A Pilot Study Investigating the Effects of a Yoga Intervention on Health and Well-Being Among a Diverse Sample of Adults
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ClinicalTrials.gov Identifier: NCT05899881 |
Recruitment Status :
Active, not recruiting
First Posted : June 12, 2023
Last Update Posted : July 7, 2023
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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 |
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
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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
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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.
- 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.
- 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.
- Attendance [ Time Frame: 10 weeks ]Number of sessions out of 10 attended
- Adherence [ Time Frame: 10 weeks ]Proportion of total sessions attended by participants
- Drop-out [ Time Frame: Baseline ]Number and percent of participants lost
- Drop-out [ Time Frame: 5 weeks ]Number and percent of participants lost
- Drop-out [ Time Frame: 10 weeks ]Number and percent of participants lost
- Retention [ Time Frame: Baseline ]Proportion of participants from each group with complete data on each outcome measure
- Retention [ Time Frame: 5 weeks ]Proportion of participants from each group with complete data on each outcome measure
- Retention [ Time Frame: 10 weeks ]Proportion of participants from each group with complete data on each outcome measure
- 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
- 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
- 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
- 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
- Recruitment [ Time Frame: Baseline ]Number and percent of men and women, age group, and weight status group enrolled
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Participant perceptions of intervention [ Time Frame: 10 weeks ]Open ended questions
- Instructor perceptions [ Time Frame: 10 weeks ]Open ended questions
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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
Canada, Ontario | |
Brock University - Brock Functional Inclusive Training Centre | |
St. Catharines, Ontario, Canada, L2S 3A1 |
Principal Investigator: | Kimberley L Gammage, PhD | Brock University |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Yoga Body image Embodiment Self-objectification Pilot |