Effects of Inhibitory Control Training in Eating Behaviors

Overweight and Obesity Clinical Trial

— N2ICT  

Official title:

The Effects of Food-Specific Inhibitory Control Training on Weight, Diet, and Neural Indices in Overweight and Obese Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599115
• Other study ID #: X17021
• Status: Completed
• Phase: N/A
• Start date: September 26, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2020
• Source: Brigham Young University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Inhibitory Control Training
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).

Locations

Country	Name	City	State
United States	Brigham Young University	Provo	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Brigham Young University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Power of Food Scale (PFS)	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.	Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Primary	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)
Primary	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.
Primary	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	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.	Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Secondary	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.	Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.

External Links

•   Open Science Framework study specific page