NCT03347071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 24, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

November 15, 2017

Last Update Submit

September 27, 2022

Conditions

Keywords

preventioncollegiate athletesyoga

Outcome Measures

Primary Outcomes (6)

  • Disordered Eating Behaviors

    Change in Eating Disorder Examination Questionnaire

    Change from Baseline in Eating Disorder Examination Questionnaire at 7 weeks

  • Self-Care Behaviors

    Change in Mindful Self-Care Scale-Short

    Change from Baseline in Mindful Self-Care Scale-Short at 7 weeks

  • Interoceptive Awareness

    Change in Multidimensional Assessment of Interoceptive Awareness

    Change from Baseline in Multidimensional Assessment of Interoceptive Awareness at 7 weeks

  • Emotional Regulation

    Change in Difficulties in Emotion Regulation Scale

    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

    Change from Baseline in Distress Tolerance Scale and State-Trait Anxiety Inventory for Adults at 7 weeks

  • Intuitive Eating

    Change in Intuitive Eating Scale

    Change from Baseline in Intuitive Eating Scale in 7 weeks

Secondary Outcomes (4)

  • Disordered Eating Behaviors

    Change from Baseline in Eating Disorder Examination Questionnaire at 19 weeks

  • Self-Care Behaviors

    Change from Baseline in Mindful Self-Care Scale-Short at 19 weeks

  • Emotional Regulation

    Change from Baseline in Difficulties in Emotion Regulation Scale at 19 weeks

  • Distress Tolerance

    Change from Baseline in Distress Tolerance Scale and State-Trait Anxiety Inventory for Adults at 19 weeks

Study Arms (2)

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

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.

Interventions

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.

Also known as: Eat Breathe Thrive Program
Prevention Course Group

Eligibility Criteria

Age18 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Excellence in Academic and Athletic Performance

Buffalo, New York, 14260, United States

Location

Related Links

MeSH Terms

Conditions

Disordered Eating Behavior

Condition Hierarchy (Ancestors)

BehaviorFeeding and Eating DisordersMental Disorders

Study Officials

  • Catherine Cook-Cottone, PhD

    Counseling, School, and Educational Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Counseling, School, and Educational Psychology Associate Professor, Ph.D.

Study Record Dates

First Submitted

November 15, 2017

First Posted

November 20, 2017

Study Start

January 24, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

September 29, 2022

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations