Effects of Inhibitory Control Training in Eating Behaviors (N2ICT)

Brigham Young University (BYU)

Status: Completed

Conditions: Overweight and Obesity

Treatments: Behavioral: Inhibitory Control Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03599115

X17021

Details and patient eligibility

About

Overweight and obese individuals will be randomly assigned to a food-specific or generic inhibitory control training. Food intake, weight, and neural indices of inhibitory control will be assessed prior, immediately after the 4-week intervention, and 12-weeks after intervention completion to assess the effectiveness of a mobile inhibitory control training intervention over time for health outcomes.

Full description

All participants will report to the lab for a baseline session, where their weight, average food intake for three days (using the Automated Self-Administer 24-hour Dietary Recall [ASA24] system), neural indices of inhibitory control (as assessed by the N2 event-related potential component during a food and genetic go/no-go task), appetitive drive toward food (as measured by the Power of Food Scale) and basic demographic information will be assessed. Based off their gender and baseline levels of inhibitory control (indicated by the N2), participants will be assigned to a four week food-specific inhibitory control training or a generic inhibitory control training. Trainings are administered on a mobile device via an app and participants select four our of five business days to complete the trainings on. Immediately after the four weeks, participants will come in for a follow-up session where their weight, food intake, N2, and appetitive drive to food will be assessed again. Finally, participants will have a 12-week waiting period where they do not complete the trainings. After the 12 weeks, they will come in for a final lab visit where their weight, food intake, N2, and appetitive drive to food will be assessed one last time.

Enrollment: 105 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overweight or Obese (BMI > 25 kg/m2)

Exclusion criteria

• Diagnosis of a psychological disorder (e.g., major depressive disorder, general anxiety disorder), neurological disorder (e.g., epilepsy, stroke), learning disability, or eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder)
• Metabolic/chronic disease (e.g., cardiovascular disease, Type II diabetes)
• Pregnant or lactating
• Current participation in a weight loss diet
• Food allergies
• Head injury that resulted in a loss of consciousness
• Avid exercisers (i.e., participate in at least 20 minutes of vigorous physical activity more than three times a week)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 2 patient groups

Inhibitory Control Training to Food Items

Experimental group

Description:

Participants complete a 10 minute training task once a day, 4 days a week, for 4 weeks. Task is administered using a mobile app (Paradigm mobile) that is installed on an iPhone or iPad. Participants receive an instruction text/email at 9am on their chosen weekdays with instructions on what task to complete and a reminder text/email at 5pm if the task has not yet been completed. Research team receives an email when the task has been completed. When the task is administered, participants see a picture for 1250ms with an inter-stimulus interval of 1250ms and have to indicate which side of the screen the picture appears (go trials). Participants are instructed to not make a response when the picture is surrounded by a black box (no-go trials). There are 6 blocks with 36 trials each, half being go and half being no-go trials. High-calorie foods are always no-go trials and low-calorie foods are always go trials.

Treatment:

Behavioral: Inhibitory Control Training

Inhibitory Control Training to Neutral Items

Active Comparator group

Description:

Participants complete a 10 minute training task once a day, 4 days a week, for 4 weeks. Task is administered using a mobile app (Paradigm mobile) that is installed on an iPhone or iPad. Participants receive an instruction text/email at 9am on their chosen weekdays with instructions on what task to complete and a reminder text/email at 5pm if the task has not yet been completed. Research team receives an email when the task has been completed. When the task is administered, participants see a picture for 1250ms with an inter-stimulus interval of 1250ms and have to indicate which side of the screen the picture appears (go trials). Participants are instructed to not make a response when the picture is surrounded by a black box (no-go trials). There are 6 blocks with 36 trials each, half being go and half being no-go trials. All pictures are of household items.

Treatment:

Behavioral: Inhibitory Control Training