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| Name | Class |
|---|---|
| University of Exeter | OTHER |
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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.
The study aims:
An a-priori power analysis performed on the G*Power software, indicated that 93 participants would be needed to detect a significant 2 (group) x 3 (time) within-between interaction effect on the primary outcome measure (emotional eating and uncontrolled eating) with a small to medium effect size (Cohen's f = 0.15), a statistical power of 1-β = .80, and at a significant level α = .05, assuming a correlation among repeated measures of r = .5. To account for possible drop-out, the number will be exceeded by 20%. The final sample size that will be recruited is 113 participants.
Patients will be recruited and assessed at baseline, 4 and 8 weeks follow-up from the University Hospital in Padova (i.e., Eating Disorders Unit and Obesity Management Unit).
Assessment phase
After providing written informed consent, participants will complete a questionnaire to collect demographic information, such as gender and age. Their weight and height will be measured by a clinician. Clinical information, such as diagnosis, psychiatric/medical comorbidities and ongoing treatment will be retrieved from hospital clinical records. Participants will complete the following self-report questionnaires, measures and computerised tasks:
A mobile App (i.e. FoodTracker), will be used to track food consumption, eating behaviours and their emotional and cognitive correlates for 3 days. Participants will be asked to complete the EMAs before and after each meal, and will also be prompted to respond to the survey questions at three random time points during the day. As a measure of physiological correlates of food consumption, glycemic responses will be monitored over a 15-day period using the FreeStyle Libre 3 device (https://www.freestyle.abbott/it-it/products/freestyle-libre-3.html), for continuous glucose monitoring (CGM). This tool collects real-time data on physiological changes in glucose regulation by measuring interstitial glucose levels every minute via a small sensor worn on the back of the upper arm. The sensor captures fluctuations in glucose throughout the day and night, providing detailed information on glycemic variability, postprandial responses, and potential episodes of hypo- or hyperglycemia.
All participants will be assessed through online self-report questionnaires at the end of the intervention (week 4) and follow-up (week 8). At all time points, weight will be measured. At 4- and 8-week follow-up, participants will complete a subset of the measures completed at baseline: Dutch Eating Behavior Questionnaire (DEBQ); Three Factors Eating Questionnaire (TFEQ); Food Cravings Questionnaire-Trait (FCQ-T); Eating Disorder Examination Questionnaire (EDE-Q); Binge Eating Scale (BES); Depression Anxiety Stress Scales Short Version (DASS-21); Work and Social Adjustment Scale (WSAS); Food liking and wanting; Food-related go/no-go task; Food-related temporal discounting task.
Intervention phase
Participants will be randomly assigned to either:
• The experimental condition (TAU + food-specific inhibitory training) or the control condition (TAU only).
All participants will be instructed to download the Food Tracker app and complete the EMAs for three days after the baseline assessment and three days after the 4-week assessment.
Participants assigned to the TAU+FoodTraining group will have access to the FoodTraning App following the baseline EMAs. They will be asked to complete a session once a day for the first week and three times a week for the remaining three weeks.
Participants in the control group will be offered access to the FoodTraining App at the end of the 8-week follow-up.
Access to the FoodTraining and FoodTracker Apps will be free of charge for participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline; 4-, and 8- weeks follow-up |
| Between-group differences (experimental vs. control group) in changes in frequency and severity of binge eating episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentina Cardi, PhD | Contact | +39049827 | valentina.cardi@unipd.it | |
| Enrico Collantoni, PhD | Contact | enrico.collantoni@unipd.it |
| Name | Affiliation | Role |
|---|---|---|
| Valentina Cardi, PhD | Department of General Psychology, University of Padova, Padova, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatry Unit, University Hospital, Padova and Bariatric Unit, University Hospital, Padova | Recruiting | Padova | Padova | 35121 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23994503 | Background | 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. | |
| 26525096 | Background |
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A plan will be established by the research team for data sharing following publication of the first manuscript
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D052018 | Bulimia Nervosa |
| D056912 | Binge-Eating Disorder |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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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.
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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.
|
| 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. |
|
Binge Eating Scale (BES), score range 0-46 (18-26= moderate bingeing; >/= 27= severe bingeing). |
| baseline; 4-, and 8- week follow-up |
| 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). | baseline; 4-, and 8- weeks follow-up |
| 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). | baseline; 4-, and 8- weeks follow-up |
| Between-group differences (experimental vs. control group) in urge to eat high calorie dense foods | Visual analogue scale to rate the urge to eat in response to images of unhealthy and healthy foods developed by the research team (score range 0-100). | baseline; 4-, and 8- weeks follow-up |
| Between-group differences (experimental vs. control group) in food-related inhibitory control level | Number of errors to the food-related go/no-go task. | baseline; 4-, and 8- weeks follow-up |
| Between-group differences (experimental vs. control group) in changes in preference for immediate food rewards as compared to money | Hyperbolic discount-rate for food rewards as compared to money to the temporal discounting task. | baseline; 4-, and 8- weeks follow-up |
| Between-group differences (experimental vs. control group) in changes in food craving | Food Cravings Questionnaire-Trait (FCQ-T), higher scores indicate higher difficulties. | baseline; 4-, and 8- weeks follow-up |
| Between-group differences (experimental vs. control group) in food-related unpleasant emotions | Longitudinal comparison of responses to EMAs (visual analogue scales developed by the research team 0-5). | 3-day evaluation at baseline, repeated at 4-, and 8- weeks follow-up |
| Acceptability and adherence of the EMA assessments (FoodTracker) | At least average 70% of participants providing a score of 7 or higher on a 1-10 Likert scale measuring the perceived acceptability of the daily assessments. | 8- weeks follow-up |
| Acceptability and adherence to glucose monitoring assessments | At least average 70% of participants providing a score of 7 or higher on a 1-10 Likert scale measuring the perceived acceptability of the daily assessments. | 8- weeks follow-up |
| Impact of food addiction on the degree of changes in response to internal emotional factors in the experimental and control groups | 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 |
| Impact of food addiction on the degree of changes in uncontrolled eating in the experimental and control groups | Uncontrolled Eating subscale of the Three-Factor Eating Questionnaire (TFEQ). Higher scores indicate greater levels of the behaviour (Uncontrolled Eating = 0-16). | baseline |
| Impact of impulsivity on the degree of changes in eating in response to internal emotional factors in the experimental and control groups | 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 levels; 3 = medium levels; 4-5 = high levels. | baseline |
| Impact of impulsivity on the degree of changes in uncontrolled eating in the experimental and control groups | Uncontrolled Eating subscale of the Three-Factor Eating Questionnaire (TFEQ). Higher scores indicate greater levels of the behaviour (Uncontrolled Eating = 0-16). | baseline |
| Between-group differences (experimental vs. control group) in changes in anxiety, stress and depression symptoms | The Depression Anxiety Stress Scales-21 (DASS-21): 3 subscales. Stress subscale: Normal: 0-10; Mild: 11-18; Moderate: 19-26; Severe: 27-34; Extremely severe: 35-42. Anxiety: Normal : 0-6, Mild : 7-9, Moderate:10-14, Severe: 15-19, Extremely severe: 20-42. Depression: Normal: 0-9, Mild : 10-12, Moderate : 13-20, Severe : 21-27, Extremely severe: 28-42. | baseline; 4-, and 8- weeks follow-up |
| Between-group differences (experimental vs. control group) in changes in social adjustment levels | Work and Social Adjustment Scale (WSAS). Total score ranges from 0 to 40 (Scores >/= 20 indicates moderately severe or worse impairment. Scores between 10 and 20 are associated with significant functional impairment but less severe clinical symptomatology) | baseline; 4-, and 8- weeks follow-up |
| Adherence to the intervention (FoodTraining) | Number of times participants complete the training task (FoodTraining) throughout the 4-week period. | 4 weeks follow-up |
| Feasibility of the intervention (FoodTraining) | At least 60% of participants completing a minimum of 70% of the training sessions. | 8- weeks follow-up |
| Acceptability of the intervention (FoodTraining) | At least 80% of participants providing a score of 7 or higher on a 1-10 Likert scale measuring the perceived acceptability and usefulness of the training. | 8- weeks follow-up |
| 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. |
| 38568882 | 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. |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |