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Trial registered on ANZCTR


Registration number
ACTRN12619000290190
Ethics application status
Approved
Date submitted
4/02/2019
Date registered
26/02/2019
Date last updated
26/02/2019
Date data sharing statement initially provided
26/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SuNDiAL Project: Survey of Nutrition, Dietary Assessment and Lifestyle
Scientific title
The SuNDiAL Project: Vegetarianism in New Zealand female adolescents
Secondary ID [1] 297284 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
SuNDiAL Project: Survey of Nutrition, Dietary Assessment and Lifestyle
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutritional inadequacies 311361 0
Condition category
Condition code
Diet and Nutrition 309998 309998 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-hour 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), provide a blood sample for the analysis of biochemical status of key nutrients (5 min), wear an accelerometer for 7 days to provide an estimate of 24 hour activity (sleep, sedentary behaviour and physical activity) and answer questions about their attitudes and beliefs about the foods they choose to eat (or not eat). All of these components will be measured over a two week time period. Data collection is occurring in two distinct time windows so participants will either undergo data collection procedures in March 2019, or August 2019.
Intervention code [1] 313534 0
Not applicable
Comparator / control treatment
vegetarians will be compared to non-vegetarians cross sectionally
Control group
Active

Outcomes
Primary outcome [1] 318909 0
Iron intake will be assessed via two 24 h recalls
Timepoint [1] 318909 0
Assessed once in either March or August 2019
Primary outcome [2] 318934 0
biochemical iron status assessed a combination of of serum ferritin and soluble transferrin receptor (measured by immunoassay) and haemoglobin concentrations (measured using a coulter counter) in the blood
Timepoint [2] 318934 0
Assessed once in either March or August 2019
Secondary outcome [1] 366381 0
Zinc intake will be assessed via two 24 hour diet records
Timepoint [1] 366381 0
Assessed once in either March or August 2019
Secondary outcome [2] 366382 0
Self perceptions of animal-product consumption, assessed via a modified version of the Dietarian Identify Questionnaire
Timepoint [2] 366382 0
Assessed once in either March or August 2019
Secondary outcome [3] 366383 0
time spent in sedentary behavior assessed via 7 day actigraphy
Timepoint [3] 366383 0
Assessed once over seven days in either March or August 2019
Secondary outcome [4] 367197 0
time spent in moderate-to-vigorous physical activity assessed via 7 day actigraphy
Timepoint [4] 367197 0
Assessed once over seven days in either March or August 2019
Secondary outcome [5] 367198 0
sleep time assessed via 7 day actigraphy
Timepoint [5] 367198 0
Assessed once over seven days in either March or August 2019
Secondary outcome [6] 367199 0
Food choice, assessed via a modified version of the Food Choice Questionnaire
Timepoint [6] 367199 0
Assessed once in either March or August 2019
Secondary outcome [7] 367200 0
rationalisation of meat consumption, assessed the Rationalizing meat consumption: The 4Ns Questionnaire
Timepoint [7] 367200 0
Assessed once either March or August 2019
Secondary outcome [8] 367201 0
Dietary habits, assessed via the Dietary Habits Questionnaire (as used in the NZ Health Survey and the NZ Adult Nutrition Survey)
Timepoint [8] 367201 0
Assessed once in either March or August 2019
Secondary outcome [9] 367202 0
Vitamin b12 concentrations in the blood, measured via electrochemiluminescence immunoassay
Timepoint [9] 367202 0
Assessed once in either March or August 2019
Secondary outcome [10] 367203 0
Vitamin b12 intake, assessed via two 24 hour diet recalls
Timepoint [10] 367203 0
Assessed in either March or August 2019
Secondary outcome [11] 367204 0
fat intake, assessed via to 24 hour diet recalls
Timepoint [11] 367204 0
assessed once in either March or August 2019
Secondary outcome [12] 367205 0
protein intake assessed via two 24 h diet recalls
Timepoint [12] 367205 0
assessed once in either March or August 2019
Secondary outcome [13] 367206 0
Carbohydrate intake assessed via two 24 hour diet recalls
Timepoint [13] 367206 0
assessed once in either March or August 2019

Eligibility
Key inclusion criteria
Female high school students between the ages of 15 to 18 years from 14 high schools across New Zealand, who speak and understand English and are able to complete the required online questionnaires
Minimum age
15 Years
Maximum age
18 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pregnancy

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample size and statistical power
A sample size of 300 high school students enrolled from 14 high schools gives 80% power to the a=0.05 level to detect a 0.5 standard deviation difference (a “moderate” difference) in continuous outcome variables between vegetarians and non-vegetarians, assuming a prevalence of vegetarianism of 20% and a design effect (for school clusters) of 1.5.

