Physical Activity Clinical Trial
Official title:
Exploring the Effect of an eHealth Intervention on Women's Physical Activity Behaviour
Verified date | March 2020 |
Source | University of Ottawa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | August 30, 2019 |
Est. primary completion date | April 22, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
All participants will need to meet the following inclusion criteria to participate in the
intervention: 1. Are a woman between the ages of 18 and 65 years 2. Can understand, read, and speak in English 3. Are able to safely engage in physical activity 4. Are not currently pregnant or lactating 5. Currently participating in less than 150 minutes of moderate or vigorous intensity physical activity and less than two strength training sessions per week 6. Are overweight or obese (i.e., have a body mass index greater than 25kg/m2) 7. Have access to the Internet and an email account 8. Have not used a wearable activity tracker within the past year (e.g., Fitbit, Apple Watch, Garmin, Polar) 9. Live within 50km of the University of Ottawa |
Country | Name | City | State |
---|---|---|---|
Canada | University of Ottawa | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Ottawa |
Canada,
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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
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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.
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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
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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.
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sociodemographic questionnaire | 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). | |
Primary | Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S) | 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). | |
Primary | Physical activity behaviour: Custom strength and resistance training questionnaire | 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). | |
Secondary | Physical activity behaviour: Direct measure | 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). | |
Secondary | Perceived autonomy support: Perceived Autonomy Support Scale for Exercise Settings (PASSES; Hagger et al., 2007) | 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). | |
Secondary | Basic psychological need satisfaction: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006) | 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). | |
Secondary | Motivational regulations: Behavioral Regulation in Exercise Questionnaire (BREQ-2R; Markland & Tobin, 2004; Wilson, Rodgers, Loitz, & Scime, 2006) | 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). | |
Secondary | Basic psychological need thwarting: Psychological Need Thwarting Scale (PNTS; Bartholomew, Ntoumanis, Ryan, & Thøgersen-Ntoumani, 2011) | 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). | |
Secondary | Positive and Negative Affect Schedule (I-PANAS-SF; Thompson, 2016; Watson, Clark, & Tellegen, 1988). | 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). | |
Secondary | Vitality: Subjective Vitality Scale (Ryan & Frederick, 1997). | 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). | |
Secondary | Depression: Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001). | 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). | |
Secondary | Wearable activity tracker usage: Multiple choice questions | 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). | |
Secondary | Recruitment rates | 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). | |
Secondary | Retention rates | The number of participants completing all scheduled assessments. | Duration of recruitment and intervention phases (9 weeks). | |
Secondary | Acceptability: Open ended questions | For participants randomized to Group 1, what participants liked, disliked, and would change about the intervention. | Duration of recruitment and intervention phases (9 weeks). | |
Secondary | Body mass | 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). | |
Secondary | Body composition | 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). | |
Secondary | Waist circumference | Change in waist circumference from baseline to post-intervention as measured using a measuring tape. | Baseline (week 0) and post-intervention (week 9). |
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