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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04857918
Other study ID # H20-03151
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 23, 2021
Est. completion date May 9, 2022

Study information

Verified date May 2022
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The STRIDE Pilot Trial is a randomized controlled pilot trial that will utilize social identity informed virtual running groups to support underactive undergraduate students' well-being and exercise behaviour. The main outcomes of this study are to determine whether the intervention is feasible and acceptable to conduct as a full-scale efficacy trial. Secondary outcomes of interest include changes in participants' exercise identity, exercise behaviour, perceived social support, and well-being. Participants' perceived social identification with their running group will also be assessed at the end of the study.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date May 9, 2022
Est. primary completion date May 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - currently residing in Canada - age 18+ - enrolled in undergraduate studies at the University of British Columbia - underactive (i.e., currently participating in less than the Canadian physical activity guidelines of 150 minutes of physical activity per week) - not experience any health contraindication which might prevent that person from participating in moderate-to-vigorous intensity exercise. - able to speak and read English - own a smart phone - have home access to the internet and a device with camera functionality Exclusion Criteria: - If a potential participant has a medical contraindication (flagged through the PAR-Q+ and ePARmedX) and have NOT been cleared to participate in physical activity by their physician they are then ineligible to participate in the study - Participants are asked to record their running and walking behaviour on the fitness application Strava, and participate in Zoom coffee chats with their running group. If an individual is unwilling to download the Strava application and/or do not want to use Zoom they will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtual running group program
The intervention will include an eight-week virtual running group program hosted on online platforms such as Zoom and the fitness application Strava. Participants will be placed in running groups of 6 people, and each running group will have the collective goal to run/walk the distance across the province of B.C., (940 km) and will meet weekly over Zoom to socialize and discuss running topics and their progress towards the group goal. Participants will receive a t-shirt with the STRIDE logo and a phone armband for carrying their smart phone during runs and walks.
Attention Control: Fitness Application Strava
The attention control condition will be instructed to record their exercise using the Strava application, and will be encouraged to participate in 150 minutes of moderate-to-vigorous exercise each week of the intervention.

Locations

Country Name City State
Canada University of British Columbia Vancouver British Columbia

Sponsors (3)

Lead Sponsor Collaborator
University of British Columbia Social Sciences and Humanities Research Council of Canada, University of Victoria

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Anderson DF, Cychosz CM. Development of an exercise identity scale. Percept Mot Skills. 1994 Jun;78(3 Pt 1):747-51. — View Citation

Bostic, T. J., Rubio, D. M., & Hood, M. (2000). A validation of the subjective vitality scale using structural equation modelling. Social Indicators Research, 52(3), 313-324. https://doi.org/10.1111/j.1541-0072.1977.tb01338.x

Conner M, Rhodes RE, Morris B, McEachan R, Lawton R. Changing exercise through targeting affective or cognitive attitudes. Psychol Health. 2011 Feb;26(2):133-49. doi: 10.1080/08870446.2011.531570. — View Citation

Courneya KS, Jones LW, Rhodes RE, Blanchard CM. Effects of different combinations of intensity categories on self-reported exercise. Res Q Exerc Sport. 2004 Dec;75(4):429-33. — View Citation

Diener, E., Wirtz, D., Tov, W., Kim-Prieto, C., Choi, D.-W., Oishi, S., & Biswas-Diener, R. (2010). New well-being measures: Short scales to assess flourishing and positive and negative feelings. Social Indicators Research, 97(2), 143-156.

Doosje, B., Ellemers, N., Spears, R. (1995) Perceived intragroup variability as a function of group status and identification. Journal of Experimental Social Psychology 31(5): 410-436.

Estabrooks PA, Bradshaw M, Dzewaltowski DA, Smith-Ray RL. Determining the impact of Walk Kansas: applying a team-building approach to community physical activity promotion. Ann Behav Med. 2008 Aug;36(1):1-12. doi: 10.1007/s12160-008-9040-0. Epub 2008 Jul 8. — View Citation

Gleibs IH, Haslam C, Haslam SA, Jones JM. Water clubs in residential care: is it the water or the club that enhances health and well-being? Psychol Health. 2011 Oct;26(10):1361-77. doi: 10.1080/08870446.2010.529140. Epub 2011 May 23. — View Citation

Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6. — View Citation

Haslam SA, O'Brien A, Jetten J, Vormedal K, Penna S. Taking the strain: social identity, social support, and the experience of stress. Br J Soc Psychol. 2005 Sep;44(Pt 3):355-70. — View 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. — View Citation

Vincze L, Rollo ME, Hutchesson MJ, Callister R, Collins CE. VITAL change for mums: a feasibility study investigating tailored nutrition and exercise care delivered by video-consultations for women 3-12 months postpartum. J Hum Nutr Diet. 2018 Jun;31(3):337-348. doi: 10.1111/jhn.12549. Epub 2018 Mar 15. — View Citation

Wilson, P. M., & Muon, S. (2008). Psychometric properties of the exercise identity scale in a university sample. International Journal of Sport and Exercise Psychology, 6, 115-131.

