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Trial registered on ANZCTR


Registration number
ACTRN12610000200088
Ethics application status
Approved
Date submitted
7/03/2010
Date registered
9/03/2010
Date last updated
10/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Health and Wellbeing During the Preschool Years
Scientific title
The Effect of a Healthy Lifestyle Program Relating to General Nutrition, Child Feeding, and Physical Activity and Behaviours on Eating and Weight Gain in Preschoolers.
Secondary ID [1] 1463 0
N/A
Universal Trial Number (UTN)
U1111-1114-2662
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
preschool child overweight and obesity 256916 0
Condition category
Condition code
Public Health 257065 257065 0 0
Health service research
Diet and Nutrition 257070 257070 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention – the intervention group will participate in 10 weekly 90 minute workshops relating to general nutrition, physical activity and behaviours, typically held at community and maternal child health centres, where parents and their children attend together. Each program group will consist of 6-10 child-parent dyads and a Mind, Exercise, Nutrition, Do It! (MEND) 2-4 trained program leader. Each session involves 30 minutes of guided active play, where parents can learn how to play with their children; 15 minutes of healthy snack time based on an evidence-based exposure-based technique to promote acceptance and increased intake of fruit and vegetables, and 45 minutes where the children participate in supervised crèche style activities and concurrently the parents attend an interactive education and skill development session, based on evidence-based group-based parent-training principles. Baseline assessment of study variables will occur at recruitment. Follow-up assessment will occur at the completion of the 10 week program and at 6 and 12 months post-intervention.
Intervention code [1] 256113 0
Prevention
Comparator / control treatment
The control participants will continue their normal habits until 15 months after recruitment, when they will receive the 10 week program. Baseline assessment of variables will occur at recruitment and follow-up assessment will occur in line with the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 257958 0
Child eating habits and daily dietary intake

The Children's Eating Behaviour Questionnaire (CEBQ) will be used to assess child eating styles/habits, specifically, fussiness and responsiveness to satiety. Typical food intake for children and their parents will be assessed using a semi-quantitative food frequency questionnaire developed by Chief Investigator Professor Boyd Swinburn for Australian preschool children. The Eating and Physical Activity Questionnaire (EPAQ) is a two page document which asks specifically about foods which have been associated with obesity in the literature - particularly beverages, fruits and vegetables, processed snack foods and takeaway foods. Quantities are in general household measures and refer to either the previous day or typical intake. Standard serving sizes are based on the Australian Guide to Eating. The EPAQ has been assessed against a 24-hour dietary recall in 90 parents of preschoolers and found to be valid. Reliability has been found to be adequate. This method of food recall has low participant burden and hence is both time and cost-efficient.
Timepoint [1] 257958 0
Baseline assessment of study variables will occur at recruitment. Follow-up assessment will occur at the completion of the 10 week program and at 6 and 12 months post-intervention.
Secondary outcome [1] 263485 0
Duration of daily child physical and sedentary activities

The Physical Activity Questionnaire for Preschool-aged Children (Pre-PAQ) is a parent self-report measure that provides a list of 24 different types of physical and sedentary activities and requires parents to report on the time spent in the activities their child did ?yesterday? and ?last weekend?. Parental proxy-reporting of their children?s time-use has been used widely in developmental research, including research by CI Skouteris, and has been shown to be a valid method of assessing individual differences in young children?s time-use habits.
Timepoint [1] 263485 0
Baseline assessment of study variables will occur at recruitment. Follow-up assessment will occur at the completion of the 10 week program and at 6 and 12 months post-intervention.
Secondary outcome [2] 263486 0
Parental knowledge of nutrition

Knowledge of child nutrition will be assessed with subscales of the Nutrition Knowledge Questionnaire.
Timepoint [2] 263486 0
Baseline assessment of study variables will occur at recruitment. Follow-up assessment will occur at the completion of the 10 week program and at 6 and 12 months post-intervention.
Secondary outcome [3] 263487 0
Child Body Mass Index (BMI)

Height and weight will be measured with a stadiometer and standardised digital scales, respectively, at all assessments for children and at baseline, and at the 6 and 12 months follow up assessment time points for parents. Children and parents will be weighed each time wearing light clothing and no shoes. Height and weight measures will then be converted to a BMI (kg/m2) for each participant. BMI will be standardized for age and gender using BMI-for-age z-scores and change will be assessed using BMI z score slope following WHO recommendations for children this age.
Timepoint [3] 263487 0
Baseline assessment of study variables will occur at recruitment. Follow-up assessment will occur at the completion of the 10 week program and at 6 and 12 months post-intervention.
Secondary outcome [4] 263488 0
Maternal Child Feeding Patterns

The Preschool Child Feeding Questionnaire (PCFQ) will measure mother's anxiety about feeding, responsibility for feeding, pressure to eat, and controlling feeding, and her concerns for her child's weight. The Child Feeding Questionnaire (CFQ) will assess maternal restriction of access to food and monitoring of food.
Timepoint [4] 263488 0
Baseline assessment of study variables will occur at recruitment. Follow-up assessment will occur at the completion of the 10 week program and at 6 and 12 months post-intervention.
Secondary outcome [5] 263489 0
Parental modelling of physical and sedentary activities

The Active Australia Survey (a validated questionnaire that measures physical activity behaviour in adults) will be used to measure parental engagement in physical and sedentary activities (duration and nature); this is retrospectively reported by parents for last 7 days.
Timepoint [5] 263489 0
Baseline assessment of study variables will occur at recruitment. Follow-up assessment will occur at the completion of the 10 week program and at 6 and 12 months post-intervention.
Secondary outcome [6] 263490 0
Child food neophobia

Pliner's Child Neophobia Scale for the extent of a child?s reluctance to eat unfamiliar food.
Timepoint [6] 263490 0
Baseline assessment of study variables will occur at recruitment. Follow-up assessment will occur at the completion of the 10 week program and at 6 and 12 months post-intervention.
Secondary outcome [7] 263501 0
Parental modelling of eating

Typical daily food intake for parents will be assessed using the National Nutrition Survey Food Frequency Questionnaire.
Timepoint [7] 263501 0
Baseline assessment of study variables will occur at recruitment. Follow-up assessment will occur at the completion of the 10 week program and at 6 and 12 months post-intervention.

