Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001280796
Ethics application status
Approved
Date submitted
9/10/2013
Date registered
20/11/2013
Date last updated
20/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of the effects of fruit intake on cardiovascular disease risk factors in children
Scientific title
A randomised controlled trial of the effects of fruit intake on cardiovascular disease risk factors in children
Secondary ID [1] 283383 0
Nil
Universal Trial Number (UTN)
Trial acronym
The FIST Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease risk factors in children 290281 0
Condition category
Condition code
Diet and Nutrition 290669 290669 0 0
Obesity
Cardiovascular 290705 290705 0 0
Coronary heart disease
Public Health 290706 290706 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of a daily serviing of fruit in the classroom over an 8 week (1 term) period. Fresh seasonal servings of fruit (a choice of apples, oranges, and bananas) were provided on a daily basis
Intervention code [1] 288106 0
Lifestyle
Comparator / control treatment
Matched control schools with no provision of fruit on a daily basis
Control group
Active

Outcomes
Primary outcome [1] 290690 0
cardiovascular risk factors including;
- Blood pressure: measured with an automatic BP monitor
- Blood cholesterol: measured with point of care Cholestex device
- Weight & Height: measured on a weight/height scale
- Body Fat: measure using Bio-impedence methods
- Physical Fitness: measured using Bench Step Test protocol and 400 m walk/run test
Timepoint [1] 290690 0
8 weeks
Primary outcome [2] 290691 0
dietary attitude and behaviour was assessed using the dietary assessment questionnaire from the Schools Nutrition Survey
Timepoint [2] 290691 0
8 weeks
Secondary outcome [1] 305042 0
parental attitude towards dietary intake and physical activity was assesssed using a questionnaire. The parental attitude questionnaire was developed specifically for the study
Timepoint [1] 305042 0
8 weeks

Eligibility
Key inclusion criteria
attend participating Year 4 and 5 classes
Minimum age
10 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
absence from school during the term

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cluster trial - schools were randomised to receive intervention or control.
Allocation involved contacting the central administration site where the allocation schedule was held.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
ANCOVA of changes in cardiovascular risk factors adjusting for baseline levels. Chi squatre analysis of catagorical data
Sample size (100 subjects per group) was based on detecting a 10% change in dietary score (25 to 23) with a standard deviation of 5% (80% power and 5% significance level). Assuming 25 students in each class and an ICC of 0.01, a design effect of 25% was added giving a target of 125 subjects per group (250 in total). These estimates were derived from the findings from a pilot Assuming a 10% drop study conducted to determine study feasibility (Chellappha, 2012).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2008
Actual
7/07/2008
Date of last participant enrolment
Anticipated
1/08/2008
Actual
1/08/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288107 0
University
Name [1] 288107 0
CCRE Therapeutics / Monash University
Country [1] 288107 0
Australia
Primary sponsor type
University
Name
Monash University
Address
6th Floor/ 99 Commercial Rd
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 286827 0
None
Name [1] 286827 0
Address [1] 286827 0
Country [1] 286827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290029 0
Monash University
Ethics committee address [1] 290029 0
Ethics committee country [1] 290029 0
Australia
Date submitted for ethics approval [1] 290029 0
Approval date [1] 290029 0
23/08/2006
Ethics approval number [1] 290029 0
2006/480

Summary
Brief summary
Background Dietary choice habits are known to influence cardiovascular disease (CVD) risk factors, which even in childhood are a predictor of future morbidity. Our objective was determining the impact of a school-based intervention of providing fruit daily in the classroom and its effects on risk factors for CVD, and dietary behavior.
Methods The study was a randomized controlled trial involving two public and two private schools, one of each in an intervention and control group. Measurement at both the start and end of eight weeks aimed to identify any changes in physiological measures, child and parental attitudes and food choices.
Results The intervention had minimal impact on physiological variables, but was effective in improving the amount of fruit and vegetables consumed and attitudes towards fruit intake. Parent lifestyle and dietary choices were poor at baseline, but significantly improved in parents of children in the intervention group compared to the control group.
Conclusion This intervention was effective in improving the amount of fruit consumed and attitudes towards fruit intake over just 2 months. It has also shown the importance of not just the school environment but also suggests the home environment can influence children developing good dietary choice habits and lifestyle.
Trial website
Trial related presentations / publications
Chellappha, J, Tonkin A, Douglas, E, Reid CM. A pilot study of the effects of fruit intake on cardiovascular risk factors in children. Infant, Child and Adolescent Nutrition, 2012; 4: 348-354.
Public notes
The final number of participants was greater than the estimated sample size requirements as all participants in participating classes were included and the class size was essentially the determinant of final numbers.

Contacts
Principal investigator
Name 43582 0
Prof Christopher Reid
Address 43582 0
CCRE Therapeutics
School of Public Health and Preventive Medicine,
Monash University,
6th Floor / 99 Commercial Rd
Melbourne
VIC 3004
Country 43582 0
Australia
Phone 43582 0
+61399030752
Fax 43582 0
Email 43582 0
[email protected]
Contact person for public queries
Name 43583 0
Prof Christopher Reid
Address 43583 0
CCRE Therapeutics
School of Public Health and Preventive Medicine
Monash University
6th Floor / 99 Commercial Rd
Melbourne
VIC 3004
Country 43583 0
Australia
Phone 43583 0
+61399030752
Fax 43583 0
Email 43583 0
[email protected]
Contact person for scientific queries
Name 43584 0
Prof Christopher Reid
Address 43584 0
CCRE Therapeutics
School of Public Health and Preventive Medicine
Monash University
6th Floor / 99 Commercial Rd
Melbourne
VIC 3004
Country 43584 0
Australia
Phone 43584 0
+61399030752
Fax 43584 0
Email 43584 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
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