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Trial record 29 of 126 for:    Recruiting, Not yet recruiting, Available Studies | "Eating Disorders"

Efficacy of Eat Breathe Thrive, a Yoga-Based Program

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ClinicalTrials.gov Identifier: NCT03348345
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : June 25, 2018
Sponsor:
Collaborators:
Give Back Yoga Foundation
Eat Breathe Thrive
State University of New York at Buffalo
Information provided by (Responsible Party):
Catherine Cook-Cottone, University at Buffalo

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.

Condition or disease Intervention/treatment Phase
Eating Disorder Symptom Behavioral: Eat Breathe Thrive Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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)
Masking Description: A computer system will randomly select participants to be enrolled in the program or waitlisted at both time points.
Primary Purpose: Prevention
Official Title: Efficacy of Eat Breathe Thrive, a Yoga-Based Program
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Eat Breathe Thrive Intervention
A manualized program designed to prevent eating disorders using psychoeducation, group work, and yoga.
Behavioral: Eat Breathe Thrive
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.

No Intervention: Wait-List
Participants are placed on a wait-list receiving no intervention.



Primary Outcome Measures :
  1. Ecological Momentary Assessments (EMA's) [ Time Frame: 7 weeks ]
    These questions assess eating disorder symptoms, positive coping, and emotion regulation and are sent randomly to participants' mobile phones up to three questions per day.

  2. Integrity Scale [ Time Frame: 7 weeks ]
    Self-report measure of truth and honesty questions. Participants are asked to indicate in the past week whether it's been very difficult, difficult, neutral, easy, or very easy to be honest in the past week with self and with others (1 = very difficult, 2 = difficult, 3= neutral, 4 = easy, 5 = very easy ) and how honest they've been in the past week with themselves and others (1 = not at all honest (about 0%), 2 = a little honest (about 25% of the time), 3= somewhat honest (about 50% of the time), 4 = quite honest (about 75% of the time), 5 = extremely honest (nearly 100% of the time). Higher scores indicate better outcomes (higher levels of ability to be honest and higher frequencies of being honest).

  3. The PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 7 weeks ]
    Self-report measure of PTSD symptoms

  4. Functional Appreciation Scale (FAS) [ Time Frame: 7 weeks ]
    Self-report measure of levels of functionality appreciation. Participants are asked to indicate the extent to which they agree with statements on appreciation for the functionality of their body (strong agree, disagree, neither agree nor disagree, agree, or strongly agree). Scores on the seven FAS items are averaged, with higher scores reflecting higher levels of functionality appreciation.

  5. Body Appreciation Scale (BAS) [ Time Frame: 7 weeks ]
    Self-report scale of body appreciation. Scale assesses extent of appreciation for one's body. Responses for 10 items are on a 5-point scale (1 = Never, 5 = Always). Scoring procedure entails averaging participants' responses to Items 1-10. Higher scores indicate higher levels of body appreciation.

  6. Eating Disorder Examination Questionnaire (EDE-Q) [ Time Frame: 7 weeks ]
    Participants are to indicate on how many of the past 28 days have they engaged in eating disordered behaviors (0 = no days, 6 = every day) and to what extent have they experienced eating disordered-related cognitions and emotions (0 = not at all, 6 = markedly). It provides frequency data on key behavioral features of eating disorders in terms of number of episodes of the behavior and in some instances number of days on which the behavior has occurred. It provides subscale scores on the severity of aspects of the psychopathology of eating disorders. Subscales are Restraint, Eating Concern, Shape Concern and Weight Concern. The ratings for the relevant items are added together and the sum divided by the total number of items forming the subscales. Higher scores indicate worse outcomes.

  7. Mindful Self-Care Scale-Short (MSCS-S) [ Time Frame: 7 weeks ]
    The MSCS-S is a 33-item scale that measures the self-reported frequency of behaviors that measure self-care behavior. Subscales are positively correlated with body esteem and negative correlated with substance use and eating disordered behavior. There are six additional clinical questions and two general questions for a total of 42 items. The scale helps identify areas of strength and weakness in mindful self-care behavior and assess interventions that serve to improve self-care. The 6 domains are: physical care, supportive relationships, mindful awareness, self-compassion and purpose, mindful relaxation, and supportive structure. There are also 6 clinical items and 3 general items assessing the individual's general/global practices. Participants are asked to indicate the frequency of their self-care behavior over the past week (how much or how often on a scale of 0= never to 6-7 = regularly). The number of items in each domain are averaged. Higher scores indicate better outcome.

  8. Embodied Intimacy Scale (EIS) [ Time Frame: 7 weeks ]
    The EIS is a 10-item scale that assesses levels of embodied intimacy in relationship with self and others (i.e. body expression, body awareness, ability to communicate through the body, ability to maintain boundaries through physical touch). Range is from 0 = never to 5, always. Items 4, 5, and 6 are reversed scored. To score, items are summed and averaged by total number of items. The higher the score, the higher the level of embodied intimacy.

