Binge EatingNCT05725408
Comparison of a Telehealth Versus In-person Intervention for Binge Eating
A study testing Dialectical behavior therapy-informed group eating intervention protocol (telehealth) and Dialectical behavior therapy-informed group eating intervention protocol (in-person) in people with Binge Eating, run by Texas A&M University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Binge Eating
- What is being tested?
- Dialectical behavior therapy-informed group eating intervention protocol (telehealth) and Dialectical behavior therapy-informed group eating intervention protocol (in-person)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 8 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
- Active suicidal ideation within the past 2 weeks
- Has been diagnosed with an intellectual disability
- Active psychosis or experiencing psychosis symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Binge Eating
- Being tested
- Dialectical behavior therapy-informed group eating intervention protocol (telehealth), Dialectical behavior therapy-informed group eating intervention protocol (in-person)
- Keywords
- binge eating, body image disturbance, telehealth, feasibility
- Medical subject headings
- Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical behavior therapy-informed group eating intervention protocol (telehealth)Behavioural
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).
Dialectical behavior therapy-informed group eating intervention protocol (in-person)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Group | Experimental | 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. Receives: Behavioral: Dialectical behavior therapy-informed group eating intervention protocol (telehealth) |
| In-Person Group | Active comparator | 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. Receives: Behavioral: Dialectical behavior therapy-informed group eating intervention protocol (in-person) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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?"
Measured: 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
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.
Measured: Participants will be asked questions immediately after the last session of the intervention (Week 10).
Secondary outcomes (9)
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Participants will be asked to complete a measure of distress tolerance at baseline and post-intervention (during the final group session).
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.
Measured: Participants will be asked to complete a measure of food insecurity at baseline/pre-intervention.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Jan 2023
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Psi Chi, American Psychological Foundation, Academy for Eating Disorders
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725408
- Sponsor's protocol ID
- IRB2022-0163D
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Telehealth Versus In-person Intervention for Binge Eating Among Adults and Adolescents
- ClinicalTrials.gov ID
- NCT05725408
- Acronym / sponsor ID
- IRB2022-0163D
- Conditions
- Binge Eating
- Keywords
- binge eating, body image disturbance, telehealth, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Psi Chi, American Psychological Foundation, Academy for Eating Disorders
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telehealth Group | Experimental | Behavioral: Dialectical behavior therapy-informed group eating intervention protocol (telehealth)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. |
| In-Person Group | Active comparator | Behavioral: Dialectical behavior therapy-informed group eating intervention protocol (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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- Active suicidal ideation within the past 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Telehealth Group |
| 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). | Behavioural | In-Person Group |
Primary outcome
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.
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?"
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.
9 secondary outcomes
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).
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).
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).
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).
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).
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).
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).
Food insecurity
Time frame: Participants will be asked to complete a measure of food insecurity at baseline/pre-intervention.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical behavior therapy-informed group eating intervention protocol (telehealth) and Dialectical behavior therapy-informed group eating intervention protocol (in-person) in people with Binge Eating, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.