SUPPLEMENTAL MATERIAL

Contents

SUPPLEMENTAL METHODS.....................................................................................2

Development and validation of a questionnaire on healthy lifestyles for children aged

9-13 years.......................................................................................................................2

Participants and study design....................................................................................2

Questionnaire development and validation...............................................................2

Questionnaire components........................................................................................4

Scale scoring..............................................................................................................5

Statistical methods.....................................................................................................5

Intervention....................................................................................................................7

Ideal cardiovascular health (ICH) score........................................................................9

Statistical analysis........................................................................................................10

Sample size calculation............................................................................................10

Statistical methods: data description and univariate analysis................................10

Statistical methods: multiple imputation procedures..............................................10

SUPPLEMENTAL RESULTS.....................................................................................12

Development and validation of a questionnaire on healthy lifestyles for children aged

9-13 years.....................................................................................................................12

Step 1. Development................................................................................................12

Step 2. Pretest..........................................................................................................12

Step 3. Test and retest..............................................................................................12

SUPPLEMENTAL FIGURES.....................................................................................14

SUPPLEMENTAL TABLES.......................................................................................15

SUPPLEMENTAL REFERENCES............................................................................34

1

SUPPLEMENTAL METHODS

Development and validation of a questionnaire on healthy lifestyles for children

aged 9-13 years

Participants and study design

The questionnaire was developed and validated in 2015 and 2016. The study population

included boys and girls aged between 9 and 13 years who had not previously been

exposed to the SI! Program. The children were recruited from two public schools in

Bogota (Colombia) using a non-probabilistic sampling method. The only exclusion

criterion was a previous diagnosis of cognitive impairment. The study was approved by

the local Institutional Review Board (IRB00007736). Participation required written

informed consent from parents and children.

Questionnaire development and validation

The questionnaire was evaluated through three consecutive steps: development, pretest,

and test-retest (Online Figure 1). All questionnaire versions were in Spanish.

Step 1- Development

An international panel of SI! Program multidisciplinary experts (n=10) was convened to

generate version 1 of the questionnaire based on item identification and extraction from

published and unpublished questionnaires (1-9). Questions were culturally adapted to 9-

13-year-old children in Colombia. Each item was then evaluated by independent experts

on a Likert scale from 0 to 10 points, generating version 2 of the questionnaire. The

questionnaire combines words and pictures to aid recall and help the children to answer

the questions. The version 2 questionnaire form was designed by a professional graphic

artist.

Step 2- Pretest

2

Questionnaire version 2 was assessed for cognitive clarification in a group of 30 boys

and girls. All the children answered the questionnaire, with each questionnaire item read

aloud to the group twice by a psychologist. The children chose and recorded their

answers on the questionnaire form. The psychologist and a pediatrician noted children’s

degree of attention during the survey and subsequently conducted structured discussions

with the group, using a checklist to assess their understanding of each question, the

answer options, the language used, and the length of the scale (number of questions).

Survey responses to each item were scored on a scale from 0 (not desirable) to 2

(desirable), and internal consistency was assessed by calculating Cronbach’s α

coefficient for the questionnaire. Based on this information, the expert panel selected 29

items, generating version 3 of the questionnaire.

Step 3- Test and retest

Questionnaire version 3 was assessed in children from a different school (n=122) during

school hours. The children were in classes of approximately 20 pupils, and the survey

was guided by 3 trained research assistants. All children answered the questionnaire,

with each questionnaire item read aloud to the class twice by a pediatrician or child

psychologist. The children chose and recorded their answers on the questionnaire form.

Once all the children had answered question 17, there was a two-minute break, during

which an assistant sang songs and encouraged the children to stand up and jump around.

The aim of this break was to motivate the children and encourage them to continue

answering the questionnaire.

The internal consistency of the instrument was assessed by calculating Cronbach’s α

coefficients for the full questionnaire, both for the whole study population and for and

for the 9-10– and 11-13–year age ranges. Cronbach’s α coefficients were additionally

calculated for the individual domains and components. The test-retest reliability of each

3

question was evaluated by re-interviewing 120 of the children 3 days after the first

evaluation and calculating intraclass correlation coefficients (ICC).

Questionnaire components

The overall goal of developing and validating the questionnaire was to generate an

instrument to evaluate KAH related to the four healthy-lifestyle intervention

components: nutrition, physical activity, human body and heart awareness, and emotion

management. Spanish and English language versions of the version 3 of the

questionnaire are provided in Online Tables 3 and 4. The contents of each component

are described below.

Nutrition

The questions address aspects of a healthy diet according to the guidelines for

cardiovascular health and risk reduction in children and adolescents (10). Parameters

include the consumption frequency of different food groups during the past week (fruit

and vegetables, a healthy breakfast, and junk food), food choices at recess, drinks

available for hydration, attitude toward eating fruit and vegetables, and knowledge

about the deleterious effect of sweets and cakes and the recommended daily intake of

fruit and vegetables.

Physical activity

This component interrogates the time spent engaged in physical activity and its

importance for health. The questions extract information about the hours spent on

sedentary activities per day (11), the frequency of moderate or vigorous physical

activity during the past week, attitudes toward physical activity, and knowledge about

the relationship between a sedentary lifestyle and obesity.

Emotion management

4

Questions in this component target conflict resolution, management of negative

emotions, self-concept, optimism, identification of personal and others’ emotions, and

caring about others’ emotions.

Human body and heart awareness

Questions in this component extract information about weekday sleeping hours,

personal history of cigarette consumption, attitudes toward smoking in the future, and

knowledge of the deleterious effects of passive smoking, the importance of caring for

the heart, heart function, activities beneficial to heart health, and the effects of exercise

on heart rate.

Scale scoring

Survey responses are scored on a scale from 0 points (not desirable) to 2 points

(desirable). The overall KAH score is derived from the weighted sum of each of the

component domains, all ranged from 0 to 8 points (Online Table 5). The overall KAH

score will thus range 0 to 96 points. Each KAH domain (knowledge, attitudes, and

habits) is scored from 0 to 32 points, and each intervention component (nutrition,

physical activity, human body and heart awareness, and emotional management) is

scored from 0 to 24 points.

Statistical methods

A sample size of 120 children was estimated for the validation study using EPIDAT 4.0,

under the assumption of an intraclass correlation coefficient (ICC) = 0.35, α = 0.05, β =

0.20. Since the main source of variability in the analysis was age, necessary sample size

was stratified for children aged 9-to-10 and 11-to-13 years. The full sample was used

for the analysis of instrument reliability.

Descriptive statistics (frequency tables) were generated for each item, and means

(±standard deviation) were calculated for demographic variables. Estimates were made

5

of the response frequency and the time required to complete the questionnaire. Internal

consistency among the items (overall and by age band) was assessed using Cronbach’s

α coefficients. In addition, Cronbach’s α coefficients were calculated for each

component (nutrition, physical activity, human body and heart awareness, and emotion

management) and domain (knowledge, attitudes, and habits). Test-retest reliability of

each question was evaluated by calculating the ICC. Reference ICC levels of reliability

were excellent (ICC >0.80), good (ICC >0.60 to 0.80), moderate (ICC >0.40 to 0.60),

and poor (ICC <0.40) (12). Acceptable internal consistency was set at a Cronbach’s α

coefficient of > 0.60, as recommended by other authors (8,13). Statistical analyses were

performed with STATA version 13.1.

6

Intervention

The SI! Program intervention was designed by a multidisciplinary team of experts in

pedagogy, pediatrics, nutrition, physical activity, psychology, cardiology, and

epidemiology. The intervention is based on the social cognitive theory which focuses on

social modeling and self-efficacy to motivate behavior change related to health (14);

and the transtheoretical model of change, which includes pre-contemplation and

contemplation stages corresponding to knowledge acquisition, a preparation phase

addressing attitudes to change, and an action and maintenance phase corresponding to

habit acquisition (15). The overall goal of the intervention was to improve

cardiovascular health and knowledge, attitudes, and habits toward a healthy lifestyle in

children aged 9-13 years.

The SI! Program intervention focuses on body and heart awareness, healthy nutrition,

promotion of physical activity, and emotion management (Online Table 2). The core of

the intervention consisted of 16 educational delivered at community centers (2

units/day, in a group of 25 children, led by 2 intervention providers) and 8 educational

units that were provided to parents/caregivers and carried out in the home setting (non-

contact activities provided individually); follow-up phone calls, text messages, and

emails were used to remind and motivate families to carry out these activities with their

children. The intervention was delivered in 6 community centers located in the urban

districts of Usaquén and Suba (Bogotá, Colombia). Children assigned to the

intervention group attended community centers for 4 hours on alternate Saturdays over a

period of 16 weeks, between May and September 2017, including a vacation period of 1

month. Thus, the 16 units were delivered over a total of 8 Saturdays (2 units / day).

Each session day was structured into 3 periods: teaching the unit (3 hours), a healthy

snack (30 minutes), and an enjoyable outdoor physical activity (30 minutes).

7

Intervention providers were a group of young teachers, trained in the components of the

SI! Program intervention by the investigators in 2 workshops: the first before the

intervention period (2 sessions of 4 hours each) and the second in the middle of the

intervention (2 sessions of 4 hours each). Intervention providers were provided with a

teaching manual to guide the conduct of each unit; the teaching manual covers basic

concepts about the 4 intervention components that were also reviewed during the

training. These manual includes step-by-step guidance to intervention providers on the

conduct of each unit. These guidelines cover goals and concepts to be covered, the

central activity in which the children participate, and a summary and conclusions.

At the beginning of the intervention, parents/caregivers were invited to attend a single

short informational session (45 minutes) as well as a community health event (health

fair) featuring motivational and informational activities.

Children assigned to control clusters attended community centers on alternate Saturdays

to receive 8 educational sessions on topics unrelated to promoting a healthy lifestyle

including study skills and techniques, executive functions and time management.

8

Ideal cardiovascular health (ICH) score

The AHA metrics for assessing ideal cardiovascular health in children were followed as

precisely as possible (16). The calculation of each AHA metric was as follows. Age-,

sex- and height-adjusted BP percentiles were calculated with available online

calculators (17,18), and ideal, intermediate, and poor BP were defined as <90th, 90-95th,

and >95th percentile, respectively. TC was classified as ideal <170 mg/dL, intermediate

170-199 mg/dL, and poor ≥200 mg/dL. Categories for fasting blood glucose were ideal

<100 mg/dL, intermediate 100–125 mg/dL, and poor ≥126 mg/dL. Age- and sex-

adjusted BMI percentiles were calculated according to Colombian growth curves (19),

and ideal, intermediate, and poor BMI categories were defined as <85th, 85-95th, and

>95th percentile, respectively. Children who had tried smoking in the 30 days preceding

the intervention or who had ever smoked at least one whole cigarette were categorized

as having poor smoking status, and all other children were classified as having an ideal

smoking status. The healthy diet score used to define dietary profiles considered ideal

intakes of fruit and vegetables ≥4.5 servings/day, fiber-rich whole grains (≥ 1

servings/day), and added sugar and sugar-sweetened beverages (≤1 serving/day).

Participants who met all three healthy dietary targets were classified as having an ideal

diet, while those meeting only 1-2 or none of the component targets were classified as

having an intermediate or poor diet, respectively. Ideal physical activity was ≥60

min/day of moderate- or vigorous-intensity activity; poor physical activity was no

physical activity reported; and intermediate activity was defined as any amount of

physical activity below the ideal threshold.

9

Statistical analysis

Sample size calculation

The sample size and the number of clusters needed to detect a mean difference between

similar-sized control and intervention groups with a cluster design were calculated a

priori using the user-written command clustersampsi in Stata. This calculation was

based on the following parameters: a between-group difference of 2.6 absolute points in

the KAH score (or 0.4 absolute points in the ICH score), a standard deviation in the

KAH score of 9.5 (or 1.5 in the ICH score), a significance level of 0.05, 80% statistical

power, 25 children per cluster, an intraclass correlation coefficient of 0.075 (20), and an

anticipated loss to follow-up rate of 20%. Thus the total number of included and

randomized clusters was 48 (24 clusters per study arm: control vs. intervention),

corresponding to an expected minimum of ~1200 children recruited in the study. This

sample size would allow detection of minimum differences of 3.6 absolute points in the

KAH score and 0.6 absolute points in the ICH score when evaluating the existence of a

potential booster effect in a pre-specified subgroup analysis.

Statistical methods: data description and univariate analysis

Data were expressed as mean (standard deviation) for continuous variables or

frequencies (percentages) for categorical variables. For univariate analyses, continuous

variables were compared using the Student t-test, while crude frequency distributions of

categorical variables were compared using the chi-square test or the Fisher exact test for

binary and/or non-ordered categorical variables and the Cochran-Mantel-Haenszel test

for ordered categorical variables, as appropriate.

Statistical methods: multiple imputation procedures

Reference-based multiple imputation, as implemented by the user-written mimix

command (21), was performed to include all randomized enrolled participants as

10

sensitivity analysis. This procedure imputes missing numerical outcomes for a

longitudinal trial with protocol deviation under distinct treatment arm-based

assumptions for the unobserved data, following the general algorithm of Carpenter,

Roger, and Kenward (22). Complete cases represented ~90% (1,078 and 1,067 out of

1216 randomized enrolled participants for the change in KAH and ICH scores,

respectively). For this analysis, missing outcome data in the intervention group was

assumed to have a distribution identical to the control group (i.e., multiple imputation

using the control distribution). To this purpose, we specified the option “copy

reference”, which assumes that the joint distribution of an individual’s observed and

missing outcome data is multivariate normal with a mean vector and covariance matrix

from the specified reference group (i.e., control). Missing data for individuals in the

reference group are imputed under on-treatment group missing at random.

The follow-up KAH or ICH overall score of the child was set as imputed (dependent)

variable. The following variables were included as covariates: baseline KAH or ICH

score (continuous variable), age (continuous variable), and sex (binary variable). The

change from baseline in the overall composite KAH or ICH score of the child was then

calculated in imputed datasets. Number of imputations was set at 20. A random-number

seed was set to ensure reproducibility of the imputed values. Estimations on the imputed

data were run with the “mi estimate” command. Multilevel linear mixed-effects models

that account for the hierarchical cluster randomized design were used to test for the

adjusted intervention effect. Fixed effects were the corresponding treatment group,

whereas clusters and families were handled as random effects. Diagnostic checks of the

imputation model were obtained using the vartable and dftable of the “mi estimate”

command. Analyses were performed using STATA version 15 (StataCorp, College

Station, Texas).

11

SUPPLEMENTAL RESULTS

Development and validation of a questionnaire on healthy lifestyles for children

aged 9-13 years

Step 1. Development

Version 1 of the questionnaire, generated by the SI! Program expert panel, included 55

multiple-choice questions. This version was evaluated by 10 external experts on a Likert

scale from 0 to 10 to assess the pertinence, relevance, and precision of each item and to

ensure the representativeness of all components. Based on this information, the external

experts selected 38 items, generating version 2 of the questionnaire.

Step 2. Pretest

For the cognitive clarification phase, questionnaire version 2 was evaluated in a group

of 30 boys and girls in one school. The age distribution was as follows: 9 years old

(n=7, 23.3%), 10 years old (n=6, 20.0%), 11 years old (n=5, 16.7%), 12 years old (n=7,

23.3%), and 13 years old (n=5, 16.7%). Analysis of internal consistency for the overall

questionnaire yielded a Cronbach’s α coefficient of 0.80. After the cognitive

clarification procedure (evaluation of children’s general question understanding, length

of the scale, etc.), 29 items were selected and reviewed by the SI! Program expert panel,

thus generating version 3 of the questionnaire (Online Table 5).

Step 3. Test and retest

Version 3 of the questionnaire was given to 122 children (mean age, 11.2 ± 1.3 years,

50.8% girls) in another school. The age distribution was as follows: 9 years old (n=13,

10.7%), 10 years old (n=28, 23.0%), 11 years old (n=33, 27.1%), 12 years old (n=24,

19.7%), 13 years old (n=24, 19.7%). The questionnaire was administered in sessions

lasting between 20 and 30 minutes. The Cronbach α coefficient for the questionnaire

overall was 0.69 (Online Table 6). Cronbach’s α coefficients for different age bands

12

were 0.72 for children aged 9 to 10 years and 0.68 for children aged 11 to 13 years. No

subsequent changes were made to the questionnaire.

Cronbach α coefficients for the individual components were 0.36 for nutrition, 0.37 for

physical activity, 0.50 for human body and heart awareness, and 0.46 for emotion

management. For domains, Cronbach α coefficients were 0.39 for knowledge, 0.58 for

attitudes, and 0.53 for habits. Test-retest reliability was estimated for each item by

calculating intraclass correlation coefficients between answers provided in the initial

evaluation and those given by 120 of the children who were re-interviewed 3 days later.

ICC values were acceptable for all items (Online Table 6).

13

SUPPLEMENTAL FIGURES

Online Figure 1. Questionnaire validation study- flow chart.

14

SUPPLEMENTAL TABLES

Online Table 1. The TIDieR (Template for Intervention Description and Replication) Checklist.

Item number

Item Where located

Primary paper

(page or appendix

number)

Other (details)

BRIEF NAME

1. Provide the name or a phrase that describes the intervention. Page 2 https://

clinicaltrials.gov/ct2/

show/NCT03119792

WHY

2. Describe any rationale, theory, or goal of the elements essential to the intervention. Page 3 Suppl. Methods (page 7)

WHAT

3. Materials: Describe any physical or informational materials used in the intervention, Page 3 Suppl.

15

including those provided to participants or used in intervention delivery or in training of intervention providers. Provide information on where the materials can be accessed (e.g. online appendix, URL).

Methods (pages 7 and 8); Online Table 2

4. Procedures: Describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities.

Page 3 Suppl. Methods (pages 7 and 8)

WHO PROVIDED

5. For each category of intervention provider (e.g. psychologist, nursing assistant), describe their expertise, background and any specific training given.

Suppl. Methods

(pages 7 and 8)

_____________

HOW

6. Describe the modes of delivery (e.g. face-to-face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individually or in a group.

Page 3 Suppl. Methods (pages 7 and 8)

16

WHERE

7. Describe the type(s) of location(s) where the intervention occurred, including any necessary infrastructure or relevant features.

Page 3 Suppl. Methods (pages 7 and 8)

WHEN and HOW MUCH

8. Describe the number of times the intervention was delivered and over what period of time including the number of sessions, their schedule, and their duration, intensity or dose.

Page 3 Suppl. Methods (pages 7 and 8)

TAILORING

9. If the intervention was planned to be personalised, titrated or adapted, then describe what, why, when, and how.

N/A _____________

MODIFICATIONS

10. If the intervention was modified during the course of the study, describe the changes (what, why, when, and how).

N/A _____________

HOW WELL

17

11. Planned: If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them.

Page 5 Online Table 10

12. Actual: If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned.

Pages 8 and 9 Figure 4

(TIDieR Checklist reproduced with permission from “Better reporting of interventions: template for interventiondescription and replication (TIDieR) checklist and guide.” Tammy C Hoffmann, Paul P Glasziou, Isabelle Boutron, et al. BMJ. Vol 348. © 2014, with permission from BMJ Publishing Group Ltd.)

18

Online Table 2. Main components of the SI! Program intervention.

Components What   Where, How

Human body

and heart

awareness

4 Units. Topics include heart function,

circulatory system, heart health, the

heart during exercise, importance of

drinking water, smoking effects, attitude

to smoking, care of the body and heart,

night-time sleeping, and active smoking.

4 units at community center

(face-to-face activities) with a

group of 25 children, delivered

by 2 intervention providers.

2 units at home (non-contact

activities) provided individually.

Physical

activity

4 Units. Topics include safety during

physical activity, effects of a sedentary

lifestyle, attitude to physical lifestyle,

and sedentary lifestyle.

4 units at community center

(face-to-face activities) with a

group of 25 children, delivered

by 2 intervention providers.

2 units at home (non-contact

activities) provided individually.

Nutrition 4 Units. Topics include aspects of a

healthy diet according to the guidelines

for cardiovascular health and risk

reduction in children and adolescents,

types of food, fruit and vegetables,

hydration, food choices at recess,

healthy breakfast, and junk food.

4 units at community center

(face-to-face activities) with a

group of 25 children, delivered

by 2 intervention providers.

2 units at home (non-contact

activities) provided individually.

Emotion

management

4 Units. This component covers conflict

resolution, management of negative

emotions, self-concept, optimism,

identification of personal and others’

emotions, and caring about others’

emotions.

  4 units at community center

(face-to-face activities) with a

group of 25 children, delivered

by 2 intervention providers.

2 units at home (non-contact

activities) provided individually.

19

Online Table 3. Survey questions (Spanish, original version).

Componentes Pregunta Posibles respuestas

Cuidado del cuerpo y el

corazón

   

1 ¿Para qué sirve el corazón? A. Aporta oxígeno a la sangre.◻B. Bombea sangre con oxígeno y nutrientes ◻

al cuerpo.C. Fabrica la sangre.◻

2 Señala la respuesta correcta en relación con el sistema circulatorio:

A. El exceso de grasa afecta a su ◻funcionamiento.

B. No podemos hacer nada por cuidarlo.◻C. El cigarrillo no influye en la salud del ◻

sistema circulatorio

3 ¿Cuál de las siguientes actividades es buena para la salud del corazón?

A. Comer como máximo tres veces al día◻B. No comer grasas ni dulces en forma ◻

abundante.C. Dedicar el tiempo libre a ver televisión, ◻

jugar en la computadora o Tablet, utilizar videojuegos o chatear.

4 ¿Por qué el corazón el corazón late más rápido inmediatamente después de hacer una actividad física?

A. La actividad física hace que el corazón se ◻acelere y funcione mal.

B. Así nos cansamos menos cuando nos ◻movemos.

C. El cuerpo necesita una mayor cantidad de ◻oxígeno.

5 ¿Beber agua es importante para la salud del cuerpo y el corazón?

A. Sí, porque el 70% del cuerpo es agua. ◻B. Sí, es importante beber, aunque no es ◻

necesario que sea agua, basta con las otras bebidas que ingerimos.

C. No, el agua no tiene nada que ver con la ◻salud.

6 ¿Qué sucede cuando una persona fuma alrededor de otra?

A. Sólo influye en la salud del que está ◻fumando

B. Afecta a los pulmones y corazón de ambos◻C. No contamina.◻

7 ¿Te gustaría fumar cuando seas mayor? A. Sí.◻B. De pronto.◻C. No.◻

20

8 ¿Crees que vale la pena cuidar tu corazón y el sistema circulatorio practicando actividad física frecuente y comiendo diferentes alimentos?

A. Sí siempre.◻B. No me interesa.◻C. Sólo a veces.◻

9 En un día de colegio habitual ¿A qué hora te duermes? ____________

¿A qué hora te despiertas?___________

10 ¿Has fumado cigarrillo alguna vez? A. Sí.◻B. No. ◻

Componentes Pregunta Posibles respuestas

Actividad física

Actividad física  

11 ¿Qué es necesario para realizar una actividad física de forma segura?

A. Evitar hacer ejercicio muchos días ◻seguidos ya que esto puede cansar los músculos

B. Comer abundantemente antes de la ◻actividad

C. Estirar y calentar los músculos antes de la ◻actividad.

12 ¿Cómo influye en la salud del cuerpo pasar mucho tiempo diario sentado viendo televisión, jugando en la computadora o Tablet, utilizando videojuegos o chateando?

A. No tiene nada que ver con la salud del ◻cuerpo.

B. Favorece el aumento de peso.◻C. Ayuda a dormir mejor.◻

13 ¿Te gusta realizar actividad física como correr, bailar o hacer cualquier deporte?

A. Poco o nada.◻B. De vez en cuando.◻C. Mucho. ◻

14 Durante un día normal, ¿cuánto tiempo pasas sentado viendo televisión, jugando en la computadora o Tablet, utilizando videojuegos o chateando?

A. Menos de 1 hora por día.◻B. 1 a 2 horas por día.◻C. Más de 2 horas por día.◻

15 Durante los últimos 7 días, ¿cuántos días has practicado una actividad física o ejercicio que TE AGITE Y TE HAGA SUDAR por un total de al menos 1 hora por día?Por ejemplo: danzas, deportes, porras, educación física, etc.

A. 1 o ningún día. ◻B. 2 a 4 días en la semana.◻C. 5 o más días en la semana.◻

Componentes Pregunta Posibles respuestas

Alimentación    

21

16 ¿Cuáles son los alimentos que no es bueno consumir a diario?

A. Grasas y azúcares.◻B. Lácteos (como queso o leche), carnes y ◻

legumbres.C. Dulces y pasteles.◻

17 ¿Cuántas porciones de frutas o verduras debe comer al día una persona para estar sana?

A. Ninguna porción.◻B. Entre 1 y 4 porciones.◻C. 5 o más porciones.◻

18 ¿Qué elegirías para calmar tu sed de forma saludable?

A. Agua.◻B. Jugos de caja.◻C. Gaseosas. ◻

19 ¿Qué harías si te sirven frutas o verduras en alguna de las comidas del día, como en el desayuno, almuerzo o la comida?

A. Las como porque me obligan.◻B. Las como con gusto.◻C. No las como.◻

20 ¿Si pudieras escoger qué comer para cuidar tu cuerpo y corazón, en el momento del recreo, qué elegirías?

A. Alimentos de paquete, empanadas y ◻gaseosas.

B. Un sánduche o fruta y agua o leche.◻C. Prefiero no comer nada.◻

21 Durante los últimos 7 días, ¿cuántos días comiste frutas o verduras?

A. 1 o ningún día.◻B. 2 a 4 días en la semana.◻C. 5 o más días en la semana. ◻

22 Durante los últimos 7 días, ¿cuántos días desayunaste alimentos como por ejemplo, lácteos (como queso o leche), huevo, fruta o cereal?

A. 1 o ningún día.◻B. 2 a 4 días en la semana.◻C. 5 o más días en la semana. ◻

23 Durante los últimos 7 días, ¿cuántos días comiste alimentos como papas a la francesa, empanadas, paquetes o gaseosas?

A. 1 o ningún día.◻B. 2 a 4 días en la semana.◻C. 5 o más días en la semana. ◻

Componentes Pregunta Posibles respuestas

Gestión de emociones

   

24 ¿Cómo se puede saber de las emociones de uno mismo o un compañero?

A. No se puede saber. ◻B. Sólo se puede saber lo que uno mismo ◻

siente.C. La expresión de la cara, los cambios en la ◻

postura del cuerpo y lo que se dice.

22

25 ¿Qué puede ayudar a sentirse mejor cuando se tienen emociones fuertes como rabia o tristeza?

A. No decírselo a nadie◻B. Respirar profundamente.◻C. Agredir a alguien, verbal o físicamente.◻

26 ¿Te gustaría conocer qué eres capaz de hacer y para qué eres bueno?

