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

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity
• Intervention / Treatment: Behavioral: Physical Activity Information; Behavioral: Physical Activity Monitoring; Behavioral: Autonomy-support

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1N6N5
      • University of Ottawa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Physical Activity Information; Participants will receive a copy of the Canadian Physical Activity Guidelines.; Behavioral: Physical Activity Monitoring; Participants will receive a wearable activity tracker (Polar A300).; 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.
Active Comparator: 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.	Behavioral: Physical Activity Information; Participants will receive a copy of the Canadian Physical Activity Guidelines.; Behavioral: Physical Activity Monitoring; Participants will receive a wearable activity tracker (Polar A300).
Active Comparator: 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.	Behavioral: Physical Activity Information; Participants will receive a copy of the Canadian Physical Activity Guidelines.

What is the study measuring?

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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: University of Ottawa

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): April 22, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: physical activity; randomized controlled trial; obesity; pilot study; eHealth; women
• Other Study ID Numbers: eHealth_Women_PA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No