Clinical trial NCT05725408: 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
Overall status: COMPLETED
Phase: NA
Conditions: Binge Eating
Keywords: binge eating
body image disturbance
telehealth
feasibility
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Psi Chi
name: American Psychological Foundation
name: Academy for Eating Disorders
First posted: 2023-02-13
Enrollment: 38
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in binge eating
timeFrame: 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.
measure: Feasibility of attending and engaging in a binge eating intervention.
timeFrame: 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.
measure: Satisfaction with the binge eating intervention
timeFrame: Participants will be asked questions immediately after the last session of the intervention (Week 10).
Secondary outcomes:
measure: Change in body image avoidance
timeFrame: 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).
measure: Change in appearance overvaluation
timeFrame: 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).
measure: Change in disordered eating (other than binge eating)
timeFrame: 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).
measure: Change in impulsivity
timeFrame: 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).
measure: Change in mindfulness skills
timeFrame: 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).
measure: Change in emotion regulation
timeFrame: 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).
measure: Change in distress tolerance
timeFrame: Participants will be asked to complete a measure of distress tolerance at baseline and post-intervention (during the final group session).
measure: Food insecurity
timeFrame: Participants will be asked to complete a measure of food insecurity at baseline/pre-intervention.
measure: Change in binge eating disorder status
timeFrame: 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).
Other outcomes:
Locations:
city: College Station
country: United States
facility: Texas A&M University
state: Texas
Study officials:
References: