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Trial registered on ANZCTR


Registration number
ACTRN12609000820202
Ethics application status
Approved
Date submitted
15/09/2009
Date registered
21/09/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of a telephone based intervention to increase fruit and vegetable consumption among preschoool aged children
Scientific title
The efficacy of a parent focused telephone intervention compared with child health mailings in increasing fruit and vegetable consumption of preschool aged children
Secondary ID [1] 253087 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
U1111-1111-8248
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inadequate fruit and vegetable consumption 243825 0
Condition category
Condition code
Public Health 239998 239998 0 0
Health promotion/education
Diet and Nutrition 252048 252048 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four 20-30 minute telephone contacts deliverred weekly (for 1 month) from trained interventionists. The telehone support will follow a script and be deliverred using computer assisted telephone interviewing software (CATI). During the telephone calls participants will receive information about the basics of a healthy diet and children’s dietary recommendations, be encouraged to make fruit and vegetables readily available and accessible, eat meals as a family and without the television on, and to identify and reduce stimuli for unhealthy eating. Furthermore the telephone calls will encourage parents to role model fruit and vegetable consumption and utilise positive parenting strategies related to child feeding.

The telephone support calls will also be facilitated by print workbook
Intervention code [1] 241264 0
Prevention
Intervention code [2] 241274 0
Behaviour
Comparator / control treatment
A printed booklet containing information about healthy eating recommendations.
Control group
Active

Outcomes
Primary outcome [1] 240902 0
Fruit and vegetable consumption. Fruit and vegetable intake will be assessed using scores on the fruit and vegetable subscale of the Children's Dietary Questionnaire (CDQ) which asks parents to report the frequency and variety of fruits and vegetables consumed by their child over the past seven days and past 24 hours
Timepoint [1] 240902 0
Baseline then 2 months, 6 months, 12 months and 18 months following intervention commencement.
Secondary outcome [1] 257592 0
Home food environment characteristics.
Changes in the characteristics of the home food environment including fruit and vegetable availability and accessibility the location where meals are eaten, and whether the television is on during mealtimes will be measured using items from the Healthy Home Survey.
Timepoint [1] 257592 0
Baseline then 2 months, 6 months, 12 months and 18 months following intervention commencement.
Secondary outcome [2] 257593 0
Role modeling. Changes in the extent to which parents role model healthy eating habits will be assessed using the proxy measure of parents' fruit and vegetable consumption. Two items will be included from the 1995 National Nutrition Survey to assess parental daily intake of fruit and vegetables (serves per day).
Timepoint [2] 257593 0
Baseline then 2 months, 6 months, 12 months and 18 months following intervention commencement.
Secondary outcome [3] 257594 0
Parent feeding practice. Changes in parent feeding practices including pressure to eat will be assessed using items Birch's Child Feeding Questionnaire and additional items from the Healthy Home Survey.
Timepoint [3] 257594 0
Baseline then 2 months, 6 months, 12 months and 18 months following intervention commencement.
Secondary outcome [4] 257600 0
Parent self efficacy will be also be assessed by scores on the Parent Self Efficacy for Child Diet scale (P-SEC).
Timepoint [4] 257600 0
Both the PSOC and P-SEC at baseline and 2 months following intervention commencement.
Only the P-SEC at 6 months, 12 months and 18 months following intervention commencement.
Secondary outcome [5] 257618 0
Adverse events: Any adverse changes in child's diet will be assessed using the Children's Dietary Questionnaire subscales. Adverse changes to the amount spent on household food purchase will also be assessed.
Timepoint [5] 257618 0
Baseline then 2 months, 6 months, 12 months and 18 months following intervention commencement.
Secondary outcome [6] 266331 0
Subgroup analysis: change in children's fruit and vegetable consumption by risk status (i.e. those meeting vs not meeting current fruit and vegetable intake recommendations at baseline).
Timepoint [6] 266331 0
2 months, 6 months, 12 months and 18 months following intervention commencement.

