HealthyNCT05899881
A Pilot Study Investigating the Effects of a Yoga Intervention on Health and Well-Being Among a Diverse Sample of Adults
A study testing Yoga intervention in people with Healthy, run by Brock University at 1 site in Canada.
Trial summary
The goal of this pilot study is to examine how to design a large-scale randomized control trial examining yoga as a way to improve positive body image in men and women across the lifespan. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Yoga intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2023to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Able to read and understand English.
- Community-dwelling and residing in Niagara Region.
- Can attend sessions at the Brock Functional Inclusive Training Centre (Bfit).
- Have not participated in yoga in the past 12 months.
- Must have no underlying medical conditions that would prevent them from practicing Hatha Yoga.
Who cannot join
- Unable to provide clearance for physical activity as assessed by Get Active questionnaire (CSEP and Health Canada, www.csep.ca) or doctor's note
- Average score >4 on the Body Appreciation Scale-2
Trial locations and contacts
1 site in 1 country.
Canada1 site
Brock University - Brock Functional Inclusive Training Centre
St. Catharines, Ontario, L2S 3A1
About this study
The goal of this pilot study is to examine how to design a large-scale randomized control trial examining yoga as a way to improve positive body image in men and women across the lifespan. The main questions it will answer are:
- Is the study acceptable to participants?
- Is recruitment, adherence, and retention adequate?
- Are study procedures appropriate?
- What is the preliminary effect of yoga on embodiment (sense of connection with the body), self-objectification (evaluating oneself based on outer appearance rather than internal functions) and body appreciation?
Participants will either take part in a 10-week yoga program or a control condition (where they will be asked to not change their lifestyle). They will complete online questionnaires at the start, middle and end of the 10-weeks.
Read the detailed description
The purposes of this pilot study are:
- To evaluate the feasibility and acceptability of a randomized control trial by assessing participant retention, data collection procedures, and adherence to engaging in a supervised Hatha yoga intervention (or control group).
- To examine preliminary effects of a yoga intervention on embodiment, self-objectification, and positive body image (i.e., body appreciation) among a diverse sample of adults men and women.
Specifically, we will test whether a 10-week Hatha yoga program will contribute to improvements in body appreciation via a) greater embodiment, and b) lower self-objectification This will allow us to calculate effect sizes for sample size calculations for future randomized controlled trials.
Clearance from the university Research Ethics Board will be obtained prior to study commencement. Participants will be recruited from community centres, social media, and traditional media in the Niagara Region. Potential participants will contact the researcher if they are interested in participating. Eligible and interested participants will be provided with a link to the baseline survey via Qualtrics, where they will complete informed consent, demographic information and measures of physical activity and body image. Once questionnaires have been completed, participants will be randomly assigned (using Microsoft Excel to randomize) to either the yoga or control group. They will be provided with instructions for their group at this time via email. They will then undergo either the 10-week yoga intervention or the control condition (see below for descriptions).
Participants will be asked to complete the same physical activity and body image measures during week 5 and at the end of 10 weeks via Qualtrics. At the final time point, participants will also be asked to complete feasibility measures (e.g., acceptability, appropriateness and feasibility of the intervention and control groups), as well as a series of questions asking about their perceptions of the yoga intervention or control group. Upon completion of all measures, participants will be fully debriefed as to the true purpose of the study and the use of deception (i.e., true purpose of the study related to positive body image); they will then be asked to provide continuing informed consent. In addition, the yoga instructors will also be asked a series of questions regarding their perceptions of the yoga intervention.
Yoga Intervention: Participants randomized to the yoga intervention will be asked to not make changes to other aspects of their lifestyle including their regular physical activity. Instructors are provided with guidelines regarding the format, poses, language, and themes of each class, but within those guidelines, instructors can design their own class each week. Each week, there will be a theme promoting empowerment or positive body image; instructors will be asked to choose specific poses, mantras, mudras, and affirmations to reinforce the theme of that week. Modifications to poses will be provided by the instructor. Yoga equipment will be provided during each yoga session.
Each yoga class will be audio recorded to document the content of the yoga classes to ensure guidelines for the classes are followed. Attendance will be recorded at each class to track adherence.
Instructors: The instructors will have a minimum of two years of teaching experience with diverse populations and must be a registered yoga teacher (e.g., RYT200/CYA-RYT200), meaning they have completed a minimum of 200 hours of yoga teacher training in a Yoga Alliance Foundation/Canadian Yoga Alliance recognized teacher training. Clothing will be standardized across instructors and appropriate for Hatha Yoga (e.g., yoga pants and a t-shirt or tank top). Instructors will be provided with an instructor manual that outlines the basic class structure and poses, themes, and language. The instructor will be blinded to the true study purpose. Instructors will then be asked to create a sample class, following the manual guidelines to teach a practice class to the research team for feedback.
Language and Themes Used in a Hatha Yoga Class
Control group: Participants randomized to the control group will be asked not to practice yoga for the duration of the study. Participants will be informed that they can engage in their regular physical activity routines and not change any other lifestyle factors. Participants in the control group will be offered one free yoga class in-person at the end of the study and offered one free pre-recorded video of a yoga class (from the intervention) at the end of the study.
Participants: A target of approximately 65 adults will be recruited (based on expected dropout of 30%).
- Conditions
- Healthy
- Being tested
- Yoga intervention
- Keywords
- Yoga, Body image, Embodiment, Self-objectification, Pilot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga interventionBehavioural
10 weeks of Hatha yoga, once per week, 60 minutes per class
| Study group | Role | What they receive |
|---|---|---|
| Yoga intervention | Experimental | 10 week yoga intervention; one yoga session per week, 60 minutes in length Receives: Behavioral: Yoga intervention |
| Control | No intervention | Waitlist control asked not to make any lifestyle changes over the 10 week intervention period, and not engage in yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body appreciation
Body Appreciation Scale-2 (Tylka \& Wood-Barcalow, 2015); 10 items, with each one rated on a 5-point scale ranging from 1 = never to 5 = always. Scores on the BAS-2 are averaged where higher scores represent higher levels of body appreciation.
Measured: Baseline
Body appreciation
Body Appreciation Scale-2 (Tylka \& Wood-Barcalow, 2015); 10 items, with each one rated on a 5-point scale ranging from 1 = never to 5 = always. Scores on the BAS-2 are averaged where higher scores represent higher levels of body appreciation.
Measured: 5 weeks
Body appreciation
Body Appreciation Scale-2 (Tylka \& Wood-Barcalow, 2015); 10 items, with each one rated on a 5-point scale ranging from 1 = never to 5 = always. Scores on the BAS-2 are averaged where higher scores represent higher levels of body appreciation.
Measured: 10 weeks
Secondary outcomes (37)
Embodiment
Body Responsiveness Scale (Daubenmier, 2005); Each item is rated on a 7-point scale from 1 = not at all true of me to 7 = always true of me. Higher scores indicate greater body responsiveness.
Measured: Baseline
Embodiment
Body Responsiveness Scale (Daubenmier, 2005); Each item is rated on a 7-point scale from 1 = not at all true of me to 7 = always true of me. Higher scores indicate greater body responsiveness.
Measured: 5 weeks
Embodiment
Body Responsiveness Scale (Daubenmier, 2005); Each item is rated on a 7-point scale from 1 = not at all true of me to 7 = always true of me. Higher scores indicate greater body responsiveness.
Measured: 10 weeks
Self-objectification
Self-Objectification Beliefs and Behaviours Scale (Lindner \& Tantleff-Dunn, 2017); 14 items, ranging from 1= strongly disagree to 5= strongly agree. Higher scores indicate higher levels of self-objectification.
Measured: Baseline
Self-objectification
Self-Objectification Beliefs and Behaviours Scale (Lindner \& Tantleff-Dunn, 2017); 14 items, ranging from 1= strongly disagree to 5= strongly agree. Higher scores indicate higher levels of self-objectification.
Measured: 5 weeks
Self-objectification
Self-Objectification Beliefs and Behaviours Scale (Lindner \& Tantleff-Dunn, 2017); 14 items, ranging from 1= strongly disagree to 5= strongly agree. Higher scores indicate higher levels of self-objectification.