A. Sí.◻B. No.◻C. Nunca he pensado en eso.◻

27 Con relación con las emociones de tus compañeros, a lo que sienten…

A. No crees que las emociones de tus ◻compañeros sean asunto tuyo

B. Sueles identificar cómo se sienten y te ◻gustaría hacerlos sentir mejor.

C. No sueles interesarte por cómo se sienten. ◻

28 ¿Qué haces cuando surgen conflictos con compañeros?

A. Avisas a un adulto en cualquier caso, ◻aunque sea algo sencillo de resolver.

B. Tienes habilidad para ayudar a resolver los◻ conflictos.

C. Nunca tratas de ayudar en los conflictos ◻entre compañeros.

29 ¿Procuras el lado positivo de las cosas? A. Casi nunca o nunca.◻B. Algunas veces.◻C. Casi siempre o siempre.◻

23

Online Table 4. Survey questions (English, translated version).

Components Question Posible answers

Care of the body and heart

   

1 What is the heart for? A. It supplies oxygen to the blood. ◻B. It pumps blood with oxygen and nutrients ◻

to the body. C. It makes blood. ◻

2 Mark the correct answer with regard to the circulatory system:

A. Excess fat affects its performance. ◻B. We cannot do anything to take care of it. ◻C. Cigarette smoking does not affect the ◻

health of the circulatory system.

3 Which of the following activities is good for the heart´s health?

A. Eating at most three times a day. ◻B. Not eating a large amount of fats or ◻

sweets. C. Spending free time watching television, ◻

playing on the computer or tablet, using video games or chatting.

4 Why does the heart beat faster right after engaging in physical activity?

A. Physical activity makes the heart ◻accelerate and malfunction.

B. In doing this, we tire less when we move. ◻C. The body needs more oxygen. ◻

5 Is drinking water important for the body´s and heart´s health?

A. Yes, because 70% of the body is water. ◻B. Yes, it is important to drink, although it ◻

does not have to be water; the other beverages we drink are enough.

C. No, water has nothing to do with health. ◻

6 What happens when someone smokes around somebody else?

A. It only affects the health of the person ◻who is smoking.

B. It affects the lungs and heart of both ◻people.

C. It does not contaminate. ◻

7 Would you like to smoke when you are older? A. Yes.◻B. Maybe.◻C. No.◻

24

8 Do you think it is worthwhile to take care of your heart and circulatory system with frequent physical activity and eating different foods?

A. Yes, always.◻B. No, it does not interest me.◻C. Only sometimes.◻

9 On a normal school day What time do you go to sleep? ____________

What time do you wake up? ___________

10 Have you ever smoked a cigarette? A. Yes.◻B. No. ◻

Components Question Possible answers

Physical activity

 

11 What is required to safely carry out physical activity?

A. Avoid exercising too many days in a row, ◻since this can tire the muscles.

B. Eat a lot before the activity. ◻C. Stretch and warm the muscles before the ◻

activity.

12 How does spending a lot of time every day watching television, playing on the computer or tablet, using video games or chatting affect the body´s health?

A. It has nothing to do with the body´s ◻health.

B. It contributes to gaining weight. ◻C. It helps you sleep better. ◻

13 Do you like to engage in physical activity like running, dancing or any sport?

A. Very little or not at all. ◻B. Once in a while.◻C. Very much. ◻

14 During a normal day, how much time do you spend sitting watching television, playing on the computer or tablet, using video games or chatting?

A. Less than one hour a day. ◻B. One to two hours a day.◻C. More than two hours a day.◻

15 In the last seven days, on how many did you engage in a physical activity which left you OUT OF BREATH AND MADE YOU SWEAT for at least one hour a day? For example: dancing, sports, cheerleading, PE, etc.

A. One or no days. ◻B. Two to four days a week.◻C. Five or more days a week.◻

Components Question Possible answers

Eating    

25

16 Which foods are not good to eat every day? A. Fats and sugars.◻B. Milk products (like cheese or milk), meats ◻

and legumes. C. Sweets and pastries.◻

17 How many servings of fruits or vegetables should a person eat every day to be healthy?

A. No servings.◻B. Between one and four servings.◻C. Five or more servings.◻

18 What would you choose to quench your thirst in a healthy way?

A. Water.◻B. Boxed juice.◻C. Soda. ◻

19 What would you do if you were served fruits or vegetables at one of the day´s meals, such as breakfast, lunch or supper?

A. I would eat them because I had to. ◻B. I would eat them willingly.◻C. I would not eat them.◻

20 If you could choose what to eat to take care of your body and heart, what would you choose to eat at recess?

A. Packaged foods, fried meat pies and sodas.◻

B. A sandwich or fruit and water or milk.◻C. I prefer not to eat anything. ◻

21 In the last seven days, on how many did you eat fruits or vegetables?

A. One or no days.◻B. Two to four days a week.◻C. Five or more days a week. ◻

22 In the last seven days, on how many did you have foods such as milk products (like cheese or milk), eggs, fruit or cereal for breakfast?

A. One or no days.◻B. Two to four days a week.◻C. Five or more days a week. ◻

23 In the last seven days, on how many did you eat foods such as french fries, fried meat pies, packaged foods or sodas?

A. One or no days.◻B. Two to four days a week.◻C. Five or more days a week. ◻

Components Question Possible answers

Management of emotions

   

24 How can you know about your own emotions or those of a friend?

A. You can´t know. ◻B. You can only know what you yourself are ◻

feeling. C. By the facial expression, changes in body ◻

posture and what the person says.

25 What can help people feel better when they feel strong emotions like anger or sadness?

A. Not telling anyone. ◻B. Breathing deeply. ◻C. Hurting someone, either verbally or ◻

physically.

26

26 Would you like to know what you are capable of doing and what you are good at?

A. Yes.◻B. No.◻C. I´ve never thought about that. ◻

27 With regard to your friends´ emotions, what they feel…

A. You don´t think your friends´ emotions ◻are your business.

B. You tend to identify how they feel and you◻ would like to make them feel better.

C. You don´t usually care how they feel. ◻

28 What do you do when there are conflicts with your friends?

A. You always tell an adult, even if it is ◻something easy to resolve.

B. You have the ability to help solve ◻conflicts.

C. You never try to help in conflicts between ◻friends.

29 Do you look for the positive side of things? A. Almost never or never. ◻B. Sometimes.◻C. Almost always or always.◻

27

Online Table 5. Questionnaire structure and scoring.

Component Domain # Item Item score

Weighted score range

Human body and heart awareness

Knowledge 1 Heart function 0, 2

0-8

2 Circulatory system 0, 23 Heart health 0, 24 The heart during exercise 0, 25 Importance of drinking water 0, 26 Smoking effects 0, 2

Attitudes 7 Attitude to smoking 0, 1, 2 0-88 Care of the body and heart 0, 1, 2Habits 9 Night-time sleeping hours 0, 1, 2 0-810 Active smoking 0, 2

Physical activity Knowledge 11 Safety during physical activity 0, 2 0-812 Effects of a sedentary lifestyle 0, 2Attitudes 13 Attitude to physical activity 0, 1, 2 0-8Habits 14 Sedentary lifestyle 0, 1, 2 0-815 Physical activity 0, 1, 2

Nutrition Knowledge 16 Types of food 0, 2 0-817 Fruits and vegetables 0, 2Attitudes 18 Hydration 0, 2

0-819 Fruits and vegetables 0, 1, 220 Food choices at recess 0, 2

Habits 21 Fruit/vegetable consumption 0, 1, 20-822 Healthy breakfast 0, 1, 2

23 Consumption of junk food 0, 1, 2

Emotion management

Knowledge 24 Identification of emotions 0, 2 0-825 Emotion management 0, 2Attitudes 26 Self-concept 0, 2

0-827 Attitude toward other people’s emotions 0, 2

Habits 28 Conflict management 0, 1, 2 0-829 Optimism 0, 1, 2

TOTAL       0-96

28

Online Table 6. Reliability of the final version of the questionnaire.

Item Alpha Cronbach ICC (95% CI)

1 Heart function 0.70 0.67 (0.56-0.76)2 Circulatory system 0.69 0.72 (0.62-0.79)3 Heart health 0.68 0.69 (0.58-0.77)

4 The heart during exercise 0.69 0.70 (0.60-0.78)5 Importance of drinking water 0.69 0.70 (0.59-0.78)

6 Smoking effects 0.68 0.81 (0.74-0.86)7 Attitude to smoking 0.67 0.82 (0.75-0.87)

8 Attitude toward care of the body/heart 0.67 0.72 (0.62-0.80)9 Night-time sleeping hours 0.68 0.81 (0.74-0.86)

10 Active smoking 0.67 0.88 (0.83-0.92)11 Safety during physical activity 0.69 0.69 (0.58-0.77)

12 Effects of a sedentary lifestyle 0.68 0.72 (0.62-0.79)13 Attitude to physical activity 0.68 0.73 (0.63-0.80)

14 Sedentary lifestyle 0.68 0.81 (0.73-0.86)15 Physical activity 0.68 0.71 (0.61-0.79)

16 Types of food 0.70 0.70 (0.59-0.78)17 Fruit and vegetables 0.69 0.66 (0.54-0.75)

18 Attitude to hydration 0.68 0.90 (0.85-0.93)19 Attitude toward fruits and vegetables 0.66 0.80 (0.72-0.85)

20 Food choices at recess 0.68 0.73 (0.63-0.80)21 Consumption of fruit and vegetables 0.68 0.68 (0.57-0.77)

22 Healthy breakfast 0.69 0.69 (0.58-0.77)23 Consumption of junk food 0.67 0.69 (0.59-0.77)

24 Identification of emotions 0.69 0.68 (0.58-0.78)25 Emotion management 0.68 0.76 (0.67-0.82)

26 Self-concept 0.68 0.67 (0.55-0.75)27 Attitude toward other people’s emotions 0.68 0.81 (0.74-0.86)

28 Conflict management 0.68 0.78 (0.69-0.84)29 Optimism 0.67 0.71 (0.60-0.79)

Total 0.69ICC, intraclass correlation coefficient; CI, confidence interval

29

Online Table 7. Knowledge, Attitudes, and Habits (KAH) toward a healthy

lifestyle of children at follow-up (post-intervention assessment).

Control

(n = 542)

Intervention

(N = 536)

KAH overall, points (range 0-96)

Overall domains

Knowledge, points (range 0-32)

Attitudes, points (range 0-32)

Habits, points (range 0-32)

70.7 (9.4)

21.8 (5.0)

27.5 (4.3)

21.4 (4.0)

71.5 (9.7)

22.4 (5.2)

27.6 (4.5)

21.6 (3.9)

Overall components

Diet, points (range 0-24)

Physical activity, points (range 0-24)

Body and heart, points (range 0-24)

Emotions, points (range 0-24)

14.5 (3.9)

16.9 (4.1)

20.8 (2.2)

18.6 (4.3)

14.9 (3.8)

17.1 (4.2)

21.1 (2.2)

18.4 (4.3)

Values are mean (standard deviation) for continuous variables or frequencies (percentages) for

categorical variables.

