- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04038658
Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation (Move-It)
Move-It: A Cluster-randomised Digital Worksite Exercise Intervention in China: Outcome and Process Evaluation
The aim of the study is to evaluate the outcomes and processes of a video and web-based worksite exercise intervention for sedentary office workers in China.
The intervention is informed by behaviour change theory, and is a digital workplace intervention (called Move-It) involving a 10-minute Qigong exercise session (video demonstration via website) which is delivered twice a day at set break times during the working day for 12 consecutive weeks.
The setting is a large organisation with 2 sites (in Beijing and Guangzhou). The objectives are to examine the effect of a video-based intervention on employees' physical activity, time spent sitting and work performance. This is tested in a 2-group, randomised wait-list control trial. This means that employees at one site receive the intervention first (site 1 - intervention group), and when they have completed (12 weeks later), the other site then receives the same intervention (site 2 - wait-list control). At the end of the intervention, there is a process evaluation with the intervention group which includes focus groups with employees and managers to gather information about the way in which the intervention was implemented. The process evaluation is based on a framework called 'Reach Effectiveness Adoption Implementation Maintenance' (RE-AIM). Data were collected at baseline (before the intervention began) and after 12 weeks in both groups.
연구 개요
상세 설명
Aim The aim of the study is to deliver a digital video-based worksite exercise intervention in China and conduct outcome and process evaluation. The objectives are: [1] to examine the effect of a video-based intervention on physical activity (PA) and weekday sitting hours (individual level); [2] to examine the effect of a video-based intervention on individual work performance (individual level); [3] to conduct a process evaluation of the intervention implementation (individual and cluster level).
Design This is a 2-arm cluster-randomised wait-list control trial, with outcomes assessed in two groups: intervention and wait-list control (objectives 1 and 2).
Clusters (sites) will be randomly allocated to groups at 1:1 ratio using computer-generated random number sequence.
Setting 2 sites of a major organisation in China (one in Beijing, one in Guangzhou), with a total of 490 employees.
Data Collection Data will be collected through online questionnaires emailed to all employee participants (Time 1 = T1). Employees in both groups will complete a second online questionnaire (Time 2 = T2). For the intervention group T2 will be immediately post-intervention, for the wait-list control group this will be just prior to receiving the intervention.
Sample size At an individual level, the estimated sample size is a minimum 72 for intervention group and 72 for control group, alpha 0.05, beta 0.2 and power 0.8.
Intervention This digital intervention consists of a series of six video clips demonstrating Qigong exercises designed to be undertaken at set exercise break times during the working day. The intervention includes a specially designed logo and selected images to be used on promotional posters and a dedicated 'Move-It' webpage. The six promotional videos are designed to be posted in sequence, one every two weeks, on the Move-It website. A Move-It icon on each employee's desktop computer screen will be scheduled to pop up twice a day as a prompt to interrupt sitting. The intervention is designed to be completed within 12 weeks.
Measures Self-report measures of PA, work performance and weekday sitting hours are taken at T1 (baseline) and T2 (12 week follow-up).
Data analysis Intervention outcome data will be analysed using the Statistical Package for the Social Sciences (IBM SPSS) Version 24.
Outcomes will be compared between the pre- and post-intervention time points. Intracluster correlations and estimated effects sizes will be presented for each outcome. Data from both clusters will be included in all analyses, and analysis is by intention-to-treat.
Process evaluation Will take place at the end of the intervention (intervention site only). This will include up to 6 focus groups (up to n=35) with employees (both participants and non-participants), organisational committee members and senior management.
These will be aligned with the RE-AIM framework to explore intervention reach, effectiveness, adoption, implementation and maintenance.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Nottingham, 영국, NG7 2HA
- University of Nottingham
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Employee of participating organisation
Exclusion Criteria:
Not an employee of participating organisation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention Group (MoveIt)
10-minute Qigong exercise session (video demonstration via website) delivered twice a day at set break times during the working day for 12 consecutive weeks
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간섭 없음: Wait-list control group
No intervention for 12 weeks.
Then received the MoveIt Intervention for 12 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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International Physical Activity Questionnaire (IPAQ) Taiwanese short form
기간: Covers a person's record of physical activity for a period of seven days
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Measure of self-reported physical activity.
Includes culturally sensitive Chinese translations for the terms "moderate", "vigorous" and "physical activity" as well as to identify representative types of physical activity for Taiwanese.
Content validity 0.994.
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Covers a person's record of physical activity for a period of seven days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Health and Work Performance Questionnaire (HPQ).
기간: Overall performance rating for the days worked over the past 4 weeks.
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Self-reported work performance. Single item was used from this scale. Item was measured on a 10-point scale ranging from 0=worst performance to 10=top performance. Item is: 'how would you rate your overall performance on the days you worked during the past 4 weeks?'. |
Overall performance rating for the days worked over the past 4 weeks.
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Weekday sitting hours
기간: 1 day (average)
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Self-reported average sitting hours per day: participants report number of hours (to the nearest whole hour) spent sitting on a typical workday.
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1 day (average)
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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신체 활동에 대한 임상 시험
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Centre Hospitalier Universitaire de la Réunion아직 모집하지 않음선천성 심장 질환 | 미분획 헤파린 | Anti Xa Activity
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University Hospital, Grenoble완전한관절만곡증 Amyoplasia 또는 원위 관절만곡증의 진단 | National Reference Center의 AMC Clinic에서 5일 다학제 평가 | Grenoble Alpes 병원의 Physical Medecin, Medical Genetic and Imaging 부서와 함께프랑스
Move-It에 대한 임상 시험
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Barron Associates, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Duke University 그리고 다른 협력자들완전한
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VA Office of Research and Development완전한
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MMSx Authority Institute for Movement Mechanics...완전한
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VA Puget Sound Health Care System완전한
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Dana-Farber Cancer InstituteNational Cancer Institute (NCI); University of Rochester; University of Massachusetts, Boston완전한
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University of Texas at AustinBaylor College of Medicine; University of Kansas Medical Center완전한
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Northwestern UniversityLynn Sage Breast Cancer Research Foundation완전한유방암 여성
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Charles University, Czech Republic모집하지 않고 적극적으로
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Integro Theranostics완전한