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

NCT ID: NCT03601663

Last Updated: 2020-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-08-30

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.

Detailed Description

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Conditions

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Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Physical Activity Information

Intervention Type BEHAVIORAL

Participants will receive a copy of the Canadian Physical Activity Guidelines.

Physical Activity Monitoring

Intervention Type BEHAVIORAL

Participants will receive a wearable activity tracker (Polar A300).

Autonomy-support

Intervention Type BEHAVIORAL

Participants will receive eight autonomy-supportive weekly emails containing information and activities to help them set goals and make changes to become physically active.

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.

Group Type ACTIVE_COMPARATOR

Physical Activity Information

Intervention Type BEHAVIORAL

Participants will receive a copy of the Canadian Physical Activity Guidelines.

Physical Activity Monitoring

Intervention Type BEHAVIORAL

Participants will receive a wearable activity tracker (Polar A300).

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.

Group Type ACTIVE_COMPARATOR

Physical Activity Information

Intervention Type BEHAVIORAL

Participants will receive a copy of the Canadian Physical Activity Guidelines.

Interventions

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Physical Activity Information

Participants will receive a copy of the Canadian Physical Activity Guidelines.

Intervention Type BEHAVIORAL

Physical Activity Monitoring

Participants will receive a wearable activity tracker (Polar A300).

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ottawa

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Brunet

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Ottawa

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 21451172 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 9327588 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 3397865 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Brunet J, Sharma S, Price J, Black M. Acceptability and Usability of a Theory-Driven Intervention via Email to Promote Physical Activity in Women Who Are Overweight or Obese: Substudy Within a Randomized Controlled Trial. JMIR Form Res. 2023 Oct 3;7:e48301. doi: 10.2196/48301.

Reference Type DERIVED
PMID: 37788048 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34927590 (View on PubMed)

Other Identifiers

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eHealth_Women_PA

Identifier Type: -

Identifier Source: org_study_id

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