Training App for Inhibitory Control Towards Food

NCT07075952 | Recruiting

• 1 other identifier: AOP3416
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity &Amp; Overweight; Bulimia Nervosa; Binge-Eating Disorder

Keywords

App; Training; Inhibitory control; Bulimia Nervosa; Binge-Eating Disorder; Obesity

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline; 4-, and 8- week follow-up

• 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).

  baseline; 4-, and 8- weeks follow-up

Secondary Outcomes (20)

• Between-group differences (experimental vs. control group) in changes in eating disorder psychopathology

  baseline; 4-, and 8- weeks follow-up

• Between-group differences (experimental vs. control group) in changes in frequency and severity of binge eating episodes

  baseline; 4-, and 8- week follow-up

• Between-group differences (experimental vs. control group) in liking of high calorie dense foods

  baseline; 4-, and 8- weeks follow-up

• Between-group differences (experimental vs. control group) in wanting of high calorie dense foods

  baseline; 4-, and 8- weeks follow-up

• Between-group differences (experimental vs. control group) in urge to eat high calorie dense foods

  baseline; 4-, and 8- weeks follow-up

Study Arms (2)

Experimental Condition (TAU + FoodTraining)

EXPERIMENTAL

Participants in the experimental condition will be asked to perform a food-specific inhibitory control training delivered through the FoodTraining App once a day for the first week and three times a week for the remaining three weeks, for five minutes each time.

Behavioral: Food-specific inhibitory control training delivered through the FoodTraining App

Control condition

ACTIVE COMPARATOR

Participants in the control group will be offered access to the FoodTraining App at the end of the 8-week follow-up.

Behavioral: Waiting list

Interventions

Waiting list BEHAVIORAL

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.

Control condition

Food-specific inhibitory control training delivered through the FoodTraining App BEHAVIORAL

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.

Experimental Condition (TAU + FoodTraining)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• visual impairment not corrected by glasses
• a diagnosis of psychosis;
• intellectual disability.

Sponsors & Collaborators

• University of Padova: lead
• University of Exeter: collaborator

Study Sites (1)

Psychiatry Unit, University Hospital, Padova and Bariatric Unit, University Hospital, Padova

Padua, Padova, 35121, Italy

RECRUITING

Related Publications (18)

• Dakanalis A, Zanetti MA, Clerici M, Madeddu F, Riva G, Caccialanza R. Italian version of the Dutch Eating Behavior Questionnaire. Psychometric proprieties and measurement invariance across sex, BMI-status and age. Appetite. 2013 Dec;71:187-95. doi: 10.1016/j.appet.2013.08.010. Epub 2013 Aug 30.

  PMID: 23994503 BACKGROUND

• Schiff S, Amodio P, Testa G, Nardi M, Montagnese S, Caregaro L, di Pellegrino G, Sellitto M. Impulsivity toward food reward is related to BMI: Evidence from intertemporal choice in obese and normal-weight individuals. Brain Cogn. 2016 Dec;110:112-119. doi: 10.1016/j.bandc.2015.10.001. Epub 2015 Oct 30.

  PMID: 26525096 BACKGROUND

• Presseller EK, Parker MN, Zhang F, Manasse S, Juarascio AS. Continuous glucose monitoring as an objective measure of meal consumption in individuals with binge-spectrum eating disorders: A proof-of-concept study. Eur Eat Disord Rev. 2024 Jul;32(4):828-837. doi: 10.1002/erv.3094. Epub 2024 Apr 3.

  PMID: 38568882 BACKGROUND

• Rania M, Caroleo M, Carbone EA, Ricchio M, Pelle MC, Zaffina I, Condoleo F, de Filippis R, Aloi M, De Fazio P, Arturi F, Segura-Garcia C. Reactive hypoglycemia in binge eating disorder, food addiction, and the comorbid phenotype: unravelling the metabolic drive to disordered eating behaviours. J Eat Disord. 2023 Sep 19;11(1):162. doi: 10.1186/s40337-023-00891-z.

  PMID: 37726785 BACKGROUND

• Cornier MA. A review of current guidelines for the treatment of obesity. Am J Manag Care. 2022 Dec;28(15 Suppl):S288-S296. doi: 10.37765/ajmc.2022.89292.

  PMID: 36525676 BACKGROUND

• Carbine KA, Muir AM, Allen WD, LeCheminant JD, Baldwin SA, Jensen CD, Kirwan CB, Larson MJ. Does inhibitory control training reduce weight and caloric intake in adults with overweight and obesity? A pre-registered, randomized controlled event-related potential (ERP) study. Behav Res Ther. 2021 Jan;136:103784. doi: 10.1016/j.brat.2020.103784. Epub 2020 Dec 8.

