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Completed

NCT Number: NCT03599115

Effects of Inhibitory Control Training in Eating Behaviors

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.

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Key information

Conditions

Overweight and Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham Young University

Provo, Utah, 84602, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Primary outcomes

  1. Caloric Intake

    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)

    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.

  2. Weight

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

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

  3. N2 Event-Related Potential Component

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

    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 outcomes

  1. No-Go Accuracy

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

    Percent of correct no-go trials during the laboratory go/no-go tasks. The investigators are interested if this improves due to the intervention.

  2. Correct Go Reaction Times

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

    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.

Other outcomes

  1. Power of Food Scale (PFS)

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

    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.

Sponsors and collaborators

Lead sponsor

Brigham Young University

Other

Registry information

Official study title

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

Acronym: N2ICT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 26, 2018
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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