- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2W6
- Faculty of Kinesiology and Physical Education, University of Toronto
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
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.
|
Comparateur actif: Wellness program and accelerometer
During the 24 week trial, control participants will receive no additional incentives when step count goals are reached.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Steps
Délai: Daily for 24 weeks
|
Steps per day will be objectively assessed using the Bluetooth enabled, medical grade, StepsCount Piezo accelerometer
|
Daily for 24 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
10 Minute Bouts of Moderate to Vigorous Physical Activity
Délai: Daily for 24 weeks
|
10 minutes bouts of moderate to vigorous physical activity per day will be objectively assessed using the Bluetooth enabled, medical grade, StepsCount Piezo accelerometer.
|
Daily for 24 weeks
|
Motivation to Exercise - Behavioural Regulation to Exercise Questionnaire; BREQ-3
Délai: Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
|
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).
|
Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
|
Walking Self-Efficacy - Self-Efficacy for Exercise Scale; SEE Scale
Délai: Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
|
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).
|
Baseline (T0; week 0), intervention end point (T2; week 12), and follow up assessments (T3; week 24).
|
10 Minute Bouts of Moderate to Vigorous Physical Activity
Délai: Intervention end point (T2; week 12), and follow up assessments (T3; week 24).
|
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).
|
Intervention end point (T2; week 12), and follow up assessments (T3; week 24).
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Guy Faulkner, PhD, University of Toronto
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- C4L-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Wellness program
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)Complété
-
Akdeniz UniversityPas encore de recrutementAVC ischémique | EncadrementTurquie
-
Johns Hopkins UniversityThe Rita and Alex Hillman Foundation; Abell Foundation; Richman Foundation; Sherman... et autres collaborateursRecrutementParentalité | Intervention parentaleÉtats-Unis
-
University of Texas Rio Grande ValleyHealth and Human Services Commission (HHSC); Pharr-San Juan-Alamo Independent... et autres collaborateursActif, ne recrute pasComportement lié à la santéÉtats-Unis
-
Children's HealthActif, ne recrute pasTroubles du spectre autistiqueÉtats-Unis
-
The University of Hong KongSydney Children's Hospitals Network; SAHKRecrutementTroubles du spectre autistiqueHong Kong
-
Hospices Civils de LyonRésilié
-
Microclinic InternationalRoyal Health Awareness Society (RHAS); Jordanian Ministry of Health (MoH)ComplétéHyperglycémie | Hypertension | Obésité | Diabète sucré, Type 2 | Diabète sucré | Diabète | Poids | Perte de poids | Pression artérielle | Gain de poids | Comportement social | Poids, Corps | Glycémie, hypertension | Mode de vie, Sain | Changement de poids, Corps | Comportement, Santé | Réduction des risques liés au mode... et d'autres conditionsJordan
-
Lady Davis InstituteComplétéSclérodermie systémiqueCanada
-
Bispebjerg HospitalAarhus University Hospital Skejby; Rigshospitalet, Denmark; Danish Cancer SocietyComplétéCancer | Arrêt du tabac | Tabagisme