Back to resultsComparison of a Telehealth Versus In-person Intervention for Binge Eating
Primary Purpose
Binge Eating
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialectical behavior therapy-informed group eating intervention protocol (telehealth)
Dialectical behavior therapy-informed group eating intervention protocol (in-person)
Sponsored by
About this trial
This is an interventional treatment trial for Binge Eating focused on measuring binge eating, body image disturbance, telehealth, feasibility
Eligibility Criteria
Inclusion Criteria for Adolescent Group: Adolescent in high school (ages ~13-18) Participant and their caregiver must be able to understand and speak English Has access to a computer device or tablet with a microphone and web camera Has access to a reliable internet connection and a private, quiet place to complete sessions Willing or able to secure transportation to the Texas A&M University campus if selected for the in-person group Engages in loss-of-control eating AND eating within a 2-hour period what most people would consider an unusually large amount of food given the circumstances Exclusion Criteria for Adolescent Group: Active suicidal ideation within the past 2 weeks Has been diagnosed with an intellectual disability Active psychosis or experiencing psychosis symptoms Caregiver is not able to participate Inclusion for Adult Group: Age 18+ Speaks and understands English Has access to a computer device or tablet with a microphone and web camera Has access to a reliable internet connection and a private, quiet place to complete sessions Willing or able to secure transportation to the Texas A&M University campus if selected for the in-person group Engages in loss-of-control eating AND eating within a 2-hour period what most people would consider an unusually large amount of food given the circumstances Exclusion Criteria for Adult Group: Active suicidal ideation within the past 2 weeks Has been diagnosed with an intellectual disability Active psychosis or experiencing psychosis symptoms
Sites / Locations
- Texas A&M UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telehealth Group
In-Person Group
Arm Description
Participants will be randomized to the telehealth group where they will attend weekly group intervention sessions online through the Zoom platform. Participants will be emailed or mailed materials for session since they will not be attending in-person. Participants will not be asked to attend any sessions or portions of the study in-person.
Participants will be randomized to the in-person group where they will attend weekly group intervention sessions at a building on the Texas A&M University campus. Participants will be emailed or provided session materials when they arrive for sessions. After the first session, they will not be attending any online sessions.
Outcomes
Primary Outcome Measures
Change in binge eating
Episodes and frequency of binge eating and binge eating behaviors via the Eating Disorder Examination Questionnaire. Two items from this scale will be used to assess for the number of episodes and frequency of binge eating. Participants are asked to respond with numeric values to these items according to their subjective view (e.g., may write "8" to to represent eight episodes of binge eating over the past 28 days). Partcipants provide a numeric response from 0+ (no maximum number). Higher scores indicate more episodes of binge eating.
Feasibility of attending and engaging in a binge eating intervention.
Participants will be asked open-ended questions in an interview format about the feasibility of attending and engaging in a binge eating intervention (telehealth or in-person). For example, one of the items asks, "Were there too many sessions or just enough?"
Satisfaction with the binge eating intervention
Participants will be asked nine questions developed by the author and collaborators about how acceptable they found the intervention (telehealth or in-person) to be (e.g., "I would recommend this program to a friend or family member who has difficulty with binge eating"). Six of the questions can be answered with either "Yes", "No", or "Don't know." The remaining three items are open-ended.
Secondary Outcome Measures
Change in body image avoidance
Engagement in body image avoidance behaviors (e.g., actively refraining from looking in the mirror) assessed via the Body Image Avoidance Questionnaire. Participants can respond according to a Likert scale of 1 (Rarely or Never) through 5 (Always). The total score can range from 0 to 95. Higher scores indicate greater body image avoidance.
Change in appearance overvaluation
The extent to which participants place large value on their appearance assessed via the Beliefs About Appearance Scale. Participants can respond according to a Likert scale of 0 (Not at all) to 4 (Extremely). Higher scores indicate greater appearance overvaluation.
Change in disordered eating (other than binge eating)
Engagement in behaviors representative of disordered eating (e.g., restriction of diet, excessive exercise, etc.) assessed via the Eating Disorder Examination Questionnaire. Most of the questions are answered by responding to a 7-point Likert scale ranging from 0 (No days) to 6 (Every day). Other items require a response in a numeric value provided by the participant (e.g., "6" for "6 days"). Other items require a response using a 7-point Likert scale ranging from 1 (Not at all) to 6 (Markedly). Participants who identify as "female" are also asked an additional question where they can either mark "yes" or "no." In all cases, positive or higher scores indicate greater engagement in disordered eating.
