NCT05795179

Brief Summary

Self-control failures are a universal challenge for healthy and clinical populations. Recent work suggests these failures may arise from excessive cognitive costs associated with exercising self-control, yet the mechanisms underlying these costs are unknown. To address this, the investigators will use a validated decision-making task that measures how much individuals will pay (from a study endowment) to restrict access to tempting rewards that may lead to self-control failures. The investigators will examine these costs to identify their cognitive, neural and affective mechanisms. First, the investigators will identify the cognitive and computational mechanism that gives rise to self-control costs. Second, the investigators will characterize the neural correlates of self-control costs and identify neural mediators and connectivity patterns stemming from these costs. Finally, the investigators will examine how different classes of stressors (physical, social, or lifetime stress) shape the behavioral and neural representations of self-control costs.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Oct 2024Apr 2028

First Submitted

Initial submission to the registry

March 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

March 21, 2023

Last Update Submit

March 9, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Average Self-Control Cost

    The self-control cost is the amount that a participant would be willing to pay to avoid temptation. This will be tested in a self-control task in which participants are shown an images of snack food and report how much they would be willing to avoid the different food items.

    Day 1

  • Change in fMRI BOLD Signal During Self-Control Decisions

    Functional MRI (fMRI) data will be analyzed to measure changes in blood-oxygen-level-dependent (BOLD) signal in the Dorsal Anterior Cingulate Cortex (dACC), Frontopolar Cortex (FPC) and Orbitofrontal Cortex (OFC) regions of interest as participants make self-control cost decisions during the self-control activity.

    Day 1 (Up to 1.5 Hours)

Study Arms (4)

Physiological Stress

EXPERIMENTAL

Healthy dieters will undergo a single-visit neuroimaging study where they will first complete demographic and self-report measures followed by a self-control decision task in an fMRI scanner. Prior to scanning, participants will be assigned to a physiological stress group and complete the corresponding stress task. For the physiological stress group, this task is the Cold-Pressor Task (CPT), a physiological stress task in which participants continuously submerge their hand and forearm in ice-water (0-4°C) for 3 minutes. After the scan, participants will wait for 1 hour in an adjacent study room where they will play out one trial of the decision-making task completed in the scanner.

Behavioral: Cold-Pressor Task (CPT)Device: Functional Magnetic Resonance Imaging (fMRI)

Social Stress

EXPERIMENTAL

Healthy dieters will undergo a single-visit neuroimaging study where they will first complete demographic and self-report measures followed by a self-control decision task in an fMRI scanner. Prior to scanning, participants will be assigned to the social stress group and complete the corresponding stress task. For the social stress group, this task is the Trier Social Stress Test (TSST), a psychosocial stressor that requires participants perform a short speech and solve math problems in front of 2 evaluative judges. After the scan, participants will wait for 1 hour in an adjacent study room where they will play out one trial of the decision-making task completed in the scanner.

Behavioral: Trier Social Stress Test (TSST)Device: Functional Magnetic Resonance Imaging (fMRI)

Physiological Non-Stress

ACTIVE COMPARATOR

Healthy dieters will undergo a single-visit neuroimaging study where they will first complete demographic and self-report measures followed by a self-control decision task in an fMRI scanner. Prior to scanning, participants will be assigned to the physiological non-stress group and complete the corresponding stress task. For the physiological non-stress group, participants will continuously submerge their hand and forearm in warm water for 3 minutes. After the scan, participants will wait for 1 hour in an adjacent study room where they will play out one trial of the decision-making task completed in the scanner.

Behavioral: Modified Non-Stress CPTDevice: Functional Magnetic Resonance Imaging (fMRI)

Social Non-Stress

ACTIVE COMPARATOR

Healthy dieters will undergo a single-visit neuroimaging study where they will first complete demographic and self-report measures followed by a self-control decision task in an fMRI scanner. Prior to scanning, participants will be assigned to the social stress group and complete the corresponding stress task. For the social non-stress group, participants will be asked to prepare for a speech that they will practice alone to themselves and complete math problems alone on a piece of scrap paper. After the scan, participants will wait for 1 hour in an adjacent study room where they will play out one trial of the decision-making task completed in the scanner.

Behavioral: Modified Non-Stress TSSTDevice: Functional Magnetic Resonance Imaging (fMRI)

Interventions

CPT is a physiological stress task in which participants continuously submerge their hand and forearm in ice-water (0-4°C) for 3 minutes.

Physiological Stress

The TSST is a psychosocial stressor that requires participants perform a short speech and solve math problems in front of 2 evaluative judges.

Social Stress

The modified non-stress CPT involves participants continuously submerging their hand and forearm in warm water for 3 minutes.

Physiological Non-Stress

For the modified non-stress TSST, participants are asked to prepare for a speech that they will practice alone to themselves and complete math problems alone on a piece of scrap paper.

Social Non-Stress

Participants will complete the self-control task in the fMRI scanner.

Physiological Non-StressPhysiological StressSocial Non-StressSocial Stress

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age, able to speak, read, and write fluently in English
  • be willing and able to follow study procedures and provide informed consent.
  • Must additionally confirm they are on a diet to maintain/lose weight and are implementing/maintaining dietary changes.

You may not qualify if:

  • History of or medication for neurologic or psychiatric disease
  • High-blood pressure or heart condition
  • Diabetes, food allergies, metabolic disorders or history of eating disorder
  • Use of corticosteroids or beta-blockers
  • Metallic implants or devices contraindicating magnetic resonance imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Self-Control

Interventions

Psychological TestsMagnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and ActivitiesTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Candace Raio

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Candace Raio

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 3, 2023

Study Start

October 1, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: candace.raio@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to candace.raio@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations