An interventional study of Now vs. Later Cue and fMRI in Binge Eating, Smoking, Tobacco and Behavior, sponsored by Stanford University. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Stanford University · Not applicable, Interventional, and Basic science
This study aims to examine targets of self-regulatory function among two exemplar populations for which behavior plays a critical role in health outcomes: smokers and individual who binge eat (BED). This is the second phase of a study that aims to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.
Health risk behavior, including poor diet, physical inactivity, tobacco and other substance use, causes as much as 40% of the illness, suffering, and early death related to chronic diseases. Non-adherence to medical regimens is an important exemplar of the challenges in changing health risk behavior -- and is common, costly (due to increased utilization of healthcare services), and associated with poor patient outcomes. This may be particularly evident among older adults who experience a disproportionate amount of the chronic disease burden in the U.S. Although an array of interventions have been shown to be effective in promoting health behavior change, much of this work has been siloed (focused on one disorder at a time).
Additionally, interventions are typically intended to engage multiple mechanisms of behavior change, but the mechanisms by which they actually work are infrequently systematically examined. Because the need to alter health-related behavior is ubiquitous across medicine, understanding the extent to which the principles of effective health behavior change, and the mechanisms by which they work, are similar or differ across health conditions and settings is a critically important area of scientific inquiry. Improving medical regimen adherence and promoting health behavior change are also crucial issues in the changing healthcare landscape, where quality, value, cost and patient-centered care are central. This line of research may allow for great strides in crafting "precision medicine" approaches for a wide array of populations.
One promising domain of putative behavior change targets is that of self-regulation -- a person's ability to manage cognitive, motivational and emotional resources to act in accordance with his/her long-term goals. In this proposal, the investigators have assembled an outstanding interdisciplinary team to 'scale up' this work to an unprecedented level by examining putative targets of behavior change within the self-regulation mechanism domain across contexts, populations, and assays - in 3 primary levels of analysis: (1) psychological (e.g., constructs such as self-efficacy; emotion regulation; response inhibition), (2) behavioral (e.g., tasks of reward responsiveness; temporal horizon), and (3) biological (structural and functional MRI of key neural circuitry). The investigators will conduct this work with two exemplar populations for which behavior plays a critical role in the course of medical regimen adherence, health, and health outcomes: (1) smokers and (2) binge eaters.
In these groups, the investigators will evaluate the extent to which participants can engage and manipulate putative targets within the self-regulation domain both within and outside of laboratory settings. 50 smokers and 50 obese/overweight persons will participate in a lab study to complete the identified tasks.
The investigators will experimentally modulate engagement of targets (e.g., stimulus set of palatable foods images or tobacco-related images as well as self-regulation interventions).
Subjects will participate in a 30 minute introductory session and a single testing session at Stanford, which will include testing using a subset of self-regulatory tasks from the following list (stop-signal task, conditional motor selective stop signal task, Stroop task, dot pattern expectancy task, attention network task, Columbia card task, task switching, delay discounting task, tower of Hanoi, and emotion regulation task). The order of assessments will be counterbalanced across subjects. Imaging will allow an assessment of the degree to which the neural systems associated with each element in the ontology can be engaged and manipulated in the clinical samples. Imaging will be performed at the Stanford Center for Neurobiological Imaging, which has a research-dedicated 3T GE MRI scanner with all necessary accessories for stimulation and recording. In addition to task-based fMRI, the investigators will collect resting-state fMRI while passively viewing either a blank screen or a movie that may include smoking or food-related stimuli. The proposed sample size of 50 per clinical group will provide sufficient power to detect delta=0.56 between groups, and a correlation of r=0.2 across the aggregated sample.
As the investigators collect data from all participants, they will include manipulations (or "motivating operations") meant to modulate putative targets within the self-regulation domain in each clinical group - to assess the extent to which participants can shift self-regulatory function both in desired and undesired directions. This will be achieved by (1) exposing subjects to specific stimulus sets relevant to the sample that may promote engagement of appetitive drives (images of highly palatable foods for obese individuals, and tobacco-related images or smokers), and (2) exposing them to an instructional manipulation ("now" vs "later" cues that instruct subjects to engage with the immediate hedonistic properties of the stimulus or the long-term consequences of using the stimulus, respectively) designed to engage self-regulatory processes in the presence of these stimulus sets.
173 studies on the registry are indexed under Bulimia; 33 are open to participants now.
This study's enrollment of 115 is above the median of 60 across 143 interventional studies indexed under Bulimia.
Browse Bulimia studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional Inclusion Criteria for Smoking sample:
Additional Inclusion Criteria for Binge Eating Sample:
Exclusion Criteria:
Additional Exclusion criteria for Binge Eating Sample:
Additional Exclusion Criteria for Smoking Sample:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
(1) exposing subjects to specific stimulus sets relevant to the sample that may promote engagement of appetitive drives (images of highly palatable foods for obese individuals), and (2) exposing them to an instructional manipulation designed to engage self-regulatory processes in the presence of these stimulus sets. Specifically, participants in this sample will be exposed to images of food and control non-food images. In different trials, subjects will be given a "now" cue instructing them to engage with the immediate hedonic properties of the stimulus or a "later" cue instructing them to imagine the long-term consequences of using the stimulus. This arm includes fMRI and the now vs. later cue intervention
Behavioral: Now vs. Later Cue · Device: fMRI
(1) exposing subjects to specific stimulus sets relevant to the sample that may promote engagement of appetitive drives (tobacco-related images or smokers), and (2) exposing them to an instructional manipulation designed to engage self-regulatory processes in the presence of these stimulus sets. A similar approach to the Binge Eating sample will be used for the smoking sample using two stimulus sets. Instead of foods and non-food control images, smokers will see smoking-related images and the same control non-food non-smoking images as the Binge Eating sample. This Arm includes fMRI and the now vs. later cue intervention
Behavioral: Now vs. Later Cue · Device: fMRI
As we collect data from all participants, we will include manipulations (or "motivating operations") meant to modulate putative targets within the self-regulation domain in each clinical group - to assess the extent to which we can shift self-regulatory function both in desired and undesired directions. More specifically, subjects will see a "now" cue instructing them to think of immediately using/consuming that stimulus or a "later" cue instruction them to think about the long-term consequences of using/consuming that stimulus. The latter cue is intended to down-regulate desire to use/consume the stimulus, and this down-regulation is measured by a subsequent probe asking subjects the degree to which they want to use/consume that stimulus.
Subjects will complete the tasks inside a functional magnetic resonance imaging device, allowing us to measure brain activity that while completing each task.
Behavioral Regulation
Interaction of stimulus class, which is the stimulus of value (smoking stimuli for smokers and palatable foods for binge eaters) vs. neutral control stimuli, with the cue, which is the now vs. later cue. The degree to which subjects can regulate their desire to consume their stimulus of value after a later cue is evidence of successful self regulation.
Time frame: A single 1.5 hour session for each subject
Regulation of fMRI activation
Interaction of stimulus class, which is the stimulus of value (smoking stimuli for smokers and palatable foods for binge eaters) vs. neutral control stimuli, with the cue, which is the now vs. later cue. The fMRI activation relating to this interaction is taken as the activation-based neural underpinnings of self-regulation.
Time frame: A single 1.5 hour session for each subject
Changes in fMRI functional connectivity
Interaction of stimulus class, which is the stimulus of value (smoking stimuli for smokers and palatable foods for binge eaters) vs. neutral control stimuli, with the cue, which is the now vs. later cue. The fMRI functional connectivity changes relating to this interaction is taken as the connectivity-based neural underpinnings of self-regulation.
Time frame: A single 1.5 hour session for each subject
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data for all outcome measures will be made available
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Upon submission of the paper detailing the findings of the research
Access criteria: All data will be shared openly, with no restrictions on access
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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