NCT01336309

Brief Summary

This study comprises 4 phases designed to systematically develop and test a reliable, valid and useful quantitative measure of the components and dimensions of yoga; each phase builds on the previous phase. Phase I aims to gain a comprehensive understanding of the relevant aspects of yoga therapy and develop a large pool of potential questionnaire items by conducting a thorough literature review and focus groups with yoga teachers and students. These data will be analyzed using rigorous qualitative methods to identify key conceptual dimensions associated with yoga interventions. Phase II will develop a prototypic questionnaire to assess yoga therapy by refining and honing information from Phase I and conducting cognitive interviews to further develop this instrument. Phase III will pilot test the measure in a field observation of yoga students and use factor analysis and item response theory to select the best items per dimension and to reduce the number of items in the measure. Phase IV will collect data on the new instrument and test the psychometric properties of the questionnaire (i.e., reliability and validity using data collected in Phases III and IV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,832

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

5.6 years

First QC Date

April 13, 2011

Last Update Submit

August 9, 2016

Conditions

Keywords

Yoga

Outcome Measures

Primary Outcomes (1)

  • EPYQ Essential Properties of Yoga Questionnaire

    The EPYQ is the survey that is being developed for this study to assess the essential properties of a yoga class or intervention

    Post yoga class in Phase IV

Study Arms (4)

Focus Group

We conducted three focus groups per site, at three sites, with around eight people each. These data were used to guide refinement and selection of the items we developed for Phase III data collection. We will administer the Yoga Research Tool.

Behavioral: Yoga Research Tool

Cognitive Interviews

We conducted cognitive interviews at three different sites, with about ten in each group. These data were used to guide refinement and selection of the items we developed for Phase III data collection. We collected this data via a large, online survey and administered the Yoga Research Tool.

Behavioral: Yoga Research Tool

Survey Prototype Administration

We administered a prototype of the study measure to a large group of yoga students, with about 450 total participants. These data were used to further inform the refinement and selection of items to be used in the final measure.

Behavioral: Yoga Research Tool

Reliability and Validity Testing

We are conducting yoga classes at community partner facilities near each site, with about ten participants in each class. Participants at each class will complete the study measure and related questionnaires, in order to test the reliability and validity of the study measure.

Behavioral: Yoga Research Tool

Interventions

We will be collecting data from a literature search, focus groups, cognitive interviews, and an online survey to build a measure for yoga researchers.

Cognitive InterviewsFocus GroupReliability and Validity TestingSurvey Prototype Administration

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Yoga teachers, students, and researchers.

You may qualify if:

  • Yoga teachers, students, and researchers

You may not qualify if:

  • Those who do not participate in regular (weekly) yoga practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crystal Park

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Erik Groessl, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR
  • Rani Elwy, PhD

    Boston University

    PRINCIPAL INVESTIGATOR
  • Susan Eisen, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 15, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations