MINDD 3: Prediabetes and Delay Discounting

NCT03664726 | Completed Results

• 1 other identifier: UH2DK109543-02
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

PreDiabetes

Keywords

Delay Discounting, Episodic Future Thinking

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Change in Working Memory Span

  Working Memory will be measured at baseline (session 1) and after receiving EFT/ERT Scarcity/Neutral intervention (up to 2 weeks post-baseline)

Study Arms (4)

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

Behavioral: Episodic Future Thinking; Behavioral: Neutral Narrative

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).

Behavioral: Episodic Recent Thinking; Behavioral: Neutral Narrative

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).

Behavioral: Episodic Future Thinking; Behavioral: Scarcity Narrative

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).

Behavioral: Episodic Recent Thinking; Behavioral: Scarcity Narrative

Interventions

Episodic Future Thinking BEHAVIORAL

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

Also known as: EFT

Episodic Future Thinking (EFT) & Neutral Narrative; Episodic Future Thinking (EFT) & Scarcity Narrative

Episodic Recent Thinking BEHAVIORAL

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

Also known as: ERT

Episodic Recent Thinking (ERT) & Neutral Narrative; Episodic Recent Thinking (ERT) & Scarcity Narrative

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.

Also known as: Scarcity

Episodic Future Thinking (EFT) & Scarcity Narrative; Episodic Recent Thinking (ERT) & Scarcity Narrative

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.

Also known as: Neutral

Episodic Future Thinking (EFT) & Neutral Narrative; Episodic Recent Thinking (ERT) & Neutral Narrative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leonard Epstein: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (2)

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

Buffalo, New York, 14214, United States

Location

Fralin Biomedical Research Institute, Virginia Tech Carilion

Roanoke, Virginia, 24016, United States

Location

Related Publications (2)

• 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.

  PMID: 32989616 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.

  PMID: 32868537 DERIVED

MeSH Terms

Conditions

Prediabetic State

Interventions

Water Insecurity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Drinking Water; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Leonard H. Epstein
• Organization: University at Buffalo

lhenet@buffalo.edu

716-829-3400

Study Officials

• Leonard H Epstein

  SUNY University at Buffalo

  PRINCIPAL INVESTIGATOR

• Warren K Bickel

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: September 10, 2018
• Study Start: February 12, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: February 21, 2023
• Results First Posted: August 4, 2022

Record last verified: 2023-02

Locations

US (2)