Efficacy of Eat Breathe Thrive, a Yoga-Based Program
Condition: Eating Disorder Symptom
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of the 7-week Eat Breathe Thrive (EBT)
      program which was designed to increase positive body image, awareness, self-regulation, and
      mindful eating habits. This program aims to achieve these things through psychoeducation of
      cultural influences of beauty standards, the basic neuropsychological systems in the body and
      how they affect eating habits, creating a community within the group members for support, and
      finally through the practice of yoga. In this randomized-controlled trial (RCT),
      investigators will be looking at whether EBT is effective in a community sample of adult
      (18-65 years old) men and women at preventing and decreasing eating disorder risk and
      increasing positive body image and emotion regulation skills through being in tune with one's
      own body, mind, and community. This will take place in a sample of community members taken at
      ten different sites around the United States and the United Kingdom.
    

Detailed description: 
      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.
    

Intervention name(s): Eat Breathe Thrive
Intervention type(s): Behavioral
Intervention description(s): Eat Breathe Thrive (EBT) program which was designed to increase positive body image, awareness, self-regulation, and mindful eating habits. This program aims to achieve these things through psychoeducation of cultural influences of beauty standards, the basic neuropsychological systems in the body and how they affect eating habits, creating a community within the group members for support, and finally through the practice of yoga.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A computer system will randomly select 100 participants (from 200) to be enrolled in the Eat Breathe Thrive (EBT) intervention group (once a week for two hours) and the other 100 will be wait-listed (WL) for seven weeks. Assessments will be done at week 1 and week 7. At week 7, WL will be enrolled in the 7-week Eat Breathe Thrive program. A second post-test will be given at the end of the second round of Eat Breathe Thrive, administered to those 100 participants only. There will also be three month follow up for all 200 participants.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: eating disorders; prevention; yoga; mindfulness; embodiment; self-regulation; functional action; interoceptive awareness