Comparison of a Telehealth Versus In-person Intervention for Binge Eating

December 8, 2023 updated by: Texas A&M University

Comparison of a Telehealth Versus In-person Intervention for Binge Eating Among Adults and Adolescents

Adults and adolescents will be asked to participate in a 10-week intervention to better understand their emotions and improve their relationship with food.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • College Station, Texas, United States, 77843
        • Texas A&M University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telehealth Group
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.
Behavioral: Dialectical behavior therapy-informed group eating intervention protocol (telehealth)
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).
Active Comparator: In-Person Group
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.
Behavioral: Dialectical behavior therapy-informed group eating intervention protocol (in-person)
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of attending and engaging in a binge eating intervention.
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.
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?"
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.
Satisfaction with the binge eating intervention
Time Frame: Participants will be asked questions immediately after the last session of the intervention (Week 10).
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.
Participants will be asked questions immediately after the last session of the intervention (Week 10).
Change in 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.
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.
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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in 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).
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.
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).
Change in 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).
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.
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).
Change in disordered eating (other than binge 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).
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.
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).
Change in 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).
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.
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).
Change in 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).
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.
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).
Change in emotion regulation
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).
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.
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).
Change in 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).
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.
Participants will be asked to complete a measure of distress tolerance at baseline and post-intervention (during the final group session).
Change in binge eating disorder status
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).
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.
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).
Food insecurity
Time Frame: Participants will be asked to complete a measure of food insecurity at baseline/pre-intervention.
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.
Participants will be asked to complete a measure of food insecurity at baseline/pre-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas A&M University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Psychological Foundation
Psi Chi
Academy for Eating Disorders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2022-0163D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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