Obesity Clinical Trial
— MOVI-KIDSOfficial title:
Effectiveness of an Intervention of Physical Activity Promotion in Schoolchildren on Preventing Obesity During the Adiposity Rebound Period: a Cross-over Randomized Cluster Trial.
Verified date | October 2013 |
Source | University of Castilla-La Mancha |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
Coordinated project whose objectives are: a) to assess the effectiveness of a physical activity intervention (MOVI-KIDS) on preventing obesity and improving fitness during the adiposity rebound period; and b) to examine the effectiveness of MOVI-KIDS on reducing the carotid intima-media thickness.
Status | Enrolling by invitation |
Enrollment | 1600 |
Est. completion date | June 2015 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 4 Years to 7 Years |
Eligibility |
Inclusion Criteria: - Schools with at least one full course of 3rd of early childhood education and one of 1st primary school. - The Boards of Governors (community participatory organ in each school) give its approval to the intervention and measurements at the beginning and end of the course. - Children 4 to 7 years old. - Children's parents/caregivers will give their written consent to the children's participation. - Collaboration in the family to respond to questionnaires on family leisure habits, sleeping, eating, getting around town, etc., included in the measurement protocol of this project. Exclusion Criteria: - Have a malformation that prevents learning of the Spanish language (or Spanish sign language). - Have some kind of physical or mental disorder identified by parents or teachers that prevent physical activity. - Have a chronic illness such as heart disease, diabetes or asthma, as determined by your pediatrician/family doctor -after analysis of the activities program- prevents participation in them. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Spain | Health and Social Research Centre, University of Castilla-La Mancha | Cuenca |
Lead Sponsor | Collaborator |
---|---|
University of Castilla-La Mancha | Carlos III Health Institute |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Prior assessment of barriers and facilitators | Nested qualitative study aimed to understand the barriers and limitations perceived by children, parents, and teachers for the physical activity of schoolchildren, using focus groups under a phenomenologic framework. | One year | No |
Primary | Body fat percentage | To reduce body fat percentage in the intervention group versus the control group in 2% in children during the adiposity rebound 4-7 years). Mean of two measurements of body fat percentage using an eight-electrode BC-418 MA bioimpedance analysis system (Tanita Corp. Tokyo, Japan). |
One year (interim analysis) | No |
Secondary | Physical fitness | It will be assessed the main components of fitness: a) muscle strength by using standing long jump test b) Flexibility by using the sit and reach test c) speed-agility (The 4x10 meters shuttle run test), d) aerobic capacity, by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 5 years. | One year (interim analysis) | No |
Secondary | Waist circumference | Waist circumference will be measured 3 times at the midpoint between the last rib and the iliac crest at the end of a normal expiration and using a flexible tape. | One year (interim analysis) | No |
Secondary | Tricipital skinfold thickness | Skinfold thickness will be measured 3 times at the triceps using a Holtain Ltd. caliper (0.2 mm accuracy and consistent 10 g/mm2 pressure between valves) | one year (interim analysis) | No |
Secondary | Blood pressure | Blood pressure will be measured twice, with a 5-min interval between measurements. The first measurement will be made after at least 5 min rest. The child will be seated, in relaxing conditions, with the right arm semi-flexed at heart level. Blood pressure will be measured with an Omron M5-I monitor (Omron Healthcare UK Ltd.) using one of 3 different cuff sizes according to arm circumference. | one year (interim analysis) | No |
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