ED Recovery Course Online RCT

Control Clinical Trial

Official title:

A Randomized Controlled Trial of the Eat Breathe Thrive Yoga for Eating Disorder Recovery Online Course

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557566
• Other study ID #: STUDY00004821
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: November 15, 2021

Study information

• Verified date: March 2022
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine whether the Eat Breathe Thrive (EBT) Yoga for Eating Disorder Recovery online course is effective in supporting eating disorder recovery.

Description:

We will conduct a block randomized controlled trial (RCT) comparing an intervention group and a waitlist control group. Participants in the intervention group will complete the Eat Breathe Thrive (EBT) Yoga for Eating Disorder Recovery online course. This course will be led by certified facilitators via Zoom and offered over the course of four weeks, comprising one two-hour session per week. The course will continue to recruit and enroll participants until sufficient power is reached for the study. At Pretest, Posttest 1, Posttest 2, and three-months Follow-Up, participants will complete a series of self-report measures (see point 12.3). Participants in the waitlist control group will only be engaged in the study assessment procedures. However, they will be given the opportunity to take part in the Yoga for Eating Disorder Recovery online course that was delivered to the intervention group, once Posttest 1 has been completed by both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants included in the study sample will be people between the ages of 18 and 65, who self-identify as women, are not pregnant, are willing to sign the consent form, are English-speakers, have not taken any EBT course before, and self-identify as recovering from an eating disorder.

Exclusion Criteria:

• The study will utilize the EBT participant application for screening (see attached). Further, those excluded will be people who do not self-identify as women, who are below 18 years old or above 65, pregnant, unable/refuse to sign the consent form, non-English speakers, have taken EBT before, and who do not self-identify as recovering from an eating disorder. Further, those who have suicidal ideations and engage in self-harm behaviors cannot be included.

Related Conditions & MeSH terms

• Control
• Yoga-Based Recovery Course

Intervention

Behavioral:
• EBT yoga-based eating disorder course
Yoga for Eating Disorder Recovery online course. This course will be led by certified facilitators via Zoom and offered over the course of four weeks, comprising one two-hour session per week. The course will continue to recruit and enroll participants until sufficient power is reached for the study.

Locations

Country	Name	City	State
United States	University at Buffalo, SUNY	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Eat Breathe Thrive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced Eating Disorder Behaviors	Reduced Eating Disorder Behaviors	at 4, 12, and 24 weeks