- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02638675
Financial Health Incentives to Promote Physical Activity Among Hospital Employees: A Randomized Control Trial
Examining Financial Health Incentives to Promote Physical Activity Among Inactive Hospital Employees: A Web-based Randomized Control Trial
연구 개요
상태
상세 설명
A 24-week, parallel arm, randomized control trial will be employed to examine the impact of incentives on physical activity among physically inactive Hamilton Health Science Corporation employees. Participants will be randomly allocated (1:1) into control (i.e. wellness program and accelerometer) or intervention groups (i.e. wellness program, accelerometer, incentives), where only intervention participants will receive reward points for completing daily step count goals.
After randomization, a baseline 'run-in' assessment phase will occur one week prior to the study intervention (T0). During this 'run-in' period, participants will wear a Bluetooth enabled StepsCount Piezo accelerometer, which will track participants' daily steps and moderate to vigorous physical activity (MVPA), and synchronize their accelerometer (i.e. upload information) to the Change4Life program for seven days. Participants will also be asked to complete the Behavioural Regulation to Exercise Questionnaire (BREQ-3) and the Self-Efficacy for Exercise Scale.
Throughout the 24-week study, all participants will be asked to wear the accelerometer and synchronize it to the Change4Life program daily. Date, steps per day, and bout minutes of MVPA per day (bouts include 10 or more continuous minutes of MVPA) will be collected when the accelerometer is synchronized. Daily synchronization from the accelerometer to the Change4Life program must be completed by 10 am the next morning. Participants will be instructed to increase their daily step counts by 1,000 and 2,000 steps above baseline (T0) over the course of the first six weeks of the study. On week 7, participants will be asked to increase daily steps per day to 3,000 over baseline, and maintain that level of activity for the duration of the study.
Outcome measures will be assessed at baseline (T0), intervention end point (T2), and follow up (T3).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5S 2W6
- Faculty of Kinesiology and Physical Education, University of Toronto
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Over the age of 18 years
- English speaking
Exclusion Criteria:
- Existing medical condition, which could be exacerbated by physical activity as measured by the Physical Activity Readiness Questionnaire.
Note. Participants cannot enrol in the study without Internet access
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: Wellness program, accelerometer, incentives
During the intervention period (weeks 1 to 12), intervention participants will be eligible to earn daily reward points contingent on step count goal achievement.
Intervention participants will earn 100 reward points (i.e.
$1) for each day that specific step count goals are reached.
During weeks 13 to 24, participants will no longer receive daily reward points for completing specific step count goals.
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All participants have access to Change4Life, a web-based health education and behaviour change program.
Individuals are rewarded with very modest incentives (uncertain chance; less than 1 in 100 chance of earning) when they complete learning modules or health tasks.
All participants will be asked to wear the StepsCount Piezo accelerometer, which tracks steps and bout minutes of MVPA per day, synchronize the device to the Change4Life program, and reach daily step count goals for 24 weeks.
During the first 12 weeks, participants will be eligible to earn $1 in vouchers (e.g., grocery, cinema) when daily goals are reached.
The total amount available over the 3-month intervention period will be $90 (9,000 points).
During weeks 13 to 24, participants will not receive daily reward points for completing step count goals.
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활성 비교기: Wellness program and accelerometer
During the 24 week trial, control participants will receive no additional incentives when step count goals are reached.
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All participants have access to Change4Life, a web-based health education and behaviour change program.
Individuals are rewarded with very modest incentives (uncertain chance; less than 1 in 100 chance of earning) when they complete learning modules or health tasks.
All participants will be asked to wear the StepsCount Piezo accelerometer, which tracks steps and bout minutes of MVPA per day, synchronize the device to the Change4Life program, and reach daily step count goals for 24 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Steps
기간: Daily for 24 weeks
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Steps per day will be objectively assessed using the Bluetooth enabled, medical grade, StepsCount Piezo accelerometer
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Daily for 24 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
10 Minute Bouts of Moderate to Vigorous Physical Activity
기간: Daily for 24 weeks
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10 minutes bouts of moderate to vigorous physical activity per day will be objectively assessed using the Bluetooth enabled, medical grade, StepsCount Piezo accelerometer.
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Daily for 24 weeks
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Motivation to Exercise - Behavioural Regulation to Exercise Questionnaire; BREQ-3
기간: Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
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Participants will be asked to complete the Behavioural Regulation to Exercise Questionnaire (BREQ-3; Markland & Tobin, 2004; Wilson et al., 2006), a 24-item questionnaire designed to measure self-determined motivation to exercise.
This questionnaire will be administered online at baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
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Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
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Walking Self-Efficacy - Self-Efficacy for Exercise Scale; SEE Scale
기간: Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
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Participants will be asked to complete a modified version of the Self-efficacy for Exercise (SEE) Scale (Resnick & Jenkins, 2000), a 9-item questionnaire designed to measure self-reported confidence to exercise (i.e.
walk).
This questionnaire will be administered online at baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
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Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
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10 Minute Bouts of Moderate to Vigorous Physical Activity
기간: Intervention end point (T2; week 12), and follow up assessments (T3; week 24).
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Participants will also be asked to complete a modified version of the International Physical Activity Questionnaire - Short Form (IPAQ-SF), a six-item questionnaire designed to measure moderate and vigorous physical activity, as well as time spent walking (Booth, 2000; Craig et al., 2003).
This questionnaire will be administered online at intervention end point (T2; week 12), and follow up assessments (T3; week 24).
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Intervention end point (T2; week 12), and follow up assessments (T3; week 24).
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공동 작업자 및 조사자
수사관
- 수석 연구원: Guy Faulkner, PhD, University of Toronto
간행물 및 유용한 링크
일반 간행물
- Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport. 2000 Jun;71(2 Suppl):S114-20. No abstract available.
- Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res. 2000 May-Jun;49(3):154-9. doi: 10.1097/00006199-200005000-00007.
- Markland D, Tobin V. A modification of the Behavioral Regulation in Exercise Questionnaire to include an assessment of amotivation. Journal of Sport and Exercise Psychology 26: 191-196, 2004.
- Wilson PM, Rodgers WM, Loitz CC, Scime G. "It's who I am…really!" The importance of integrated regulation in exercise contexts. Journal of Biobehavioral Research 11: 79-104, 2006.
- Mitchell M, White L, Oh P, Kwan M, Gove P, Leahey T, Faulkner G. Examining Incentives to Promote Physical Activity Maintenance Among Hospital Employees Not Achieving 10,000 Daily Steps: A Web-Based Randomized Controlled Trial Protocol. JMIR Res Protoc. 2016 Dec 12;5(4):e231. doi: 10.2196/resprot.6285.
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 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- C4L-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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