Eligibility
Key inclusion criteria
Parents of children who attend preschool in the Greater Newcastle region of NSW will be invited to participate. To be eligible, parents must: 1. Have a child 3 to 5 years old. 2. Reside with their child at least four days a week. 3. Have a child without special dietary requirements or allergies which may be adversely affected by the intervention or require specialised tailoring of the intervention. 4. Be English Speaking
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents who: do not have a child 3 to 5 years old; do not reside with their child at least four days a week; have a child with dietary requirements or allergies which may be adversely affected by the intervention; or do not speak English will be excluded

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 will occur in two phases. In phase one, information packs and consent forms will be mailed to randomly selected preschools in the local area. Preschools who do not return the study forms indiciating their interest or otherwise in participation in the study will be telephoned by a research assistant two weeks following receipt of the initial study information mailing. Study information sheets and consent forms will then be distributed to parents of children 3-5 years attending participating preschools. Reminder letters will be distributed through preschools to parents in the same way 1-2 weeks later. Parents providing written informed consent will participate in the study. Following the recruitment of both preschools and parents each preschool will be randomly assigned to an experimental or control condition. All parents whose children attend preschools randomised to the experimental condition will receive the intervention, while those in the control group will receive minimal support. Allocation to groups will be concealed. Random allocation will occur following recruitment of all participants in each preschool (cluster). The randomisation will be conducted by and independent statistician who is not a member of the research team at central adminstration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to experimental or control groups will be by block randomisation to maximise the likelihood that the number of participants allocated to each condition remains approximately equal.

An independent statistician using a randomisation function in a statistical package will perform the block 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)
Recruitment postcode(s) [1] 2077 0
2280
Recruitment postcode(s) [2] 2078 0
2317
Recruitment postcode(s) [3] 2079 0
2298
Recruitment postcode(s) [4] 2080 0
2281
Recruitment postcode(s) [5] 2081 0
2287
Recruitment postcode(s) [6] 2082 0
2299
Recruitment postcode(s) [7] 2083 0
2283
Recruitment postcode(s) [8] 2084 0
2284
Recruitment postcode(s) [9] 2085 0
2303
Recruitment postcode(s) [10] 2086 0
2315
Recruitment postcode(s) [11] 2087 0
2285
Recruitment postcode(s) [12] 2088 0
2289
Recruitment postcode(s) [13] 2089 0
2318
Recruitment postcode(s) [14] 2090 0
2291
Recruitment postcode(s) [15] 2091 0
2319
Recruitment postcode(s) [16] 2092 0
2304
Recruitment postcode(s) [17] 2093 0
2314
Recruitment postcode(s) [18] 2094 0
2324
Recruitment postcode(s) [19] 2095 0
2300
Recruitment postcode(s) [20] 2096 0
2320
Recruitment postcode(s) [21] 2097 0
2265
Recruitment postcode(s) [22] 2098 0
2285
Recruitment postcode(s) [23] 2099 0
2290
Recruitment postcode(s) [24] 2100 0
2267
Recruitment postcode(s) [25] 2101 0
2291
Recruitment postcode(s) [26] 2102 0
2305
Recruitment postcode(s) [27] 2103 0
2306
Recruitment postcode(s) [28] 2104 0
2293

Funding & Sponsors
Funding source category [1] 243730 0
Government body
Name [1] 243730 0
NSW Cancer Institute
Address [1] 243730 0
PO Box 41
ALEXANDRIA NSW 1435
Australia
Country [1] 243730 0
Australia
Primary sponsor type
Individual
Name
Luke Wolfenden
Address
Locked Bag 10
Wallsend NSW 2287
Country
Australia
Secondary sponsor category [1] 237091 0
University
Name [1] 237091 0
Newcastle University
Address [1] 237091 0
University Drive
Callaghan NSW 2308
Australia
Country [1] 237091 0
Australia
Other collaborator category [1] 860 0
Other Collaborative groups
Name [1] 860 0
Hunter New England Population Health
Address [1] 860 0
Locked Bag 10
Wallsend NSW 2287
Country [1] 860 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243856 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 243856 0
Hunter New England Human Research Ethics Committee
Hunter New England Health
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 243856 0
Australia
Date submitted for ethics approval [1] 243856 0
03/10/2008
Approval date [1] 243856 0
07/11/2008
Ethics approval number [1] 243856 0
08/10/15/5.09

Summary
Brief summary
The home and family food environment are among the most influential factors in shaping children’s dietary habits. The aim of the study is to assess the effectiveness of a telephone based intervention in supporting parents of children aged 3-5 years to modify their home and family food environment to increase their child’s fruit and vegetable consumption.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30278 0
Address 30278 0
Country 30278 0
Phone 30278 0
Fax 30278 0
Email 30278 0
Contact person for public queries
Name 13525 0
luke wolfenden
Address 13525 0
locked Bag 10
Wallsend NSW 2287
Country 13525 0
Australia
Phone 13525 0
+61 2 4985 5168
Fax 13525 0
Email 13525 0
luke.wolfenden@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 4453 0
luke wolfenden
Address 4453 0
locked Bag 10
Wallsend NSW 2287
Country 4453 0
Australia
Phone 4453 0
+61 2 4985 5168
Fax 4453 0
Email 4453 0
luke.wolfenden@hnehealth.nsw.gov.au

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