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Recruiting Not applicable

Training App for Inhibitory Control Towards Food

NCT07075952 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-10-01
Last updated
2025-12-30

Condition(s) studied

Obesity &Amp; OverweightBulimia NervosaBinge-Eating Disorder

Investigational drug(s) / intervention(s)

Food-specific inhibitory control training delivered through the FoodTraining AppWaiting list

Food-specific inhibitory control training delivered through the FoodTraining App: Participants will complete one training session per day for the first week and three sessions per week for the following three weeks (4 weeks in total). Each session lasts about 5 minutes and includes 3 blocks of stimuli presentation. In each block, 32 images (8 low-energy-dense foods, 8 high-energy-dense foods, 16 neutral objects) are presented for 1500ms with a 500ms interstimulus interval. One-hundred ms after the image presentation, a red or green circle appears. Participants will have to tap the image when a green circle appears ("go" trials) and inhibit a response when a red circle appears ("no-go" trials). Low-energy-dense foods are always paired with "go" trials, high-energy-dense foods with "no-go" trials, and neutral objects with either "go" or "no-go" trials. After each block, participants receive feedback on mean accuracy and reaction time. Participants can personalise the training by selecting up to three categories of high-energy-dense foods to include.

Waiting list: Participants allocated to the control condition will not have access to the FoodTraining App during the active phase of the study (8 weeks), but will be offered the opportunity to access the app at the end of the 8-week follow-up period. This ensures that all participants, regardless of group allocation, will have the chance to benefit from the intervention once data collection is complete.

Study summary

The aim of this project is to test the feasibility, acceptability and clinical impact of a mobile app-based intervention (FoodTraining) to strengthen food-related inhibitory control over 4 weeks, in a sample of people with eating or weight disorders (i.e. obesity, binge-eating disorder (BED), or bulimia nervosa (BN)) receiving standard outpatient treatment (i.e., treatment as usual (TAU) encompassing guided self-help or psychotherapy, pharmacological therapy or diet). The training will be offered in addition to TAU (experimental group) and compared to TAU alone (control group).

Participants will complete questionnaires to measure eating behaviour, eating disorder psychopathology, symptoms of anxiety, depression and stress, social functioning and quality of life at baseline, 4 and 8 weeks. They will also complete momentary assessments using a mobile application (FoodTracker) to report on food intake along with related thoughts, emotions, and behaviours and will wear small, non-invasive sensors to track real-time fluctuations in glucose levels for 15 days.

Participants will also perform a food-related go-no go task and a food-related temporal discounting task at baseline, 4 and 8 weeks.

Finally, this study will pilot the use of a semi-structured interview to characterise the history of weight, the appetite system, eating-related habits in the family and learning of eating behaviours and attitudes in people with eating or weight disorders.

Eligibility

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * BMI in the obesity range (\>30) or a clinician-formulated diagnosis of binge eating disorder or bulimia nervosa; * knowledge of Italian or English; * access to a mobile device (e.g. smartphone, tablet). Exclusion Criteria: * visual impairment not corrected by glasses * a diagnosis of psychosis; * intellectual disability.

Primary outcome measure(s)

  • Between-group differences (experimental vs. control group) in changes in tendency to eat in response to emotional eating — baseline; 4-, and 8- week follow-up
    Emotional eating subscale of the Dutch Eating Behavior Questionnaire (DEBQ). Higher scores indicate a greater tendency to eat in response to internal emotional factors. Sum and mean of the scores for each subscale item: 1-2 = low level of that eating behaviour; 3 = medium level; 4-5 = high level.
  • Between-group differences (experimental vs. control group) in changes in uncontrolled eating behaviours — baseline; 4-, and 8- weeks follow-up
    Uncontrolled Eating subscale of the Three-Factor Eating Questionnaire (TFEQ). Higher scores indicate greater levels of the behaviour (Cognitive Restraint = 0-21; Uncontrolled Eating = 0-16; Emotional Eating = 0-14).

Trial sites (1)

FacilityCityRegionStatus
Psychiatry Unit, University Hospital, Padova and Bariatric Unit, University Hospital, Padova Padova Padova Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07075952 on ClinicalTrials.gov ↗ ← All trials in Italy