ED Recovery Course Online RCT

NCT ID: NCT04557566

Last Updated: 2022-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-11-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Yoga-Based Recovery Course Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT- EBT Yoga-Based Course and Control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

EBT yoga-based eating disorder course

Intervention Type BEHAVIORAL

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.

Control

Wait list control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eat Breathe Thrive

UNKNOWN

Sponsor Role collaborator

University at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Catherine Cook-Cottone

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University at Buffalo, SUNY

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004821

Identifier Type: -

Identifier Source: org_study_id

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