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MINDD 3: Prediabetes and Delay Discounting (MINDD)

Primary Purpose

PreDiabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Episodic Future Thinking

Episodic Recent Thinking

Scarcity Narrative

Neutral Narrative

About this trial

This is an interventional basic science trial for PreDiabetes focused on measuring Delay Discounting, Episodic Future Thinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Prediabetes: Participants must have a diagnosis of prediabetes within the last 2 years or meet criteria for prediabetes. The American Diabetes Association guidelines defines prediabetes as Fasting Plasma Glucose (FPG) 100-125 mg/dl, 2h glucose 140-199 mg/dl after Oral Glucose Tolerance Test (OGTT), or hemoglobin A1c (HbA1c) approximately 5.7-6.4%.
Comorbidities: Participants must have a history of comorbid diagnosis such as hypertension and/or hyperlipidemia to participate in the behavioral portion of this study. Hypertension is defined as blood pressure greater than 140/90 on two separate occasions at least one week apart, or medical management for hypertension (i.e. medications including Lisinopril and Diovan). Dyslipidemia is defined by LDL greater than 130 mg/dl, or non-fasting non HDL cholesterol ≥160mg/dL or medical management for dyslipidemia (medications including Niacin, Lovastatin).

Exclusion Criteria:

Type 2 Diabetes: Individuals will be excluded if they have Type 2 Diabetes.
Pregnancy: Women who are pregnant or lactating will be excluded from participation.
Conditions that affect adherence: Participants should not have a condition that would limit participation which include medical conditions that would affect individuals' ability to use the computer for prolonged period of time; leave the individual unable to ambulate; or current diagnoses of an eating disorder (anorexia, bulimia,), unmanaged psychiatric disorder (depression, anxiety, attention deficit hyperactivity disorder (ADHD), schizophrenia), or an intellectual impairment that would impact study adherence.
Abnormal glucose related to medications: Participants should not be taking medications that would limit participation and cause abnormal glucose levels (e.g. atypical antipsychotic medications or glucocorticoids) including diabetic drugs such as Metformin.
Unwilling or unable to eat study food: Participants who are unwilling or not able to eat the study food (a PowerBar) will not be able to take part in this study.

Prior participation in similar studies: Individuals who have recently participated in a laboratory study using similar methods may also be excluded.

Do not meet discounting criteria: Individuals who do not meet discounting criteria (e.g. nonsystematic discounting) on a delay discounting task may be excluded.

Sites / Locations

University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine
Fralin Biomedical Research Institute, Virginia Tech Carilion

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Episodic Future Thinking (EFT) & Neutral Narrative

Episodic Recent Thinking (ERT) & Neutral Narrative

Episodic Future Thinking (EFT) & Scarcity Narrative

Episodic Recent Thinking (ERT) & Scarcity Narrative

Arm Description

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

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).

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).

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).

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03664726

First Posted

April 4, 2018

Last Updated

February 16, 2023

Sponsor

Leonard Epstein

Collaborators

Virginia Polytechnic Institute and State University

1. Study Identification

Unique Protocol Identification Number

NCT03664726

Brief Title

MINDD 3: Prediabetes and Delay Discounting

Acronym

MINDD

Official Title

Delay Discounting as a Target for Self-Regulation in Prediabetes

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

February 12, 2018 (Actual)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Leonard Epstein

Collaborators

Virginia Polytechnic Institute and State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PreDiabetes

Keywords

Delay Discounting, Episodic Future Thinking

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

Participants will be assigned to complete an episodic future or recent thinking task and asked to describe positive events for different time periods.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Episodic Future Thinking (EFT) & Neutral Narrative

Arm Type

Experimental

Arm Description

Arm Title

Episodic Recent Thinking (ERT) & Neutral Narrative

Arm Type

Active Comparator

Arm Description

Arm Title

Episodic Future Thinking (EFT) & Scarcity Narrative

Arm Type

Experimental

Arm Description

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).

Arm Title

Episodic Recent Thinking (ERT) & Scarcity Narrative

Arm Type

Experimental

Arm Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Episodic Future Thinking

Other Intervention Name(s)

EFT

Intervention Description

Participants will be instructed to use their episodic future cues as they engage in different decision making tasks.

Intervention Type

Behavioral

Intervention Name(s)

Episodic Recent Thinking

Other Intervention Name(s)

ERT

Intervention Description

Participants will be instructed to use their episodic recent cues as they engage in different decision making tasks.

Intervention Type

Behavioral

Intervention Name(s)

Scarcity Narrative

Other Intervention Name(s)

Scarcity

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Neutral Narrative

Other Intervention Name(s)

Neutral

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Delay Discounting

Description

Time Frame

Delay Discounting will be measured at baseline (session 1) and after receiving EFT/ERT and Scarcity/Narrative (within about 2 weeks)

Title

Reinforcing Value of Food

Description

Time Frame

Session 2

Secondary Outcome Measure Information:

Title

Change in Working Memory Span

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Prediabetes: Participants must have a diagnosis of prediabetes within the last 2 years or meet criteria for prediabetes. The American Diabetes Association guidelines defines prediabetes as Fasting Plasma Glucose (FPG) 100-125 mg/dl, 2h glucose 140-199 mg/dl after Oral Glucose Tolerance Test (OGTT), or hemoglobin A1c (HbA1c) approximately 5.7-6.4%. Comorbidities: Participants must have a history of comorbid diagnosis such as hypertension and/or hyperlipidemia to participate in the behavioral portion of this study. Hypertension is defined as blood pressure greater than 140/90 on two separate occasions at least one week apart, or medical management for hypertension (i.e. medications including Lisinopril and Diovan). Dyslipidemia is defined by LDL greater than 130 mg/dl, or non-fasting non HDL cholesterol ≥160mg/dL or medical management for dyslipidemia (medications including Niacin, Lovastatin). Exclusion Criteria: Type 2 Diabetes: Individuals will be excluded if they have Type 2 Diabetes. Pregnancy: Women who are pregnant or lactating will be excluded from participation. Conditions that affect adherence: Participants should not have a condition that would limit participation which include medical conditions that would affect individuals' ability to use the computer for prolonged period of time; leave the individual unable to ambulate; or current diagnoses of an eating disorder (anorexia, bulimia,), unmanaged psychiatric disorder (depression, anxiety, attention deficit hyperactivity disorder (ADHD), schizophrenia), or an intellectual impairment that would impact study adherence. Abnormal glucose related to medications: Participants should not be taking medications that would limit participation and cause abnormal glucose levels (e.g. atypical antipsychotic medications or glucocorticoids) including diabetic drugs such as Metformin. Unwilling or unable to eat study food: Participants who are unwilling or not able to eat the study food (a PowerBar) will not be able to take part in this study. Prior participation in similar studies: Individuals who have recently participated in a laboratory study using similar methods may also be excluded. Do not meet discounting criteria: Individuals who do not meet discounting criteria (e.g. nonsystematic discounting) on a delay discounting task may be excluded.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leonard H Epstein

Organizational Affiliation

SUNY University at Buffalo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Warren K Bickel

Organizational Affiliation

Virginia Polytechnic Institute and State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University at Buffalo, Department of Pediatrics, Division of Behavioral Medicine

City

Buffalo

State/Province

New York

ZIP/Postal Code

14214

Country

United States

Facility Name

Fralin Biomedical Research Institute, Virginia Tech Carilion

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

It is not yet known if there will be a plan to make IPD available

Citations:

PubMed Identifier

32989616

Citation

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.

Results Reference

derived

PubMed Identifier

32868537

Citation

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.

Results Reference

derived

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MINDD 3: Prediabetes and Delay Discounting

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