Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period. (MOVI-KIDS)
Effectiveness of an Intervention of Physical Activity Promotion in Schoolchildren on Preventing Obesity During the Adiposity Rebound Period: a Cross-over Randomized Cluster Trial.
연구 개요
상세 설명
The prevalence of overweight in Spanish children in the puberty age is among the highest in the world and increasing quickly. Our group has done so far two interventions based on after-school programs of recreational physical activity to control obesity and other cardiovascular risk factors in primary school children (8-to-11 years)in Cuenca, Spain.
The first edition, called MOVI, showed moderate effect in reducing adiposity and improving the lipid profile, but did not significantly improve overall cardiometabolic risk, mainly because of did not reduce blood insulin levels. A second edition (MOVI-2), increased duration and intensity of the sessions and was more focused on increased muscle strength. Preliminary analysis also show a decrease in body fat, a reduction of global cardiometabolic because of decreased insulin levels.
Our project integrates a multidimensional intervention to promote physical activity, with a mixed design (cross-over randomized trial, and a qualitative study) and consist of two sub-projects that share the same study population: "Effectiveness of an intervention of physical activity promotion in schoolchildren on preventing obesity during the adiposity rebound period: a cross-over randomized cluster trial" and "Effectiveness of physical activity intervention to prevent obesity and improve academic performance in children with and without ADHD risk".
The two interventions are based on a cross-over randomized trial aimed to test the effectiveness of an intervention to promote physical activity in the school environment (MOVI-KIDS) during two-years in 22 schools (20 public and two private schools) in the provinces of Cuenca and Ciudad Real, Spain.
This principal subproject consisted of a mixed study including both the trial cited above and a nested qualitative study aimed to identify barriers and facilitators to physical activity in children in the school environment (social and family factors, urban planning, etc.), and produce knowledge about the perceptions of children, parents and teachers on how you can improve conditions of physical and social environment to facilitate physical activity.
The hypotheses of this third edition are that a multidimensional intervention promoting physical activity in children at the adiposity rebound period (4-7 years),in the school environment (MOVI-KIDS), lasting two-years, will to:
- Reduce the body fat percentage in the intervention group versus the control group in 2%.
- Improve the several components of fitness: aerobic capacity, strength, speed and agility.
- Reduce the carotid intima-media thickness and
- Reduce fat, increase fat free mass, and reduce sedentary behavior.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cuenca, 스페인, 16071
- Health and Social Research Centre, University of Castilla-La Mancha
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 제어
개입 없음
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실험적: MOVI-KIDS 프로그램
개입 그룹
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MOVI-KIDS는 다음으로 구성된 다차원 개입입니다. b) 학생들이 어떻게 더 활동적이 될 수 있는지에 대해 학부모와 교사에게 설명하는 세션 및 c) 쉬는 시간 동안 신체 활동을 촉진하기 위한 운동장 개입(환경 변화: 장비, 시설, 그림 등)(MOVI-Playground).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Body fat percentage
기간: One year (interim analysis)
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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)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Physical fitness
기간: One year (interim analysis)
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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.
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One year (interim analysis)
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Waist circumference
기간: One year (interim analysis)
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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.
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One year (interim analysis)
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Tricipital skinfold thickness
기간: one year (interim analysis)
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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)
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one year (interim analysis)
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Blood pressure
기간: one year (interim analysis)
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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.
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one year (interim analysis)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Prior assessment of barriers and facilitators
기간: One year
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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.
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One year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Vicente Martínez-Vizcaíno, PhD, Health and Social Research Centre, University of Castilla-La Mancha, Cuenca, Spain
간행물 및 유용한 링크
일반 간행물
- Martinez-Vizcaino V, Pozuelo-Carrascosa DP, Garcia-Prieto JC, Cavero-Redondo I, Solera-Martinez M, Garrido-Miguel M, Diez-Fernandez A, Ruiz-Hermosa A, Sanchez-Lopez M. Effectiveness of a school-based physical activity intervention on adiposity, fitness and blood pressure: MOVI-KIDS study. Br J Sports Med. 2020 Mar;54(5):279-285. doi: 10.1136/bjsports-2018-099655. Epub 2019 Jan 9.
- Pozuelo-Carrascosa DP, Sanchez-Lopez M, Cavero-Redondo I, Torres-Costoso A, Bermejo-Cantarero A, Martinez-Vizcaino V. Obesity as a Mediator between Cardiorespiratory Fitness and Blood Pressure in Preschoolers. J Pediatr. 2017 Mar;182:114-119.e2. doi: 10.1016/j.jpeds.2016.11.005. Epub 2016 Nov 29.
- Martinez-Vizcaino V, Mota J, Solera-Martinez M, Notario-Pacheco B, Arias-Palencia N, Garcia-Prieto JC, Gonzalez-Garcia A, Alvarez-Bueno C, Sanchez-Lopez M; MOVI-KIDS group. Rationale and methods of a randomised cross-over cluster trial to assess the effectiveness of MOVI-KIDS on preventing obesity in pre-schoolers. BMC Public Health. 2015 Feb 22;15:176. doi: 10.1186/s12889-015-1512-0.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
MOVI-키즈에 대한 임상 시험
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University of Castilla-La ManchaCarlos III Health Institute완전한
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University of Castilla-La ManchaCarlos III Health Institute완전한
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