Eligibility
Key inclusion criteria
Preschool children aged 2-5 years; Parents of these preschool children. Parents will be eligible to take part if they can provide informed consent, are over 18 years of age and can read and write English. Parents and their children will be from diverse ethnic backgrounds. Participants can be either gender.
Minimum age
2 Years
Maximum age
5 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents will be excluded from the study if they cannot provide informed consent, are under 18 years of age or cannot read and write English.

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)
The participants will beparents of 2-4 year old children. Parents will be eligible to take part if they can provide informed consent, are 18 years of age or older, and can read and write English. After assessment, parents who meet the inclusion criterion, and do not display exclusion criteria, will be randomly allocated to either the MEND 2-4 intervention (n = 100) or the wait-list control group (n = 100).

The method of alllocation concealment will involve contacting the holder of the allocation schedule who is at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A coded, double-blinded, variable-length permuted blocks randomised treatment allocation schedule produced by computer algorithm will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomised Controlled Trial (intervention and wait-list control) with 10-week (post intervention) and 6 and 12 month follow-up; run at multiple community health centres in Melbourne and regional Victoria.
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] 256609 0
Government body
Name [1] 256609 0
Australian Research Council Linkage Scheme
Address [1] 256609 0
1st Floor, 8 Brindabella Circuit
Brindabella Business Park
GPO Box 2702
CANBERRA
ACT 2601
AUSTRALIA
Country [1] 256609 0
Australia
Primary sponsor type
Other
Name
Better Health Company (Formerly MEND Australia)
Address
35 Vannam Drive, Ashwood 3147, Victoria, Australia
Country
Australia
Secondary sponsor category [1] 255900 0
None
Name [1] 255900 0
Address [1] 255900 0
Country [1] 255900 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258639 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 258639 0
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Ethics committee country [1] 258639 0
Australia
Date submitted for ethics approval [1] 258639 0
02/11/2009
Approval date [1] 258639 0
Ethics approval number [1] 258639 0
DU-HREC 2009-180

Summary
Brief summary
The overall goal of the current project is to conduct a randomised controlled trial (RCT) to measure the effectiveness of the MEND 2-4 program. The intervention will provide information to parents and support them to establish and/or maintain healthy behaviours and attitudes around diet and physical activity for themselves and their preschool child(ren).
In comparison to the wait-list control group, at the completion of the 10-week intervention program, and at 6 and 12 months post intervention, the intervention group preschoolers will: (1) demonstrate greater consumption of fruit and vegetables, and a decrease in consumption of high fat, high sugar cordials, soft-drinks and juices and non-essential, energy dense snack foods; (2) exhibit less problematic eating habits, specifically higher responsiveness to satiety, less fussiness, and less neophobia; (3) demonstrate greater increases in physical activity and greater decreases in time spent in sedentary behaviours, specifically TV viewing; (4) exhibit lower BMI-for-age z scores.
In comparison to the wait-list control group, at the completion of the intervention program, and at 6 and 12 months post intervention, the intervention group parents will: (1) increase the frequency with which they limit the offering of high fat, high sugar cordials, soft-drinks and juices and non-essential, energy dense snack foods to their child; (2) increase the frequency with which they offer vegetables and fruit, water and milk (rather than cordials, soft-drinks and juices) to their child; (3) demonstrate improved knowledge regarding key aspects of child eating, physical activity and sedentary behaviours relevant to the prevention of obesity and improving child health generally; (4) reduce the frequency with which they use restrictive feeding practices and increase the frequency with which they use covert methods of controlling access to unhealthy foods; (5) increase the frequency with which they model healthy behaviours around diet and physical activity; (6) provide greater opportunities for children to engage in physical activity and reduce their opportunities for engagement in sedentary behaviours.
Trial website
N/A
Trial related presentations / publications
Skouteris H, Hill B, McCabe M, Swinburn B, Sacher P, Chadwick P. Recruitment evaluation of a preschooler obesity-prevention intervention. Early Child Development and Care 2013: 1-9.
Public notes

Contacts
Principal investigator
Name 30903 0
Prof Helen Skouteris
Address 30903 0
School of Psychology
Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country 30903 0
Australia
Phone 30903 0
+61392517699
Fax 30903 0
Email 30903 0
helens@deakin.edu.au
Contact person for public queries
Name 14150 0
Prof Helen Skouteris
Address 14150 0
School of Psychology
Deakin University
221 Burwood Highway
Burwood, Victoria
Melbourne
3125
Australia
Country 14150 0
Australia
Phone 14150 0
61 3 9251 7699
Fax 14150 0
61 3 9244 6858
Email 14150 0
helens@deakin.edu.au
Contact person for scientific queries
Name 5078 0
Prof Helen Skouteris
Address 5078 0
School of Psychology
Deakin University
221 Burwood Highway
Burwood, Victoria
Melbourne
3125
Australia
Country 5078 0
Australia
Phone 5078 0
61 3 9251 7699
Fax 5078 0
61 3 9244 6858
Email 5078 0
helens@deakin.edu.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