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Trial registered on ANZCTR


Registration number
ACTRN12614000850673
Ethics application status
Approved
Date submitted
14/07/2014
Date registered
8/08/2014
Date last updated
8/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
An educational intervention to promote healthy lifestyles in preschool aged children
Scientific title
5210:a cluster randomised controlled trial to evaluate the effectiveness of a combined family- and childcare centre-based educational intervention for improving energy-related behaviors among preschool aged children
Secondary ID [1] 284974 0
none
Universal Trial Number (UTN)
U1111-1159-2168
Trial acronym
5210: five(5) portions/d of fruit and vegetable; two(2) or more hours/d of outdoor play; one(1) or less hour/d of screen time; zero (0 )servings/d of sugar-sweetened beverages
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Energy related behaviors 292456 0
Primary prevention of obesity 292457 0
Condition category
Condition code
Public Health 292773 292773 0 0
Health promotion/education
Diet and Nutrition 292960 292960 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Educational intervention was based on the following components over a six months period (from the end of November 2012 to the end of May 2013):
a)Two sequential, face to face, motivational interviews with parents, each lasting about 25 minutes, aimed to promote healthy family behaviour changes; each interview was problem-oriented taking into account the findings of baseline self reported diaries with respect to children’s 5210 behaviors in the family setting: daily intake of fruit and vegetable; daily time spent for outdoor play and screen time; daily intake of sweetened beverages . The first interview was conducted by the district pediatric nurse and the second (1-2 months later) by primary care (family) paediatricians in the primary care offices.
Before the implementation of the intervention, both nurses and pediatricians had been separately trained in the practice of motivational interviewing by means of two distinct courses of 20 hours (subdivided in four sessions) conducted by specialists in the method.
Motivational interviewing is a communication technique that enhance self-efficacy and motivation for change. Components include: de-emphasizing labelling, giving the parent responsibility for identifying which behaviours are problematic, encouraging parents to clarify and resolve ambivalence about change, setting goals to initiate the change process.
b)Four teachers-led educational units for all 5210 behavioral goals direcly oriented on children were delivered in the child care centres, at the same time of the family-based intervention in order to promote translation of healthy behaviors in the family setting.
The duration of an educational unit was about 2 hours per day (alternating any 5210 component in different days of the week) but each single unit often triggered related actions put on the curriculum in a creative way.
In the middle of the intervention we met the teachers to know and collect the ongoing activities and to stimulate new actions.
A summary of the educational activities implemented at childcare centres follows.
TO PROMOTE MORE FRUIT AND VEGETABLE (FV) INTAKE:
- eating vegetable first at childcare centre lunch
-strategic allocation of those children “good eaters of FV” at different tables to promote intake in bad eaters by means of peer imitation
- experiences of growing a vegetable garden involving kids in the whole process of planting, watering, organic fertilizing, picking up when vegetable is mature, preparing and tasting at lunch and/or snack
- invention of stories with FV characters performed by children
- invention of a song about FV properties that was producted as a compact disk
- handling experiences with FV components aimed to artistic creations
TO PROMOTE MORE INDOOR/OUTDOOR PHYSICAL ACTIVITY EVERY DAY:
- Before the beginning of the intervention, the research team had provided for all teachers an 8 hour active training in two separate days, led by physical activity specialists of UISP (Unione Italiana Sport per Tutti), grouping the teachers in 3 groups according to school nearness. The training supported integration of physical activity across other learning areas linking to the service’s existing curriculum, programs and activity.
The strategies to increase child physical activity levels and reduce time spent being sedentary in childcare centres included one or more of the following actions planned and delivered by teachers:
-increasing daily time spent for outdoor unstructured active play: at least two daily opportunities , weather permitting
-increasing variety of portable equipment for active indoor/outdoor play (ball, skipping-rope…)
-active participation of teachers to indoor and outdoor play throughout the day (role modelling)
-introduction of new psychomotor paths in curriculum
-inclusion of brief structured activities each day
-remotion whenever possible of barriers to outdoor play
-modulation of indoor classroom routine activities toward more energy expenditure (e.g. singing a song or listening to music combined with promotion of dance to reduce time for sedentary activities)
-providing verbal guidance (prompts to extend active play) and encouragement (positive statements about children’s activity)
-sharing policies on promotion of physical activity with parents.
In the middle time of intervention one refreshing focus group lasting 4 hours was conducted from the UISP specialists with all the teachers to support and strengthen the ongoing intervention.
TO REDUCE SCREEN TIME:
The guideline to limit television or videos for sporadic educational purposes was already established in every childcare centre. As a consequence, the teachers’ efforts aimed to ameliorate parents screen-related routine in the family context
- teachers promoted a bright activity of books (age- appropriated) lending to parents to stimulate interactive reading with their kids, to the detriment of screen time in the household setting
- An ecological day without TV was promoted by some childcare centres in which parents agreed on keeping TV turned off during a whole weekend day and their children reported coloured drawings about the alternative activities they had enjoyed with parents.
TO LIMIT SUGAR SWEETENED BEVERAGES:
At snacks it was established as a guideline to offer only the following kind of beverage: school-made fruit/vegetable centrifuged, fresh orange juice or a 100% fruit juice with no added sweeteners or partially skim pasteurized milk according to weekly menu planning.
It was promoted water drinking (already existing as a guideline at lunch) on occasion of birthdays or other parties celebrated at school, to the detriment of sweetened beverages.

In addition to this, teachers exposed in the childcare centres a poster that our staff produced (the same is present in pediatrician’s office waiting room) highlighting 5210 target behaviors.
The teachers of a childcare centre produced a film (lasting 5 minutes) interpreted by children in which the enjoying activities implemented at school for achieving a greater intake of fruit/vegetable and more physical activity were reported.

c)Diffusion of informative tools to parents and teachers
Several tools were created by the research team to assist pediatricians and nurses in supporting parents in behaviour change.
An educational folder to reinforce 5210 goals and the importance of parent role-modelling was submitted to parents during motivational interviews session.
The same poster 5210 used in childcare centres was exposed in the pediatric office’s waiting room to stimulate dialogue during well-child care visits.
A guide manual was offered to all parents and teachers to inform about evidence-based actions and strategies which may facilitate 5210 changes in the household context and in childcare centre.
Intervention code [1] 289794 0
Prevention
Comparator / control treatment
Children randomised in the control arm received the routine standard of health promotion and surveillance planned by their primary care pediatricians (well child care visits) and were engaged in routine educational activities offered by childcare centers
Control group
Active

Outcomes
Primary outcome [1] 292622 0
Pre-post intervention change in percent rate of children who report a combined health behavior score (CHBS), resulting from the sum of each single 5210 score, at the lowest behavioral risk class when evaluated in the household context of life.
To calculate this coarse behavioral marker we first established the following gold standards: 4 or more portions/d of fruit and vegetable intake; 2 or more hours/d of outdoor play; 1 hour/d or less of screen time; 0 serving/d of sweet beverages. We assigned a score from 0 (best behavior ) to 2 (worst behavior) to each single energy related-evidence based 5210 behavior ; the sum of these four scores leads to the combined health behavior score (range 0-8) that we graded in 3 classes of growing behavioral risk: class 1(score 0-2); class 2 (score 3-5); class 3 (score 6-8).
Baseline and follow up instruments used for assessment encompass:
- children's 5210 behaviors prospectively recorded from parents by means of diaries during the last saturday of october and the first two saturday of november in the household context. these measurements include: daily portions of fruit and vegetable intake, daily time spent in outdoor play and in screen time, daily intake of sweet beverages. For each behavior we used the average value of 3 saturdays
Parents self reported at the commencement of the study their own weight and height, level of education, employment status for a secondly multivariate analysis.
Timepoint [1] 292622 0
Timepoints of measurements collection for primary outcome analysis: baseline (Oct/Nov 2012) and at 1 year (Oct/Nov 2013) and 2 years (Oct/Nov 2014) after intervention commencement
Secondary outcome [1] 309360 0
By means of parents’ self -reported diaries, we evaluated children’s portions intake per day of fruit and vegetable in the family context.The diary was compiled during the last saturday of October and the first two saturdays of November at timepoints.
We assigned a score from 0 (best behavior ) to 2 (worst behavior) as indicated below.
-Number of daily portions of fruit and vegetable consumed cumulatively:
score 0 if 4 or more portions/d; score 1 if 2-3 portions/d; score 2 if less than 2 portions/d
After this, we evaluate this secondary outcome as pre-post intervention change in percent rate of children who report a "health behavior” score (average of three Saturdays)at the lowest behavioral risk class, that is score equal to 0.
Timepoint [1] 309360 0
Timepoints of measurements collection for this secondary outcome analysis: baseline (Oct/Nov 2012), at 1 year (Oct/Nov 2013) and 2 years (Oct/Nov 2014) after intervention commencement
Secondary outcome [2] 309389 0
By means of parents’ self-reported diaries, we evaluated how much time children spent in free outdoor play per day in the family context.The diary was compiled during the last saturday of October and the first two saturdays of November at timepoints.
We assigned a score from 0 (best behavior ) to 2 (worst behavior) as indicated below.
-Daily time of outdoor free play (minutes)
score 0 if equal to or more than 120 min/d; score 1 if 60-119 min/d; score 2 if less than 60 min/d
After this, we evaluate this secondary outcome as pre-post intervention change in percent rate of children who report a "health behavior” score (average of three Saturdays)at the lowest behavioral risk class, that is score equal to 0.
Timepoint [2] 309389 0
Timepoints of measurements collection for this secondary outcome analysis: baseline (Oct/Nov 2012), at 1 year (Oct/Nov 2013) and 2 years (Oct/Nov 2014) after intervention commencement
Secondary outcome [3] 309390 0
By means of parents’ self -reported diaries, we evaluated children's screen time per day in the family context.The diary was compiled during the last saturday of October and the first two saturdays of November at timepoints.
We assigned a score from 0 (best behavior ) to 2 (worst behavior) as indicated below.
-Daily time of screen exposure (minutes) (TV/DVD/Videogames)
score 0 if equal to or less than 60 min/d; score 1 if 61-120 min/d; score 2 if more than 120 min/d
After this, we evaluate this secondary outcome as pre-post intervention change in percent rate of children who report a "health behavior” score (average of three Saturdays) at the lowest behavioral risk class, that is score equal to 0.
Timepoint [3] 309390 0
Timepoints of measurements collection for this secondary outcome analysis: baseline (Oct/Nov 2012), at 1 year (Oct/Nov 2013) and 2 years (Oct/Nov 2014) after intervention commencement

















Secondary outcome [4] 309391 0
By means of parents’self -reported diaries, we evaluated number of glasses of sweetened beverages intake per day in the family context.The diary was compiled during the last saturday of October and the first two saturdays of November at timepoints.
We assigned a score from 0 (best behavior ) to 2 (worst behavior) as indicated below.
-Daily intake of sugar sweetened beverage/ fruit drinks: n. glasses
score 0 if 0 glass/d; score 1 if 1 glass/d; score 2 if more than 1 glass/d
After this, we evaluate this secondary outcome as pre-post intervention change in percent rate of children who report a "health behavior” score (average of three Saturdays) at the lowest behavioral risk class, that is score equal to 0.
Timepoint [4] 309391 0
Timepoints of measurements collection for this secondary outcome analysis: baseline (Oct/Nov 2012) and at 1 year (Oct/Nov 2013) and 2 years (Oct/Nov 2014) after intervention commencement
Secondary outcome [5] 309741 0
Children 's standard deviation score body mass index (BMI).
Children's weight and height measures, from which we calculated BMI , were carried out at school from trained pediatric nurses
Timepoint [5] 309741 0
Timepoints of measurements collection for this secondary outcome analysis: baseline BMI (Oct/Nov 2012), at 1 year (Oct/Nov 2013) and 2 years (Oct/Nov 2014) after intervention commencement
Secondary outcome [6] 309742 0
Percent rate of children with a trajectory of BMI crossing upward equal to or greater than 0.1 kg/m2 and equal to or greater than 1 standard deviation
Timepoint [6] 309742 0
Timepoints of measurements collection for this secondary outcome analysis: baseline BMI (Oct/Nov 2012), at 1 year (Oct/Nov 2013) and 2 years (Oct/Nov 2014) after intervention commencement
Secondary outcome [7] 309743 0
Number of families removing the television or avoiding putting a television in the room where the child sleeps.
By means of a parents’self –reported questionnaire we evaluated pre-post intervention change in the percent rate of families who has a television in the room where the child sleeps. This questionnaire was not validated
Timepoint [7] 309743 0
Timepoints of measurements collection for this secondary outcome analysis: baseline (Oct/Nov 2012) and at 1 year (Oct/Nov 2013) and 2 years (Oct/Nov 2014) after intervention commencement

Eligibility
Key inclusion criteria
Elegibility criteria for clusters were: public type school; childcare centers located in the city of Cesena, number of children 3 years old per cluster equal to or greater than 10.
Elegibility criteria for participants were: children born in the year 2009 attending the first class of childcare session at the implementation of the study; no chronic medical problem that would preclude study participation; Italian families or italian speaking foreign families
Minimum age
33 Months
Maximum age
45 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
not speaking italian ; chronic disease that precludes study participation; age off predefined range ; absence of other inclusion criteria

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This trial is a cluster randomized controlled trial: only the participants allocated to the intervention arm receive the planned intervention, while the control participants receive the routine standard of health promotion and surveillance planned by their family pediatricians and are engaged in the routine educational activities offered by childcare centres.
The evaluation of the outcomes will encompass all subjects initially recruited, even those lost to follow up for any reason, according to the "intention to treat" principle in order to evaluate the effectiveness of the treatment in real conditions.
The presentation of findings from our trial is in accordance with CONSORT Guidelines for cluster RCT (Campbell M.K., Elbourne DR, Altman D.G. CONSORT statement: extension to cluster randomised trials; BMJ 2004; 328:702-708)
Only secondly we will also perform the analysis per protocol on those children who complete the experimental protocol.
We calculated sample size taking into account the intracluster correlation coefficient, the primary outcome, the expected effect and the power of the study as it follows.
One year before the current RCT, we pre-tested 5210 behaviors in the family setting among a group of 3 years old children attending thre first class of a childcare centre in our city, by means of the same diaries of current trial. This pre-test revealed 30% of them performing a "combined health behavior score" in the lowest class risk. As a consequence we hypothesized that our intervention would have increased the percentage of children reporting the lowest behavioural risk score from 30% to 45% (primary outcome) after 1 year and 2 years with a 80% power at an alfa level of 0.05% and C.I. 95%. To detect this mean difference between the intervention and control group (taking into account the intracluster correlation coefficient) and assuming a mean number of 27 children per cluster , we needed a number of 8 cluster per group, with 216 children per group. To account for an expected drop out of 20%, a corresponding increased number were sought.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
1/10/2012
Date of last participant enrolment
Anticipated
15/10/2012
Actual
15/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
439
Accrual to date
Final
Recruitment outside Australia
Country [1] 6212 0
Italy
State/province [1] 6212 0
Forli-Cesena (FC)

Funding & Sponsors
Funding source category [1] 289594 0
Commercial sector/Industry
Name [1] 289594 0
"OROGEL"s.p.a.
Country [1] 289594 0
Italy
Primary sponsor type
Individual
Name
Maurizio Iaia
Address
Unita Operativa Pediatria e Consultorio Familiare
piazza Anna Magnani 146; 47522 Cesena (FC)
Country
Italy
Secondary sponsor category [1] 288278 0
Individual
Name [1] 288278 0
Melissa Pasini
Address [1] 288278 0
Unita Operativa Pediatria e Consultorio Familiare
piazza Anna Magnani 146- 47522 Cesena (FC)
Country [1] 288278 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291337 0
CEIIAV COMITATO ETICO IRST IRCCS AVR
Ethics committee address [1] 291337 0
Istituto Scientifico Romagnolo per lo Studio e la Cura dei tumori IRST- IRCCS srl- via Piero Maroncelli 40;
47014 Meldola (FC)
Ethics committee country [1] 291337 0
Italy
Date submitted for ethics approval [1] 291337 0
03/09/2012
Approval date [1] 291337 0
19/02/2014
Ethics approval number [1] 291337 0
Prot. 1114/2014

Summary
Brief summary
The primary purpose of the study is to evaluate if a combined family- and childcare center- based educational intervention will promote 4 healthy behaviors:higher fruit and vegetable intake, more outdoor free play, less screen time and less sweetened beverages.
Trial website

http://www.ausl-cesena.emr.it/AziendaeStruttura/DipartimentiTerritoriali/DipartimentoCurePrimarie/UOPediatriaeConsultorioFamiliare/PediatriadiComunit%C3%A0/progetto5210.aspx
Trial related presentations / publications
In the trial website you can click:
-Locandina del progetto (Project poster)
-Pieghevole del progetto (Project leaflet)
-Manuale per genitori e insegnanti (Guide Manual for parents and teachers)
Manuale per operatori sanitari (Guide Manual for health professionals)
-Il progetto 5210 in slides (5210 slides)
-Il progetto in sintesi (A brief summary of 5210 project)
Public notes
We received in September 2012 an informal approval to implement our trial from our local Ethical Committee, before the recruitment of the first participant. Just in that time it was going a deep rearrangement of our Public Health Area, aimed to the unification of four local health authorities (one of them is Cesena with 180000 inhabitants) in a single Healthcare authority named "Romagna Area" with a shift to one milion inhabitants). This unification became operational in January 2014 resulting in a delay in the formal release of public acts; as a consequence, we received formal approval immediately after the unification of 4 ethical committees in the new single Ethical Committee named CEIIAV COMITATO ETICO IRST IRCCS AVR at 19/02/2014.
For confirmation please contact dr Massimo Farneti, Director of Community Pediatrics Unit at the local health authority of Cesena in Romagna Area who has maintained direct dealings with the Ethics Committee, at the following e-mail:
[email protected]

Contacts
Principal investigator
Name 49882 0
Dr Maurizio Iaia
Address 49882 0
Unita Operativa Pediatria e Consultorio Familiare
Piazza Anna Magnani 146; 47522 CESENA (FC)
Country 49882 0
Italy
Phone 49882 0
+39 3476875959
Fax 49882 0
+39-0547394215
Email 49882 0
[email protected]
Contact person for public queries
Name 49883 0
Maurizio Iaia
Address 49883 0
Unita Operativa Pediatria e Consultorio Familiare
Piazza Anna Magnani 146; 47522 CESENA (FC)
Country 49883 0
Italy
Phone 49883 0
+39 3476875959
Fax 49883 0
+39-0547394215
Email 49883 0
[email protected]
Contact person for scientific queries
Name 49884 0
Maurizio Iaia
Address 49884 0
Unita Operativa Pediatria e Consultorio Familiare
Piazza Anna Magnani 146; 47522 CESENA (FC)
Country 49884 0
Italy
Phone 49884 0
+39 3476875959
Fax 49884 0
+39-0547394215
Email 49884 0
[email protected]

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