ED Recovery Course Online RCT

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

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.

Study Overview

• Status: Completed
• Conditions: Control; Yoga-Based Recovery Course
• Intervention / Treatment: Behavioral: EBT yoga-based eating disorder course

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 277
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14260
      • University at Buffalo, SUNY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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.
NO_INTERVENTION: Control; Wait list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced Eating Disorder Behaviors	Reduced Eating Disorder Behaviors	at 4, 12, and 24 weeks

Collaborators and Investigators

• Sponsor: University at Buffalo
• Collaborators: Eat Breathe Thrive

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): November 15, 2021
• Study Completion (ACTUAL): November 15, 2021

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (ACTUAL): September 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 9, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00004821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No