Clinical trial NCT03599115: Effects of Inhibitory Control Training in Eating Behaviors
Official title: The Effects of Food-Specific Inhibitory Control Training on Weight, Diet, and Neural Indices in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: inhibitory control training
food
event-related potentials
weight reduction
Lead sponsor: Brigham Young University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Caloric Intake
timeFrame: Three days will be completed at baseline, immediately after the intervention, and at the 12 week follow-up visit (total of 9 recalls)
measure: Weight
timeFrame: Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
measure: N2 Event-Related Potential Component
timeFrame: Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Secondary outcomes:
measure: No-Go Accuracy
timeFrame: Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
measure: Correct Go Reaction Times
timeFrame: Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Other outcomes:
measure: Power of Food Scale (PFS)
timeFrame: Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Locations:
city: Provo
country: United States
facility: Brigham Young University
state: Utah
Study officials:
References: