Overweight and ObesityN2ICTNCT03599115
Effects of Inhibitory Control Training in Eating Behaviors
A study of Overweight and Obesity, run by Brigham Young University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2017to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight or Obese (BMI > 25 kg/m2)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Food-Specific Inhibitory Control Training on Weight, Diet, and Neural Indices in Overweight and Obese Adults
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Inhibitory Control Training
- Keywords
- inhibitory control training, food, event-related potentials, weight reduction
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhibitory Control TrainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Inhibitory Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Secondary outcomes (2)
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.
Measured: Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
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.
Measured: Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start26 Sep 2017
- Primary completion1 Mar 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham Young University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaylie Carbine, Brigham Young University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599115
- Sponsor's protocol ID
- X17021
- Acronym
- N2ICT
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Food-Specific Inhibitory Control Training on Weight, Diet, and Neural Indices in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT03599115
- Acronym / sponsor ID
- N2ICT / X17021
- Conditions
- Overweight and Obesity
- Keywords
- inhibitory control training, food, event-related potentials, weight reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Brigham Young UniversityUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Inhibitory Control Training to Food Items | Experimental | Behavioral: Inhibitory Control TrainingParticipants 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. |
| Inhibitory Control Training to Neutral Items | Active comparator | Behavioral: Inhibitory Control TrainingParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Overweight or Obese (BMI > 25 kg/m2)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhibitory Control TrainingComputerized 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). | Behavioural | Inhibitory Control Training to Food Items, Inhibitory Control Training to Neutral Items |
Primary outcome
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.
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.
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.
2 secondary outcomes
No-Go Accuracy
Time frame: Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Correct Go Reaction Times
Time frame: Assessed at baseline, immediately after the intervention, and at the 12-week follow-up visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Open Science Framework study specific pageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Overweight and Obesity, run by Brigham Young University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.