Exploring the Effect of an Intervention on Women's Physical Activity Behaviour

Study Overview
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Brief Summary
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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.

Official Title
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Exploring the Effect of an eHealth Intervention on Women's Physical Activity Behaviour

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Physical Activity Information
* Behavioral: Physical Activity Monitoring
* Behavioral: Autonomy-support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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. | Behavioral: Physical Activity Information<br>* Participants will receive a copy of the Canadian Physical Activity Guidelines.<br>Behavioral: Physical Activity Monitoring<br>* Participants will receive a wearable activity tracker (Polar A300).<br>Behavioral: Autonomy-support<br>* Participants will receive eight autonomy-supportive weekly emails containing information and activities to help them set goals and make changes to become physically active.<br>|
| Active Comparator: Group 2<br>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. | Behavioral: Physical Activity Information<br>* Participants will receive a copy of the Canadian Physical Activity Guidelines.<br>Behavioral: Physical Activity Monitoring<br>* Participants will receive a wearable activity tracker (Polar A300).<br>|
| Active Comparator: Group 3<br>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. | Behavioral: Physical Activity Information<br>* Participants will receive a copy of the Canadian Physical Activity Guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 
| Retention rates | The number of participants completing all scheduled assessments. | Duration of recruitment and intervention phases (9 weeks). | 
| 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). | 
| 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). | 
| 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). | 
| 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, obesity, pilot study, randomized controlled trial, women, eHealth