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility and Acceptability: Participant interest in the program Total number of individuals expressing interest in the program. Recorded from recruitment to follow-up (Week 8)
Primary Feasibility and Acceptability: Participant enrolment Participant enrolment will be assessed with the total number of participants enrolled in the study. Follow up (Week 8)
Primary Feasibility and Acceptability: Affective attitudes towards exercise Participants' affective attitudes towards exercise will be assessed using four bipolar semantic differential adjectives (Conner et al., 2011) rated on a seven-point scale ranging from 1 to 7 (pleasant-unpleasant; enjoyable-unenjoyable; exciting-boring; satisfying-unsatisfying). The four items will be mean-scored (potential range 1-7), with higher scores reflecting higher positive affective attitudes towards exercise, and a more positive outcome. Change from Baseline (Week 0) to follow-up (Week 8)
Primary Feasibility and Acceptability: Program satisfaction One item, adapted from a pilot study conducted by Vincze et al. (2018), will be used to assess general satisfaction with the program. Participants (virtual running program only) will rate their satisfaction with the STRIDE program on a 5-point Likert-type scale anchored by 1 (Not at all satisfied) to 5 (Extremely satisfied). Higher scores will reflect greater program satisfaction and a more positive outcome. Follow-up (Week 8)
Primary Feasibility and Acceptability: Study Retention The percentage of participants who adhere to the study. Recorded from Baseline (Week 0) to follow up (Week 8)
Primary Feasibility and Acceptability: Questionnaire completion rates Percentage of questionnaires completed. Recorded from Baseline (Week 0) to follow up (Week 8)
Primary Feasibility and Acceptability: Program attendance Percentage of weekly Zoom meetings attended. Recorded from Baseline (Week 0) to follow up (Week 8)
Primary Feasibility and Acceptability: Semi structured interviews 10 semi-structured interviews will be conducted with members of the intervention group to assess participants' experiences and satisfaction with the program, as well as their perceptions of social support, group identification, and exercise identity throughout the program. Follow up (Week 8)
Secondary Well-Being (Psychological Flourishing) Domain general well-being will be assessed using the 8-item Flourishing Scale from Diener et el., (2010). Participants will respond to the 8 flourishing items on a 7-point Likert-type scale anchored by 1 (Strongly disagree) to 7 (Strongly agree). The 8 items will be mean-scored (potential range 1-7), with higher scores indicating higher psychological flourishing and a more positive outcome. Change from Baseline (Week 0) to follow-up (Week 8)
Secondary Perceived Social Support Received in the Context of Exercise Social support in the context of exercise will be assessed using a four-item social support scale (Gleibs et al., 2011; Haslam et al., 2005) adapted for the context of exercise participation. Participants will respond to the 4 social support items on a 5-point Likert-type scale anchored by 1 (Strongly Disagree) to 5 (Strongly Agree). The 4 items will be mean-scored (potential range 1-5), with higher scores reflecting greater perceived social support from others in the context of exercise and a more positive outcome. Change from Baseline (Week 0) to follow-up (Week 8)
Secondary Well-Being (Subjective Vitality) Participants will complete the six-item (Bostic et al., 2000) Subjective Vitality Scale (SVS; Ryan & Frederick, 1997) adapted for the context of exercise behaviour. Participants will respond to the 6 exercise-related subjective vitality items on a 7-point Likert-type scale anchored by 1 (Not at All True) to 7 (Very True). The 6 items will be mean-scored (potential range 1-7), with higher scores reflecting greater subjective experiences of vitality in the context of exercise and a more positive outcome. Change from Baseline (Week 0) to follow-up (Week 8)
Secondary Exercise Identity Participants will complete the nine-item Exercise Identity Scale (Anderson & Cychosz, 1994). Participants will respond to the 9 exercise identity items on a 7-point Likert-type scale anchored by 1 (Strongly Disagree) to 7 (Strongly Agree). Consistent with Wilson and Muon (2008), two separate scores will be calculated to reflect the role-identity dimension and the exercise beliefs dimension of the scale. Items 1, 2, and 6 will be mean-scored (potential range 1-7), with higher score reflecting a greater role identity in relation to exercise behaviour, and items 3, 4, 5, 7, 8, and 9 will be mean-scored (potential range 1-7), with higher scores reflecting greater exercise-related beliefs and a more positive outcome. Change from Baseline (Week 0) to follow-up (Week 8)
Secondary Social Identification with the Running Group Using a four-item social identification scale (Doosje et al., 1995), participants in the intervention condition will respond to four items inquiring the degree to which they positively identify with their running group. Participants will respond to the 4 social identification items using a 7-point Likert-type scale anchored by 1 (Strongly Disagree) to 7 (Strongly Agree). The 4 items will be mean-scored (potential range 1-7), with higher scores reflecting stronger positive identification with the running group and a more positive outcome. Follow-up (Week 8)
Secondary Exercise Behaviour In reference to the past month, participants will report the number of times per week (on average) they engaged in mild, moderate, and vigorous exercise using the Godin Leisure Time Exercise Questionnaire (Godin & Shephard, 1985), and the average duration of mild, moderate, and vigorous exercise sessions (Courneya et al., 2004). Consistent with Courneya et al. (2004), the researchers will create an indicator of average weekly moderate-to-vigorous exercise minutes (in past month) for each participant using the following equation: (number of moderate exercise bouts x average minutes per bout) + (number of vigorous exercise bouts x average minutes per bout). The scores will have a minimum value of 0 minutes, with more minutes indicating greater participation in moderate-to-vigorous exercise and a more positive outcome. Change from Baseline (Week 0) to follow-up (Week 8)
Secondary Weekly exercise behaviour (activity type) Participants will log their daily exercise (type of activity) at the end of each week Week 1, 2, 3, 4, 5, 6, 7, and 8
Secondary Weekly exercise behaviour (activity duration) Participants will log their daily exercise (duration of activity) at the end of each week Week 1, 2, 3, 4, 5, 6, 7, and 8
Secondary Demographics Items addressing sex/gender, age, ethnicity, height, weight, residence (City, Province), disability, marital status, swelling type, living situation (alone, others), undergraduate major Baseline (Week 0)
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