 1 and 2 will be parents or guardians of grade 4 school children who are enrolled in an existing cohort study, Life on Holidays. Additionally, participants must have a home-based wireless internet connection (Wi-Fi or mobile internet) with access to a compatible device (smartphone, tablet, laptop or desktop computer with Bluetooth), reside in greater Adelaide, be proficient in English, and be ambulant.
All criteria will remain the same for wave 3, with the exception of the first criterion. Instead of being parents of a child enrolled in Life on Holidays, participants will be parents of children aged 5-12 years, recruited from the general public.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are currently experiencing a life-threatening illness or condition that impacts daily lifestyle and health, have a pacemaker or any other implanted medical device, or are pregnant.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Activity (i.e. proportion of time spent in sleep, sedentary behaviour, light physical activity, and moderate-to-vigorous physical activity) and diet (i.e. proportion of macronutrients in the diet) will be quantified as compositions.

Aim 1: Annual rhythms in adults’ weight, activity and diet will be described graphically using Loess curves.
Aim 2: Associations between change in adults’ weight, activity and diet will be examined using linear mixed effects modelling.
Aim 3 (using linked data from Life on Holidays): A series of linear mixed effects models will be used to examine associations between change in children’s weight (standardised body mass index), activity and diet and change in parents’ weight, activity and diet, respectively.
Aim 4 (using linked data from Life on Holidays): Factor analysis will be used to derive factors from responses on the baseline home environment questionnaire. Linear mixed effects modelling will be used to examine the association between home environment factor scores and parenting style and change in children’s weight, activity and diet.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/10/2019
Actual
1/12/2019
Date of last participant enrolment
Anticipated
3/08/2020
Actual
1/12/2020
Date of last data collection
Anticipated
31/12/2021
Actual
31/12/2021
Sample size
Target
375
Accrual to date
Final
375
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 303403 0
Government body
Name [1] 303403 0
National Health and Medical Research Council
Country [1] 303403 0
Australia
Primary sponsor type
University
Name
The University of South Australia
Address
GPO Box 2471 Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 303446 0
None
Name [1] 303446 0
Address [1] 303446 0
Country [1] 303446 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303932 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 303932 0
Ethics committee country [1] 303932 0
Australia
Date submitted for ethics approval [1] 303932 0
Approval date [1] 303932 0
07/04/2019
Ethics approval number [1] 303932 0
201901

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

Contacts
Principal investigator
Name 95298 0
A/Prof Carol Maher
Address 95298 0
University of South Australia, School of Health Sciences.
GPO Box 2471 Adelaide SA 5001, Australia
Country 95298 0
Australia
Phone 95298 0
+61 8 8302 2315
Fax 95298 0
Email 95298 0
[email protected]
Contact person for public queries
Name 95299 0
Carol Maher
Address 95299 0
University of South Australia, School of Health Sciences.
GPO Box 2471 Adelaide SA 5001, Australia
Country 95299 0
Australia
Phone 95299 0
+61 8 8302 2315
Fax 95299 0
Email 95299 0
[email protected]
Contact person for scientific queries
Name 95300 0
Carol Maher
Address 95300 0
University of South Australia, School of Health Sciences.
GPO Box 2471 Adelaide SA 5001, Australia
Country 95300 0
Australia
Phone 95300 0
+61 8 8302 2315
Fax 95300 0
Email 95300 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


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
SourceTitleYear of PublicationDOI
EmbaseChanges in diet, activity, weight, and wellbeing of parents during COVID-19 lockdown.2021https://dx.doi.org/10.1371/journal.pone.0248008
EmbaseHow do 24-h movement behaviours change during and after vacation? A cohort study.2023https://dx.doi.org/10.1186/s12966-023-01416-2
EmbaseWeather associations with physical activity, sedentary behaviour and sleep patterns of Australian adults: a longitudinal study with implications for climate change.2023https://dx.doi.org/10.1186/s12966-023-01414-4
EmbaseWeekly, Seasonal, and Festive Period Weight Gain Among Australian Adults.2023https://dx.doi.org/10.1001/jamanetworkopen.2023.26038
N.B. These documents automatically identified may not have been verified by the study sponsor.