Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000960752
Ethics application status
Approved
Date submitted
22/08/2013
Date registered
29/08/2013
Date last updated
16/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Milk for Schools programme on milk and dairy consumption in Auckland children in years 3 and 4
Scientific title
Effects of the milk for schools programme on milk consumption in children in years 3-4 in Auckland.
Secondary ID [1] 283059 0
Nil
Universal Trial Number (UTN)
U1111-1146-9463
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low milk consumption 289899 0
Condition category
Condition code
Diet and Nutrition 290264 290264 0 0
Other diet and nutrition disorders
Public Health 290318 290318 0 0
Health promotion/education

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This cohort observational trial will evaluate the effects of the Milk for Schools programme on milk and dairy consumption in children in years 3-4 attending Auckland schools involved in the Term 4 2013 programme roll out.
Intervention code [1] 287781 0
Not applicable
Comparator / control treatment
No control condition.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290291 0
Frequency of having at least 2 servings of plain milk or other dairy products (cheese and yogurt) per day.

Assessed by self-report questionnaire designed specifically for this study and completed by the child during class hours.
Timepoint [1] 290291 0
Baseline, and years 1 and 2.
Secondary outcome [1] 304248 0
Weight.
Measured to the nearest 0.1kg, using a digital scale.
Timepoint [1] 304248 0
Baseline, and years 1 and 2.
Secondary outcome [2] 304249 0
Height.
Measured to the nearest 0.1cm with a stadiometer
Timepoint [2] 304249 0
Baseline, and years 1 and 2.
Secondary outcome [3] 304250 0
BMI
Calculated from height and weight.
Timepoint [3] 304250 0
Baseline, and years 1 and 2.
Secondary outcome [4] 304251 0
Sitting height.
Measured to the nearest 0.1 cm with a stadiometer, according to standard procedures, with the child sitting on the floor.
Timepoint [4] 304251 0
Baseline, and years 1 and 2.
Secondary outcome [5] 304252 0
Waist circumference.
Measured using a flexible non-elastic tape measure.
Timepoint [5] 304252 0
Baseline, and years 1 and 2.
Secondary outcome [6] 304253 0
Milk and dairy consumption habits (frequency of milk and dairy consumption).
Assessed by self-report questionnaire designed specifically for this study and completed by the child during class hours.
Timepoint [6] 304253 0
Baseline, and years 1 and 2.
Secondary outcome [7] 304254 0
Consumption of soft drinks.
Assessed by self-report questionnaire designed specifically for this study and completed by the child during class hours.
Timepoint [7] 304254 0
Baseline, and years 1 and 2.

Eligibility
Key inclusion criteria
Child in Years 3 & 4 enrolled in a participating school, able to provide informed consent or assent to participate, speaks and understands English
Minimum age
7 Years
Maximum age
9 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
Prospective
Statistical methods / analysis
Statistical analyses will be performed using SAS version 9.3 (SAS Institute Inc. Cary NC). A 5% significance level (two-sided) will be considered in all statistical tests (if any). Demographic information and baseline measures on child participants in the study will be summarised by school deciles as quintiles and overall. Continuous variables will be presented as numbers of observed and missing values, mean, standard deviation, median, and range. Categorical variables will be presented as frequencies and percentages.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/10/2013
Actual
21/10/2013
Date of last participant enrolment
Anticipated
25/11/2013
Actual
25/11/2013
Date of last data collection
Anticipated
Actual
12/11/2015
Sample size
Target
300
Accrual to date
Final
511
Recruitment outside Australia
Country [1] 5327 0
New Zealand
State/province [1] 5327 0

Funding & Sponsors
Funding source category [1] 287823 0
Commercial sector/Industry
Name [1] 287823 0
Fonterra
Country [1] 287823 0
New Zealand
Primary sponsor type
University
Name
National Institute for Health Innovation, University of Auckland
Address
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 286553 0
None
Name [1] 286553 0
Address [1] 286553 0
Country [1] 286553 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289770 0
Health and Disability Ethics Committee
Ethics committee address [1] 289770 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 289770 0
New Zealand
Date submitted for ethics approval [1] 289770 0
29/08/2013
Approval date [1] 289770 0
Ethics approval number [1] 289770 0
Ethics committee name [2] 293740 0
Health and Disability Committee
Ethics committee address [2] 293740 0
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
WELLINGTON
Ethics committee country [2] 293740 0
New Zealand
Date submitted for ethics approval [2] 293740 0
18/04/2013
Approval date [2] 293740 0
20/09/2013
Ethics approval number [2] 293740 0
13/NTA/155/AM01

Summary
Brief summary
The aim of this study is to evaluate the impact of the Fonterra Milk for Schools programme on children’s dietary habits (particularly milk and dairy consumption) and anthropometric measures. Students in randomly selected Auckland schools participating in the Milk for Schools programme who are in years 3 and 4 will take part in the baseline assessment, and will be followed for up to 2 years. We aim to recruit 300 children in total. Children will complete a questionnaire in class during Term 4 2013 (baseline), and anthropometric measures will also be taken. Demographic information will be summarised. Descriptive statistics will be conducted for milk and dairy habits and knowledge and attitudes towards milk and other dairy products. There will also be the potential to follow-up these participants after 1 and 2 years. At follow-up, paired statistical tests will be conducted to evaluate the level of significance in reported differences in milk and dairy intakes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42330 0
Dr Clare Wall
Address 42330 0
Discipline of Nutrition
Faculty of Medicine and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1010
Country 42330 0
New Zealand
Phone 42330 0
+64 9 373 7599 ext 89875
Fax 42330 0
Email 42330 0
[email protected]
Contact person for public queries
Name 42331 0
Karen Carter
Address 42331 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 42331 0
New Zealand
Phone 42331 0
+64 9 373 7599 ext. 87863
Fax 42331 0
Email 42331 0
[email protected]
Contact person for scientific queries
Name 42332 0
Karen Carter
Address 42332 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand
Country 42332 0
New Zealand
Phone 42332 0
+64 9 373 7599 ext. 87863
Fax 42332 0
Email 42332 0
[email protected]

No information has been provided regarding IPD availability


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.