Cardiovascular Health
Conditions
Keywords
behavioral modification, health communication, prevention
Brief summary
As part of the Colombian Hearty Health Initiative program led by Mount Sinai Cardiovascular Institute, a multidisciplinary team design and implemented a pedagogic and communication strategies for the promotion of healthy heart habits (PPHH) in preschoolers. This included educational materials, pedagogical activities and the use of Sesame Workshop healthy habits for life materials. For Colombia, the latter were largely developed in collaboration with the Colombian Society of Pediatrics, Colombian Society of Cardiology and Cardiovascular Surgery, Colsubsidio and Fundación Cardioinfantil-Instituto de Cardiología.
Detailed description
Background Increased levels of risk factors during childhood create an important life-long burden that favors the development of cardiovascular (CVD) disease in adulthood. Epidemiologic studies have demonstrated that cardiovascular disease risk factors are identifiable in childhood and persist through to adulthood. It is unknown whether interventions targeting preschoolers may change knowledge, attitudes and habits (KAH) towards healthy lifestyles and, eventually, reduce the burden of CVD. The goal of the proposed study is to assess over a five month intervention period, the impact of an educational intervention on preschooler's knowledge of, habits and attitudes towards healthy eating and living an active lifestyle. The impact of the intervention will be also assessed in parents and teachers. Methods The investigators will conduct a cluster, randomized controlled trial in 1216 pre-school children 3 to 5 years of age, 928 parents, and 120 teachers from 14 preschool facilities in Bogotá, Colombia in a low socioeconomic and underprivileged community. Randomization will occur at the facility level. The intervention will include classroom activities and use of printed material (books, posters, teachers' guides, games) and videos. Meanwhile, children in the control facilities will continue with their usual curriculum. A structured survey will be used at baseline and end of study to evaluate changes in KAH and the authors a priori give differential weights (70-20-10, respectively) to the scores to compose a standardized weighted total score (WTS). The primary outcome will be the change in children's WTS and the secondary outcomes will be the changes in parents' and teachers´ WTS. Potential Impact of the Trial If found to be effective in improving the short-term changes in knowledge, attitudes and habits, the educational intervention may have the potential to influence the children's' diet and physical activity patterns throughout their lifetimes by early interventions when attitudes and habits are formed. The program also targets parents and teachers who contribute to shape children's attitudes and habits and who are often at high risk for health problems associated with unhealthy diet and limited physical activity themselves. The program aims to empower local partners in the health, education, media and government sectors to build up the capacities to ensure sustainability. If proven efficacious in the short term, further evaluative studies should test the hypothesis that this program will serve as an effective and sustainable model to improve children's health worldwide.
Interventions
BEHAVIORALChildren-Multicomponent intervention
The intervened children were provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes. Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children. Teachers also participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received a teacher's guide.
Sponsors
Icahn School of Medicine at Mount Sinai
Fundación Cardioinfantil Instituto de Cardiología
Sesame Workshop
Valentin Fuster
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Children attending one of the 14 H.I. in Usaquén * Children who are 3, 4, or 5 years of age at the time of the beginning of the intervention
Exclusion criteria
* Unwillingness to provide informed consent * Children who have received formal training in healthy habits in nutrition and / or physical activity in the 6 months prior to the start of the follow-up period of the study. * Children who plan to receive formal training in healthy habits in nutrition and / or physical activity during the follow-up study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in KAH Score for Children | at baseline and at 6 months | Change in weighted knowledge, attitude, habit (KAH) (70/20/10) score among children after 5 months of intervention as compared to prior to intervention. The study hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, differential weights (70, 20, and 10, respectively) were given to the scores a priori to compose a standardized weighted total score (WTS). The developed questionnaires measured knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers. Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KAH Score for Parents | at baseline and at 6 months | Change in Weighted knowledge, attitude, habit (KAH) score (70/20/10) among parents after 5 months of intervention as compared to prior to intervention. Because we hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, we a priori gave differential weights (70, 20, and 10, respectively) to the scores to compose a standardized weighted total score (WTS). Questionnaires were developedheae to measure knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers. Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome |
| KAH Score for Teachers | at baseline and at 6 months | Change in Weighted knowledge, attitude, habit (KAH) score (70/20/10) among teachers after 5 months of intervention as compared to prior to intervention. Because we hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, we a priori gave differential weights (70, 20, and 10, respectively) to the scores to compose a standardized weighted total score (WTS). We developed questionnaires to measure knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers. Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome |
| Body Mass Index - BMI | baseline | The body mass index (BMI), or Quetelet index, is a measure of relative weight based on an individual's mass and height = Kg/m² |
Countries
Colombia
Participant flow
Recruitment details
Recruitment in 14 preschool facilities in Usaquén (Bogotá, Colombia) between May and November, 2009
Participants by arm
| Arm | Count |
|---|---|
| Healthy Habits Intervention - Children Preschool Facility\* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes. | 622 |
| Usual Curriculum - Children Control preschool facilities continued with their usual preschool curriculum | 594 |
| Healthy Habits Intervention - Parents/Caregivers Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children. | 493 |
| Usual Curriculum - Parents/Caregivers Control preschool facilities continued with their usual preschool curriculum | 435 |
| Healthy Habits Intervention - Teachers Teachers participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received teacher's guide. | 64 |
| Usual Curriculum - Teachers Control preschool facilities continued with their usual preschool curriculum | 71 |
| Total | 2,279 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 51 | 49 | 34 | 24 | 9 | 6 |
Baseline characteristics
| Characteristic | Healthy Habits Intervention - Children | Usual Curriculum - Children | Healthy Habits Intervention - Parents/Caregivers | Usual Curriculum - Parents/Caregivers | Healthy Habits Intervention - Teachers | Usual Curriculum - Teachers | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | NA years | NA years | 31.25 years STANDARD_DEVIATION 8.1 | 29.94 years STANDARD_DEVIATION 6.8 | 39.04 years STANDARD_DEVIATION 10.6 | 35.05 years STANDARD_DEVIATION 8.9 | NA years |
| Age, Customized age 3 | 342 participants | 309 participants | NA participants | NA participants | NA participants | NA participants | 651 participants |
| Age, Customized age 4 | 270 participants | 266 participants | NA participants | NA participants | NA participants | NA participants | 536 participants |
| Age, Customized age 5 | 10 participants | 19 participants | NA participants | NA participants | NA participants | NA participants | 29 participants |
| Gender Female | 296 Participants | 275 Participants | 412 Participants | 373 Participants | 55 Participants | 64 Participants | 1475 Participants |
| Gender Male | 326 Participants | 319 Participants | 81 Participants | 62 Participants | 9 Participants | 7 Participants | 804 Participants |
| Region of Enrollment Colombia | 622 participants | 594 participants | 493 participants | 435 participants | 64 participants | 71 participants | 2279 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in KAH Score for Children
Change in weighted knowledge, attitude, habit (KAH) (70/20/10) score among children after 5 months of intervention as compared to prior to intervention. The study hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, differential weights (70, 20, and 10, respectively) were given to the scores a priori to compose a standardized weighted total score (WTS). The developed questionnaires measured knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers. Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome
Time frame: at baseline and at 6 months
Population: The analysis was done with children that answered al questions in 3 topics: knowledge, attitudes and habits.~Change Score in Weighted total score controlling for Cluster Effect, Sex, Age, Children's Weight, and Teacher's Educational Level after 5-Month Intervention.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthy Habits Intervention | Change in KAH Score for Children | 7.66 units on a scale |
| Usual Curriculum | Change in KAH Score for Children | 3.76 units on a scale |
p-value: <0.00195% CI: [1.64, 6.16]t-test, 2 sided
Secondary
Body Mass Index - BMI
The body mass index (BMI), or Quetelet index, is a measure of relative weight based on an individual's mass and height = Kg/m²
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Habits Intervention | Body Mass Index - BMI | 16.57 Kg/m² | Standard Deviation 0.45 |
| Usual Curriculum | Body Mass Index - BMI | 16.4 Kg/m² | Standard Deviation 0.49 |
Secondary
KAH Score for Parents
Change in Weighted knowledge, attitude, habit (KAH) score (70/20/10) among parents after 5 months of intervention as compared to prior to intervention. Because we hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, we a priori gave differential weights (70, 20, and 10, respectively) to the scores to compose a standardized weighted total score (WTS). Questionnaires were developedheae to measure knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers. Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome
Time frame: at baseline and at 6 months
Population: Change in weighted total score controlling for Cluster Effect, Sex, Age, Children's Weight, and Teacher's Educational Level after 5-Month Intervention. Data available only for 402 parents in healthy habits arm and 360 parents in usual curriculum arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthy Habits Intervention | KAH Score for Parents | 6.12 units on a scale |
| Usual Curriculum | KAH Score for Parents | 2.04 units on a scale |
p-value: <0.00195% CI: [2.03, 6.12]t-test, 2 sided
Secondary
KAH Score for Teachers
Change in Weighted knowledge, attitude, habit (KAH) score (70/20/10) among teachers after 5 months of intervention as compared to prior to intervention. Because we hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, we a priori gave differential weights (70, 20, and 10, respectively) to the scores to compose a standardized weighted total score (WTS). We developed questionnaires to measure knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers. Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome
Time frame: at baseline and at 6 months
Population: Change in weighted total score controlling for Cluster Effect, Sex, Age, Children's Weight, and Teacher's Educational Level after 5-Month Intervention. Data available only for 37 teachers in healthy habits arm and 35 teachers in usual curriculum arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthy Habits Intervention | KAH Score for Teachers | 7.24 units on a scale |
| Usual Curriculum | KAH Score for Teachers | 1.88 units on a scale |
p-value: =0.0695% CI: [-0.29, 11.01]t-test, 2 sided