Clinical trial NCT05899881: A Pilot Study Investigating the Effects of a Yoga Intervention on Health and Well-Being Among a Diverse Sample of Adults
Official title: A Pilot Study Investigating the Effects of a Yoga Intervention on Health and Well-Being Among a Diverse Sample of Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Yoga
Body image
Embodiment
Self-objectification
Pilot
Lead sponsor: Brock University
Sponsor class: OTHER
Collaborators: name: Social Sciences and Humanities Research Council of Canada
First posted: 2023-06-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study in which participants are randomly assigned to either a yoga group or waitlist control group
Primary purpose: OTHER

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%).

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

Primary outcomes:
measure: Body appreciation
timeFrame: Baseline
measure: Body appreciation
timeFrame: 5 weeks
measure: Body appreciation
timeFrame: 10 weeks
Secondary outcomes:
measure: Embodiment
timeFrame: Baseline
measure: Embodiment
timeFrame: 5 weeks
measure: Embodiment
timeFrame: 10 weeks
measure: Self-objectification
timeFrame: Baseline
measure: Self-objectification
timeFrame: 5 weeks
measure: Self-objectification
timeFrame: 10 weeks
measure: Body surveillance
timeFrame: Baseline
measure: Body surveillance
timeFrame: 5 weeks
measure: Body surveillance
timeFrame: 10 weeks
measure: Functionality appreciation
timeFrame: Baseline
measure: Functionality appreciation
timeFrame: 5 weeks
measure: Functionality appreciation
timeFrame: 10 weeks
measure: Authentic body pride
timeFrame: Baseline
measure: Authentic body pride
timeFrame: 5 weeks
measure: Authentic body pride
timeFrame: 10 weeks
measure: Fitness-related authentic body pride
timeFrame: Baseline
measure: Fitness-related authentic body pride
timeFrame: 5 weeks
measure: Fitness-related authentic body pride
timeFrame: 10 weeks
measure: Body image flexibility
timeFrame: Baseline
measure: Body image flexibility
timeFrame: 5 weeks
measure: Body image flexibility
timeFrame: 10 weeks
measure: 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);
timeFrame: Baseline
measure: 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);
timeFrame: 5 weeks
measure: 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);
timeFrame: 10 weeks
measure: Attendance
timeFrame: 10 weeks
measure: Adherence
timeFrame: 10 weeks
measure: Drop-out
timeFrame: Baseline
measure: Drop-out
timeFrame: 5 weeks
measure: Drop-out
timeFrame: 10 weeks
measure: Retention
timeFrame: Baseline
measure: Retention
timeFrame: 5 weeks
measure: Retention
timeFrame: 10 weeks
measure: Acceptability of the Intervention as assessed by Weiner et al.'s (2017) acceptability measure
timeFrame: 10 weeks
measure: Feasibility of intervention as assessed by Weiner et al.'s (2017) feasibility measure
timeFrame: 10 weeks
measure: Appropriateness of intervention as assessed by Weiner et al.'s (2017) appropriateness measure
timeFrame: 10 weeks
measure: Interest in engaging in the yoga intervention
timeFrame: Baseline
measure: Recruitment
timeFrame: Baseline
Other outcomes:
measure: Physical activity
timeFrame: Baseline
measure: Physical activity
timeFrame: 5 weeks
measure: Physical activity
timeFrame: 10 weeks
measure: Stress
timeFrame: Baseline
measure: Stress
timeFrame: 5 weeks
measure: Stress
timeFrame: 10 weeks
measure: Depression
timeFrame: Baseline
measure: Depression
timeFrame: 5 weeks
measure: Depression
timeFrame: 10 weeks
measure: Participant perceptions of intervention
timeFrame: 10 weeks
measure: Instructor perceptions
timeFrame: 10 weeks
Locations:
city: St. Catharines
country: Canada
facility: Brock University - Brock Functional Inclusive Training Centre
state: Ontario
Study officials:
affiliation: Brock University
name: Kimberley L Gammage, PhD
role: PRINCIPAL_INVESTIGATOR
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