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Trial registered on ANZCTR


Registration number
ACTRN12611000277943
Ethics application status
Approved
Date submitted
14/03/2011
Date registered
16/03/2011
Date last updated
17/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial to increase fruit and vegetable consumption in parents
Scientific title
The efficacy of a peer-led brief nutrition education intervention in increasing fruit and vegetable consumption in parents: a wait-list community-based randomised trial .
Secondary ID [1] 259660 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Consumption of fruit and vegetables 261226 0
Condition category
Condition code
Diet and Nutrition 259372 259372 0 0
Other diet and nutrition disorders
Public Health 259532 259532 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consisted of a 90 minute, peer-led, small group education session. The session content included teaching the recommended intakes and serving sizes for fruit and vegetables; the amount of the food budget that should be spent on fruit and vegetables and the health benefits of fruit and vegetables for the family. The budgeting aspects of the sessions helped to enhance the participants' motivation to purchase and consume more fruit and vegetables, whilst recipe modification and strategies for including fruit and vegetables throughout the day helped to define an ‘action’ phase of how to make the changes. The sessions were supported with printed educational materials including a cookbook. The sessions were followed by a newsletter mailed to participants at week 2 and 5 after attending the session. The newsletters were designed to reinforce what was learnt at the sessions, to provide further educational information and to motivate participants to make the required changes in consumption.
Intervention code [1] 258087 0
Behaviour
Intervention code [2] 258101 0
Prevention
Intervention code [3] 264227 0
Lifestyle
Comparator / control treatment
Control participants were enrolled with the expectation that they would be offered the intervention, but the delivery to the control group was delayed for a period of six weeks to allow them to complete their post-program surveys (waitlist control).
Control group
Active

Outcomes
Primary outcome [1] 262188 0
The primary outcome is fruit and vegetable consumption was measured using the Dietary Questionnaire for Epidemiological Studies (DQES) descibed in serves per day (1 serve of fruit = 150g and 1 serve veg = 75g).
Timepoint [1] 262188 0
Outcomes were measures 6 weeks post-intervention.
Secondary outcome [1] 273293 0
Knowledge of recommended intakes and serve sizes for fruit and vegetables. These were measured by short questions.
Timepoint [1] 273293 0
Outcomes were measures 6 weeks post-intervention.
Secondary outcome [2] 273294 0
Stage of change for fruit and vegetable consumption. This was measured separately for fruit and vegetables by an algortithm.
Timepoint [2] 273294 0
Outcomes were measures 6 weeks post-intervention.
Secondary outcome [3] 273332 0
Number and type of barriers to fruit and vegetable consumption. These were measured by yes/no answers to pre-identified barriers.
Timepoint [3] 273332 0
Outcomes were measures 6 weeks post-intervention.

Eligibility
Key inclusion criteria
Eligible participants included parents or carers of primary school-aged children residing in the Hunter region of Australia who were not consuming the recommended daily intake of fruit and vegetables at the time of the trial . Participants had to be willing to undertake the complete Fruit & Veg $ense Program and intend to remain in the Hunter region for the 6 months subsequent to their enrolment in the trial.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those parents who were already consuming the recommended daily intake of fruit and vegetables at the time of the trial .

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)
Recruitment of participants to the trial was from free-living community members using newspaper advertisements and other advertising, word of mouth, recruitment presentations or recruitment through schools, sporting clubs, shopping centres and other community organisations. There were no incentives offered for participation. Participants were not charged to attend the educational sessions and all resources were provided at no cost.
Participants were screened for inclusion using a pre-defined telephone script by Project Officers or Project Volunteers. Eligible participants were then posted written informed consent forms and were asked to complete the pre-program surveys. Once participants returned their forms by mail, they were allocated to either the intervention or the control group in order of receipt of the envelopes by mail. The trial continued until a sufficient sample size had been attained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The group allocation sequence was generated via computer-generated randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258559 0
Charities/Societies/Foundations
Name [1] 258559 0
Cancer Council NSW
Address [1] 258559 0
153 Dowling Street
Wooloomooloo
NSW 2011
Country [1] 258559 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Council NSW
Address
153 Dowling Street
Wooloomooloo
NSW 2011
Country
Australia
Secondary sponsor category [1] 257704 0
Individual
Name [1] 257704 0
Dr Erica James
Address [1] 257704 0
Faculty of Health
University of Newcastle
School of Medicine and Public Health
Corner of King and Watt Streets
Newcastle NSW 2300
Country [1] 257704 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260534 0
Cancer Council NSW (EC00345)
Ethics committee address [1] 260534 0
153 Dowling Street
Wooloomooloo
NSW 2011
Ethics committee country [1] 260534 0
Australia
Date submitted for ethics approval [1] 260534 0
22/05/2008
Approval date [1] 260534 0
24/06/2008
Ethics approval number [1] 260534 0
233

Summary
Brief summary
The Cancer Council NSW has implemented the Eat It To Beat It Program designed to decrease cancer risk, with the focus on changing individual food purchasing decisions to increase fruit and vegetable consumption. Strategies target
parents and carers of primary school aged children in the Hunter region of NSW.
The goals of this nutrition intervention program are to increase the consumption of fruit and vegetables by the target group by 0.4 serves per day by the end of 2010.

The Eat It To Beat It Program has a number of strategies to achieve its aims. One of the strategies for the program is
The Fruit & Veg $ense Program. This program consists of:
* The Shopping and Budgeting session.
* Two newsletters sent to participants at weeks 2 and 5.

The randomised controlled trial will determine the efficacy of the Fruit & Veg $ense Program.

The research hypothesis is that “Compared with the control group, the participants who complete the Fruit & Veg $ense Program will consume more fruit and vegetables.”
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32254 0
Address 32254 0
Country 32254 0
Phone 32254 0
Fax 32254 0
Email 32254 0
Contact person for public queries
Name 15501 0
Kathy Chapman
Address 15501 0
Cancer Council NSW
153 Dowling Street
Wooloomooloo
NSW 2011
Country 15501 0
Australia
Phone 15501 0
+61 2 93341720
Fax 15501 0
+61 2 9356 3866
Email 15501 0
kathyc@nswcc.org.au
Contact person for scientific queries
Name 6429 0
Colleen Glasson
Address 6429 0
PO Box 1393
Potts Point
NSW 2011
Country 6429 0
Australia
Phone 6429 0
+61 (0)413992987
Fax 6429 0
Email 6429 0
colleenglasson@bigpond.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary