NCT04557566

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
277

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

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

September 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

September 15, 2020

Last Update Submit

March 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduced Eating Disorder Behaviors

    Reduced Eating Disorder Behaviors

    at 4, 12, and 24 weeks

Study Arms (2)

EBT yoga-based eating disorder course

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Wait list control

Interventions

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.

EBT yoga-based eating disorder course

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIdentify as female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo, SUNY

Buffalo, New York, 14260, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: RCT- EBT Yoga-Based Course and Control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 21, 2020

Study Start

January 1, 2021

Primary Completion

November 15, 2021

Study Completion

November 15, 2021

Last Updated

March 25, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations