Clinical trial NCT03348345: Efficacy of Eat Breathe Thrive, a Yoga-Based Program
Official title: Efficacy of Eat Breathe Thrive, a Yoga-Based Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder Symptom
Keywords: eating disorders
prevention
yoga
mindfulness
embodiment
self-regulation
functional action
interoceptive awareness
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: Give Back Yoga Foundation
name: Eat Breathe Thrive
name: State University of New York at Buffalo
First posted: 2017-11-20
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ecological Momentary Assessments (EMA's)
timeFrame: 7 weeks
measure: Integrity Scale
timeFrame: 7 weeks
measure: The PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 7 weeks
measure: Functional Appreciation Scale (FAS)
timeFrame: 7 weeks
measure: Body Appreciation Scale (BAS)
timeFrame: 7 weeks
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: 7 weeks
measure: Mindful Self-Care Scale-Short (MSCS-S)
timeFrame: 7 weeks
measure: Embodied Intimacy Scale (EIS)
timeFrame: 7 weeks
measure: Social Subscale of the Social and Emotional Loneliness Scale for Adults-Short (SELSA-S)
timeFrame: 7 weeks
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: 7 weeks
measure: Mindful Eating Questionnaire (MEQ)
timeFrame: 7 weeks
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 7 weeks
measure: Distress Tolerance Scale (DTS)
timeFrame: 7 weeks
measure: Substance Abuse subscale of College Counseling Assessment of Psychological Symptoms (CCAPS)
timeFrame: 7 weeks
measure: Self-Compassion Scale-Short (SCS-S)
timeFrame: 7 weeks
measure: Demographic information
timeFrame: 7 weeks
measure: State-Trait Anxiety Inventory for Adults
timeFrame: 7 weeks
measure: Beck's Depression Inventory
timeFrame: 7 weeks
measure: Treatment Integrity
timeFrame: 7 weeks
measure: Pre-Post Class Questions
timeFrame: 7 weeks
measure: EBT Program Acceptability and Feasibility Questions
timeFrame: 7 weeks
Secondary outcomes:
measure: Program Questions for Post-Test and Follow Up
timeFrame: 7 weeks
measure: Brief COPE Inventory
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Catherine Cook-Cottone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cook-Cottone, C. P. (2006). The attuned representational model for the primary prevention of eating disorders: An overview for school psychologists. Psychology in the Schools, 43, 223-230.
citation: Cook-Cottone CP. Incorporating positive body image into the treatment of eating disorders: A model for attunement and mindful self-care. Body Image. 2015 Jun;14:158-67. doi: 10.1016/j.bodyim.2015.03.004. Epub 2015 Apr 15.
citation: Cook-Cottone, C. P., Tribole, E., & Tylka, T. (2013). Healthy eating in schools: Evidenced-based interventions to help kids thrive. Washington, DC: American Psychological Association.
citation: McIntosh VV, Bulik CM, McKenzie JM, Luty SE, Jordan J. Interpersonal psychotherapy for anorexia nervosa. Int J Eat Disord. 2000 Mar;27(2):125-39. doi: 10.1002/(sici)1098-108x(200003)27:23.0.co;2-4.