Binge EatingNCT06683456
EMOTE: a Smartphone Application for Binge Eating Based on DBT Skills
A study testing eMOTE in people with Binge Eating, run by Universidade do Porto at 1 site in Portugal.
Trial summary
Binge eating, whether formally diagnosed or occurring at subthreshold levels, is associated with adverse health consequences and decreased quality of life. Access to accessible, cost-effective interventions that effectively address binge eating episodes is critical for individuals with this condition, and smartphone… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Binge Eating
- What is being tested?
- eMOTE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female;
- aged 18 years or older;
- self-report at least one binge eating episode over the past four weeks;
- owned a smartphone;
- fluent in Portuguese.
Who cannot join
- attending psychotherapy (face-to-face or digital) or another clinical trial;
- body mass index below 18.5;
- self-report an average of eight or more episodes of binge eating or inappropriate compensatory behaviours per week;
- being pregnant;
- self-report bipolar disorder, psychotic disorder, substance abuse, suicidal ideation or borderline personality disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Psychology and Educational and Education Sciences
Porto, Porto District, 4200-135
Telma Cruz, MSc, 226079700 ext. 393, up202001408@edu.fpce.up.pt
Mariana Martins, PhD, 226079700 ext. 393, mmartins@fpce.up.pt
About this study
Official title: EMOTE: a Smartphone Application for Binge Eating Based on DBT Skills: a Randomized Controlled Trial
Binge eating, whether formally diagnosed or occurring at subthreshold levels, is associated with adverse health consequences and decreased quality of life.
Access to accessible, cost-effective interventions that effectively address binge eating episodes is critical for individuals with this condition, and smartphone applications have demonstrated promise in treating binge eating and related disorders.
This study aims to evaluate the efficacy of eMOTE, a novel smartphone application for binge eating based on Dialectical Behavior Therapy (DBT) skills. For this purpose, a randomized controlled trial will be conducted in which women who self-report binge eating episodes will be randomly assigned to the app intervention group or a waiting list group.
Read the detailed description
eMOTE is a self-help application for women struggling with binge eating episodes. The application was developed based on DBT skills and has four modules: psychoeducation, mindfulness skills, emotion regulation skills, and distress tolerance skills. Additionally, it includes two self-monitoring diaries that allow the input of data related to food, behaviors, feelings, and exercises. The application content will be delivered through text, audios, and videos.
For this study, adult individuals with binge eating episodes who are fluent in Portuguese and own a smartphone will be recruited. The recruitment will be conducted through social media, the University of Porto, and other relevant institutions.
Participants who enrol in eMOTE will be required to fill out online self-report instruments and provide their body mass index (BMI) at baseline (T0), two months (T1), and four months after randomization (T2). A researcher not involved in the study will conduct the randomization process.
Participants will be randomly allocated to two groups: the experimental and control groups. In the experimental group, the participants will have access to eMOTE for eight weeks, while in the control group, the participants will be on a waiting list for eight weeks, and after this period, the participants will have access to eMOTE. The investigators will analyze the changes in the frequency of objective and subjective binge eating episodes, eating disorder psychopathology, BMI, intuitive eating, depression, anxiety, stress, compensatory behaviors, mindfulness, and difficulties in emotion regulation.
- Conditions
- Binge Eating
- Being tested
- eMOTE
- Keywords
- DBT, Binge Eating, Feeding and Eating Disorders, Application
- Medical subject headings
- Bulimia, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eMOTEBehavioural
The intervention combines psychoeducation, mindfulness skills, emotion regulation skills, and distress tolerance skills, along with self-monitoring of meals, behaviours and feelings.
| Study group | Role | What they receive |
|---|---|---|
| eMOTE | Experimental | Participants will have access to eMOTE for eight weeks. Receives: Behavioral: eMOTE |
| Waiting List | No intervention | Participants will be on a waiting list group for eight weeks. After that period, the participants will have access to eMOTE. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in binge eating symptoms
Assessed by Binge Eating Scale - BES. The Binge Eating Scale (BES) is a 16-item self-report questionnaire used to assess the presence and severity of binge eating behaviors. The scale's total score can range from 0 to 46, with higher scores indicating more severe levels of binge eating.
