Training App for Inhibitory Control Towards Food
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Padova
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
visual impairment not corrected by glasses
a diagnosis of psychosis;
intellectual disability.
Trial design
Design model
Parallel
Treatments tested in this trial
Food-specific inhibitory control training delivered through the FoodTraining App
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
113 Participants
are divided into 2 treatment groupsGroup A: Experimental Condition (TAU + FoodTraining)Experimental treatment 1 intervention
Group B: Control conditionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Between-group differences (experimental vs. control group) in changes in tendency to eat in response to emotional eating
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.
Time frame
baseline; 4-, and 8- week follow-up2
Between-group differences (experimental vs. control group) in changes in uncontrolled eating behaviours
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).
Time frame
baseline; 4-, and 8- weeks follow-upSecondary outcomes
1
Between-group differences (experimental vs. control group) in changes in eating disorder psychopathology
Eating Disorder Examination Questionnaire (EDE-Q; total score. min=0; max=6, cut-off 4). Higher scores indicating increased eating difficulties.
Time frame
baseline; 4-, and 8- weeks follow-up2
Between-group differences (experimental vs. control group) in changes in frequency and severity of binge eating episodes
Binge Eating Scale (BES), score range 0-46 (18-26= moderate bingeing; \>/= 27= severe bingeing).
Time frame
baseline; 4-, and 8- week follow-up3
Between-group differences (experimental vs. control group) in liking of high calorie dense foods
Visual analogue scale to rate the degree of food liking in response to images of unhealthy and healthy foods developed by the research team (score range 0-100).
Time frame
baseline; 4-, and 8- weeks follow-up4
Between-group differences (experimental vs. control group) in wanting of high calorie dense foods
Visual analogue scale to rate the degree of food wanting in response to images of unhealthy and healthy foods developed by the research team (score range 0-100).
Time frame
baseline; 4-, and 8- weeks follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Padova
Lead sponsor
University of Exeter
Collaborator
Source ClinicalTrials.gov