Change in impulsivity
Engagement in impulsive behaviors (e.g., sensation-seeking) assessed via the UPPS-P Impulsive Behavior Scale (UPPS-P = urgency, premeditation, perseverance, sensation seeking, and positive urgency...it is not usually spelled out). Participants are asked to respond using a 4-point Likert scale ranging from 0 (Agree strongly) to 3 (Disagree strongly). Higher scores indicate higher levels of impulsivity.
Change in mindfulness skills
Current engagement in mindful activities or practices assessed via the Kentucky Inventory of Mindfulness Skills. Participants are asked to respond using a 5-point Likert scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true). Higher scores indicate more, or greater, use of mindfulness skills.
Change in emotion regulation
Ability to regulate or suppress emotions or engage in cognitive reappraisal are assessed via the Emotion Regulation Questionnaire (ERQ). Participants are asked to respond according to a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater use of cognitive reappraisal and emotional suppression.
Change in distress tolerance
Ability to tolerate distress assessed via the Distress Tolerance Scale (DTS). Participants are asked to respond according to a 5-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores indicate greater, or higher, distress tolerance.
Food insecurity
Level of food insecurity assessed via the United States Household Food Security Survey Module: Six-item Short Form. Items are multiple choice (e.g., "often true", "sometimes true", "never true", or "don't know or refuse to answer"). Scores are coded and then scored such that higher scores indicate greater, or higher, food insecurity. Scores can range from 0 to 6.
Change in binge eating disorder status
The Questionnaire on Weight and Eating Patterns, Revised, Diagnostic and Statistical Manual of Mental Disorders Version 5 (QEWP-5) will be used to assess and diagnose individuals with binge eating disorder. Items are assessed using multiple choice and open-ended questions. Scores are summed together to determine whether the criteria for binge eating disorder are met.
Full Information
NCT ID
NCT05725408
First Posted
January 18, 2023
Last Updated
July 24, 2023
Sponsor
Texas A&M University
Collaborators
Psi Chi, American Psychological Foundation, Academy for Eating Disorders
1. Study Identification
Unique Protocol Identification Number
NCT05725408
Brief Title
Comparison of a Telehealth Versus In-person Intervention for Binge Eating
Official Title
Comparison of a Telehealth Versus In-person Intervention for Binge Eating Among Adults and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas A&M University
Collaborators
Psi Chi, American Psychological Foundation, Academy for Eating Disorders
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adults and adolescents will be asked to participate in a 10-week intervention to better understand their emotions and improve their relationship with food.
Detailed Description
Adults and adolescents will be asked to participate in a 10-week eating intervention to better understand and manage their emotions and improve their relationship with food. Participants will fill out questionnaires related to their engagement in body avoidance behaviors and disordered eating, and assess their self-reported levels of impulsivity, food insecurity, mindfulness skills, emotion regulation skills, and distress tolerance skills. Participants will also be asked questions to assess the feasibility and acceptability of the telehealth format.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating
Keywords
binge eating, body image disturbance, telehealth, feasibility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to either an in-person group or a telehealth group. Both will receive the same intervention but using different formats for delivery.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telehealth Group
Arm Type
Experimental
Arm Description
Participants will be randomized to the telehealth group where they will attend weekly group intervention sessions online through the Zoom platform. Participants will be emailed or mailed materials for session since they will not be attending in-person. Participants will not be asked to attend any sessions or portions of the study in-person.
Arm Title
In-Person Group
Arm Type
Active Comparator
Arm Description
Participants will be randomized to the in-person group where they will attend weekly group intervention sessions at a building on the Texas A&M University campus. Participants will be emailed or provided session materials when they arrive for sessions. After the first session, they will not be attending any online sessions.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical behavior therapy-informed group eating intervention protocol (telehealth)
Intervention Description
A 10-week, skills-based group eating intervention. Online/telehealth meetings will last approximately 1 hour each session, besides the first session (1.5 hours, orientation and assessments) and the final session (approx. 2-2.5 hours, session plus final assessments and exit interview).
