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Effects of Inhibitory Control Training in Eating Behaviors (N2ICT)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inhibitory Control Training
Sponsored by
Brigham Young University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring inhibitory control training, food, event-related potentials, weight reduction

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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)

Sites / Locations

  • Brigham Young University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inhibitory Control Training to Food Items

Inhibitory Control Training to Neutral Items

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

No-Go Accuracy
Percent of correct no-go trials during the laboratory go/no-go tasks. The investigators are interested if this improves due to the intervention.
Correct Go Reaction Times
Time in ms to correctly respond to a go trial during the laboratory tasks. The investigators are interested if reaction times get faster due to the intervention.

Full Information

First Posted
June 25, 2018
Last Updated
July 7, 2020
Sponsor
Brigham Young University
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1. Study Identification

Unique Protocol Identification Number
NCT03599115
Brief Title
Effects of Inhibitory Control Training in Eating Behaviors
Acronym
N2ICT
Official Title
The Effects of Food-Specific Inhibitory Control Training on Weight, Diet, and Neural Indices in Overweight and Obese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 26, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham Young University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
inhibitory control training, food, event-related potentials, weight reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhibitory Control Training to Food Items
Arm Type
Experimental
Arm 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.
Arm Title
Inhibitory Control Training to Neutral Items
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Inhibitory Control Training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Caloric Intake
Description
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.
Time Frame
Three days will be completed at baseline, immediately after the intervention, and at the 12 week follow-up visit (total of 9 recalls)
Title
Weight
Description
Weight will be measured in kilograms using a stadiometer to see if weight changes over the course of the study.
Time Frame
Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Title
N2 Event-Related Potential Component
Description
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.
Time Frame
Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Secondary Outcome Measure Information:
Title
No-Go Accuracy
Description
Percent of correct no-go trials during the laboratory go/no-go tasks. The investigators are interested if this improves due to the intervention.
Time Frame
Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Title
Correct Go Reaction Times
Description
Time in ms to correctly respond to a go trial during the laboratory tasks. The investigators are interested if reaction times get faster due to the intervention.
Time Frame
Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Other Pre-specified Outcome Measures:
Title
Power of Food Scale (PFS)
Description
The PFS assesses thoughts, feelings, and motivations to consume palatable food. It provides a measure of the appetitive drive individuals have to consume food. There are 15 items on the PFS, each ranging from 1 (don't agree at all) to 5 (strongly agree). The PFS is divided into 3 subscales that assess appetitive drive in 3 different environmental situations: when food is available (6 items), when food is physically present (4 items), and when food has been tasted (5 items). Subtotal scores are calculated by taking the mean of all the individual items in each subscale (subscale scores ranging from 1 to 5). An overall score, which is calculated by averaging the three subscale scores, will be used as the outcome of interest (overall score ranging from 1 to 5). A higher overall score on the PFS indicates there is a higher appetitive drive to consume food. The investigators will test if the appetitive drive to consume food changes over time due to the intervention.
Time Frame
Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Brigham Young University
City
Provo
State/Province
Utah
ZIP/Postal Code
84602
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol, materials, and analysis plans are already posted on the Open Science Framework (https://osf.io/szxua/). Actual study data (de-identified) will be made available, along with analysis codes, once the study has been complete and published.
IPD Sharing 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.
IPD Sharing URL
https://osf.io/szxua/
Links:
URL
https://osf.io/szxua/
Description
Open Science Framework study specific page

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Effects of Inhibitory Control Training in Eating Behaviors

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