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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
| Fundación Cardioinfantil Instituto de Cardiología | OTHER |
| Sesame Workshop | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children-Multicomponent intervention | Experimental | 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. |
|
| children - control group | No Intervention | The control preschool facilities continued with their usual preschool curriculum |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Children-Multicomponent intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at baseline and at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valentin Fuster, MD, PhD | Icahn School of Medicine at Mount Sinai | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación CardioInfantil Instituto de Cardiología | Bogotá | Colombia |
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Recruitment in 14 preschool facilities in Usaquén (Bogotá, Colombia) between May and November, 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Habits Intervention | 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. |
| FG001 | Usual Curriculum | children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum |
| FG002 | 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. |
| FG003 | Usual Curriculum - Parents/Caregivers | Control preschool facilities continued with their usual preschool curriculum |
| FG004 | 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. |
| FG005 | Usual Curriculum - Teachers | Control preschool facilities continued with their usual preschool curriculum |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline and at 6 months |
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adverse events information not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Habits Intervention | 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. |
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minimal participation of teachers in initial planning stage. small number of teachers evaluated has limited the statistical power in this group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Valentin Fuster | Icahn School of Medicine at Mount Sinai | 212-241-3852 | valentin.fuster@mssm.edu |
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|
| at baseline and at 6 months |
| 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 | at baseline and at 6 months |
| 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 | baseline |
| Usual Curriculum - Children |
Control preschool facilities continued with their usual preschool curriculum |
| BG002 | 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. |
| BG003 | Usual Curriculum - Parents/Caregivers | Control preschool facilities continued with their usual preschool curriculum |
| BG004 | 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. |
| BG005 | Usual Curriculum - Teachers | Control preschool facilities continued with their usual preschool curriculum |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Gender | Children: gender (male/female) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Healthy Habits Intervention | Preschool Facility* Intervention Arm 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. |
| OG001 | Usual Curriculum | education imparted by teachers control preschool facilities continued with their usual preschool curriculum |
|
|
|
| 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 | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline and at 6 months |
|
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|
|
| 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 | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | at baseline and at 6 months |
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| 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 | Posted | Mean | Standard Deviation | Kg/m² | baseline |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Curriculum | children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum | 0 | 0 | 0 | 0 |
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