Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03347071
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : September 30, 2020
Sponsor:
Collaborator:
Give Back Yoga Foundation
Information provided by (Responsible Party):
Catherine Cook-Cottone, University at Buffalo

Brief Summary:
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.

Condition or disease Intervention/treatment
Disordered Eating Behaviors Behavioral: Prevention Course Group

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of a Yoga-Based Course in Preventing Disordered Eating in Female Collegiate Athletes: A Controlled Study
Actual Study Start Date : January 24, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Group/Cohort Intervention/treatment
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 Name: 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.



Primary Outcome Measures :
  1. Disordered Eating Behaviors [ Time Frame: Change from Baseline in Eating Disorder Examination Questionnaire at 7 weeks ]
    Change in Eating Disorder Examination Questionnaire

  2. Self-Care Behaviors [ Time Frame: Change from Baseline in Mindful Self-Care Scale-Short at 7 weeks ]
    Change in Mindful Self-Care Scale-Short

  3. Interoceptive Awareness [ Time Frame: Change from Baseline in Multidimensional Assessment of Interoceptive Awareness at 7 weeks ]
    Change in Multidimensional Assessment of Interoceptive Awareness

  4. Emotional Regulation [ Time Frame: Change from Baseline in Difficulties in Emotion Regulation Scale at 7 weeks ]
    Change in Difficulties in Emotion Regulation Scale

  5. 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

  6. Intuitive Eating [ Time Frame: Change from Baseline in Intuitive Eating Scale in 7 weeks ]
    Change in Intuitive Eating Scale


Secondary Outcome Measures :
  1. Disordered Eating Behaviors [ Time Frame: Change from Baseline in Eating Disorder Examination Questionnaire at 19 weeks ]
    Change in Eating Disorder Examination Questionnaire

  2. Self-Care Behaviors [ Time Frame: Change from Baseline in Mindful Self-Care Scale-Short at 19 weeks ]
    Change in Mindful Self-Care Scale-Short

  3. Emotional Regulation [ Time Frame: Change from Baseline in Difficulties in Emotion Regulation Scale at 19 weeks ]
    Change in Difficulties in Emotion Regulation Scale

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347071


Locations
Layout table for location information
United States, New York
Center for Excellence in Academic and Athletic Performance
Buffalo, New York, United States, 14260
Sponsors and Collaborators
University at Buffalo
Give Back Yoga Foundation
Investigators
Layout table for investigator information
Principal Investigator: Catherine Cook-Cottone, PhD Counseling, School, and Educational Psychology
Additional Information:
Layout table for additonal information
Responsible Party: Catherine Cook-Cottone, Counseling, School, and Educational Psychology Associate Professor, Ph.D., University at Buffalo
ClinicalTrials.gov Identifier: NCT03347071    
Other Study ID Numbers: EBTSA01
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Catherine Cook-Cottone, University at Buffalo:
prevention
collegiate athletes
yoga