An educational intervention to promote healthy lifestyles in preschool aged children

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000850673
• Date of registration: 08/08/2014
• Prospective Registration: No
• Primary sponsor: Maurizio Iaia
• 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
• Date of first enrolment: 01/10/2012
• Target sample size: 439
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12614000850673.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;

Countries of recruitment

Italy

Contacts

• Name: Dr Maurizio Iaia

• Name: Dr Maurizio Iaia

Key inclusion & exclusion criteria

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
Exclusion criteria: not speaking italian ; chronic disease that precludes study participation; age off predefined range ; absence of other inclusion criteria

Age minimum: 33 Months
Age maximum: 45 Months
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Public Health - Health promotion/education

Diet and Nutrition - Obesity

Energy related behaviors;Primary prevention of obesity;
Energy related behaviors
Primary prevention of obesity

Intervention(s)

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

Primary Outcome(s)

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.[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(s)

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.






[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 ]

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.










[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 ]

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
[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 ]

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.







[ 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

















]

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.




[ 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 ]

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 [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 ]

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[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 ID(s)

none

Source(s) of Monetary Support

"OROGEL"s.p.a.

Secondary Sponsor(s)

Melissa Pasini

Ethics review

Status: Approved
Approval date:
Contact:

CEIIAV COMITATO ETICO IRST IRCCS AVR