Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000453280
Ethics application status
Not yet submitted
Date submitted
25/05/2009
Date registered
12/06/2009
Date last updated
12/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Children’s dairy foods, physical activity and health.
Scientific title
What are the short and long term effects on food, energy and nutrient intake of school children when their parents are advised to replace regular-fat dairy foods with reduced/low fat alternatives?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High prevalence of children (over age 4 years) consuming regular fat dairy foods despite nutrition recommendations to consume reduced or low fat varieties. 4851 0
Condition category
Condition code
Diet and Nutrition 237198 237198 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Parents will receive individualized nutrition education about the significance of the recommended dietary changes, creating a supportive home environment, overcoming barriers and resistance to change. Parents will be provided with dietary advice including explicit written and pictorial information on appropriate dairy products to purchase. The education sessions will be delivered during four 30 minute appointments over the first 12 weeks of the intervention (weeks 1,4,8,12). The intervention will be delivered to the parent only (children will not be required to attend the intervention sessions).
Intervention code [1] 236633 0
Behaviour
Comparator / control treatment
Control: Parents will receive general health information with no specific reduced fat dairy nutrition education, and will be encouraged to continue with their “usual” dietary pattern for the intervention period. To ensure study contact and process is similar between the intervention and control groups, parents in this group will receive individualized advice about non nutrition health messages such as reducing children’s television viewing time. The education sessions will be delivered during four 30 minute appointments over the first 12 weeks of the intervention (weeks 1,4,8,12). The intervention will be delivered to the parent only (children will not be required to attend the intervention sessions).
Control group
Active

Outcomes
Primary outcome [1] 238010 0
Change in children's intake of total and saturated fat from dairy foods. Children's intake will be measured on three occassions (weeks 0,12,24) using multiple (3 days) 24 hour recalls at each occasion. The multiple pass 24 hour recall method will be conducted by a dietitian in person (day 1) and then by phone (day 2 and 3).
Timepoint [1] 238010 0
Weeks 0, 12 and 24
Primary outcome [2] 238011 0
Change in overall dietary intake (food choices, energy and nutrient intake, diet quality).Children's intake will be measured on three occassions (weeks 0,12,24) using multiple (3 days) 24 hour recalls at each occasion. The multiple pass 24 hour recall method will be conducted by a dietitian in person (day 1) and then by phone (day 2 and 3).
The rigorous method used to collect dietary intake will allow nutrient intakes to be estimated. Diet quality will be assessed using a validated index.
Timepoint [2] 238011 0
Weeks 0, 12 and 24
Secondary outcome [1] 242154 0
Compliance to intervention measured by a change in pentadecanoic acid as a biomarker for dairy fat intake; degree of change in dairy food choices using the pantry inventory and dietary recall; exploring the facilitators and barriers to intervention compliance (parental, child and intervention factors).
Timepoint [1] 242154 0
Weeks 0, 12 and 24
Secondary outcome [2] 242155 0
The degree of dietary change (full, partial, or nil) from regular fat dairy foods to reduced/low-fat varieties will be associated with the degree of overall dietary change.
Dietary change will be detiremined using the 24 hour recall data and verified using nutrient (saturated fat) and biomarker (pentadecanoic acid) data. "Full" change will reflect children consuming only reduced-low dairy fat products, "nil" change children consuming only regular fat dairy products and "partial" change will be a mixed of both full and low fat products.
Timepoint [2] 242155 0
12 and 24 weeks

Eligibility
Key inclusion criteria
Healthy children aged between 4 and 13 years.
Children and early teens have been selected as parent-led dietary change is appropriate across this age group (detailed below). Additionally this age group is an appropriate target for substitution, rather than ‘eat more’ dairy food message.
Child is a regular fat “dairy consumer”
“Dairy consumer” is defined as a child who consumes a minimum of 2 serves of dairy foods (milk, cheese, yoghurt, dairy desserts, ice-cream) on the day prior to study eligibility screening AND
Child usually consumes regular fat milk and cheese.
Child living in the Adelaide Metropolitan area.
Child able to visit study site on 4 occasions over the study period and give informed and written assent
Parent/ caregiver with adequate written and spoken English, prepared to attend all intervention and assessment sessions (visit study site on 6 occasions and participate in 6 data collection phone calls) and give informed and written consent (parental consent and on behalf of child) .
Minimum age
4 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Sibling enrolled in the study (Note: Parents will be asked to implement the intervention as a family, but nominate one child for study assessment to prevent any clustering effect)
Child consuming any reduced-fat or low-fat milk or cheese, and less than 2 serves of dairy foods per day
Child has any allergy or intolerance to dairy products
Any pre-existing medical condition which affects dietary intake

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Families will be recruited via public advertisement and media, and also from the database of children who have participated in previous Commonwealth Scientific and Industrial Research Organization (CSIRO) studies (Note all families have previously agreed to be listed on this database and contacted for future research). Study families may need to be recruited in two waves depending on the interest and response to advertisements. It is estimated that the majority of participant recruitment will be completed within a 3 month period. Allocation to treatment will be randomized. Staff member conducting initial assessment will be blinded to treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized to one of two groups via computer program (www.randomization.com). Block randomization will be used matching the two groups for children’s age and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study will be a randomised controlled trial with parallel design. The intervention will run for 12 weeks with a 12 week follow up period (total of 24 weeks).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5015 0
Commercial sector/Industry
Name [1] 5015 0
Dairy Australia
Country [1] 5015 0
Australia
Primary sponsor type
Government body
Name
CSIRO Human Nutrition
Address
Gate 13
Kintore Avenue
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 4533 0
Commercial sector/Industry
Name [1] 4533 0
Dairy Australia
Address [1] 4533 0
Dairy Australia, Level 5, IBM Centre, 60 City Road, Southbank, Victoria, 3006
Country [1] 4533 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 7113 0
CSIRO Human Ethics Commitee
Ethics committee address [1] 7113 0
Ethics committee country [1] 7113 0
Australia
Date submitted for ethics approval [1] 7113 0
10/06/2009
Approval date [1] 7113 0
Ethics approval number [1] 7113 0

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

Contacts
Principal investigator
Name 29644 0
Address 29644 0
Country 29644 0
Phone 29644 0
Fax 29644 0
Email 29644 0
Contact person for public queries
Name 12891 0
Jan Stokes
Address 12891 0
PO BOX 10041
Adelaide BC
SA 5000
Country 12891 0
Australia
Phone 12891 0
+61 8 83038888
Fax 12891 0
+61 8 83038899
Email 12891 0
[email protected]
Contact person for scientific queries
Name 3819 0
Gilly Hendrie
Address 3819 0
PO BOX 10041
Adelaide BC
SA 5000
Country 3819 0
Australia
Phone 3819 0
+61 8 83050662
Fax 3819 0
+61 8 83038899
Email 3819 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.