Measured: 10 weeks
Body surveillance
Objectified Body Consciousness Scale (McKinley \& Hyde, 1996); 7 items rated on 7-point scale ranging from 1 = strongly disagree to 7 = strongly agree; higher scores represent higher survellance
Measured: Baseline
Body surveillance
Objectified Body Consciousness Scale (McKinley \& Hyde, 1996); 7 items rated on 7-point scale ranging from 1 = strongly disagree to 7 = strongly agree; higher scores represent higher survellance
Measured: 5 weeks
Body surveillance
Objectified Body Consciousness Scale (McKinley \& Hyde, 1996); 7 items rated on 7-point scale ranging from 1 = strongly disagree to 7 = strongly agree; higher scores represent higher survellance
Measured: 10 weeks
Functionality appreciation
Functional Appreciation Scale (Alleva et al., 2017); seven items, each one rated from 1= strongly disagree to 5 = strongly agree. Scores on the FAS are averaged where higher scores indicate higher levels of functionality appreciation.
Measured: Baseline
Functionality appreciation
Functional Appreciation Scale (Alleva et al., 2017); seven items, each one rated from 1= strongly disagree to 5 = strongly agree. Scores on the FAS are averaged where higher scores indicate higher levels of functionality appreciation.
Measured: 5 weeks
Functionality appreciation
Functional Appreciation Scale (Alleva et al., 2017); seven items, each one rated from 1= strongly disagree to 5 = strongly agree. Scores on the FAS are averaged where higher scores indicate higher levels of functionality appreciation.
Measured: 10 weeks
Authentic body pride
Body Self-Conscious Emotions Scale (Castonguay et al., 2014) - Authentic pride subscale - 4 items rated on a 7-point Likert scale from 1 = not at all true of me to 7 = very true of me). Higher scores indicate greater amounts of each emotion.
Measured: Baseline
Authentic body pride
Body Self-Conscious Emotions Scale (Castonguay et al., 2014) - Authentic pride subscale - 4 items rated on a 7-point Likert scale from 1 = not at all true of me to 7 = very true of me). Higher scores indicate greater amounts of each emotion.
Measured: 5 weeks
Authentic body pride
Body Self-Conscious Emotions Scale (Castonguay et al., 2014) - Authentic pride subscale - 4 items rated on a 7-point Likert scale from 1 = not at all true of me to 7 = very true of me). Higher scores indicate greater amounts of each emotion.
Measured: 10 weeks
Fitness-related authentic body pride
Body Self-Conscious Emotions - Fitness Related Instrument (Castonguay et al., 2016) - Authentic body pride - Participants rate the degree to which 4 statements apply to them on a 5-point Likert scale from 1 = never to 5 = always. Higher scores indicate higher levels of fitness aspects of authentic pride.
Measured: Baseline
Fitness-related authentic body pride
Body Self-Conscious Emotions - Fitness Related Instrument (Castonguay et al., 2016) - Authentic body pride - Participants rate the degree to which 4 statements apply to them on a 5-point Likert scale from 1 = never to 5 = always. Higher scores indicate higher levels of fitness aspects of authentic pride.
Measured: 5 weeks
Fitness-related authentic body pride
Body Self-Conscious Emotions - Fitness Related Instrument (Castonguay et al., 2016) - Authentic body pride - Participants rate the degree to which 4 statements apply to them on a 5-point Likert scale from 1 = never to 5 = always. Higher scores indicate higher levels of fitness aspects of authentic pride.
Measured: 10 weeks
Body image flexibility
Body Image-Acceptance and Action Questionnaire (Sandoz et al., 2013); Participants rate the degree to which each of 12 statement applies to them on a 7-point Likert scale from 1 = never true to 7 = always true. Higher scores indicate higher levels of body image flexibility
Measured: Baseline
Body image flexibility
Body Image-Acceptance and Action Questionnaire (Sandoz et al., 2013); Participants rate the degree to which each of 12 statement applies to them on a 7-point Likert scale from 1 = never true to 7 = always true. Higher scores indicate higher levels of body image flexibility
Measured: 5 weeks
Body image flexibility
Body Image-Acceptance and Action Questionnaire (Sandoz et al., 2013); Participants rate the degree to which each of 12 statement applies to them on a 7-point Likert scale from 1 = never true to 7 = always true. Higher scores indicate higher levels of body image flexibility
Measured: 10 weeks
Satisfaction with function of the body and appearance of the body as assessed by Satisfaction with Body Function and Body Appearance Scale (Reboussin et al., 2000);
Satisfaction with Body Function and Body Appearance Scale (Reboussin et al., 2000); Participants rate the degree to which each of 9 statements is true of them on a 7-point Likert scale from 1 = very dissatisfied to 7 = very satisfied. Higher scores indicated higher levels of body satisfaction.
Measured: Baseline
Satisfaction with function of the body and appearance of the body as assessed by Satisfaction with Body Function and Body Appearance Scale (Reboussin et al., 2000);
Satisfaction with Body Function and Body Appearance Scale (Reboussin et al., 2000); Participants rate the degree to which each of 9 statements is true of them on a 7-point Likert scale from 1 = very dissatisfied to 7 = very satisfied. Higher scores indicated higher levels of body satisfaction.
Measured: 5 weeks
Satisfaction with function of the body and appearance of the body as assessed by Satisfaction with Body Function and Body Appearance Scale (Reboussin et al., 2000);
Satisfaction with Body Function and Body Appearance Scale (Reboussin et al., 2000); Participants rate the degree to which each of 9 statements is true of them on a 7-point Likert scale from 1 = very dissatisfied to 7 = very satisfied. Higher scores indicated higher levels of body satisfaction.
Measured: 10 weeks
Attendance
Number of sessions out of 10 attended
Measured: 10 weeks
Adherence
Proportion of total sessions attended by participants
Measured: 10 weeks
Drop-out
Number and percent of participants lost
Measured: Baseline
Drop-out
Number and percent of participants lost
Measured: 5 weeks
Drop-out
Number and percent of participants lost
Measured: 10 weeks
Retention
Proportion of participants from each group with complete data on each outcome measure
Measured: Baseline
Retention
Proportion of participants from each group with complete data on each outcome measure
Measured: 5 weeks
Retention
Proportion of participants from each group with complete data on each outcome measure
Measured: 10 weeks
Acceptability of the Intervention as assessed by Weiner et al.'s (2017) acceptability measure
Acceptability of Intervention Measure (adapted from Weiner et al., 2017); comprised of 5 items; each item rated on a 5-point scale ranging from 1 = completely disagree to 5 = completely agree. Assesses perception among participants that the yoga intervention is agreeable, palatable, or satisfactory. Higher scores represent higher acceptability
Measured: 10 weeks
Feasibility of intervention as assessed by Weiner et al.'s (2017) feasibility measure
Feasibility of Intervention Measure (adapted from Weiner et al., 2017); 5-item measure, with each item rated on a 5-point scale ranging from 1 = completely disagree to 5 = completely agree. Assesses the extent to which the yoga intervention can be successfully carried out in this setting.Higher scores represent higher feasibility
Measured: 10 weeks
Appropriateness of intervention as assessed by Weiner et al.'s (2017) appropriateness measure
Intervention Appropriateness Measure (adapted from Weiner et al., 2017); 5-item measure, with each item rated on a 5-point scale ranging from 1 = completely disagree to 5 = completely agree. Assesses perceived fit, relevance, or compatibility of the yoga intervention in this setting and sample. Higher scores represent higher appropriateness
Measured: 10 weeks
Interest in engaging in the yoga intervention
Number of participants (by age and gender) who express interest in the study by contacting the research team
Measured: Baseline
Recruitment
Number and percent of men and women, age group, and weight status group enrolled
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start29 May 2023
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study in which participants are randomly assigned to either a yoga group or waitlist control group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada
- Responsible party
- Principal investigator, Kimberley Gammage, Brock University
- Investigators
- Kimberley L Gammage, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899881
- Sponsor's protocol ID
- 22-205
- Status last verified
- Jul 2023
- First submitted
- 24 May 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.
PubMed 25462882Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Tylka TL, Wood-Barcalow NL. What is and what is not positive body image? Conceptual foundations and construct definition. Body Image. 2015 Jun;14:118-29. doi: 10.1016/j.bodyim.2015.04.001. Epub 2015 Apr 25.
PubMed 25921657Alleva JM, Tylka TL, van Oorsouw K, Montanaro E, Perey I, Bolle C, Boselie J, Peters M, Webb JB. The effects of yoga on functionality appreciation and additional facets of positive body image. Body Image. 2020 Sep;34:184-195. doi: 10.1016/j.bodyim.2020.06.003. Epub 2020 Jul 1.
PubMed 32622294Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17.
PubMed 28822275Castonguay, A. L., Sabiston, C. M., Kowalski, K. C., & Wilson, P. M. Introducing an instrument to measure body and fitness-related self-conscious emotions: The BSE-FIT. Psychology of Sport and Exercise. 2016; 23: 1-12.
Castonguay AL, Pila E, Wrosch C, Sabiston CM. Body-related self-conscious emotions relate to physical activity motivation and behavior in men. Am J Mens Health. 2015 May;9(3):209-21. doi: 10.1177/1557988314537517. Epub 2014 Jun 4.
PubMed 24899517Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Daubenmier, J. J. The relationship of yoga, body awareness, and body responsiveness to self-objectification and disordered eating. Psychology of Women Quarterly. 2005; 29(2): 207-219.
Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
PubMed 26978655Frayeh, & Lewis, B. A. The effect of mirrors on women's state body image responses to yoga. Psychology of Sport and Exercise. 2018; 35: 47-54.
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.
PubMed 4053261Lakens D. Calculating and reporting effect sizes to facilitate cumulative science: a practical primer for t-tests and ANOVAs. Front Psychol. 2013 Nov 26;4:863. doi: 10.3389/fpsyg.2013.00863.
PubMed 24324449Lindner, D., & Tantleff-Dunn, S. The development and psychometric evaluation of the Self-Objectification Beliefs and Behaviors Scale. Psychology of Women Quarterly. 2017; 41(2): 254-272.
Menzel, & Levine, M. P. Embodying experiences and the promotion of positive body image: The example of competitive athletics. In Self-objectification in women: Causes, consequences, and counteractions. Washington, DC: American Psychological Association. 2011; (pp. 163-186).
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Effects of a Yoga Intervention on Health and Well-Being Among a Diverse Sample of Adults
- ClinicalTrials.gov ID
- NCT05899881
- Acronym / sponsor ID
- 22-205
- Conditions
- Healthy
- Keywords
- Yoga, Body image, Embodiment, Self-objectification, Pilot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Collaborators
- Social Sciences and Humanities Research Council of Canada
- Study start
- 29 May 2023 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to examine how to design a large-scale randomized control trial examining yoga as a way to improve positive body image in men and women across the lifespan. The main questions it will answer are:
- Is the study acceptable to participants?
- Is recruitment, adherence, and retention adequate?
- Are study procedures appropriate?
- What is the preliminary effect of yoga on embodiment (sense of connection with the body), self-objectification (evaluating oneself based on outer appearance rather than internal functions) and body appreciation?
Participants will either take part in a 10-week yoga program or a control condition (where they will be asked to not change their lifestyle). They will complete online questionnaires at the start, middle and end of the 10-weeks.
Detailed description
The purposes of this pilot study are:
- To evaluate the feasibility and acceptability of a randomized control trial by assessing participant retention, data collection procedures, and adherence to engaging in a supervised Hatha yoga intervention (or control group).
- To examine preliminary effects of a yoga intervention on embodiment, self-objectification, and positive body image (i.e., body appreciation) among a diverse sample of adults men and women.
Specifically, we will test whether a 10-week Hatha yoga program will contribute to improvements in body appreciation via a) greater embodiment, and b) lower self-objectification This will allow us to calculate effect sizes for sample size calculations for future randomized controlled trials.
Clearance from the university Research Ethics Board will be obtained prior to study commencement. Participants will be recruited from community centres, social media, and traditional media in the Niagara Region. Potential participants will contact the researcher if they are interested in participating. Eligible and interested participants will be provided with a link to the baseline survey via Qualtrics, where they will complete informed consent, demographic information and measures of physical activity and body image. Once questionnaires have been completed, participants will be randomly assigned (using Microsoft Excel to randomize) to either the yoga or control group. They will be provided with instructions for their group at this time via email. They will then undergo either the 10-week yoga intervention or the control condition (see below for descriptions).
