Effects of Inhibitory Control Training in Eating Behaviors

NCT03599115 | Completed

• 1 other identifier: X17021
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obesity

Keywords

inhibitory control training; food; event-related potentials; weight reduction

Outcome Measures

Primary Outcomes (3)

• Caloric Intake

  Using the Automated Self-Administered 24-hour Dietary Recall (ASA24), participants will record their food intake for two weekdays and one weekend, two of which will be randomly assigned and one which will be the day they report to their lab visit. Caloric intake, as quantified by ASA24, will be averaged for the three days and statistically analyzed to see if average caloric intake changes over time due to the inhibitory control training arm.

  Three days will be completed at baseline, immediately after the intervention, and at the 12 week follow-up visit (total of 9 recalls)

• Weight

  Weight will be measured in kilograms using a stadiometer to see if weight changes over the course of the study.

  Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.

• N2 Event-Related Potential Component

  The N2 is a negative deflection in the event-related potential waveform occurring 200 to 300 ms after the onset of a stimulus and is larger (i.e., more negative) when an individual has to withhold a dominant response. It is a neural reflection of inhibitory control. The investigators will assess if the N2 amplitude gets larger as a result of inhibitory control training (as individuals will be better at recruiting inhibitory control resources). The investigators will also see if the N2 predicts who is successful at losing weight and reducing caloric intake after the intervention, to better understand the mechanism of action for inhibitory control training.

  Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.

Secondary Outcomes (2)

• No-Go Accuracy

  Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.

• Correct Go Reaction Times

  Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.

Other Outcomes (1)

• Power of Food Scale (PFS)

  Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.

Study Arms (2)

Inhibitory Control Training to Food Items

EXPERIMENTAL

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.

Behavioral: Inhibitory Control Training

Inhibitory Control Training to Neutral Items

ACTIVE COMPARATOR

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.

Behavioral: Inhibitory Control Training

Interventions

Inhibitory Control Training BEHAVIORAL

Computerized go/no-go task where individuals make responses to certain items (go trials) and withhold responses from certain items (no-go trials, in this case, trials surrounded by a black box). Intervention is designed to target and improve inhibitory control cognitive mechanisms in general (generic arm) or towards high-calorie foods specifically (food arm).

Inhibitory Control Training to Food Items; Inhibitory Control Training to Neutral Items

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham Young University: lead

Study Sites (1)

Brigham Young University

Provo, Utah, 84602, United States

Location

Related Links

• Open Science Framework study specific page

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are told there is only one intervention for the study and are not aware if they have been assigned to the intervention group or the active control. Research assistants collecting data are blind to what arm the participant was assigned to. During data preprocessing steps, individuals will be blind to what group a participant belongs too (and all data will be preprocessed together). Only when conducting statistical analyses will the principle investigator be aware of what participant belongs to what group, in order to conduct group analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are two arms of this study: food-specific inhibitory control training (condition of interest) and a generic inhibitory control training (active control). Given baseline levels of inhibitory control (assessed at baseline visit), participants are randomly assigned to the generic or food-specific month long inhibitory control training. All other protocols, including baseline and follow-up visits and assessment of food intake and weight, are identical and follow the same time line across the two arms.

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 26, 2018
• Study Start: September 26, 2017
• Primary Completion: March 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Once data collection and data analysis has been completed and published in a scientific journal, the study data (de-identified) will either be posted on an open science website, such as the Open Science Framework, or will be given to other researchers upon request.

Locations

US (1)