Cardiovascular HealthPhase 3NCT01551355
Promoting Heart Health in Preschool Children
A Phase 3 study testing Children-Multicomponent intervention in people with Cardiovascular Health, run by Valentin Fuster at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Health
- What is being tested?
- Children-Multicomponent intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,279 participants
- Where
- 1 siteColombia
- Study dates
- Jul 2009to Jul 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Intervention to Promote Healthy Heart Habits in Pre-School Children
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.
Read the 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.
- Conditions
- Cardiovascular Health
- Being tested
- Children-Multicomponent intervention
- Keywords
- behavioral modification, health communication, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children-Multicomponent interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Children-Multicomponent intervention |
| children - control group | No intervention | The control preschool facilities continued with their usual preschool curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline and at 6 months
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJul 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valentin Fuster
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Fundación Cardioinfantil Instituto de Cardiología, Sesame Workshop
- Responsible party
- Sponsor-investigator, Valentin Fuster, Icahn School of Medicine at Mount Sinai
- Investigators
- Valentin Fuster, MD, PhD, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551355
- Sponsor's protocol ID
- GCO 09-0702
- Status last verified
- Nov 2016
- First submitted
- 5 Mar 2012
- Last updated
- 9 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intervention to Promote Healthy Heart Habits in Pre-School Children
- ClinicalTrials.gov ID
- NCT01551355
- Acronym / sponsor ID
- GCO 09-0702
- Conditions
- Cardiovascular Health
- Keywords
- behavioral modification, health communication, prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,279 participants (actual)
- Lead sponsor
- Valentin FusterUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Fundación Cardioinfantil Instituto de Cardiología, Sesame Workshop
- Study start
- Jul 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Posted 9 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children-Multicomponent intervention | Experimental | Behavioral: Children-Multicomponent interventionThe 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 |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Children-Multicomponent interventionThe 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. | Behavioural | Children-Multicomponent intervention |
Primary outcome
Change in KAH Score for Children
Time frame: 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
3 secondary outcomes
KAH Score for Parents
Time frame: at baseline and at 6 months
KAH Score for Teachers
Time frame: at baseline and at 6 months
Body Mass Index - BMI
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentin Fuster, MD, PhD study chair
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Children-Multicomponent intervention in people with Cardiovascular Health, run by Valentin Fuster at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in KAH Score for Children (time frame: at baseline and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2017.