Participants will be asked to complete the same physical activity and body image measures during week 5 and at the end of 10 weeks via Qualtrics. At the final time point, participants will also be asked to complete feasibility measures (e.g., acceptability, appropriateness and feasibility of the intervention and control groups), as well as a series of questions asking about their perceptions of the yoga intervention or control group. Upon completion of all measures, participants will be fully debriefed as to the true purpose of the study and the use of deception (i.e., true purpose of the study related to positive body image); they will then be asked to provide continuing informed consent. In addition, the yoga instructors will also be asked a series of questions regarding their perceptions of the yoga intervention.
Yoga Intervention: Participants randomized to the yoga intervention will be asked to not make changes to other aspects of their lifestyle including their regular physical activity. Instructors are provided with guidelines regarding the format, poses, language, and themes of each class, but within those guidelines, instructors can design their own class each week. Each week, there will be a theme promoting empowerment or positive body image; instructors will be asked to choose specific poses, mantras, mudras, and affirmations to reinforce the theme of that week. Modifications to poses will be provided by the instructor. Yoga equipment will be provided during each yoga session.
Each yoga class will be audio recorded to document the content of the yoga classes to ensure guidelines for the classes are followed. Attendance will be recorded at each class to track adherence.
Instructors: The instructors will have a minimum of two years of teaching experience with diverse populations and must be a registered yoga teacher (e.g., RYT200/CYA-RYT200), meaning they have completed a minimum of 200 hours of yoga teacher training in a Yoga Alliance Foundation/Canadian Yoga Alliance recognized teacher training. Clothing will be standardized across instructors and appropriate for Hatha Yoga (e.g., yoga pants and a t-shirt or tank top). Instructors will be provided with an instructor manual that outlines the basic class structure and poses, themes, and language. The instructor will be blinded to the true study purpose. Instructors will then be asked to create a sample class, following the manual guidelines to teach a practice class to the research team for feedback.
Language and Themes Used in a Hatha Yoga Class
Control group: Participants randomized to the control group will be asked not to practice yoga for the duration of the study. Participants will be informed that they can engage in their regular physical activity routines and not change any other lifestyle factors. Participants in the control group will be offered one free yoga class in-person at the end of the study and offered one free pre-recorded video of a yoga class (from the intervention) at the end of the study.
Participants: A target of approximately 65 adults will be recruited (based on expected dropout of 30%).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study in which participants are randomly assigned to either a yoga group or waitlist control group
| Arm | Type | Receives |
|---|---|---|
| Yoga intervention | Experimental | Behavioral: Yoga intervention10 week yoga intervention; one yoga session per week, 60 minutes in length |
| Control | No intervention | –Waitlist control asked not to make any lifestyle changes over the 10 week intervention period, and not engage in yoga |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older.
- Able to read and understand English.
- Community-dwelling and residing in Niagara Region.
- Can attend sessions at the Brock Functional Inclusive Training Centre (Bfit).
- Have not participated in yoga in the past 12 months.
Key exclusion criteria (2 listed)
- Unable to provide clearance for physical activity as assessed by Get Active questionnaire (CSEP and Health Canada, www.csep.ca) or doctor's note
- Average score >4 on the Body Appreciation Scale-2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga intervention10 weeks of Hatha yoga, once per week, 60 minutes per class | Behavioural | Yoga intervention |
Primary outcome
Body appreciation
Time frame: Baseline
Body Appreciation Scale-2 (Tylka \& Wood-Barcalow, 2015); 10 items, with each one rated on a 5-point scale ranging from 1 = never to 5 = always. Scores on the BAS-2 are averaged where higher scores represent higher levels of body appreciation.
Body appreciation
Time frame: 5 weeks
Body Appreciation Scale-2 (Tylka \& Wood-Barcalow, 2015); 10 items, with each one rated on a 5-point scale ranging from 1 = never to 5 = always. Scores on the BAS-2 are averaged where higher scores represent higher levels of body appreciation.
Body appreciation
Time frame: 10 weeks
Body Appreciation Scale-2 (Tylka \& Wood-Barcalow, 2015); 10 items, with each one rated on a 5-point scale ranging from 1 = never to 5 = always. Scores on the BAS-2 are averaged where higher scores represent higher levels of body appreciation.
