NCT05899881

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 29, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

May 24, 2023

Last Update Submit

July 6, 2023

Conditions

Healthy

Keywords

YogaBody imageEmbodimentSelf-objectificationPilot

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (37)

  • Embodiment

    Baseline

  • Embodiment

    5 weeks

  • Embodiment

    10 weeks

  • Self-objectification

    Baseline

  • Self-objectification

    5 weeks

  • +32 more secondary outcomes

Other Outcomes (11)

  • Physical activity

    Baseline

  • Physical activity

    5 weeks

  • Physical activity

    10 weeks

  • +8 more other outcomes

Study Arms (2)

Yoga intervention

EXPERIMENTAL

10 week yoga intervention; one yoga session per week, 60 minutes in length

Behavioral: Yoga intervention

Control

NO INTERVENTION

Waitlist control asked not to make any lifestyle changes over the 10 week intervention period, and not engage in yoga

Interventions

Yoga interventionBEHAVIORAL

10 weeks of Hatha yoga, once per week, 60 minutes per class

Yoga intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University - Brock Functional Inclusive Training Centre

St. Catharines, Ontario, L2S 3A1, Canada

Location

Related Publications (18)

  • Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.

    PMID: 25462882BACKGROUND

  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

    PMID: 28851459BACKGROUND

  • Tylka TL, Wood-Barcalow NL. What is and what is not positive body image? Conceptual foundations and construct definition. Body Image. 2015 Jun;14:118-29. doi: 10.1016/j.bodyim.2015.04.001. Epub 2015 Apr 25.

    PMID: 25921657BACKGROUND

  • Alleva JM, Tylka TL, van Oorsouw K, Montanaro E, Perey I, Bolle C, Boselie J, Peters M, Webb JB. The effects of yoga on functionality appreciation and additional facets of positive body image. Body Image. 2020 Sep;34:184-195. doi: 10.1016/j.bodyim.2020.06.003. Epub 2020 Jul 1.

    PMID: 32622294BACKGROUND

  • Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17.

    PMID: 28822275BACKGROUND

  • 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.

    BACKGROUND

  • Castonguay AL, Pila E, Wrosch C, Sabiston CM. Body-related self-conscious emotions relate to physical activity motivation and behavior in men. Am J Mens Health. 2015 May;9(3):209-21. doi: 10.1177/1557988314537517. Epub 2014 Jun 4.

    PMID: 24899517BACKGROUND

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND

  • 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.

    BACKGROUND

  • Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.

    PMID: 26978655BACKGROUND

  • 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.

    BACKGROUND

  • Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

    PMID: 4053261BACKGROUND

  • Lakens D. Calculating and reporting effect sizes to facilitate cumulative science: a practical primer for t-tests and ANOVAs. Front Psychol. 2013 Nov 26;4:863. doi: 10.3389/fpsyg.2013.00863.

    PMID: 24324449BACKGROUND

  • 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.

    BACKGROUND

  • 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).

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

Study Officials

  • Kimberley L Gammage, PhD

    Brock University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Pilot study in which participants are randomly assigned to either a yoga group or waitlist control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 12, 2023

Study Start

May 29, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)