An interventional study of eMOTE in Binge Eating, sponsored by Universidade do Porto. Recruiting at 1 site in Portugal. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Universidade do Porto · Not applicable, Interventional, and Treatment
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.
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.
173 studies on the registry are indexed under Bulimia; 33 are open to participants now.
This study's planned enrollment of 68 is above the median of 60 across 143 interventional studies indexed under Bulimia.
Browse Bulimia studies →Universidade do Porto is the lead sponsor of 174 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will have access to eMOTE for eight weeks.
Behavioral: eMOTE
Participants will be on a waiting list group for eight weeks. After that period, the participants will have access to eMOTE.
The intervention combines psychoeducation, mindfulness skills, emotion regulation skills, and distress tolerance skills, along with self-monitoring of meals, behaviours and feelings.
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.
Time frame: 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.
Time frame: From Baseline to 2-months follow-up
Changes in BMI
Assessed by a Body Composition Analyzer
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: T1 - immediately after intervention
Changes in emotion regulation
Assessed by Difficulties in Emotion Regulation Scale - DERS. The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report questionnaire designed to assess difficulties in emotional regulation. The total score on DERS can range from 36 to 180, with higher scores indicating greater difficulties in regulating emotions.
Time frame: From Baseline to 2-months follow-up
Changes in mindfulness
Assessed by Mindful Attention and Awareness Scale - MAAS. The Mindful Attention and Awareness Scale (MAAS) is a 15-item self-report instrument that measures the extent to which individuals act with awareness in daily life. The total score can range from 1 to 6, and higher scores indicate more mindfulness.
Time frame: From Baseline to 2-months follow-up
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Mar 2025, 11 months after the start.
Of 68 non-industry interventional studies with no phase under Bulimia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's planned 11 months is below that.
Counting every sponsor, half of 70 studies reached it within 26 months; a quarter within 10 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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