Intervention Type
Behavioral
Intervention Name(s)
Dialectical behavior therapy-informed group eating intervention protocol (in-person)
Intervention Description
A 10-week, skills-based group eating intervention. In-person meetings will last approximately 1 hour each session, besides the first session (1.5 hours, orientation and assessments, online) and the final session (approx. 2-2.5 hours, session plus final assessments and exit interview).
Primary Outcome Measure Information:
Title
Change in binge eating
Description
Episodes and frequency of binge eating and binge eating behaviors via the Eating Disorder Examination Questionnaire. Two items from this scale will be used to assess for the number of episodes and frequency of binge eating. Participants are asked to respond with numeric values to these items according to their subjective view (e.g., may write "8" to to represent eight episodes of binge eating over the past 28 days). Partcipants provide a numeric response from 0+ (no maximum number). Higher scores indicate more episodes of binge eating.
Time Frame
Participants will be asked to complete a measure of binge eating at baseline and immediately after the last session of the intervention (Week 10) to assess change in binge eating behaviors.
Title
Feasibility of attending and engaging in a binge eating intervention.
Description
Participants will be asked open-ended questions in an interview format about the feasibility of attending and engaging in a binge eating intervention (telehealth or in-person). For example, one of the items asks, "Were there too many sessions or just enough?"
Time Frame
Participants will be asked these questions via a brief exit interview immediately after the last session of the intervention (Week 10) to assess intervention feasibility.
Title
Satisfaction with the binge eating intervention
Description
Participants will be asked nine questions developed by the author and collaborators about how acceptable they found the intervention (telehealth or in-person) to be (e.g., "I would recommend this program to a friend or family member who has difficulty with binge eating"). Six of the questions can be answered with either "Yes", "No", or "Don't know." The remaining three items are open-ended.
Time Frame
Participants will be asked questions immediately after the last session of the intervention (Week 10).
Secondary Outcome Measure Information:
Title
Change in body image avoidance
Description
Engagement in body image avoidance behaviors (e.g., actively refraining from looking in the mirror) assessed via the Body Image Avoidance Questionnaire. Participants can respond according to a Likert scale of 1 (Rarely or Never) through 5 (Always). The total score can range from 0 to 95. Higher scores indicate greater body image avoidance.
Time Frame
Participants will be asked to complete the Body Image Avoidance Questionnaire weekly to assess changes in body image avoidance throughout the intervention (at baseline/pre-intervention and every week at the beginning of the session, weeks 2-10).
Title
Change in appearance overvaluation
Description
The extent to which participants place large value on their appearance assessed via the Beliefs About Appearance Scale. Participants can respond according to a Likert scale of 0 (Not at all) to 4 (Extremely). Higher scores indicate greater appearance overvaluation.
Time Frame
Participants will be asked to complete the Beliefs About Appearance Scale weekly to assess change in appearance overvaluation throughout the intervention (at baseline and every week at the beginning of the session, weeks 2-10).
Title
Change in disordered eating (other than binge eating)
Description
Engagement in behaviors representative of disordered eating (e.g., restriction of diet, excessive exercise, etc.) assessed via the Eating Disorder Examination Questionnaire. Most of the questions are answered by responding to a 7-point Likert scale ranging from 0 (No days) to 6 (Every day). Other items require a response in a numeric value provided by the participant (e.g., "6" for "6 days"). Other items require a response using a 7-point Likert scale ranging from 1 (Not at all) to 6 (Markedly). Participants who identify as "female" are also asked an additional question where they can either mark "yes" or "no." In all cases, positive or higher scores indicate greater engagement in disordered eating.
Time Frame
Participants will be asked to complete a measure of disordered eating at baseline/pre-intervention and immediately after the final session of the intervention (Week 10).
Title
Change in impulsivity
Description
Engagement in impulsive behaviors (e.g., sensation-seeking) assessed via the UPPS-P Impulsive Behavior Scale (UPPS-P = urgency, premeditation, perseverance, sensation seeking, and positive urgency...it is not usually spelled out). Participants are asked to respond using a 4-point Likert scale ranging from 0 (Agree strongly) to 3 (Disagree strongly). Higher scores indicate higher levels of impulsivity.
Time Frame
Participants will be asked to complete a measure of impulsivity at baseline/pre-intervention and immediately after the final session of the intervention (Week 10).
Title
Change in mindfulness skills
Description
Current engagement in mindful activities or practices assessed via the Kentucky Inventory of Mindfulness Skills. Participants are asked to respond using a 5-point Likert scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true). Higher scores indicate more, or greater, use of mindfulness skills.
Time Frame
Participants will be asked to complete a measure of mindfulness at baseline/pre-intervention and immediately after the final session of the intervention (Week 10).
Title
Change in emotion regulation
Description
Ability to regulate or suppress emotions or engage in cognitive reappraisal are assessed via the Emotion Regulation Questionnaire (ERQ). Participants are asked to respond according to a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater use of cognitive reappraisal and emotional suppression.
Time Frame
Participants will be asked to complete a measure of emotion regulation at baseline/pre-intervention and immediately after the final session of the intervention (Week 10).
Title
Change in distress tolerance
Description
Ability to tolerate distress assessed via the Distress Tolerance Scale (DTS). Participants are asked to respond according to a 5-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores indicate greater, or higher, distress tolerance.
Time Frame
Participants will be asked to complete a measure of distress tolerance at baseline and post-intervention (during the final group session).
Title
Food insecurity
Description
Level of food insecurity assessed via the United States Household Food Security Survey Module: Six-item Short Form. Items are multiple choice (e.g., "often true", "sometimes true", "never true", or "don't know or refuse to answer"). Scores are coded and then scored such that higher scores indicate greater, or higher, food insecurity. Scores can range from 0 to 6.
Time Frame
Participants will be asked to complete a measure of food insecurity at baseline/pre-intervention.
Title
Change in binge eating disorder status
Description
The Questionnaire on Weight and Eating Patterns, Revised, Diagnostic and Statistical Manual of Mental Disorders Version 5 (QEWP-5) will be used to assess and diagnose individuals with binge eating disorder. Items are assessed using multiple choice and open-ended questions. Scores are summed together to determine whether the criteria for binge eating disorder are met.
Time Frame
Participants will be asked to complete a diagnostic measure of binge eating disorder at baseline/pre-intervention and immediately after the final session of the intervention (Week 10).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Adolescent Group:
Adolescent in high school (ages ~13-18)
Participant and their caregiver must be able to understand and speak English
Has access to a computer device or tablet with a microphone and web camera
Has access to a reliable internet connection and a private, quiet place to complete sessions
Willing or able to secure transportation to the Texas A&M University campus if selected for the in-person group
Engages in loss-of-control eating AND eating within a 2-hour period what most people would consider an unusually large amount of food given the circumstances
Exclusion Criteria for Adolescent Group:
Active suicidal ideation within the past 2 weeks
Has been diagnosed with an intellectual disability
Active psychosis or experiencing psychosis symptoms
Caregiver is not able to participate
Inclusion for Adult Group:
Age 18+
Speaks and understands English
Has access to a computer device or tablet with a microphone and web camera
Has access to a reliable internet connection and a private, quiet place to complete sessions
Willing or able to secure transportation to the Texas A&M University campus if selected for the in-person group
Engages in loss-of-control eating AND eating within a 2-hour period what most people would consider an unusually large amount of food given the circumstances
Exclusion Criteria for Adult Group:
Active suicidal ideation within the past 2 weeks
Has been diagnosed with an intellectual disability
Active psychosis or experiencing psychosis symptoms
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Schueler, M.S.
Phone
979-845-6152
Email
jschueler1@tamu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sherecce Fields, PhD
Phone
979-845-3774
Email
safields@tamu.edu
Facility Information:
Facility Name
Texas A&M University
City
College Station
State/Province
Texas
ZIP/Postal Code
77843
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherecce Fields, PhD
Phone
979-845-3774
Email
safields@tamu.edu
First Name & Middle Initial & Last Name & Degree
Carly McCord, PhD
First Name & Middle Initial & Last Name & Degree
Robyn Douglas, M.S.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of a Telehealth Versus In-person Intervention for Binge Eating
We'll reach out to this number within 24 hrs