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

NCT03601663 | Completed

• 1 other identifier: eHealth_Women_PA
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Activity

Keywords

physical activity; obesity; pilot study; randomized controlled trial; women; eHealth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Physical activity behaviour: Direct measure

  Duration of intervention phase (8 weeks).

• Perceived autonomy support: Perceived Autonomy Support Scale for Exercise Settings (PASSES; Hagger et al., 2007)

  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)

  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)

  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)

  Baseline (week 0), post-intervention (week 9), and follow-up (week 21).

Other Outcomes (1)

• Sociodemographic questionnaire

  Baseline (week 0).

Study Arms (3)

Group 1

EXPERIMENTAL

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; Behavioral: Physical Activity Monitoring; Behavioral: Autonomy-support

Group 2

ACTIVE COMPARATOR

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; Behavioral: Physical Activity Monitoring

Group 3

ACTIVE COMPARATOR

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

Interventions

Physical Activity Information BEHAVIORAL

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

Group 1; Group 2; Group 3

Physical Activity Monitoring BEHAVIORAL

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

Group 1; Group 2

Autonomy-support 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 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

Location

Related Publications (11)

• 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.

  PMID: 21451172 BACKGROUND

• 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

  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.

  PMID: 11556941 BACKGROUND

• 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.

  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.

  PMID: 9327588 BACKGROUND

• 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

  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.

  PMID: 3397865 BACKGROUND

• 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.

  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.

  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.

  PMID: 37788048 DERIVED

• 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.

  PMID: 34927590 DERIVED

MeSH Terms

Conditions

Motor Activity; Obesity

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 26, 2018
• Study Start: September 1, 2018
• Primary Completion: April 22, 2019
• Study Completion: August 30, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)