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

Study Overview
=================
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.

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%).

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Yoga intervention


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot study in which participants are randomly assigned to either a yoga group or waitlist control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga intervention<br>10 week yoga intervention; one yoga session per week, 60 minutes in length | Behavioral: Yoga intervention<br>* 10 weeks of Hatha yoga, once per week, 60 minutes per class<br>|
| No Intervention: Control<br>Waitlist control asked not to make any lifestyle changes over the 10 week intervention period, and not engage in yoga | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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. | 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. | 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. | 10 weeks | 
| Attendance | Number of sessions out of 10 attended | 10 weeks | 
| Adherence | Proportion of total sessions attended by participants | 10 weeks | 
| Drop-out | Number and percent of participants lost | Baseline | 
| Drop-out | Number and percent of participants lost | 5 weeks | 
| Drop-out | Number and percent of participants lost | 10 weeks | 
| Retention | Proportion of participants from each group with complete data on each outcome measure | Baseline | 
| Retention | Proportion of participants from each group with complete data on each outcome measure | 5 weeks | 
| Retention | Proportion of participants from each group with complete data on each outcome measure | 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 | 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 | 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 | 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 | Baseline | 
| Recruitment | Number and percent of men and women, age group, and weight status group enrolled | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Yoga, Body image, Embodiment, Self-objectification, Pilot