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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601663
• Other study ID #: eHealth_Women_PA
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: March 2020
• Source: University of Ottawa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Physical Activity Information
Participants will receive a copy of the Canadian Physical Activity Guidelines.
• Physical Activity Monitoring
Participants will receive a wearable activity tracker (Polar A300).
• Autonomy-support
Participants will receive eight autonomy-supportive weekly emails containing information and activities to help them set goals and make changes to become physically active.

Locations

Country	Name	City	State
Canada	University of Ottawa	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Ottawa

Country where clinical trial is conducted

Canada, 

References & Publications (9)

Bartholomew KJ, Ntoumanis N, Ryan RM, Thøgersen-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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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.

Outcome

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).