Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000185965
Ethics application status
Approved
Date submitted
31/01/2020
Date registered
18/02/2020
Date last updated
17/11/2020
Date data sharing statement initially provided
18/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
SuNDiAL Project: Survey of Nutrition Dietary Assessment and Lifestyle 2020: Adolescent Males
Scientific title
SuNDiAL Project: Survey of Nutrition Dietary Assessment and Lifestyle 2020: Adolescent Males
Secondary ID [1] 300406 0
none
Universal Trial Number (UTN)
Trial acronym
SuNDiAL 2020
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutritional Status 316048 0
Dietary Habits 316049 0
Condition category
Condition code
Diet and Nutrition 314324 314324 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will complete two 24-h diet recalls (retrospective recall of diet; each taking approximately 30 min to complete) to provide an estimate of usual dietary intake (the first of these recalls will be performed on a school day, the second will be performed on a Saturday or Sunday, no more than 2 weeks after the first recall). They will also complete two previous day activity recalls (retrospective recall of activity, including sleep, physical activity, sedentary time and screen use; each taking approximately 30 min to complete). Participants will also provide a blood sample for analysis of lipid and HbA1c concentrations, a urine sample for analysis of iodine concentrations (5 min)wear an accelerometer for 7 days to provide an estimate of 24 h activity (sleep, sedentary behavior and physical activity) and answer questions about their attitudes and beliefs about the foods they choose to eat (or not eat) All these components will be measured over a two week time period. Data collection will occur in two distinct time periods so participants will either undergo data collection procedures between February and April 2020 or August and October 2020
Intervention code [1] 316697 0
Not applicable
Comparator / control treatment
Study is observational - no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322701 0
Nutrient intake assess via two 24 h recalls
Timepoint [1] 322701 0
assessed once in either February-April OR August-October 2020
Secondary outcome [1] 379346 0
HbA1c concentrations in the blood measured by assay
Timepoint [1] 379346 0
assessed once in either February-April OR August-October 2020
Secondary outcome [2] 379347 0
total cholesterol in the blood measured by assay
Timepoint [2] 379347 0
assessed once in either February-April OR August-October 2020
Secondary outcome [3] 379348 0
Blood pressure measured using an automated sphygmomanometer
Timepoint [3] 379348 0
assessed once in either February-April OR August-October 2020
Secondary outcome [4] 379349 0
Urinary iodine concentrations measured by assay
Timepoint [4] 379349 0
assessed once in either February-April OR August-October 2020
Secondary outcome [5] 379350 0
Food choice, assessed via a modified version of the Food Choice Questionnaire
Timepoint [5] 379350 0
assessed once in either February-April OR August-October 2020
Secondary outcome [6] 379351 0
Rationalization of meat consumption, assessed via the Rationalizing meal consumption: The 4Ns Questionnaire
Timepoint [6] 379351 0
assessed once in either February-April OR August-October 2020
Secondary outcome [7] 379352 0
Dietary Habits assessed via the Dietary Habits Questionnaire (used in the NZ Health Survey)
Timepoint [7] 379352 0
assessed once in either February-April OR August-October 2020
Secondary outcome [8] 379353 0
24 activity patterns, assessed via 7 day actigraphy
Timepoint [8] 379353 0
assessed once over 7 days in either February-April OR August-October 2020
Secondary outcome [9] 379354 0
Screen time, assessed via two previous day activity recall
Timepoint [9] 379354 0
assessed once in either February-April OR August-October 2020
Secondary outcome [10] 379768 0
HDL concentrations measured in blood by assay
Timepoint [10] 379768 0
assessed once in either February-April OR August-October 2020

Eligibility
Key inclusion criteria
Male high school students between the ages of 15 to 18 years from 20 high schools across New Zealand, who speak and understand English, and are able to complete the required online questionniare
Minimum age
15 Years
Maximum age
18 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample size and statistical power
To estimate mean nutrient intakes with a 95% precision interval, 100 participants will be required to give a precision level of +/-0.2 SD (standard deviations). To allow for drop-outs, incomplete data and a small design effect from school clusters, we aim to recruit at least 150 boys. In a similar study of adolescent girls (SuNDiAL Project 2019) the intra-class correlation for nutrient intakes within schools was small (less than 0.04), meaning that the design effect from school clusters is likely to be less than 1.5 (if at least 10 boys from each school participate).

Statistical methods
Statistical analyses will be carried out using Stata (StataCorp. 2017.Stata Statistical Software: Release 16 College Station, TX: StataCorp LLC). School clusters will be accounted for in all analyses using appropriate methodology (for example, with the survey command, a sandwich estimator, or as a random effect). Dietary intake estimates will be adjusted for ‘usual intake’ using the Multiple Source Method (MSM) [7]. Estimates of prevalence and means will be reported with 95% confidence intervals.


Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Covid-19
Date of first participant enrolment
Anticipated
21/02/2020
Actual
24/02/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
20/03/2020
Date of last data collection
Anticipated
31/12/2020
Actual
17/04/2020
Sample size
Target
150
Accrual to date
Final
128
Recruitment outside Australia
Country [1] 22285 0
New Zealand
State/province [1] 22285 0
Otago

Funding & Sponsors
Funding source category [1] 304830 0
University
Name [1] 304830 0
University of Otago
Country [1] 304830 0
New Zealand
Primary sponsor type
University
Name
Department of Human Nutrition, University of Otago
Address
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 305162 0
None
Name [1] 305162 0
Address [1] 305162 0
Country [1] 305162 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305241 0
University of Otago Human Ethics Committee
Ethics committee address [1] 305241 0
Ethics committee country [1] 305241 0
New Zealand
Date submitted for ethics approval [1] 305241 0
20/01/2019
Approval date [1] 305241 0
10/02/2020
Ethics approval number [1] 305241 0
H20/004

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

Contacts
Principal investigator
Name 99734 0
Dr Meredith Peddie
Address 99734 0
Department of Human Nutrition University of Otago PO Box 56 Dunedin 9054
Country 99734 0
New Zealand
Phone 99734 0
+6434798157
Fax 99734 0
Email 99734 0
[email protected]
Contact person for public queries
Name 99735 0
Meredith Peddie
Address 99735 0
Department of Human Nutrition University of Otago PO Box 56 Dunedin 9054
Country 99735 0
New Zealand
Phone 99735 0
+6434798157
Fax 99735 0
Email 99735 0
[email protected]
Contact person for scientific queries
Name 99736 0
Meredith Peddie
Address 99736 0
Department of Human Nutrition University of Otago PO Box 56 Dunedin 9054
Country 99736 0
New Zealand
Phone 99736 0
+6434798157
Fax 99736 0
Email 99736 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• only to researchers who provide a methodologically sound proposal only case-by-case basis

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual de-identified participant data underlying published results only

What types of analyses could be done with individual participant data?
• only to achieve the aims of the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
from publication with no end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by principal investigator, who can be emailed ([email protected]) requests to access data.

Are there extra considerations when requesting access to individual participant data?
No


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
EmbaseHow does being overweight moderate associations between diet and blood pressure in male adolescents?.2021https://dx.doi.org/10.3390/nu13062054
EmbaseUsing a 24 h activity recall (Star-24) to describe activity in adolescent boys in new zealand: Comparisons between a sample collected before, and a sample collected during the covid-19 lockdown.2021https://dx.doi.org/10.3390/ijerph18158035
N.B. These documents automatically identified may not have been verified by the study sponsor.