Promoting Heart Health in Preschool Children

NCT01551355 | Completed Phase 3 Results

• 1 other identifier: GCO 09-0702
• Study Type: interventional
• Target: 2,279
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Health

Keywords

behavioral modification; health communication; prevention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• KAH Score for Parents

  at baseline and at 6 months

• KAH Score for Teachers

  at baseline and at 6 months

• Body Mass Index - BMI

  baseline

Study Arms (2)

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.

Behavioral: Children-Multicomponent intervention

children - control group

NO INTERVENTION

The control preschool facilities continued with their usual preschool curriculum

Interventions

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.

Children-Multicomponent intervention

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Valentin Fuster: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Fundación Cardioinfantil Instituto de Cardiología: collaborator
• Sesame Workshop: collaborator

Study Sites (1)

Fundación CardioInfantil Instituto de Cardiología

Bogotá, Colombia

Location

Limitations and Caveats

minimal participation of teachers in initial planning stage. small number of teachers evaluated has limited the statistical power in this group.

Results Point of Contact

• Title: Dr. Valentin Fuster
• Organization: Icahn School of Medicine at Mount Sinai

valentin.fuster@mssm.edu

212-241-3852

Study Officials

• Valentin Fuster, MD, PhD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician-in-Chief

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 12, 2012
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 9, 2017
• Results First Posted: January 9, 2017

Record last verified: 2016-11

Locations

CO (1)