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Classroom Standing Desks for Reducing Sitting Time in Children

2017년 4월 28일 업데이트: Luís Bettencourt Sardinha, University of Lisbon

Effects of Sit-to-stand Desks on Behavior and Cognitive Function in Children

In this trial the investigators aim to verify the potential impacts of a multi-level intervention with standing desks on behavior and cognitive function in children

연구 개요

상태

완전한

개입 / 치료

상세 설명

This is a cluster controlled trial conducted in a school setting. Two classes (intervention and control) of sixth grade will be selected from a large, centrally located school in Lisbon. The intervention will take place over a period of 16 weeks and will be composed of physical environmental (standing desks), social environment, and education/behavior components. Objective measurements of physical activity and sedentary behavior (ActiGraph GT3X+ accelerometer and activPAL inclinometer), school performance (students grades), attention (D2 test), memory (Rey complex figure), fluid intelligence (Raven's Progressive Matrices), visuo-spatial short term working memory (Corsi block-tapping test), processing speed and inhibitory function (Stoop test) will be assessed. Finally, anthropometry and stakeholders' perceptions will also be obtained at baseline and after the intervention.

연구 유형

중재적

등록 (실제)

49

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Lisbon, 포르투갈, 1800-071
        • Danilo Rodrigues Pereira da Silva

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

11년 (어린이)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Aged between 11 and 13 years-old
  • Be able to postural changes

Exclusion Criteria:

  • Do not return the written informed consent properly signed by parents/guardians

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intervention
Sit-to-stand desks (Ergotron LearnFit®) will replace standard desks. In addition, meeting with parents and teacher's training will be conducted in order to support behavior change.

Multi-level intervention focused on school environment (furniture) will be conducted.

Device: Sit-to-stand desks (Ergotron LearnFit®); Device: (Actigraph, Pensacola, FL, USA); Device: ActivPALTM .

간섭 없음: Control
Control classroom will maintain their routine in sitting desks.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Sedentary behavior
기간: 16 weeks
Sedentary behavior will be assessed trough the sitting time (min/day) given by ActivPALTM micro device (PAL Technologies Limited, Glasgow, UK). The device will be attached on anterior mid-line of the participants right thigh though 3MTM TegadermTM Transparent Film Roll (4 in x 11yd). Participants will wear the inclinometer continuously for seven days, including shower and sleep time, except in swimming activities. The ActivPAL3TM software v.7.2.32 will be used to data reduction. In addition to the baseline and follow-up measurements, the inclinometer will be used during the intervention just in school time to better clarify the sit-to-stand desks use.
16 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Physical activity
기간: 16 weeks
Physical activity will be measured though Actigraph GT3X+ accelerometers (Actigraph, Pensacola, FL, USA). Participants will be instructed to wear the device on the right rip (near the iliac crest) during waking hours for seven days. The device will be attached via an elastic belt and must will removed only in water-based activities. Will be considered a valid evaluations which had four or more days (including one of weekend) of a minimum of 600 minutes of wear. The Choi et al. [16] criteria of wear time and Evenson et al. [17] cuttoffs to PA intensities will be applicable with 15s epochs (collected at 30Hz) by Actilife v.6.10.4. The participants shall register in daily record the time which the device is removed and the reason.
16 weeks
Academic achievement
기간: 16 weeks
Participants grades will be obtained in both assessments points. Individual and sum of disciplines grades changes will be considered to comparisons purposes.
16 weeks
Participants self-reported measurements
기간: 16 weeks
Information about self-perception of physical and mental health, academic performance, behaviors (exercise and sleep habits) and social relationship will be assessed by a specific questionnaire for the participants. In addition, the intervention group ones will report their expectations (before) and perceptions (after) of the standing desks use.
16 weeks
Stakeholders perceptions
기간: 16 weeks
Parents/guardians (individual level) and teachers perceptions (cluster level) about discipline, social interaction, academic performance and health behaviors of the children will be collected by a questionnaire filled before and after the intervention.
16 weeks
Cost-effectiveness
기간: 16 weeks
Considering the costs of classroom environmental adaptations and their effects on primary and secondary outcomes, the incremental cost-effectiveness ratio will be calculated comparing with costs of a traditional classroom.
16 weeks
Cognitive function - Coop Corsi block-tapping test
기간: 16 weeks
Visual-spatial working memory capacity will be assessed through Coop Corsi block-tapping test. A 3 × 3 grid of 9 blocks indicates a spatial sequence by changing the colour of one block at a time, and participants were then asked to repeat that sequence by clicking on the blocks in the same order. During the 12 trials, sequence length increased by 1 block location each time the participant correctly repeated the sequence. Any error in repeating a sequence led to the next sequence being shortened by one location. The variable of interest was mean memory span, calculated as the average length of the three longest correctly repeated sequences.
16 weeks
Cognitive function - Stroop color test
기간: 16 weeks
Sensitivity to interference and the ability to suppress an automated response will be assessed using the Stroop color test. The Stroop test consists in two levels. Both levels involve the test word being placed in the center of the screen, with the target and distractor presented randomly on the right or left of the test word. The target position was counterbalanced for the left and right side within each test level. The participant is asked to respond as quickly as possible, using the left and right arrow keys, to identify the position of the target word. The variable of interest is the proportion of correct responses made.
16 weeks
Cognitive function - d2 test
기간: 16 weeks

Sustained attention and visual scanning ability will be assessed using the d2 test. This paper-and-pencil task requires participants to detect "d" symbols with two dashes (that may be located either both above, both below, or one above and one below the "d") among distractors ("d's" with one, three, or four marks or "p's" with one or two marks).

The concentration performance score was determined on the number of correct responses minus errors. Higher scores indicate a better and more stable performance.

16 weeks
Neuropsychological assessment - Raven's matrices test
기간: 16 weeks
Neuropsychological assessment will be assessed using the Raven's Progressive Matrices. The test provides a simplified 36-item paper format. Each item contains a pattern problem with one part removed and six pictured inserts of which one contains the correct pattern. Participants point to the pattern piece they select or to its number. The total score is the total number of matrices completed correctly, and the test is thus scored out of 36.
16 weeks
Neuropsychological assessment - Rey-Osterrieth complex figure test
기간: 16 weeks
Neuropsychological assessment will be assessed using the Rey-Osterrieth complex figure test. The Rey-Osterrieth complex figure test (ROCF) is a neuropsychological assessment in which participants are asked to reproduce a complicated line drawing, first by copying it freehand (direct), and then drawing from memory (delayed copying). ROCF includes 18 units and the maximum score for each of the two tasks (direct and delayed copying) is 36. Two points are given when the element is correctly reproduced, 1 point when the reproduction is distorted, incomplete but placed properly, or complete but placed poorly; 0.5 point is credited when the element is distorted or incomplete and placed poorly. A zero score is given when the unit is absent or not recognizable.
16 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 의자: Luís Sardinha, PhD, University of Lisbon

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 1월 4일

기본 완료 (실제)

2016년 6월 9일

연구 완료 (실제)

2016년 6월 17일

연구 등록 날짜

최초 제출

2016년 9월 13일

QC 기준을 충족하는 최초 제출

2017년 4월 28일

처음 게시됨 (실제)

2017년 5월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 5월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 4월 28일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • LSardinha

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

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. .

Intervention에 대한 임상 시험

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