Measured: From Baseline to 2-months follow-up
Changes in objective binge eating episodes
Assessed by Eating Disorder Examination Questionnaire - EDE-Q. The Eating Disorder Examination Questionnaire (EDE-Q) is a 36-item self-report tool designed to assess the range, frequency, and severity of behaviors associated with eating disorder diagnoses. The total score on the EDE-Q can range from 0 to 6, with higher scores indicating more severe eating difficulties.
Measured: From Baseline to 2-months follow-up
Secondary outcomes (7)
Changes in BMI
Assessed by a Body Composition Analyzer
Measured: From Baseline to 2-months follow-up
Changes in intuitive eating
Assessed by Intuitive Eating Scale-2 - IES-2. The Intuitive Eating Scale-2 (IES-2) includes 23 items assessing various dimensions of intuitive eating. The total score on the IES-2 can range from 1 to 5, with higher scores indicate a greater tendency toward intuitive eating behaviors.
Measured: From Baseline to 2-months follow-up
Changes in depression, anxiety and stress
Assessed by Depression, Anxiety and Stress Scale - 21 - DASS-21. The Depression Anxiety Stress Scales-21 (DASS-21) is a 21-item self-report questionnaire designed to measure levels of depression, anxiety, and stress. The scale provides three scores, one for each subscale, where the minimum is 0 and the maximum is 21, with higher scores indicate greater severity of emotional distress in each of these areas.
Measured: From Baseline to 2-months follow-up
Changes in eating disorder psychopathology
Assessed by Eating Disorder Examination Questionnaire - EDE-Q. The Eating Disorder Examination Questionnaire (EDE-Q) is a 36-item self-report tool designed to assess the range, frequency, and severity of behaviors associated with eating disorder diagnoses. The total score on the EDE-Q can range from 0 to 6, with higher scores indicating more severe eating difficulties.
Measured: From Baseline to 2-months follow-up
Changes in subjective binge eating episodes
Assessed by Eating Disorder Examination Questionnaire - EDE-Q. The Eating Disorder Examination Questionnaire (EDE-Q) is a 36-item self-report tool designed to assess the range, frequency, and severity of behaviors associated with eating disorder diagnoses. The total score on the EDE-Q can range from 0 to 6, with higher scores indicating more severe eating difficulties.
Measured: From Baseline to 2-months follow-up
Changes in compensatory behaviors
Assessed by Eating Disorder Examination Questionnaire - EDE-Q. The Eating Disorder Examination Questionnaire (EDE-Q) is a 36-item self-report tool designed to assess the range, frequency, and severity of behaviors associated with eating disorder diagnoses. The total score on the EDE-Q can range from 0 to 6, with higher scores indicating more severe eating difficulties.
Measured: From Baseline to 2-months follow-up
Acceptability
Assessed by utility and satisfaction with the digital intervention. Participants will rate the usefulness of each module and their satisfaction with it, using a scale from 1 to 5, ranging from "not at all" to "extremely".
Measured: T1 - immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Apr 2024
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Telma Cruz, MSc, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683456
- Sponsor's protocol ID
- FPCEUP/RH5
- Status last verified
- Nov 2024
- First submitted
- 29 Jul 2024
- Last updated
- 12 Nov 2024
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMOTE: a Smartphone Application for Binge Eating Based on DBT Skills: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06683456
- Acronym / sponsor ID
- FPCEUP/RH5
- Conditions
- Binge Eating
- Keywords
- DBT, Binge Eating, Feeding and Eating Disorders, Application
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 12 Nov 2024 (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.
Binge eating, whether formally diagnosed or occurring at subthreshold levels, is associated with adverse health consequences and decreased quality of life.
Access to accessible, cost-effective interventions that effectively address binge eating episodes is critical for individuals with this condition, and smartphone applications have demonstrated promise in treating binge eating and related disorders.
This study aims to evaluate the efficacy of eMOTE, a novel smartphone application for binge eating based on Dialectical Behavior Therapy (DBT) skills. For this purpose, a randomized controlled trial will be conducted in which women who self-report binge eating episodes will be randomly assigned to the app intervention group or a waiting list group.
Detailed description
eMOTE is a self-help application for women struggling with binge eating episodes. The application was developed based on DBT skills and has four modules: psychoeducation, mindfulness skills, emotion regulation skills, and distress tolerance skills. Additionally, it includes two self-monitoring diaries that allow the input of data related to food, behaviors, feelings, and exercises. The application content will be delivered through text, audios, and videos.
For this study, adult individuals with binge eating episodes who are fluent in Portuguese and own a smartphone will be recruited. The recruitment will be conducted through social media, the University of Porto, and other relevant institutions.
Participants who enrol in eMOTE will be required to fill out online self-report instruments and provide their body mass index (BMI) at baseline (T0), two months (T1), and four months after randomization (T2). A researcher not involved in the study will conduct the randomization process.
Participants will be randomly allocated to two groups: the experimental and control groups. In the experimental group, the participants will have access to eMOTE for eight weeks, while in the control group, the participants will be on a waiting list for eight weeks, and after this period, the participants will have access to eMOTE. The investigators will analyze the changes in the frequency of objective and subjective binge eating episodes, eating disorder psychopathology, BMI, intuitive eating, depression, anxiety, stress, compensatory behaviors, mindfulness, and difficulties in emotion regulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eMOTE | Experimental | Behavioral: eMOTEParticipants will have access to eMOTE for eight weeks. |
| Waiting List | No intervention | –Participants will be on a waiting list group for eight weeks. After that period, the participants will have access to eMOTE. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- female;
- aged 18 years or older;
- self-report at least one binge eating episode over the past four weeks;
- owned a smartphone;
- fluent in Portuguese.
Key exclusion criteria (5 listed)
- attending psychotherapy (face-to-face or digital) or another clinical trial;
- body mass index below 18.5;
- self-report an average of eight or more episodes of binge eating or inappropriate compensatory behaviours per week;
- being pregnant;
- self-report bipolar disorder, psychotic disorder, substance abuse, suicidal ideation or borderline personality disorder.
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 |
|---|---|---|
| eMOTEThe intervention combines psychoeducation, mindfulness skills, emotion regulation skills, and distress tolerance skills, along with self-monitoring of meals, behaviours and feelings. | Behavioural | eMOTE |
Primary outcome
Changes in binge eating symptoms
Time frame: From Baseline to 2-months follow-up
Assessed by Binge Eating Scale - BES. The Binge Eating Scale (BES) is a 16-item self-report questionnaire used to assess the presence and severity of binge eating behaviors. The scale's total score can range from 0 to 46, with higher scores indicating more severe levels of binge eating.
Changes in objective binge eating episodes
Time frame: From Baseline to 2-months follow-up
Assessed by Eating Disorder Examination Questionnaire - EDE-Q. The Eating Disorder Examination Questionnaire (EDE-Q) is a 36-item self-report tool designed to assess the range, frequency, and severity of behaviors associated with eating disorder diagnoses. The total score on the EDE-Q can range from 0 to 6, with higher scores indicating more severe eating difficulties.
7 secondary outcomes
Changes in BMI
Time frame: From Baseline to 2-months follow-up
Changes in intuitive eating
Time frame: From Baseline to 2-months follow-up
Changes in depression, anxiety and stress
Time frame: From Baseline to 2-months follow-up
Changes in eating disorder psychopathology
Time frame: From Baseline to 2-months follow-up
Changes in subjective binge eating episodes
Time frame: From Baseline to 2-months follow-up
Changes in compensatory behaviors
Time frame: From Baseline to 2-months follow-up
Acceptability
Time frame: T1 - immediately after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Binge Eating
Not yet recruiting
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
Binge Eating, Overweight and Obesity
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
Recruiting
Multisensory Processing of Alcohol Cues in Young Adult Binge Drinkers
Drinking, Binge
Active, not recruitingEarly Phase 1
Naltrexone Neuroimaging in Teens With Eating Disorders
Eating Disorders, Binge Eating
RecruitingPhase 4
A Neuropsychobiological Approach to Optimize Patient Selection for GLP-1-based Pharmacotherapy for Weight Management Across the Binge Eating Spectrum
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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.
Telma Cruz, MSc principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eMOTE in people with Binge Eating, run by Universidade do Porto at 1 site in Portugal.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Nov 2024. 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Telma Cruz, MSc (220400667 ext. 393, telmandreiacruz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in binge eating symptoms (time frame: From Baseline to 2-months follow-up). The study lists 2 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 12 Nov 2024.