Disordered Eating BehaviorsNCT03347071
Effects of a Yoga-Based Course in Preventing Disordered Eating in Female Collegiate Athletes
An observational study of Disordered Eating Behaviors, run by University at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Disordered Eating Behaviors
- What is being tested?
- Prevention Course Group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Participant is a female undergraduate student-athletes at the university
Who cannot join
- There are no exclusion criteria not already covered within the criteria for inclusion stated
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Excellence in Academic and Athletic Performance
Buffalo, New York, 14260
About this study
Official title: 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.
Read the 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.
- Conditions
- Disordered Eating Behaviors
- Being tested
- Prevention Course Group
- Keywords
- prevention, collegiate athletes, yoga
- Medical subject headings
- Disordered Eating Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention Course GroupBehavioural
Also called Eat Breathe Thrive Program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Prevention Course Group | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Disordered Eating Behaviors
Change in Eating Disorder Examination Questionnaire
Measured: Change from Baseline in Eating Disorder Examination Questionnaire at 7 weeks
Self-Care Behaviors
Change in Mindful Self-Care Scale-Short
Measured: Change from Baseline in Mindful Self-Care Scale-Short at 7 weeks
Interoceptive Awareness
Change in Multidimensional Assessment of Interoceptive Awareness
Measured: Change from Baseline in Multidimensional Assessment of Interoceptive Awareness at 7 weeks
Emotional Regulation
Change in Difficulties in Emotion Regulation Scale
Measured: Change from Baseline in Difficulties in Emotion Regulation Scale at 7 weeks
Distress Tolerance
Change in Distress Tolerance Scale and State-Trait Anxiety Inventory for Adults
Measured: Change from Baseline in Distress Tolerance Scale and State-Trait Anxiety Inventory for Adults at 7 weeks
Intuitive Eating
Change in Intuitive Eating Scale
Measured: Change from Baseline in Intuitive Eating Scale in 7 weeks
Secondary outcomes (4)
Disordered Eating Behaviors
Change in Eating Disorder Examination Questionnaire
Measured: Change from Baseline in Eating Disorder Examination Questionnaire at 19 weeks
Self-Care Behaviors
Change in Mindful Self-Care Scale-Short
Measured: Change from Baseline in Mindful Self-Care Scale-Short at 19 weeks
Emotional Regulation
Change in Difficulties in Emotion Regulation Scale
Measured: Change from Baseline in Difficulties in Emotion Regulation Scale at 19 weeks
Distress Tolerance
Change in Distress Tolerance Scale and State-Trait Anxiety Inventory for Adults
Measured: Change from Baseline in Distress Tolerance Scale and State-Trait Anxiety Inventory for Adults at 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start24 Jan 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disordered Eating BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Give Back Yoga Foundation
- Responsible party
- Principal investigator, Catherine Cook-Cottone, University at Buffalo
- Investigators
- Catherine Cook-Cottone, PhD, Principal investigator, Counseling, School, and Educational Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347071
- Sponsor's protocol ID
- EBTSA01
- Status last verified
- Sep 2020
- First submitted
- 15 Nov 2017
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Yoga-Based Course in Preventing Disordered Eating in Female Collegiate Athletes: A Controlled Study
- ClinicalTrials.gov ID
- NCT03347071
- Acronym / sponsor ID
- EBTSA01
- Conditions
- Disordered Eating Behaviors
- Keywords
- prevention, collegiate athletes, yoga
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- Give Back Yoga Foundation
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention Course Group | – | Behavioral: Prevention Course GroupThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Participant is a female undergraduate student-athletes at the university
Key exclusion criteria (1 listed)
- There are no exclusion criteria not already covered within the criteria for inclusion stated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention Course GroupAlso: Eat Breathe Thrive ProgramThe 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. | Behavioural | Prevention Course Group |
Primary outcome
Disordered Eating Behaviors
Time frame: Change from Baseline in Eating Disorder Examination Questionnaire at 7 weeks
Change in Eating Disorder Examination Questionnaire
Self-Care Behaviors
Time frame: Change from Baseline in Mindful Self-Care Scale-Short at 7 weeks
Change in Mindful Self-Care Scale-Short
Interoceptive Awareness
Time frame: Change from Baseline in Multidimensional Assessment of Interoceptive Awareness at 7 weeks
Change in Multidimensional Assessment of Interoceptive Awareness
Emotional Regulation
Time frame: Change from Baseline in Difficulties in Emotion Regulation Scale at 7 weeks
Change in Difficulties in Emotion Regulation Scale
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
Intuitive Eating
Time frame: Change from Baseline in Intuitive Eating Scale in 7 weeks
Change in Intuitive Eating Scale
4 secondary outcomes
Disordered Eating Behaviors
Time frame: 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
Emotional Regulation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Curriculum offered in the prevention course is from the Eat Breathe Thrive ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Cook-Cottone, PhD principal investigator
Counseling, School, and Educational Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disordered Eating Behaviors, run by University at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disordered Eating Behaviors (time frame: Change from Baseline in Eating Disorder Examination Questionnaire at 7 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.