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

NCT05725408 | Completed

• 1 other identifier: IRB2022-0163D
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating

Keywords

binge eating; body image disturbance; telehealth; feasibility

Outcome Measures

Primary Outcomes (3)

• 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.

  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?"

  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.

  Participants will be asked questions immediately after the last session of the intervention (Week 10).

Secondary Outcomes (9)

• Change in 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

  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)

  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

  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

  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).

Study Arms (2)

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.

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.

Behavioral: Dialectical behavior therapy-informed group eating intervention protocol (in-person)

Interventions

Dialectical behavior therapy-informed group eating intervention protocol (telehealth) BEHAVIORAL

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).

Telehealth Group

Dialectical behavior therapy-informed group eating intervention protocol (in-person) BEHAVIORAL

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).

In-Person Group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Active suicidal ideation within the past 2 weeks
• Has been diagnosed with an intellectual disability
• Active psychosis or experiencing psychosis symptoms

Sponsors & Collaborators

• Texas A&M University: lead
• Psi Chi: collaborator
• American Psychological Foundation: collaborator
• Academy for Eating Disorders: collaborator

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

MeSH Terms

Conditions

Bulimia

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 13, 2023
• Study Start: January 1, 2023
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)