Efficacy of Eat Breathe Thrive, a Yoga-Based Program

Background: Eating disorders appear predominantly in three types; Anorexia Nervosa [AN].
Bulimia Nervosa [BN], and Binge Eating Disorder [BED]. All three are complex, dangerous
mental disorders which deeply affect the quality of life and well-being of the person
struggling with it. Eating disorders often sprout from difficulty regulating oneself, and
presents as a disturbance of both body image, eating behaviors, and relationship to
themselves and others. Since these disorders cause deep disruption between the body and the
mind of the person affected, it is imperative that a mind-body approach be taken into
consideration for both prevention and treatment options. Likewise, interpersonal
relationships are known to suffer as a result of eating disorder symptomatology, and as such,
increasing positive social interaction and closeness through community building can act as a
support for those affected by this illness. Combining a focus of oneself within support
system is one way eating disorders can be healed and even prevented. Since eating disorders
are lethal illnesses, prevention of development should be investigated. With a focus on self
and body acceptance, community support, and psychoeducation into eating disorders and
possible causes, prevention methods can flourish. The Eat Breathe Thrive program has been
utilized in communities, eating disorder clinics, and school systems with positive expressed
outcomes. Participants in these populations have reported benefits of feeling more empowered,
more connected to themselves and others, and more aware of their body's responses to media's
attempts at conveying cultural beauty standards. Eat Breathe Thrive aims to accomplish these
benefits through community building within a group atmosphere, as well as through yoga, which
has been used in the past as an eating disorder prevention and recovery tool via the
mind-body connection. By incorporating mind-body practices such as yoga into a program that
emphasizes community, self-acceptance, and cultural influence awareness, Eat Breathe Thrive
is able to lower eating disorder risk among many populations. From engaging with others and
developing a strong investment in themselves, the individuals are then able to sustain proper
health, relationships, and overall well-being.

The study will utilize self-report surveys to examine the preventative effects of
participation in EBT, a 7-week course, utilizing a randomized-controlled trial (RCT) with a
community sample of adult (18-65 years old) men and women.

It is hypothesized that: 1) intervention groups will show a decrease in eating disorder
symptoms when compared to controls, 2) intervention groups will show increased in self-care
behaviors compared to controls, 3) intervention groups will show an increase in measures of
embodied intimacy and a decrease in social and emotional intimacy when compared to controls,
4) intervention groups will show an increase in interoceptive awareness and mindful eating
when compared to controls, 5) intervention groups will show a decrease in difficulties with
emotion regulation and an increase in distress tolerance when compared to controls, 6)
intervention groups will show an increase in their overall mental health functioning, 7)
those who are enrolled in two consecutive EBT groups will show better maintenance of
increased wellbeing as well as better maintenance in decreased symptomatology as compared to
those who took the intervention only one time.

Data will be collected from ten sites around the United States and the United Kingdom where
certified Eat Breathe Thrive community facilitators teach the program. Since each group is
ran by two facilitators, each group will be recruiting twenty individuals (ten per
facilitator) from the community for their respective program for a total of 200 participants.
According to calculations of a power analysis, a minimum sample size of 114 participants is
required. Given that the average number of participants enrolled in EBT groups is 10-20,
investigators believe the sample size of 200 to be attainable across the 10 sites. Each EBT
facilitator will recruit at a rate of ten or more participants, resulting in twenty to thirty
per group so that each group has at least twenty participants after they are randomized.
These participants will be screened by research assistant and doctoral student Esther Estey,
to ensure they meet the inclusion criteria and have been deemed eligible to participate in
the EBT program by EBT facilitators.

Setting: The facilities in which research will be conducted include the University at
Buffalo, yoga studios, and community centers. All locations will be private and confidential.

Data Collection:

- Participants will be assessed at pre-post, and at three month follow up

- Participants will be assessed daily through a phone app for Ecological Momentary
Assessments (EMAs)

- Facilitators will complete a Treatment Integrity Check and submit attendance online once
per week to maintain adherence to treatment and program protocols and standards. The
treatment integrity check will be scored yes or no for a total score for the group.

Data Management and Statistical Analysis: Investigators will use a pretest-posttest
randomized control group design. Only quantitative data will be provided for analysis.
Specifically, responses on assessment measures, completed at pre- and post-test will be
analyzed using a statistical analysis program such as SPSS. All data collected from the
online surveys will be screened, checked for outliers, missing data, and other issues.
Appropriate techniques will be used for missing data depending on the patterns and frequency
(e.g. multiple imputation). Descriptive statistics will be calculated to determine the
transfer of Eat Breathe Thrive curriculum concepts from the course into the lives of the
participants. An analysis of variance will help in determining whether the Eat Breathe Thrive
program had improved outcome results compared to the controlled group at the end of the
program and 3 months following program completion.

Quality Assurance: The lead investigator will provide updated copies of all forms (IRB
approval, consent forms, protocol, and HIPPA authorization) to each site. There will be
weekly contact with each site in order to maintain consistency and support throughout the
duration of the study. These check-ins will be done by the lead investigator herself, or two
of the Master's level research assistants. All facilitators of groups will complete weekly
integrity measures online after every EBT session via email link sent out by research
assistant in order to maintain compliance to study protocol. Facilitators will be available
for bi-weekly individual phone meetings as well as bi-weekly online group conference calls
(through Zoom, which is HIPAA compliant, or other HIPAA compliant web formats). Other forms
of bi-weekly communication may include email, text, or other technological means.

Plan to Address Missing Data: Quantitative data (pre and post) will be collected using an
online data management software (e.g., SelectSurvey.Net). Access to the researchers' account
is secure with a password shared only by lead study researchers. Data will be screened for
outliers, suspect patters, or any anomalies in the data set. Dr. Guyker will oversee this and
research members will use appropriate techniques to correct and/or work with missing data
(e.g. multiple imputation).

Provisions to Monitor Data and Ensure Safety of Subjects: Any evidence that a participant may
be at imminent risk (e.g., suicidality, self-harm), whether expressed during the program or
upon completing measures, will be immediately addressed by the group facilitators and/or
researchers. Specific to facilitators, participants exhibiting these behaviors will be
referred, by a their facilitator, to a local treatment provider according to EBT protocol and
dismissed from the EBT program as well as discontinued from the study as to protect from
further harm. Facilitators will abide by EBT protocol for ensuring safety of participants and
withdrawing participants who pose risk to the group. Investigators will survey the data the
week after data collection at each assessment point (pretest, posttest 1, posttest 2, and
follow-up. If investigators notice any patterns where it might be indicative of the
participant needing extra support, investigators will notify the appropriate facilitator to
do a referral. The PI and doctoral student Esther Estey will meet and evaluate the data set,
watching for trends that are concerning. Although investigators will not be assessing for
suicidality and danger to others, investigators will report to facilitators if they notice
any general trends that suggest that a participant might need support. The facilitator will
then follow up with the participant and provide a referral as indicated.

Inclusion Criteria:

- Those included will be men and women between the ages of 18 and 65 who are not
pregnant, are willing to sign the consent form, are English-speakers, have not taken
EBT before, and have been deemed eligible to participate in the EBT program by EBT
facilitators.

Exclusion Criteria:

- Since the scope of this study is adult, non-pregnant English-speaking adults, those
excluded will be men and 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 whom have been deemed ineligible to participate in the EBT program by EBT
facilitators.