NCT03579810.
Methods |
Type of trial: efficacy Allocation: randomised Intervention model: parallel assignment Masking: none (open‐label) |
Participants |
Estimated number of schools: 9 Estimated number of students: 870 Inclusion criteria (schools): private schools located in the urban area of Bogotá with an appropriate physical activity space and infrastructure, that allowed study conduction Exclusion criteria (schools): schools that have received interventions longer than 1 month in healthy habits (nutrition and/or physical activity) during the year prior to the start of the study or during study follow‐up, schools with a history of annual dropout greater than 10% Inclusion criteria (students): aged 4 to 8 years Exclusion criteria (students): − |
Interventions |
Intervention: a 2.5‐year pedagogical intervention to increase knowledge, attitudes, and healthy lifestyle habits about physical activity, healthy eating, and knowledge of the body and heart, targeting children, parents, and teachers. Among children, the intervention included class activities (1/week) and the use of educational materials (posters and educative guide). For parents, the intervention included 3 workshops/year (2 hours each), sending healthy notes (1/month), and celebrating healthy family day (1/year). For teachers, the intervention included 3 workshops/y (2 hours each); planning and implementing pedagogical activities with students (1/week); and conducting follow‐up visits to school (1/month) Comparators: children received the standard curriculum in health and physical activity of the national Ministry of Education. For parents and teachers, this included 3 workshops/y (2 hours each) about first aid and accident prevention |
Outcomes |
Primary outcomes: physical activity energy expenditure, healthy food consumption Secondary outcomes: BMI, waist circumference, total cholesterol, triglycerides, fasting glucose, blood pressure, health food consumption (teachers), healthy food consumption (parents) Other outcomes: − |
Reason for awaiting classification | Noted as complete in clinical trials registry, but no results published |
Stated aim of study | Quote: "the objectives of this project are to evaluate changes in healthy foods consumption and energy expenditure in children from kindergarten to second grade of elementary school that receives pedagogical intervention (PI) adapted to its context, compared to another EC that develops its habitual curriculum. In addition, this study evaluates changes on cardiovascular risk factors in children. Also, it evaluates changes in healthy foods consumption in their parents and teachers" |
Notes |