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| Name | Class |
|---|---|
| Virginia Polytechnic Institute and State University | OTHER |
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The proposed research will translate research on delay discounting to the prevention of Type 2 diabetes (T2D) in persons with prediabetes. In this study, the investigators will verify target engagement (DD) by examining if EFT improves DD under conditions shown to increase discounting of the future. Prediabetics will be randomized to receive EFT/ERT in a factorial design when experiencing simulated poverty/neutral conditions, respectively. The effects will be measured on DD. The investigators predict that poverty conditions will increase discounting of the future for ERT subjects, but those receiving EFT will show levels of DD similar to levels observed for participants in the wealth condition.
The prevention of Type 2 diabetes in an obese person with prediabetes requires developing a healthier lifestyle. The rational approach for someone with prediabetes would be to eat healthier, be more active, lose weight, and manage their comorbidities. However, preliminary research suggests that individuals with Type 2 diabetes discount the future and engage in behaviors that maximize current pleasure and short-term gain; thus, daily choices needed to improve future health are rare in this population. Delay discounting (DD) describes the choice of smaller immediate versus larger delayed rewards. This behavioral process is related to a wide variety of health choices, ranging from preventive health to behavioral and medical regimen adherence, including regimens used for Type 2 diabetes. The investigators believe that DD provides a target for one type of self-regulation that can improve a wide variety of health behaviors and medical adherence.
Research from our laboratories has shown that episodic future thinking (EFT), a form of prospection which reduces the bias towards immediate gratification, activates brain regions involved in planning and prospection such that future rewards have increased value and the extent of delay discounting is reduced. Cueing individuals to think about future events during inter-temporal decision-making reduces the rate of DD, eating in and outside of the laboratory, and smoking behavior. The overarching goal of this research is to use an experimental medicine approach to translate basic research on DD and EFT into clinical interventions to prevent the transition from prediabetes to a diagnosis of Type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Episodic Future Thinking (EFT) & Neutral Narrative | Experimental | Participants will complete an episodic thinking task to generate episodic cues where they will list and describe events for different time periods.The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event (e.g., vacations, weddings, parties, and so forth). EFT participants will list positive future events they are looking forward to and list events that could happen at different general future time points (e.g., 1 month, 2-6 months, 7-12 months). Participants will also be asked to think about a neutral narrative that describes a situation in which changes to their income are neutral or minimal |
|
| Episodic Recent Thinking (ERT) & Neutral Narrative | Active Comparator | Participants will complete an episodic recent thinking task to generate episodic cues where they will list and describe events for different time periods. The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event. ERT participants will list positive recent events they enjoyed and list events that happened recently (e.g. 1 - 7 days ago). Participants will also be asked to think about a neutral narrative that describes a situation in which changes to their income are neutral or minimal (e.g. department job transfer). |
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| Episodic Future Thinking (EFT) & Scarcity Narrative | Experimental | Participants will complete an episodic thinking task to generate episodic cues where they will list and describe events for different time periods.The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event (e.g., vacations, weddings, parties, and so forth). EFT participants will list positive future events they are looking forward to and list events that could happen at different general future time points (e.g., 1 month, 2-6 months, 7-12 months). Participants will also be asked to think about a narrative to induce a scarcity mindset by describing a situation in which changes to their income are negative (e.g. loss of job). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Episodic Future Thinking | Behavioral | Participants will be instructed to use their episodic future cues as they engage in different decision making tasks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Delay Discounting | Delay Discounting will be measured using monetary Delay Discounting tasks with $100 as the delayed reward. Delay discounting is assessed using Area Under the Curve (AUC), or time*indifference point/delay. AUC for delay discounting included time (x-axis) and indifference point (y-axis), or the amount of money at which the immediate and delayed options are approximately equal. Indifference points are a percentage of the max amount (range 0 - 100). AUC adds the calculated areas for each timepoint from the previous timepoint. Ordinal AUC was used as the measure. Ordinal AUC normalizes the horizontal axis time points to have equal distances between them. AUC ranges from 0 (most impulsive, did not choose delay) to 100 (least impulsive, always chose delay). This is the difference in delay discounting between session 2 and session 1. Larger numbers indicate a decrease in discounting, or less impulsive, while smaller/negative numbers indicate an increase in discounting, or more impulsive. | Delay Discounting will be measured at baseline (session 1) and after receiving EFT/ERT and Scarcity/Narrative (within about 2 weeks) |
