Clinical trial NCT03601663: Exploring the Effect of an Intervention on Women's Physical Activity Behaviour
Official title: Exploring the Effect of an eHealth Intervention on Women's Physical Activity Behaviour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: physical activity
obesity
pilot study
randomized controlled trial
women
eHealth
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Physical activity behaviour: International Physical Activity Questionnaire Short Form (IPAQ-S)
timeFrame: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
measure: Physical activity behaviour: Custom strength and resistance training questionnaire
timeFrame: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
Secondary outcomes:
measure: Physical activity behaviour: Direct measure
timeFrame: Duration of intervention phase (8 weeks).
measure: Perceived autonomy support: Perceived Autonomy Support Scale for Exercise Settings (PASSES; Hagger et al., 2007)
timeFrame: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
measure: Basic psychological need satisfaction: Psychological Need Satisfaction in Exercise Scale (PNSE; Wilson, Rogers, Rodgers, & Wild, 2006)
timeFrame: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
measure: Motivational regulations: Behavioral Regulation in Exercise Questionnaire (BREQ-2R; Markland & Tobin, 2004; Wilson, Rodgers, Loitz, & Scime, 2006)
timeFrame: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
measure: Basic psychological need thwarting: Psychological Need Thwarting Scale (PNTS; Bartholomew, Ntoumanis, Ryan, & Thøgersen-Ntoumani, 2011)
timeFrame: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
measure: Positive and Negative Affect Schedule (I-PANAS-SF; Thompson, 2016; Watson, Clark, & Tellegen, 1988).
timeFrame: : Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
measure: Vitality: Subjective Vitality Scale (Ryan & Frederick, 1997).
timeFrame: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
measure: Depression: Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001).
timeFrame: Baseline (week 0), post-intervention (week 9), and follow-up (week 21).
measure: Wearable activity tracker usage: Multiple choice questions
timeFrame: Post-intervention (week 9).
measure: Recruitment rates
timeFrame: Duration of recruitment and intervention phases (9 weeks).
measure: Retention rates
timeFrame: Duration of recruitment and intervention phases (9 weeks).
measure: Acceptability: Open ended questions
timeFrame: Duration of recruitment and intervention phases (9 weeks).
measure: Body mass
timeFrame: Baseline (week 0) and post-intervention (week 9).
measure: Body composition
timeFrame: Baseline (week 0) and post-intervention (week 9).
measure: Waist circumference
timeFrame: Baseline (week 0) and post-intervention (week 9).
Other outcomes:
measure: Sociodemographic questionnaire
timeFrame: Baseline (week 0).
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
References:
citation: 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.
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
citation: 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.
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.
citation: 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.
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
citation: 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.
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.
citation: 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.
citation: 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.