30

Online Table 8. Ideal Cardiovascular Health (ICH) scores of children at follow-up

(post-intervention assessment).

Control

(N = 538)

Intervention

(N = 529)

ICH overall, points (range 0-14) 11.0 (1.3) 10.8 (1.4)

Categorized ICH overall score, n (%)

Poor cardiovascular health

Intermediate cardiovascular health

Ideal cardiovascular health

71 (13.2)

380 (70.6)

87 (16.2)

77 (14.6)

386 (73.0)

66 (12.5)

Number of ideal ICH metrics, n (%)

0

1

2

3

4

5

6

7

0 (0.0)

0 (0.0)

7 (1.3)

64 (11.9)

175 (32.5)

205 (38.1)

87 (16.2)

0 (0.0)

0 (0.0)

2 (0.4)

18 (3.4)

57 (10.8)

178 (33.7)

208 (39.3)

66 (12.5)

0 (0.0)

Health metrics

Body mass index, n (%)

Poor, >95th percentile

Intermediate, 85th-95th percentile

Ideal, <85th percentile

14 (2.6)

36 (6.7)

488 (90.7)

16 (3.0)

47 (8.9)

466 (88.1)

31

Blood pressure, n (%)

Poor, >95th percentile

Intermediate, 90-95th percentile

Ideal, <90th percentile

Total cholesterol, n (%)

Poor, ≥ 200 mg/dL

Intermediate, 170-199 mg/dL

Ideal, <170 mg/dL

Glucose, n (%)

Poor, ≥ 126 mg/dL

Intermediate, 100-125 mg/dL

Ideal, <100 mg/dL

Current smoking, n (%)

Poor, tried before

Ideal, never tried

Physical activity, n (%)

Poor, none

Intermediate, 1-59 min/day

Ideal, ≥60 min/day

Diet score, n (%)

Poor, 0 components

Intermediate, 1-2 components

Ideal, 3 components

42 (7.8)

40 (7.4)

456 (84.8)

42 (7.8)

152 (28.3)

344 (63.9)

14 (2.6)

122 (22.7)

402 (74.7)

1 (0.2)

537 (99.8)

14 (2.6)

306 (56.9)

218 (40.5)

175 (32.5)

355 (66.0)

8 (1.5)

44 (8.3)

39 (7.4)

446 (84.3)

38 (7.2)

165 (31.2)

326 (61.6)

17 (3.2)

113 (21.4)

399 (75.4)

1 (0.2)

528 (99.8)

29 (5.5)

315 (59.6)

185 (35.0)

185 (35.0)

337 (63.7)

7 (1.3)

Values are mean (standard deviation) for continuous variables or frequencies (percentages) for

categorical variables.

32

Online Table 9. Prevalence of healthy changes in ideal cardiovascular health (ICH)

metrics and behaviors.

Within-group change Between-group difference

Control, n (%) Intervention, n (%) Odds Ratio (95% CI) p-value

Categorized ICH overall 114 (21.2%) 91 (17.2%) 0.77 (0.53 to 1.13) 0.180

Health metrics

Body mass index 11 (2.0%) 9 (1.7%) 0.84 (0.39 to 1.79) 0.651

Blood pressure 90 (16.7%) 73 (13.8%) 0.75 (0.47 to 1.20) 0.230

Total cholesterol 197 (36.6%) 194 (36.7%) 1.01 (0.75 to 1.37) 0.951

Glucose 39 (7.2%) 27 (5.1%) 0.68 (0.40 to 1.18) 0.170

Current smoking 1 (0.2%) 0 (0.0%) ~1.00 -

Physical activity 106 (19.7%) 89 (16.8%) 0.80 (0.57 to 1.12) 0.196

Diet score 110 (20.4%) 95 (18.0%) 0.82 (0.56 to 1.20) 0.307

Data are presented as counts (prevalences) of children exhibiting a healthy change for all

component metrics of the ICH score (from poor to intermediate or ideal status, or from

intermediate to ideal status). Between-group differences reflect odds ratios and 95% confidence

intervals (CI) derived from multilevel mixed-effects logistic regression models (with the control

group as reference). Fixed effects were the corresponding treatment group, while cluster and

family were handled as random effects. An odds ratio greater than 1 indicates that the

probability of a healthy change was higher in the intervention group than in the control group.

An odds ratio lower than 1 indicates that the probability of a healthy change was higher in the

control group than in the intervention group.

ICH, ideal cardiovascular health.

33

Online Table 10. Strategies implemented to increase adherence in the present trial.

Level Description

Study personnel Study personnel participating in the retention strategies consisted of

researchers, 2 young physicians, 6 former school directors (one for each

community center), and 12 intervention providers (2 for each community

center).

Training of study personnel in retention strategies (showing empathy

toward children’s personal situation)

Assignment to each participant of a former primary school director

and 1 intervention provider, who made calls to remind parents about

upcoming Saturday sessions at the community centers.

Family Explaining study requirements and details to families, including

potential benefits.

Community involvement through focus groups to learn about

families’ expectations and to explain study details.

Scheduling sessions according to family time preferences

(morning/afternoon)

Maintaining updated contact information (multiple contacts for each

participant).

Children Creation of a project identity by distributing bracelets featuring the

name of the study.

Free bus transportation from homes to community centers

Bicycle raffle open to children attending sessions

Distribution of complimentary sports shirts to participating children

School visits to update parents’ phone numbers

34

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