37 secondary outcomes
Embodiment
Time frame: Baseline
Embodiment
Time frame: 5 weeks
Embodiment
Time frame: 10 weeks
Self-objectification
Time frame: Baseline
Self-objectification
Time frame: 5 weeks
Self-objectification
Time frame: 10 weeks
Body surveillance
Time frame: Baseline
Body surveillance
Time frame: 5 weeks
Body surveillance
Time frame: 10 weeks
Functionality appreciation
Time frame: Baseline
Functionality appreciation
Time frame: 5 weeks
Functionality appreciation
Time frame: 10 weeks
Authentic body pride
Time frame: Baseline
Authentic body pride
Time frame: 5 weeks
Authentic body pride
Time frame: 10 weeks
Fitness-related authentic body pride
Time frame: Baseline
Fitness-related authentic body pride
Time frame: 5 weeks
Fitness-related authentic body pride
Time frame: 10 weeks
Body image flexibility
Time frame: Baseline
Body image flexibility
Time frame: 5 weeks
Body image flexibility
Time frame: 10 weeks
Satisfaction with function of the body and appearance of the body as assessed by Satisfaction with Body Function and Body Appearance Scale (Reboussin et al., 2000);
Time frame: Baseline
Satisfaction with function of the body and appearance of the body as assessed by Satisfaction with Body Function and Body Appearance Scale (Reboussin et al., 2000);
Time frame: 5 weeks
Satisfaction with function of the body and appearance of the body as assessed by Satisfaction with Body Function and Body Appearance Scale (Reboussin et al., 2000);
Time frame: 10 weeks
Attendance
Time frame: 10 weeks
Adherence
Time frame: 10 weeks
Drop-out
Time frame: Baseline
Drop-out
Time frame: 5 weeks
Drop-out
Time frame: 10 weeks
Retention
Time frame: Baseline
Retention
Time frame: 5 weeks
Retention
Time frame: 10 weeks
Acceptability of the Intervention as assessed by Weiner et al.'s (2017) acceptability measure
Time frame: 10 weeks
Feasibility of intervention as assessed by Weiner et al.'s (2017) feasibility measure
Time frame: 10 weeks
Appropriateness of intervention as assessed by Weiner et al.'s (2017) appropriateness measure
Time frame: 10 weeks
Interest in engaging in the yoga intervention
Time frame: Baseline
Recruitment
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Background: PubMed 25462882Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 25921657Tylka TL, Wood-Barcalow NL. What is and what is not positive body image? Conceptual foundations and construct definition. Body Image. 2015 Jun;14:118-29. doi: 10.1016/j.bodyim.2015.04.001. Epub 2015 Apr 25.
- Background: PubMed 32622294Alleva JM, Tylka TL, van Oorsouw K, Montanaro E, Perey I, Bolle C, Boselie J, Peters M, Webb JB. The effects of yoga on functionality appreciation and additional facets of positive body image. Body Image. 2020 Sep;34:184-195. doi: 10.1016/j.bodyim.2020.06.003. Epub 2020 Jul 1.
- Background: PubMed 28822275Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17.
- BackgroundCastonguay, A. L., Sabiston, C. M., Kowalski, K. C., & Wilson, P. M. Introducing an instrument to measure body and fitness-related self-conscious emotions: The BSE-FIT. Psychology of Sport and Exercise. 2016; 23: 1-12.
- Background: PubMed 24899517Castonguay AL, Pila E, Wrosch C, Sabiston CM. Body-related self-conscious emotions relate to physical activity motivation and behavior in men. Am J Mens Health. 2015 May;9(3):209-21. doi: 10.1177/1557988314537517. Epub 2014 Jun 4.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundDaubenmier, J. J. The relationship of yoga, body awareness, and body responsiveness to self-objectification and disordered eating. Psychology of Women Quarterly. 2005; 29(2): 207-219.
- Background: PubMed 26978655Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
- BackgroundFrayeh, & Lewis, B. A. The effect of mirrors on women's state body image responses to yoga. Psychology of Sport and Exercise. 2018; 35: 47-54.
- Background: PubMed 4053261Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberley L Gammage, PhD principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga intervention in people with Healthy, run by Brock University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body appreciation (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05899881, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.