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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03347071
Other study ID # EBTSA01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 24, 2018
Est. completion date June 30, 2019

Study information

Verified date September 2020
Source University at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Center for Excellence in Academic and Athletic Performance Buffalo New York

Sponsors (2)

Lead Sponsor Collaborator
University at Buffalo Give Back Yoga Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disordered Eating Behaviors Change in Eating Disorder Examination Questionnaire Change from Baseline in Eating Disorder Examination Questionnaire at 7 weeks
Primary Self-Care Behaviors Change in Mindful Self-Care Scale-Short Change from Baseline in Mindful Self-Care Scale-Short at 7 weeks
Primary Interoceptive Awareness Change in Multidimensional Assessment of Interoceptive Awareness Change from Baseline in Multidimensional Assessment of Interoceptive Awareness at 7 weeks
Primary Emotional Regulation Change in Difficulties in Emotion Regulation Scale Change from Baseline in Difficulties in Emotion Regulation Scale at 7 weeks
Primary Distress Tolerance 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
Primary Intuitive Eating Change in Intuitive Eating Scale Change from Baseline in Intuitive Eating Scale in 7 weeks
Secondary Disordered Eating Behaviors Change in Eating Disorder Examination Questionnaire Change from Baseline in Eating Disorder Examination Questionnaire at 19 weeks
Secondary Self-Care Behaviors Change in Mindful Self-Care Scale-Short Change from Baseline in Mindful Self-Care Scale-Short at 19 weeks
Secondary Emotional Regulation Change in Difficulties in Emotion Regulation Scale Change from Baseline in Difficulties in Emotion Regulation Scale at 19 weeks
Secondary Distress Tolerance 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
See also
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