Statistical methods
Statistical analyses will be carried out using Stata (Stata Corp, Texas). 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). Estimates of prevalence and means will be reported with 95% confidence intervals. A binary variable for vegetarianism will be created and comparisons between vegetarians and non-vegetarians will be carried out using appropriate regression models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21247 0
New Zealand
State/province [1] 21247 0

Funding & Sponsors
Funding source category [1] 301842 0
Charities/Societies/Foundations
Name [1] 301842 0
Lotteries Health Reseach Grant
Address [1] 301842 0
The Department of Internal Affairs
Level One, Bloomfield House
46-50 Bloomfield Terrace
LOWER HUTT, 5010
Country [1] 301842 0
New Zealand
Funding source category [2] 301844 0
University
Name [2] 301844 0
Univerisity of Otago
Address [2] 301844 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country [2] 301844 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] 301587 0
Individual
Name [1] 301587 0
Meredith Peddie
Address [1] 301587 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country [1] 301587 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302543 0
Univeristy of Otago Human Ethics Committee (Health)
Ethics committee address [1] 302543 0
University of Otago
PO Box 56
Dunedin
9054
Ethics committee country [1] 302543 0
New Zealand
Date submitted for ethics approval [1] 302543 0
21/01/2019
Approval date [1] 302543 0
04/02/2019
Ethics approval number [1] 302543 0
H19/004

Summary
Brief summary
The aim of the SuNDial project is to compare the nutritional and health status of vegetarian and non-vegetarian adolescent women. There are very limited data about dietary intake and lifestyle in this age group who exhibit increasing interest in adopting vegetarian eating patterns. Three hundred females aged between 15 and 18 years will be recruited to participate from secondary schools throughout New Zealand between February and October 2019. Participants will complete two 24-hour diet recalls to provide an estimate of usual dietary intake, provide a blood sample for the analysis of biochemical status of key nutrients, wear an accelerometer for 7 days to provide an estimate of 24 hour activity (sleep, sedentary behaviour and physical activity) and answer questions about their attitudes and beliefs about the foods they choose to eat (or not eat). Comparisons of these outcomes will be made between vegetarians and non-vegetarians using regression models for nutrient intake and status, and scores from questionnaires about attitudes and beliefs; and fractional multinomial logit models for 24 hour activity. Results will be used to inform public health policy about appropriate ways to follow a more plant-based approach to eating without increasing the risk of deficiency of nutrients such as iron and calcium, or inadvertently increasing saturated fat or sodium intakes.
Trial website
www.otago.ac.nz/sundial
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90586 0
Dr Jill Haszard
Address 90586 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 90586 0
New Zealand
Phone 90586 0
+64 3 479 5683
Fax 90586 0
Email 90586 0
jill.haszard@otago.ac.nz
Contact person for public queries
Name 90587 0
Dr Meredith Peddie
Address 90587 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 90587 0
New Zealand
Phone 90587 0
+64 3 479 8157
Fax 90587 0
Email 90587 0
meredith.peddie@otago.ac.nz
Contact person for scientific queries
Name 90588 0
Dr Jill Haszard
Address 90588 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 90588 0
New Zealand
Phone 90588 0
+64 3 479 5683
Fax 90588 0
Email 90588 0
jill.haszard@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual de-identified participant data underlying published results only
When will data be available (start and end dates)?
from publication with no end date determined
Available to whom?
Only to researchers who provide a methodologically sound proposal on a case-by-case basis
Available for what types of analyses?
only to achieve the aims of the approved proposal
How or where can data be obtained?
access subject to approvals by principal investigator
What supporting documents are/will be available?
No other documents available
Summary results
No Results