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

July 6, 2023 updated by: Kimberley Gammage, Brock University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • St. Catharines, Ontario, Canada, L2S 3A1
        • Brock University - Brock Functional Inclusive Training Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga intervention
10 week yoga intervention; one yoga session per week, 60 minutes in length
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
5 weeks
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.
10 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
5 weeks
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.
10 weeks
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.
Baseline
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.
5 weeks
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.
10 weeks
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.
Baseline
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.
5 weeks
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 weeks
Participant perceptions of intervention
Time Frame: 10 weeks
Open ended questions
10 weeks
Instructor perceptions
Time Frame: 10 weeks
Open ended questions
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kimberley L Gammage, PhD, Brock University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2023

Primary Completion (Estimated)

August 1, 2023

Study Completion (Estimated)

August 1, 2023

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 22-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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