Physical Activity Clinical Trial
Official title:
The UBC Socializing Together While Running InDEpendently (STRIDE) Pilot Trial: A Social Identity Informed Virtual Running Group Program
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 |
Verified date | May 2022 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Social Sciences and Humanities Research Council of Canada, University of Victoria |
Canada,
Anderson DF, Cychosz CM. Development of an exercise identity scale. Percept Mot Skills. 1994 Jun;78(3 Pt 1):747-51. — View Citation
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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
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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
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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
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* Note: There are 13 references in all — Click here to view all references
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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