| Reinforcing Value of Food | Reinforcing value of food was measured using the relative reinforcing efficacy questionnaire in which participants are asked how many portions of food they would purchase at various prices. Intensity is the number of portions they would purchase and consume when the price is $0. | Session 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Working Memory Span | Backwards Corsi is a task that assesses visuo-spatial short term working memory. Participants are asked to watch a series of squares on a computer screen and repeat the sequence backwards. This is done several times and the highest number of correctly remembered locations is the span score, with a possible score of 2 - 9 locations total. Span score represents the number of locations that can be recalled backwards. Larger span scores indicate more locations can be remembered and recalled correctly backwards. This is the difference in score between session 2 and session 1. Larger numbers indicate greater change during the experimental manipulation or better working memory, while smaller or negative numbers indicates lower working memory during the experimental manipulation versus baseline. Numbers close to 0 represent little to no change. |
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Inclusion Criteria:
Exclusion Criteria:
Prior participation in similar studies: Individuals who have recently participated in a laboratory study using similar methods may also be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Leonard H Epstein | SUNY University at Buffalo | Principal Investigator |
| Warren K Bickel | Virginia Polytechnic Institute and State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine | Buffalo | New York | 14214 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32989616 | Derived | Stein JS, Craft WH, Paluch RA, Gatchalian KM, Greenawald MH, Quattrin T, Mastrandrea LD, Epstein LH, Bickel WK. Bleak present, bright future: II. Combined effects of episodic future thinking and scarcity on delay discounting in adults at risk for type 2 diabetes. J Behav Med. 2021 Apr;44(2):222-230. doi: 10.1007/s10865-020-00178-7. Epub 2020 Sep 28. | |
| 32868537 | Derived | Bickel WK, Stein JS, Paluch RA, Mellis AM, Athamneh LN, Quattrin T, Greenawald MH, Bree KA, Gatchalian KM, Mastrandrea LD, Epstein LH. Does Episodic Future Thinking Repair Immediacy Bias at Home and in the Laboratory in Patients With Prediabetes? Psychosom Med. 2020 Sep;82(7):699-707. doi: 10.1097/PSY.0000000000000841. |
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It is not yet known if there will be a plan to make IPD available
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Participants completed a screening session prior to randomization (n = 149), in which they completed baseline measures of delay discounting and food reinforcement. 78 participants were eligible and randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will also be asked to think about a narrative to induce a scarcity mindset by describing a situation in which changes to their income are negative (e.g. loss of job). |
| FG001 | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Future Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will also be asked to think about a neutral narrative that describes a situation in which changes to their income are neutral or minimal (e.g. department job transfer). |
| FG002 | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will also be asked to think about a narrative to induce a scarcity mindset by describing a situation in which changes to their income are negative (e.g. loss of job). |
| FG003 | Episodic Recent Thinking (ERT) & Neutral Narrative | Episodic Recent Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will also be asked to think about a neutral narrative that describes a situation in which changes to their income are neutral or minimal (e.g. department job transfer). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will read a narrative to induce a scarcity mindset, in which they are asked to imagine a scenario in which they have lost their job and have no current secondary income. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Delay Discounting | Delay Discounting will be measured using monetary Delay Discounting tasks with $100 as the delayed reward. Delay discounting is assessed using Area Under the Curve (AUC), or time*indifference point/delay. AUC for delay discounting included time (x-axis) and indifference point (y-axis), or the amount of money at which the immediate and delayed options are approximately equal. Indifference points are a percentage of the max amount (range 0 - 100). AUC adds the calculated areas for each timepoint from the previous timepoint. Ordinal AUC was used as the measure. Ordinal AUC normalizes the horizontal axis time points to have equal distances between them. AUC ranges from 0 (most impulsive, did not choose delay) to 100 (least impulsive, always chose delay). This is the difference in delay discounting between session 2 and session 1. Larger numbers indicate a decrease in discounting, or less impulsive, while smaller/negative numbers indicate an increase in discounting, or more impulsive. | Posted | Mean | Standard Deviation | time*indifference point/delay | Delay Discounting will be measured at baseline (session 1) and after receiving EFT/ERT and Scarcity/Narrative (within about 2 weeks) |
|
Adverse event data was examined between the initial session and the second session (about 2 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will read a narrative to induce a scarcity mindset, in which they are asked to imagine a scenario in which they have lost their job and have no current secondary income. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leonard H. Epstein | University at Buffalo | 716-829-3400 | lhenet@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2018 | Jul 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000085222 | Water Insecurity |
| ID | Term |
|---|---|
| D060766 | Drinking Water |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Participants will be assigned to complete an episodic future or recent thinking task and asked to describe positive events for different time periods.
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|
| Episodic Recent Thinking (ERT) & Scarcity Narrative | Experimental | Participants will complete an episodic recent thinking task to generate episodic cues where they will list and describe events for different time periods. The episodic component of the thinking task will occur while the participants are asked to describe what they are imagining about each event. ERT participants will list positive recent events they enjoyed and list events that happened recently (e.g. 1 - 7 days ago). Participants will also be asked to think about a narrative to induce a scarcity mindset by describing a situation in which changes to their income are negative (e.g. loss of job). |
|
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| Episodic Recent Thinking | Behavioral | Participants will be instructed to use their episodic recent cues as they engage in different decision making tasks. |
|
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| Scarcity Narrative | Behavioral | Participants will read a narrative to induce a scarcity mindset, in which they are asked to imagine a scenario in which they have lost their job and have no current secondary income. |
|
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| Neutral Narrative | Behavioral | Participants will read a narrative in which they are asked to imagine a scenario in which they have been transferred between departmental jobs, with little change in salary/commute. |
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| Working Memory will be measured at baseline (session 1) and after receiving EFT/ERT Scarcity/Neutral intervention (up to 2 weeks post-baseline) |
| Fralin Biomedical Research Institute, Virginia Tech Carilion |
| Roanoke |
| Virginia |
| 24016 |
| United States |
| BG001 | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Future Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will read a narrative in which they are asked to imagine a scenario in which they have been transferred between departmental jobs, with little change in salary/commute. |
| BG002 | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will read a narrative to induce a scarcity mindset, in which they are asked to imagine a scenario in which they have lost their job and have no current secondary income. |
| BG003 | Episodic Recent Thinking (ERT) & Neutral Narrative | Episodic Recent Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will read a narrative in which they are asked to imagine a scenario in which they have been transferred between departmental jobs, with little change in salary/commute. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| hbA1c | Count of Participants | Participants |
|
| Delay discounting | Area under the curve (AUC) for delay discounting included time (x-axis) and indifference point (y-axis), or the amount of money at which the immediate and delayed options are approximately equal. Indifference points are a percentage of the max amount (range 0 - 100). AUC adds the calculated areas for each timepoint from the previous timepoint. Ordinal AUC was used as the measure. Ordinal AUC normalizes the horizontal axis time points to have equal distances between them. AUC ranges from 0 (most impulsive, did not choose delay) to 100 (least impulsive, always chose delay). | Mean | Standard Deviation | time*indifference point/delay |
|
| Site Enrollment | Count of Participants | Participants |
|
| Reinforcing Value of Food; Intensity | Reinforcing value of food, intensity represents the number of pre-specified portions of food a person would consume when the price is $0/per portion. | Two participants did not complete the relative reinforcing value of food questionnaire at baseline. | Mean | Standard Deviation | number of food portions |
|
| Title |
|---|
| Description |
|---|
| OG000 | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will also be asked to think about a narrative to induce a scarcity mindset by describing a situation in which changes to their income are negative (e.g. loss of job). |
| OG001 | Episodic Future Thinking (EFT) and Neutral Narrative | Episodic Future Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will also be asked to think about a neutral narrative that describes a situation in which changes to their income are neutral or minimal (e.g. department job transfer). |
| OG002 | Episodic Recent Thinking (ERT) and Scarcity Narrative | Episodic Recent Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will also be asked to think about a narrative to induce a scarcity mindset by describing a situation in which changes to their income are negative (e.g. loss of job). |
| OG003 | Episodic Recent Thinking (ERT) & Neutral Narrative | Episodic Recent Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will also be asked to think about a neutral narrative that describes a situation in which changes to their income are neutral or minimal (e.g. department job transfer). |
|
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| Primary | Reinforcing Value of Food | Reinforcing value of food was measured using the relative reinforcing efficacy questionnaire in which participants are asked how many portions of food they would purchase at various prices. Intensity is the number of portions they would purchase and consume when the price is $0. | Two participants did not complete Reinforcing value measures | Posted | Mean | Standard Deviation | number of food portions purchased at $0 | Session 2 |
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| Secondary | Change in Working Memory Span | Backwards Corsi is a task that assesses visuo-spatial short term working memory. Participants are asked to watch a series of squares on a computer screen and repeat the sequence backwards. This is done several times and the highest number of correctly remembered locations is the span score, with a possible score of 2 - 9 locations total. Span score represents the number of locations that can be recalled backwards. Larger span scores indicate more locations can be remembered and recalled correctly backwards. This is the difference in score between session 2 and session 1. Larger numbers indicate greater change during the experimental manipulation or better working memory, while smaller or negative numbers indicates lower working memory during the experimental manipulation versus baseline. Numbers close to 0 represent little to no change. | Five participants did not complete both measures of the spatial span task. | Posted | Mean | Standard Deviation | number of locations | Working Memory will be measured at baseline (session 1) and after receiving EFT/ERT Scarcity/Neutral intervention (up to 2 weeks post-baseline) |
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|
|
| 0 |
| 21 |
| 0 |
| 20 |
| 0 |
| 21 |
| EG001 | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Future Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will read a narrative in which they are asked to imagine a scenario in which they have been transferred between departmental jobs, with little change in salary/commute. | 0 | 20 | 0 | 21 | 0 | 20 |
| EG002 | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will read a narrative to induce a scarcity mindset, in which they are asked to imagine a scenario in which they have lost their job and have no current secondary income. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG003 | Episodic Recent Thinking (ERT) & Neutral Narrative | Episodic Recent Thinking: Participants will be instructed to use their episodic cues as they engage in different decision making tasks Narrative: Participants will read a narrative in which they are asked to imagine a scenario in which they have been transferred between departmental jobs, with little change in salary/commute. | 0 | 19 | 0 | 19 | 0 | 19 |
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| D004700 | Endocrine System Diseases |
| D019602 |
| Food and Beverages |
| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| HbA1c %5.7-6.4 |
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