  9. Social Subscale of the Social and Emotional Loneliness Scale for Adults-Short (SELSA-S) [ Time Frame: 7 weeks ]
    The SELSA-S consists of 15 items assessing social and emotional loneliness. It has a 7-point Likert-type response scale ranging from 1 (strongly agree) to 7 (strongly disagree). There are three subscales: Social, Family, and Romantic. Subscale scores are computed by calculating the mean of subscale item responses. Items 2, 3, 5, 6, 8, 9, 11, 12, and 14 are reversed scored. To compute a total score, items indicated are reversed scored then a total mean is computed. High scores indicate high levels of emotional and social loneliness.

  10. Multidimensional Assessment of Interoceptive Awareness (MAIA) [ Time Frame: 7 weeks ]
    The MAIA is a 32-item self-report measure of interoceptive body awareness. It assesses 8 constructs: Noticing, Non-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting. The range is from 0 = never, to 5 = always. Summary Score = sum of subscale scores average of each subscale scores ÷ 5. Reverse-score items are 5, 6, and 7 on Not-Distracting, and items 8 and 9 on Not-Worrying. The higher the score, the higher the levels of interoceptive body awareness.

  11. Mindful Eating Questionnaire (MEQ) [ Time Frame: 7 weeks ]
    Self-report measure of mindful eating

  12. Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 7 weeks ]
    DERS is a 36-item multidimensional assessment of emotion regulation and dysregulation. Total score is the sum of all subscales. The measure yields a total score as well as scores on six sub-scales: Nonacceptance of emotional responses, Difficulty engaging in Goal-directed behavior, Impulse control difficulties, Lack of emotional awareness, Limited access to emotion regulation strategies, and Lack of emotional clarity. Range is from 0 = never to 5 = always. Higher scores suggest greater problems with emotion regulation.

  13. Distress Tolerance Scale (DTS) [ Time Frame: 7 weeks ]
    DTS is a 15-item assessment of beliefs about feelings of distress. Range is from 1 = strongly agree to 5 = disagree. Item 6 is reverse scored. Subscale scores are the mean of the items. The higher-order DTS is formed from the mean of the four subscales. The higher the score, the more positive the outcome.

  14. Substance Abuse subscale of College Counseling Assessment of Psychological Symptoms (CCAPS) [ Time Frame: 7 weeks ]
    Self-report measure of substance abuse. Range is from "never used" to "used 30-60 days in the past 60 days" to assess alcohol and substance use and on the item concerning drinking, three or fewer to seven or more drinks. The higher the score, the more negative the outcome.

  15. Self-Compassion Scale-Short (SCS-S) [ Time Frame: 7 weeks ]
    The SCS-S scale assesses levels of self-compassion. Range is from 1 = almost never to 5 = almost always. Subscale scores are computed by calculating the mean of subscale item responses. To compute a total self-compassion score, reverse score the negative subscale items - self-judgment, isolation, and over-identification (i.e., 1 = 5, 2 = 4, 3 = 3, 4 = 2, 5 = 1) - then compute a total mean. The higher the score, the higher the level of self-compassion.

  16. Demographic information [ Time Frame: 7 weeks ]
    Questions on demographic information

  17. State-Trait Anxiety Inventory for Adults [ Time Frame: 7 weeks ]
    Self-report measure of anxiety symptoms

  18. Beck's Depression Inventory [ Time Frame: 7 weeks ]
    A self-report measure of depression symptoms

  19. Treatment Integrity [ Time Frame: 7 weeks ]
    A weekly assessment of treatment integrity

  20. Pre-Post Class Questions [ Time Frame: 7 weeks ]
    A weekly assessment of stress, relaxation and embodiment

  21. EBT Program Acceptability and Feasibility Questions [ Time Frame: 7 weeks ]
    Post-test assessment of participants' perceptions of acceptability and feasibility of the EBT program


Secondary Outcome Measures :
  1. Program Questions for Post-Test and Follow Up [ Time Frame: 7 weeks ]
    Post-test assessment of other mind-body activities engaged in during time of study

  2. Brief COPE Inventory [ Time Frame: 7 weeks ]
    Description of coping mechanisms during stressful events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348345


Contacts
Contact: Catherine Cook-Cottone, PhD 716-645-1128 cpcook@buffalo.edu
Contact: Esther E Estey, MA 716-645-1128 estherebtstudy@gmail.com

Locations
United States, New York
University at Buffalo Recruiting
Buffalo, New York, United States, 14260
Contact: Esther E. Estey, MA    716-645-1128    estherebtstudy@gmail.com   
Sponsors and Collaborators
University at Buffalo
Give Back Yoga Foundation
Eat Breathe Thrive
State University of New York at Buffalo
Investigators
Principal Investigator: Catherine Cook-Cottone, PhD University at Buffalo

Publications:
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.
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.

Responsible Party: Catherine Cook-Cottone, Principal Investigator, University at Buffalo
ClinicalTrials.gov Identifier: NCT03348345     History of Changes
Other Study ID Numbers: EBTC01
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing is not included in the IRB.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Catherine Cook-Cottone, University at Buffalo:
eating disorders
prevention
yoga
mindfulness
embodiment
self-regulation
functional action
interoceptive awareness

Additional relevant MeSH terms:
Feeding and Eating Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action