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.