An interventional study of Episodic Future Thinking and Episodic Recent Thinking in PreDiabetes, sponsored by Leonard Epstein. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Leonard Epstein · Not applicable, Interventional, and Basic science
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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This study's enrollment of 78 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.
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Exclusion Criteria:
Prior participation in similar studies: Individuals who have recently participated in a laboratory study using similar methods may also be excluded.
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
Behavioral: Episodic Future Thinking · Behavioral: Neutral Narrative
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).
Behavioral: Episodic Recent Thinking · Behavioral: Neutral Narrative
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).
Behavioral: Episodic Future Thinking · Behavioral: Scarcity Narrative
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).
Behavioral: Episodic Recent Thinking · Behavioral: Scarcity Narrative
Participants will be instructed to use their episodic future cues as they engage in different decision making tasks.
Also known as: EFT
Participants will be instructed to use their episodic recent cues as they engage in different decision making tasks.
Also known as: ERT
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.
Also known as: Scarcity
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.
Also known as: Neutral
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.
Time frame: 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.
Time frame: Session 2
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.
Time frame: Working Memory will be measured at baseline (session 1) and after receiving EFT/ERT Scarcity/Neutral intervention (up to 2 weeks post-baseline)
| Milestone | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking (ERT) & Neutral Narrative |
|---|---|---|---|---|
| Started | 21 | 20 | 18 | 19 |
| Completed | 21 | 20 | 18 | 19 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| time*indifference point/delay | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking (EFT) and Neutral Narrative | Episodic Recent Thinking (ERT) and Scarcity Narrative | Episodic Recent Thinking (ERT) & Neutral Narrative |
|---|---|---|---|---|
| Change in Delay Discounting | -0.002 ± 0.032 | 0.108 ± 0.032 | -0.069 ± 0.034 | 0.035 ± 0.033 |
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.
| number of food portions purchased at $0 | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking (ERT) & Neutral Narrative |
|---|---|---|---|---|
| Reinforcing Value of Food | 9.9 ± 2.4 | 10.7 ± 2.5 | 10.6 ± 2.5 | 7.4 ± 2.5 |
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.
| number of locations | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Recent Thinking (ERT) & Neutral Narrative | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Recent Thinking (ERT) & Scarcity Narrative |
|---|---|---|---|---|
| Change in Working Memory Span | 0.05 ± 0.48 | 0.41 ± 0.51 | 0.72 ± 0.49 | 0.16 ± 0.48 |
Collected over Adverse event data was examined between the initial session and the second session (about 2 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Episodic Future Thinking (EFT) & Scarcity Narrative | 0/21 (0%) | 0/20 (0%) | 0/21 (0%) |
| Episodic Future Thinking (EFT) & Neutral Narrative | 0/20 (0%) | 0/21 (0%) | 0/20 (0%) |
| Episodic Recent Thinking (ERT) & Scarcity Narrative | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Episodic Recent Thinking (ERT) & Neutral Narrative | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking (ERT) & Neutral Narrative | Total |
|---|---|---|---|---|---|
| Mean | 47.57 ± 12.72 | 50.55 ± 34.45 | 50.61 ± 10.41 | 52.89 ± 11.38 | 50.33 ± 12.51 |
| Sex: Female, Male(Participants) | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking (ERT) & Neutral Narrative | Total |
|---|---|---|---|---|---|
| Female | 17 | 15 | 13 | 16 | 61 |
| Male | 4 | 5 | 5 | 3 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking (ERT) & Neutral Narrative | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 0 | 0 | 2 |
| Not Hispanic or Latino | 19 | 19 | 16 | 19 | 73 |
| Unknown or Not Reported | 0 | 1 | 2 | 0 | 3 |
| Race (NIH/OMB)(Participants) | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking (ERT) & Neutral Narrative | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 | 0 | 2 |
| Asian | 0 | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 5 | 8 | 6 | 9 | 28 |
| White | 14 | 11 | 8 | 10 | 43 |
| More than one race | 1 | 0 | 2 | 0 | 3 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking (ERT) & Neutral Narrative | Total |
|---|---|---|---|---|---|
| United States | 21 | 20 | 18 | 19 | 78 |
| hbA1c(Participants) | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking (ERT) & Neutral Narrative | Total |
|---|---|---|---|---|---|
| HbA1c % 5.4-5.6 | 11 | 10 | 10 | 9 | 40 |
| HbA1c %5.7-6.4 | 10 | 10 | 8 | 10 | 38 |
| Delay discounting(time*indifference point/delay) | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking (ERT) & Neutral Narrative | Total |
|---|---|---|---|---|---|
| $100 Delay Discounting | 0.54 ± 0.16 | 0.49 ± 0.17 | 0.52 ± 0.18 | 0.51 ± 0.20 | 0.51 ± 0.17 |
| $1000 Delay Discounting | 0.61 ± 0.19 | 0.57 ± 0.21 | 0.60 ± 0.23 | 0.59 ± 0.20 | 0.59 ± 0.21 |
| Site Enrollment(Participants) | Episodic Future Thinking (EFT) & Scarcity Narrative | Episodic Future Thinking (EFT) & Neutral Narrative | Episodic Recent Thinking (ERT) & Scarcity Narrative | Episodic Recent Thinking (ERT) & Neutral Narrative | Total |
|---|---|---|---|---|---|
| University at Buffalo | 12 | 13 | 11 | 11 | 47 |
| Virginia Tech Carilon | 9 | 7 | 7 | 8 | 31 |
1 further baseline measures are reported on the registry.
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Plan to share: Undecided — It is not yet known if there will be a plan to make IPD available
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