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A Pilot Study Investigating the Effects of a Yoga Intervention on Health and Well-Being Among a Diverse Sample of Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05899881
Recruitment Status : Active, not recruiting
First Posted : June 12, 2023
Last Update Posted : July 7, 2023
Sponsor:
Collaborator:
Social Sciences and Humanities Research Council of Canada
Information provided by (Responsible Party):
Kimberley Gammage, Brock University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Healthy Behavioral: Yoga intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot study in which participants are randomly assigned to either a yoga group or waitlist control group
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study Investigating the Effects of a Yoga Intervention on Health and Well-Being Among a Diverse Sample of Adults
Actual Study Start Date : May 29, 2023
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Arm Intervention/treatment
Experimental: Yoga intervention
10 week yoga intervention; one yoga session per week, 60 minutes in length
Behavioral: Yoga intervention
10 weeks of Hatha yoga, once per week, 60 minutes per class

No Intervention: Control
Waitlist control asked not to make any lifestyle changes over the 10 week intervention period, and not engage in yoga



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Embodiment [ Time Frame: Baseline ]
    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.

  2. Embodiment [ Time Frame: 5 weeks ]
    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.

  3. Embodiment [ Time Frame: 10 weeks ]
    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.

  4. Self-objectification [ Time Frame: Baseline ]
    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.

  5. Self-objectification [ Time Frame: 5 weeks ]
    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.

  6. Self-objectification [ Time Frame: 10 weeks ]
    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.

  7. Body surveillance [ Time Frame: Baseline ]
    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

  8. Body surveillance [ Time Frame: 5 weeks ]
    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

  9. Body surveillance [ Time Frame: 10 weeks ]
    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

  10. Functionality appreciation [ Time Frame: Baseline ]
    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.

  11. Functionality appreciation [ Time Frame: 5 weeks ]
    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.

  12. Functionality appreciation [ Time Frame: 10 weeks ]
    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.

  13. Authentic body pride [ Time Frame: Baseline ]
    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.

  14. Authentic body pride [ Time Frame: 5 weeks ]
    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.

  15. Authentic body pride [ Time Frame: 10 weeks ]
    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.

  16. Fitness-related authentic body pride [ Time Frame: Baseline ]
    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.

  17. Fitness-related authentic body pride [ Time Frame: 5 weeks ]
    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.

  18. Fitness-related authentic body pride [ Time Frame: 10 weeks ]
    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.

  19. Body image flexibility [ Time Frame: Baseline ]
    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

  20. Body image flexibility [ Time Frame: 5 weeks ]
    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

  21. Body image flexibility [ Time Frame: 10 weeks ]
    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

  22. 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 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.

  23. 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 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.

  24. 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 ]
    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.

  25. Attendance [ Time Frame: 10 weeks ]
    Number of sessions out of 10 attended

  26. Adherence [ Time Frame: 10 weeks ]
    Proportion of total sessions attended by participants

  27. Drop-out [ Time Frame: Baseline ]
    Number and percent of participants lost

  28. Drop-out [ Time Frame: 5 weeks ]
    Number and percent of participants lost

  29. Drop-out [ Time Frame: 10 weeks ]
    Number and percent of participants lost

  30. Retention [ Time Frame: Baseline ]
    Proportion of participants from each group with complete data on each outcome measure

  31. Retention [ Time Frame: 5 weeks ]
    Proportion of participants from each group with complete data on each outcome measure

  32. Retention [ Time Frame: 10 weeks ]
    Proportion of participants from each group with complete data on each outcome measure

  33. Acceptability of the Intervention as assessed by Weiner et al.'s (2017) acceptability measure [ Time Frame: 10 weeks ]
    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

  34. Feasibility of intervention as assessed by Weiner et al.'s (2017) feasibility measure [ Time Frame: 10 weeks ]
    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

  35. Appropriateness of intervention as assessed by Weiner et al.'s (2017) appropriateness measure [ Time Frame: 10 weeks ]
    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

  36. Interest in engaging in the yoga intervention [ Time Frame: Baseline ]
    Number of participants (by age and gender) who express interest in the study by contacting the research team

  37. Recruitment [ Time Frame: Baseline ]
    Number and percent of men and women, age group, and weight status group enrolled


Other Outcome Measures:
  1. Physical activity [ Time Frame: Baseline ]
    Godin Leisure Time Physical Activity Questionnaire (Godin & Shephard, 1985); Participants are asked to report the number of times they engaged in mild, moderate, and strenuous physical activity for greater than 15 min during the last 7-day period. A total score is calculated by multiplying the frequencies of mild, moderate, and strenuous activity by corresponding metabolic equivalent task values (three, five, and nine, respectively) and summing the scores. Higher scores are reflective of greater energy expenditure.

