Exploring the Effect of an Intervention on Women's Physical Activity Behaviour
23 de marzo de 2020 actualizado por: Jennifer Brunet, University of Ottawa
Exploring the Effect of an eHealth Intervention on Women's Physical Activity Behaviour
Physical activity has been shown to reduce the risk of chronic diseases and promote physical and mental health and wellbeing, yet few women are active enough to see these benefits.
Wearable activity trackers show promise for helping people increase their physical activity levels by supporting self-monitoring.
However, few researchers have examined how providing people with these devices impacts physical activity levels, or motivation for physical activity which is a significant and robust predictor of physical activity.
Based on previous research, it is possible that women's physical activity levels would be more likely to increase if they received an autonomy-supportive intervention to enhance motivation in addition to a wearable activity tracker.
A pilot, three-armed randomized controlled trial was developed to test this hypothesis and to assess if changes in perceived autonomy-support, basic psychological need satisfaction/thwarting, motivational regulations, wellbeing indicators are associated with changes in physical activity over time.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
49
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Ontario
-
Ottawa, Ontario, Canadá, K1N6N5
- University of Ottawa
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
All participants will need to meet the following inclusion criteria to participate in the intervention:
- Are a woman between the ages of 18 and 65 years
- Can understand, read, and speak in English
- Are able to safely engage in physical activity
- Are not currently pregnant or lactating
- Currently participating in less than 150 minutes of moderate or vigorous intensity physical activity and less than two strength training sessions per week
- Are overweight or obese (i.e., have a body mass index greater than 25kg/m2)
- Have access to the Internet and an email account
- Have not used a wearable activity tracker within the past year (e.g., Fitbit, Apple Watch, Garmin, Polar)
- Live within 50km of the University of Ottawa
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group 1
Participants in the main experimental group will receive a copy of the Canadian Physical Activity Guidelines that provide basic information about and recommendations for physical activity, a wearable activity tracker to support self-monitoring, and autonomy-support delivered through weekly emails to help enhance motivation for physical activity.
|
Participants will receive a copy of the Canadian Physical Activity Guidelines.
Participants will receive a wearable activity tracker (Polar A300).
Participants will receive eight autonomy-supportive weekly emails containing information and activities to help them set goals and make changes to become physically active.
|
|
Comparador activo: Group 2
Participants in this comparison group will receive a copy of the Canadian Physical Activity Guidelines that provide basic information about and recommendations for physical activity, and a wearable activity tracker to support self-monitoring.
They will not receive any specific support to enhance motivation for physical activity.
|
Participants will receive a copy of the Canadian Physical Activity Guidelines.
Participants will receive a wearable activity tracker (Polar A300).
|
|
Comparador activo: Group 3
Participants in this information-only comparison group will receive a copy of the Canadian Physical Activity Guidelines that provide basic information about and recommendations for physical activity.
|
Participants will receive a copy of the Canadian Physical Activity Guidelines.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S)
Periodo de tiempo: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention, and from post-intervention to follow-up.
|
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
|
Physical activity behaviour: Custom strength and resistance training questionnaire
Periodo de tiempo: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
Change in strength and resistance training habits from baseline to post-intervention, and from post-intervention to follow-up.
|
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physical activity behaviour: Direct measure
Periodo de tiempo: Duration of intervention phase (8 weeks).
|
Change in weekly directly measured levels of physical activity as measured by accelerometers (Polar A300), which will be worn by participants assigned to Group 1 and Group 2 during waking hours for the duration of the intervention.
|
Duration of intervention phase (8 weeks).
|
|
Perceived autonomy support: Perceived Autonomy Support Scale for Exercise Settings (PASSES; Hagger et al., 2007)
Periodo de tiempo: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
Change in perceived autonomy support for physical activity from baseline to post-intervention, and from post-intervention to follow-up.
|
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
|
Basic psychological need satisfaction: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)
Periodo de tiempo: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
Change in basic psychological need satisfaction for physical activity from baseline to post-intervention, and from post-intervention to follow-up.
|
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
|
Motivational regulations: Behavioral Regulation in Exercise Questionnaire (BREQ-2R; Markland & Tobin, 2004; Wilson, Rodgers, Loitz, & Scime, 2006)
Periodo de tiempo: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
Change in motivational regulations for physical activity from baseline to post-intervention, and from post-intervention to follow-up.
|
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
|
Basic psychological need thwarting: Psychological Need Thwarting Scale (PNTS; Bartholomew, Ntoumanis, Ryan, & Thøgersen-Ntoumani, 2011)
Periodo de tiempo: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
Change in basic psychological need thwarting activity from baseline to post-intervention, and from post-intervention to follow-up.
|
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
|
Positive and Negative Affect Schedule (I-PANAS-SF; Thompson, 2016; Watson, Clark, & Tellegen, 1988).
