Trial Outcomes & Findings for Promoting Heart Health in Preschool Children (NCT NCT01551355)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2279 participants

Primary outcome timeframe

at baseline and at 6 months

Results posted on

2017-01-09

Participant Flow

Recruitment in 14 preschool facilities in Usaquén (Bogotá, Colombia) between May and November, 2009

Participant milestones

Participant milestones
Measure	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.	Usual Curriculum children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum	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.	Usual Curriculum - Parents/Caregivers Control preschool facilities continued with their usual preschool curriculum	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.	Usual Curriculum - Teachers Control preschool facilities continued with their usual preschool curriculum
Overall Study STARTED	622	594	493	435	64	71
Overall Study COMPLETED	571	545	459	411	55	65
Overall Study NOT COMPLETED	51	49	34	24	9	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Usual Curriculum children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum	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.	Usual Curriculum - Parents/Caregivers Control preschool facilities continued with their usual preschool curriculum	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.	Usual Curriculum - Teachers Control preschool facilities continued with their usual preschool curriculum
Overall Study Lost to Follow-up	51	49	34	24	9	6

Baseline Characteristics

Promoting Heart Health in Preschool Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Habits Intervention - Children n=622 Participants 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.	Usual Curriculum - Children n=594 Participants Control preschool facilities continued with their usual preschool curriculum	Healthy Habits Intervention - Parents/Caregivers n=493 Participants Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children.	Usual Curriculum - Parents/Caregivers n=435 Participants Control preschool facilities continued with their usual preschool curriculum	Healthy Habits Intervention - Teachers n=64 Participants 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.	Usual Curriculum - Teachers n=71 Participants Control preschool facilities continued with their usual preschool curriculum	Total n=2279 Participants Total of all reporting groups
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	31.25 years STANDARD_DEVIATION 8.1 • n=5 Participants	29.94 years STANDARD_DEVIATION 6.8 • n=4 Participants	39.04 years STANDARD_DEVIATION 10.6 • n=21 Participants	35.05 years STANDARD_DEVIATION 8.9 • n=8 Participants	NA years STANDARD_DEVIATION NA • n=8 Participants
Age, Customized age 3	342 participants n=5 Participants	309 participants n=7 Participants	NA participants n=5 Participants	NA participants n=4 Participants	NA participants n=21 Participants	NA participants n=8 Participants	651 participants n=8 Participants
Age, Customized age 4	270 participants n=5 Participants	266 participants n=7 Participants	NA participants n=5 Participants	NA participants n=4 Participants	NA participants n=21 Participants	NA participants n=8 Participants	536 participants n=8 Participants
Age, Customized age 5	10 participants n=5 Participants	19 participants n=7 Participants	NA participants n=5 Participants	NA participants n=4 Participants	NA participants n=21 Participants	NA participants n=8 Participants	29 participants n=8 Participants
Gender Female	296 Participants n=5 Participants	275 Participants n=7 Participants	412 Participants n=5 Participants	373 Participants n=4 Participants	55 Participants n=21 Participants	64 Participants n=8 Participants	1475 Participants n=8 Participants
Gender Male	326 Participants n=5 Participants	319 Participants n=7 Participants	81 Participants n=5 Participants	62 Participants n=4 Participants	9 Participants n=21 Participants	7 Participants n=8 Participants	804 Participants n=8 Participants
Region of Enrollment Colombia	622 participants n=5 Participants	594 participants n=7 Participants	493 participants n=5 Participants	435 participants n=4 Participants	64 participants n=21 Participants	71 participants n=8 Participants	2279 participants n=8 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Healthy Habits Intervention n=433 Participants 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.	Usual Curriculum n=425 Participants education imparted by teachers control preschool facilities continued with their usual preschool curriculum
Change in KAH Score for Children	7.66 units on a scale Interval 6.94 to 8.38	3.76 units on a scale Interval 3.4 to 4.12

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Healthy Habits Intervention n=402 Participants 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.	Usual Curriculum n=360 Participants education imparted by teachers control preschool facilities continued with their usual preschool curriculum
KAH Score for Parents	6.12 units on a scale Interval 5.53 to 6.71	2.04 units on a scale Interval 1.83 to 2.25

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Healthy Habits Intervention n=37 Participants 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.	Usual Curriculum n=35 Participants education imparted by teachers control preschool facilities continued with their usual preschool curriculum
KAH Score for Teachers	7.24 units on a scale Interval 4.83 to 9.65	1.88 units on a scale Interval 1.23 to 2.53

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Healthy Habits Intervention n=622 Participants 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.	Usual Curriculum n=594 Participants education imparted by teachers control preschool facilities continued with their usual preschool curriculum
Body Mass Index - BMI	16.57 Kg/m² Standard Deviation 0.45	16.4 Kg/m² Standard Deviation 0.49

Adverse Events

Healthy Habits Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Curriculum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Valentin Fuster

Icahn School of Medicine at Mount Sinai

Phone: 212-241-3852

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place