  2. Physical activity [ Time Frame: 5 weeks ]
    Godin Leisure Time Physical Activity Questionnaire (Godin & Shephard, 1985); Participants are asked to report the number of times they engaged in mild, moderate, and strenuous physical activity for greater than 15 min during the last 7-day period. A total score is calculated by multiplying the frequencies of mild, moderate, and strenuous activity by corresponding metabolic equivalent task values (three, five, and nine, respectively) and summing the scores. Higher scores are reflective of greater energy expenditure.

  3. Physical activity [ Time Frame: 10 weeks ]
    Godin Leisure Time Physical Activity Questionnaire (Godin & Shephard, 1985); Participants are asked to report the number of times they engaged in mild, moderate, and strenuous physical activity for greater than 15 min during the last 7-day period. A total score is calculated by multiplying the frequencies of mild, moderate, and strenuous activity by corresponding metabolic equivalent task values (three, five, and nine, respectively) and summing the scores. Higher scores are reflective of greater energy expenditure.

  4. Stress [ Time Frame: Baseline ]
    Perceived Stress Scale (Cohen et al., 1983). 10 items rated on a 5-point Likert scale from 0 = never to 4 = very often. Higher scores indicate higher levels of perceived stress.

  5. Stress [ Time Frame: 5 weeks ]
    Perceived Stress Scale (Cohen et al., 1983). 10 items rated on a 5-point Likert scale from 0 = never to 4 = very often. Higher scores indicate higher levels of perceived stress.

  6. Stress [ Time Frame: 10 weeks ]
    Perceived Stress Scale (Cohen et al., 1983). 10 items rated on a 5-point Likert scale from 0 = never to 4 = very often. Higher scores indicate higher levels of perceived stress.

  7. Depression [ Time Frame: Baseline ]
    Center for Epidemiologic Studies Depression Scale (Radloff, 1997); Participants rate the degree to which each statement is true of them on a range from 0 = rarely or none to 3 = most or almost all the time. Questions scores are then summed to provide an overall score ranging from 0 to 60. Higher scores indicate greater depression symptoms.

  8. Depression [ Time Frame: 5 weeks ]
    Center for Epidemiologic Studies Depression Scale (Radloff, 1997); Participants rate the degree to which each statement is true of them on a range from 0 = rarely or none to 3 = most or almost all the time. Questions scores are then summed to provide an overall score ranging from 0 to 60. Higher scores indicate greater depression symptoms.

  9. Depression [ Time Frame: 10 weeks ]
    Center for Epidemiologic Studies Depression Scale (Radloff, 1997); Participants rate the degree to which each statement is true of them on a range from 0 = rarely or none to 3 = most or almost all the time. Questions scores are then summed to provide an overall score ranging from 0 to 60. Higher scores indicate greater depression symptoms.

  10. Participant perceptions of intervention [ Time Frame: 10 weeks ]
    Open ended questions

  11. Instructor perceptions [ Time Frame: 10 weeks ]
    Open ended questions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05899881


Locations
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Canada, Ontario
Brock University - Brock Functional Inclusive Training Centre
St. Catharines, Ontario, Canada, L2S 3A1
Sponsors and Collaborators
Brock University
Social Sciences and Humanities Research Council of Canada
Investigators
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Principal Investigator: Kimberley L Gammage, PhD Brock University
Publications:
Castonguay, 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.
Daubenmier, 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.
Frayeh, & 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.
Lindner, 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).
Radloff, L. S. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977; 1(3): 385-401.
Reboussin, B. A., Rejeski, W. J., Martin, K. A., Callahan, K., Dunn, A. L., King, A. C., & Sallis, J. F. Correlates of satisfaction with body function and body appearance in middle- and older aged adults: The activity counseling trial (ACT). Psychology & Health. 2000; 15(2): 239-254.
Sandoz, E. K., Wilson, K. G., Merwin, R. M., & Kellum, K. K. Assessment of body image flexibility: The body image-acceptance and action questionnaire. Journal of Contextual Behavioral Science. 2013; 2(1-2): 39-48.

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Responsible Party: Kimberley Gammage, Professor, Brock University
ClinicalTrials.gov Identifier: NCT05899881    
Other Study ID Numbers: 22-205
First Posted: June 12, 2023    Key Record Dates
Last Update Posted: July 7, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kimberley Gammage, Brock University:
Yoga
Body image
Embodiment
Self-objectification
Pilot