  PMID: 33316579 BACKGROUND

• de Klerk MT, Smeets PAM, la Fleur SE. Inhibitory control as a potential treatment target for obesity. Nutr Neurosci. 2023 May;26(5):429-444. doi: 10.1080/1028415X.2022.2053406. Epub 2022 Mar 28.

  PMID: 35343884 BACKGROUND

• Keeler JL, Chami R, Cardi V, Hodsoll J, Bonin E, MacDonald P, Treasure J, Lawrence N. App-based food-specific inhibitory control training as an adjunct to treatment as usual in binge-type eating disorders: A feasibility trial. Appetite. 2022 Jan 1;168:105788. doi: 10.1016/j.appet.2021.105788. Epub 2021 Oct 30.

  PMID: 34728250 BACKGROUND

• Cardi V, Meregalli V, Di Rosa E, Derrigo R, Faustini C, Keeler JL, Favaro A, Treasure J, Lawrence N. A community-based feasibility randomized controlled study to test food-specific inhibitory control training in people with disinhibited eating during COVID-19 in Italy. Eat Weight Disord. 2022 Oct;27(7):2745-2757. doi: 10.1007/s40519-022-01411-9. Epub 2022 Jun 6.

  PMID: 35666376 BACKGROUND

• Bottesi G, Ghisi M, Altoe G, Conforti E, Melli G, Sica C. The Italian version of the Depression Anxiety Stress Scales-21: Factor structure and psychometric properties on community and clinical samples. Compr Psychiatry. 2015 Jul;60:170-81. doi: 10.1016/j.comppsych.2015.04.005. Epub 2015 Apr 15.

  PMID: 25933937 BACKGROUND

• Calugi S, Milanese C, Sartirana M, El Ghoch M, Sartori F, Geccherle E, Coppini A, Franchini C, Dalle Grave R. The Eating Disorder Examination Questionnaire: reliability and validity of the Italian version. Eat Weight Disord. 2017 Sep;22(3):509-514. doi: 10.1007/s40519-016-0276-6. Epub 2016 Apr 2.

  PMID: 27039107 BACKGROUND

• Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.

  PMID: 11983645 BACKGROUND

• Cepeda-Benito A, Gleaves DH, Fernandez MC, Vila J, Williams TL, Reynoso J. The development and validation of Spanish versions of the State and Trait Food Cravings Questionnaires. Behav Res Ther. 2000 Nov;38(11):1125-38. doi: 10.1016/s0005-7967(99)00141-2.

  PMID: 11060941 BACKGROUND

• Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.

  PMID: 3981480 BACKGROUND

• Gormally J, Black S, Daston S, Rardin D. The assessment of binge eating severity among obese persons. Addict Behav. 1982;7(1):47-55. doi: 10.1016/0306-4603(82)90024-7.

  PMID: 7080884 BACKGROUND

• Innamorati M, Imperatori C, Manzoni GM, Lamis DA, Castelnuovo G, Tamburello A, Tamburello S, Fabbricatore M. Psychometric properties of the Italian Yale Food Addiction Scale in overweight and obese patients. Eat Weight Disord. 2015 Mar;20(1):119-27. doi: 10.1007/s40519-014-0142-3. Epub 2014 Jul 29.

  PMID: 25069837 BACKGROUND

• Fossati A, Di Ceglie A, Acquarini E, Barratt ES. Psychometric properties of an Italian version of the Barratt Impulsiveness Scale-11 (BIS-11) in nonclinical subjects. J Clin Psychol. 2001 Jun;57(6):815-28. doi: 10.1002/jclp.1051.

  PMID: 11344467 BACKGROUND

• Labonte K, Nielsen DE. Measuring food-related inhibition with go/no-go tasks: Critical considerations for experimental design. Appetite. 2023 Jun 1;185:106497. doi: 10.1016/j.appet.2023.106497. Epub 2023 Mar 7.

  PMID: 36893916 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight; Bulimia Nervosa; Binge-Eating Disorder; Alzheimer Disease

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding and Eating Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Valentina Cardi, PhD

  Department of General Psychology, University of Padova, Padova, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valentina Cardi, PhD

CONTACT

+39049827; valentina.cardi@unipd.it

Enrico Collantoni, PhD

CONTACT

enrico.collantoni@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Each participant will be assigned an identification code (ID-code) randomly generated by a computer. The outcome assessors will be blind to whether participants will be assigned to the experimental or control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study will use a randomised controlled design to test the impact of food-specific inhibitory control training offered in addition to treatment as usual on eating behaviour, eating attitudes and several areas of individual functioning in people with bulimia nervosa, binge eating disorder or obesity.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: October 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)