Periodo de tiempo: : Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
Change in affect from baseline to post-intervention, and from post-intervention to follow-up.
|
: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
|
Vitality: Subjective Vitality Scale (Ryan & Frederick, 1997).
Periodo de tiempo: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
Change in vitality affect from baseline to post-intervention, and from post-intervention to follow-up.
|
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
|
Depression: Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001).
Periodo de tiempo: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
Change in depressive symptoms from baseline to post-intervention, and from post-intervention to follow-up.
|
Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
|
|
Wearable activity tracker usage: Multiple choice questions
Periodo de tiempo: Post-intervention (week 9).
|
Frequency of wearable activity tracker usage in general during the intervention phase for participants randomized to Group 1 or Group 2.
|
Post-intervention (week 9).
|
|
Recruitment rates
Periodo de tiempo: Duration of recruitment and intervention phases (9 weeks).
|
The number of eligible participants who enrol in the study out of the number assessed for eligibility.
|
Duration of recruitment and intervention phases (9 weeks).
|
|
Retention rates
Periodo de tiempo: Duration of recruitment and intervention phases (9 weeks).
|
The number of participants completing all scheduled assessments.
|
Duration of recruitment and intervention phases (9 weeks).
|
|
Acceptability: Open ended questions
Periodo de tiempo: Duration of recruitment and intervention phases (9 weeks).
|
For participants randomized to Group 1, what participants liked, disliked, and would change about the intervention.
|
Duration of recruitment and intervention phases (9 weeks).
|
|
Body mass
Periodo de tiempo: Baseline (week 0) and post-intervention (week 9).
|
Change in body mass measured from baseline to post-intervention as determined using a scale (Tanita BWB 800S).
|
Baseline (week 0) and post-intervention (week 9).
|
|
Body composition
Periodo de tiempo: Baseline (week 0) and post-intervention (week 9).
|
Change in body composition from baseline to post-intervention as determined by a scale (Tanita BWB 800S) that uses bioelectrical impedance to assess body composition.
|
Baseline (week 0) and post-intervention (week 9).
|
|
Waist circumference
Periodo de tiempo: Baseline (week 0) and post-intervention (week 9).
|
Change in waist circumference from baseline to post-intervention as measured using a measuring tape.
|
Baseline (week 0) and post-intervention (week 9).
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sociodemographic questionnaire
Periodo de tiempo: Baseline (week 0).
|
Sociodemographic and health information will be collected at baseline to describe the sample.
Measures include age, marital status, race, level of education, employment status, household income, number and age of children, self-rated health, medical conditions, menstrual status, smoking history, and weight-related goals.
|
Baseline (week 0).
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Bartholomew KJ, Ntoumanis N, Ryan RM, Thogersen-Ntoumani C. Psychological need thwarting in the sport context: assessing the darker side of athletic experience. J Sport Exerc Psychol. 2011 Feb;33(1):75-102. doi: 10.1123/jsep.33.1.75.
- Hagger, M. S., Chatzisarantis, N. L., Hein, V., Pihu, M., Soós, I., & Karsai, I. (2007). The perceived autonomy support scale for exercise settings (PASSES): Development, validity, and cross-cultural invariance in young people. Psychology of Sport and Exercise, 8(5), 632-653. doi:10.1016/j.psychsport.2006.09.001
- Markland, D., & Tobin, V. (2004). A modification to the behavioural regulation in exercise questionnaire to include an assessment of amotivation. Journal of Sport & Exercise Psychology, 26, 191-196.
- Ryan RM, Frederick C. On energy, personality, and health: subjective vitality as a dynamic reflection of well-being. J Pers. 1997 Sep;65(3):529-65. doi: 10.1111/j.1467-6494.1997.tb00326.x.
- Thompson, E. R. (2016). Development and validation of an internationally reliable short-form of the Positive and Negative Affect Schedule (PANAS). Journal of Cross-Cultural Psychology, 38(2), 227-242. doi:10.1177/0022022106297301
- Wilson, P. M., Rodgers, W. M., Loitz, C., & Scime, G. (2006). "It's who I am… really!" The importance of integrated regulation in exercise contexts. Journal of Applied Biobehavioural Research, 11(2), 79-104.
- Wilson, P. M., Rogers, T., Rodgers, W. M., & Wild, C. (2006). The psychological need satisfaction in exercise scale. Journal of Sport & Exercise Psychology, 28, 231-251.
- Black M, Brunet J. A Wearable Activity Tracker Intervention With and Without Weekly Behavioral Support Emails to Promote Physical Activity Among Women Who Are Overweight or Obese: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 16;9(12):e28128. doi: 10.2196/28128.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2018
Finalización primaria (Actual)
22 de abril de 2019
Finalización del estudio (Actual)
30 de agosto de 2019
Fechas de registro del estudio
Enviado por primera vez
4 de julio de 2018
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2018
Publicado por primera vez (Actual)
26 de julio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
23 de marzo de 2020
Última verificación
1 de marzo de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- eHealth_Women_PA
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .