Effects of a Yoga-Based Course in Preventing Disordered Eating in Female Collegiate Athletes

September 27, 2022 updated by: Catherine Cook-Cottone, University at Buffalo

Effects of a Yoga-Based Course in Preventing Disordered Eating in Female Collegiate Athletes: A Controlled Study

The purpose of the study is to evaluate effects of a 7-week undergraduate course, incorporating Eat Breathe Thrive program curriculum, offered to female student-athletes in order to increase positive body image, emotional regulation, interoceptive awareness, self-care skills, and intuitive eating. The undergraduate course is structured around the Eat Breathe Thrive program curriculum, which aims to: a) teach somatic practices that increase interoceptive awareness, b) provide healthy tools for emotional regulation, c) allow for the creation of community-based networks of support, and (d) foster a sense of meaning and purpose through service activities. In a non-randomized controlled trial, the investigators plan to examine whether this preventative undergraduate course is found effective in a female student-athlete population in preventing and decreasing eating disorder risk. The investigators also plan to examine whether the program is found effective in increasing protective factors, such as self-care behaviors, interoceptive awareness, intuitive eating, and emotional regulation skills.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To the investigators' knowledge, there are no studies that incorporate yoga into eating disorder prevention intervention in a student-athlete population, indicating a gap in literature that the proposed study aims to address. In this study, a 7-week undergraduate course offered to female student-athletes, which incorporates Eat Breathe Thrive program curriculum, will be examined to evaluate preventative effects. The Eat Breathe Thrive program was selected by the course instructors to provide female student-athletes with mental health support, utilizing an interactive multisession format with a positive psychology orientation. Eat Breathe Thrive's curriculum focuses on the reduction of eating disorder risk by lesson plans centered around positive engagement with others and developing a strong relationship with self. This framework is based on the idea that individuals are able to sustain proper health, relationships, and overall well-being using the positive embodiment tools and psychoeducational information learned. The study aims to contribute to the eating disorder literature targeting female student-athletes by examining the effects of a prevention program delivered as part of an undergraduate course.

It is hypothesized that:

  • Prevention course participants will show a decrease in disordered eating behaviors when compared to controls.
  • Prevention course participants will show an increase in self-care behaviors compared to controls.
  • Prevention course participants will show an increase in interoceptive awareness, intuitive eating, and emotional regulation when compared to controls.
  • Prevention course participants will show a decrease in difficulties with emotional regulation and an increase in tolerance to distress when compared to controls.
  • Prevention course participants will show better maintenance of wellbeing as well as better maintenance in decreased symptomatology as compared to compared to controls.

The study will employ self-report surveys to examine the preventative effects of participation in a 7-week course utilizing a longitudinal non-randomized control design with Division I female student-athletes in western New York. Participants will be current female student-athletes recruited within the university's athletic department. Experimental group participants will be recruited from their enrollment in the prevention course offered that incorporates the Eat Breathe Thrive curriculum. Since the prevention course has a capacity of 30 students per semester, data will be collected for four 7-week semesters to account for total sample size. The study will be recruiting from a total of 120 female student-athletes in the experimental group. Female student-athletes not enrolled in the prevention course will be recruited for control. Each semester, course enrollment numbers will be matched by recruiting research participants from the rest of the female student-athlete population at the university (those who are not enrolled in the course). Female student-athletes in the experimental and control groups will complete all study measures at the same time points throughout the study. This study is based on the need to provide female student-athletes with greater access to effective tools and strategies that support their well-being as well as to protect this high-risk population against the development of an eating disorder.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

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

  • United States
    • New York
      • Buffalo, New York, United States, 14260
        • Center for Excellence in Academic and Athletic Performance

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Participants are from the undergraduate student-athlete population at the university who are currently a member of one of the Division I sports teams. Specifically, female undergraduate student-athletes, ranging from ages 18-24.

Description

Inclusion Criteria:

  • Participant is a female undergraduate student-athletes at the university

Exclusion Criteria:

  • There are no exclusion criteria not already covered within the criteria for inclusion stated

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Prevention Course Group
The Prevention Course Group is composed of female student-athletes enrolled in the 7-week prevention course. The course occurs once a week (1 hour, 40 minute sessions) for a total of 7-weeks during the academic semester. Approximately 1 hour of each class session is lecture based, leaving 40 minutes for yoga practice administered by a certified yoga instructor. The course instructor is certified in Eat Breathe Thrive Program delivery. The course teaching assistant is certified in yoga instruction.
Behavioral: Prevention Course Group
The undergraduate prevention course is structured around Eat Breathe Thrive Program curriculum. The course aims to teach somatic practices, provide healthy tools for emotional regulation, allow for the creation of community-based networks of support, foster a sense of meaning and purpose through service activities, and practice these learned skills through yoga.
Other Names:
  • Eat Breathe Thrive Program
Control Group
The Control Group is composed of female student-athletes not enrolled in the 7-week prevention course. Female student-athletes in this group will not be enrolled in the course during the period of data collection, nor will they have previously completed the course.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disordered Eating Behaviors
Time Frame: Change from Baseline in Eating Disorder Examination Questionnaire at 7 weeks
Change in Eating Disorder Examination Questionnaire
Change from Baseline in Eating Disorder Examination Questionnaire at 7 weeks
Self-Care Behaviors
Time Frame: Change from Baseline in Mindful Self-Care Scale-Short at 7 weeks
Change in Mindful Self-Care Scale-Short
Change from Baseline in Mindful Self-Care Scale-Short at 7 weeks
Interoceptive Awareness
Time Frame: Change from Baseline in Multidimensional Assessment of Interoceptive Awareness at 7 weeks
Change in Multidimensional Assessment of Interoceptive Awareness
Change from Baseline in Multidimensional Assessment of Interoceptive Awareness at 7 weeks
Emotional Regulation
Time Frame: Change from Baseline in Difficulties in Emotion Regulation Scale at 7 weeks
Change in Difficulties in Emotion Regulation Scale
Change from Baseline in Difficulties in Emotion Regulation Scale at 7 weeks
Distress Tolerance
Time Frame: Change from Baseline in Distress Tolerance Scale and State-Trait Anxiety Inventory for Adults at 7 weeks
Change in Distress Tolerance Scale and State-Trait Anxiety Inventory for Adults
Change from Baseline in Distress Tolerance Scale and State-Trait Anxiety Inventory for Adults at 7 weeks
Intuitive Eating
Time Frame: Change from Baseline in Intuitive Eating Scale in 7 weeks
Change in Intuitive Eating Scale
Change from Baseline in Intuitive Eating Scale in 7 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disordered Eating Behaviors
Time Frame: Change from Baseline in Eating Disorder Examination Questionnaire at 19 weeks
Change in Eating Disorder Examination Questionnaire
Change from Baseline in Eating Disorder Examination Questionnaire at 19 weeks
Self-Care Behaviors
Time Frame: Change from Baseline in Mindful Self-Care Scale-Short at 19 weeks
Change in Mindful Self-Care Scale-Short
Change from Baseline in Mindful Self-Care Scale-Short at 19 weeks
Emotional Regulation
Time Frame: Change from Baseline in Difficulties in Emotion Regulation Scale at 19 weeks
Change in Difficulties in Emotion Regulation Scale
Change from Baseline in Difficulties in Emotion Regulation Scale at 19 weeks
Distress Tolerance
Time Frame: Change from Baseline in Distress Tolerance Scale and State-Trait Anxiety Inventory for Adults at 19 weeks
Change in Distress Tolerance Scale and State-Trait Anxiety Inventory for Adults
Change from Baseline in Distress Tolerance Scale and State-Trait Anxiety Inventory for Adults at 19 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University at Buffalo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Give Back Yoga Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catherine Cook-Cottone, PhD, Counseling, School, and Educational Psychology

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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EBTSA01

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

product manufactured in and exported from the U.S.

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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