Trial Outcomes & Findings for MINDD 3: Prediabetes and Delay Discounting (NCT NCT03664726)
NCT ID: NCT03664726
Last Updated: 2023-02-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
78 participants
Primary outcome timeframe
Delay Discounting will be measured at baseline (session 1) and after receiving EFT/ERT and Scarcity/Narrative (within about 2 weeks)
Results posted on
2023-02-21
Participant Flow
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
Participant milestones
| Measure |
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).
|
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).
|
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).
|
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).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
18
|
19
|
|
Overall Study
COMPLETED
|
21
|
20
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two participants did not complete the relative reinforcing value of food questionnaire at baseline.
Baseline characteristics by cohort
| Measure |
Episodic Future Thinking (EFT) & Scarcity Narrative
n=21 Participants
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.
|
Episodic Future Thinking (EFT) & Neutral Narrative
n=20 Participants
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.
|
Episodic Recent Thinking (ERT) & Scarcity Narrative
n=18 Participants
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.
|
Episodic Recent Thinking (ERT) & Neutral Narrative
n=19 Participants
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.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.57 years
STANDARD_DEVIATION 12.72 • n=21 Participants
|
50.55 years
STANDARD_DEVIATION 34.45 • n=20 Participants
|
50.61 years
STANDARD_DEVIATION 10.41 • n=18 Participants
|
52.89 years
STANDARD_DEVIATION 11.38 • n=19 Participants
|
50.33 years
STANDARD_DEVIATION 12.51 • n=78 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=21 Participants
|
15 Participants
n=20 Participants
|
13 Participants
n=18 Participants
|
16 Participants
n=19 Participants
|
61 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=21 Participants
|
5 Participants
n=20 Participants
|
5 Participants
n=18 Participants
|
3 Participants
n=19 Participants
|
17 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=21 Participants
|
19 Participants
n=20 Participants
|
16 Participants
n=18 Participants
|
19 Participants
n=19 Participants
|
73 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=78 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=21 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=21 Participants
|
8 Participants
n=20 Participants
|
6 Participants
n=18 Participants
|
9 Participants
n=19 Participants
|
28 Participants
n=78 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=21 Participants
|
11 Participants
n=20 Participants
|
8 Participants
n=18 Participants
|
10 Participants
n=19 Participants
|
43 Participants
n=78 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=21 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=78 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=21 Participants
|
20 participants
n=20 Participants
|
18 participants
n=18 Participants
|
19 participants
n=19 Participants
|
78 participants
n=78 Participants
|
|
hbA1c
HbA1c % 5.4-5.6
|
11 Participants
n=21 Participants
|
10 Participants
n=20 Participants
|
10 Participants
n=18 Participants
|
9 Participants
n=19 Participants
|
40 Participants
n=78 Participants
|
|
hbA1c
HbA1c %5.7-6.4
|
10 Participants
n=21 Participants
|
10 Participants
n=20 Participants
|
8 Participants
n=18 Participants
|
10 Participants
n=19 Participants
|
38 Participants
n=78 Participants
|
|
Delay discounting
$100 Delay Discounting
|
0.54 time*indifference point/delay
STANDARD_DEVIATION 0.16 • n=21 Participants
|
0.49 time*indifference point/delay
STANDARD_DEVIATION 0.17 • n=20 Participants
|
0.52 time*indifference point/delay
STANDARD_DEVIATION 0.18 • n=18 Participants
|
0.51 time*indifference point/delay
STANDARD_DEVIATION 0.20 • n=19 Participants
|
0.51 time*indifference point/delay
STANDARD_DEVIATION 0.17 • n=78 Participants
|
|
Delay discounting
$1000 Delay Discounting
|
0.61 time*indifference point/delay
STANDARD_DEVIATION 0.19 • n=21 Participants
|
0.57 time*indifference point/delay
STANDARD_DEVIATION 0.21 • n=20 Participants
|
0.60 time*indifference point/delay
STANDARD_DEVIATION 0.23 • n=18 Participants
|
0.59 time*indifference point/delay
STANDARD_DEVIATION 0.20 • n=19 Participants
|
0.59 time*indifference point/delay
STANDARD_DEVIATION 0.21 • n=78 Participants
|
|
Site Enrollment
University at Buffalo
|
12 Participants
n=21 Participants
|
13 Participants
n=20 Participants
|
11 Participants
n=18 Participants
|
11 Participants
n=19 Participants
|
47 Participants
n=78 Participants
|
|
Site Enrollment
Virginia Tech Carilon
|
9 Participants
n=21 Participants
|
7 Participants
n=20 Participants
|
7 Participants
n=18 Participants
|
8 Participants
n=19 Participants
|
31 Participants
n=78 Participants
|
|
Reinforcing Value of Food; Intensity
|
9.9 number of food portions
STANDARD_DEVIATION 6.9 • n=20 Participants • Two participants did not complete the relative reinforcing value of food questionnaire at baseline.
|
10.7 number of food portions
STANDARD_DEVIATION 15.1 • n=19 Participants • Two participants did not complete the relative reinforcing value of food questionnaire at baseline.
|
106 number of food portions
STANDARD_DEVIATION 11.7 • n=18 Participants • Two participants did not complete the relative reinforcing value of food questionnaire at baseline.
|
7.4 number of food portions
STANDARD_DEVIATION 7.1 • n=19 Participants • Two participants did not complete the relative reinforcing value of food questionnaire at baseline.
|
9.6 number of food portions
STANDARD_DEVIATION 10.6 • n=76 Participants • Two participants did not complete the relative reinforcing value of food questionnaire at baseline.
|
PRIMARY outcome
Timeframe: Delay Discounting will be measured at baseline (session 1) and after receiving EFT/ERT and Scarcity/Narrative (within about 2 weeks)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.
Outcome measures
| Measure |
Episodic Future Thinking (EFT) & Scarcity Narrative
n=21 Participants
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).
|
Episodic Future Thinking (EFT) and Neutral Narrative
n=20 Participants
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).
|
Episodic Recent Thinking (ERT) and Scarcity Narrative
n=18 Participants
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).
|
Episodic Recent Thinking (ERT) & Neutral Narrative
n=19 Participants
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).
|
|---|---|---|---|---|
|
Change in Delay Discounting
|
-0.002 time*indifference point/delay
Standard Deviation 0.032
|
0.108 time*indifference point/delay
Standard Deviation 0.032
|
-0.069 time*indifference point/delay
Standard Deviation 0.034
|
0.035 time*indifference point/delay
Standard Deviation 0.033
|
PRIMARY outcome
Timeframe: Session 2Population: Two participants did not complete Reinforcing value measures
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.
Outcome measures
| Measure |
Episodic Future Thinking (EFT) & Scarcity Narrative
n=20 Participants
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).
|
Episodic Future Thinking (EFT) and Neutral Narrative
n=19 Participants
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).
|
Episodic Recent Thinking (ERT) and Scarcity Narrative
n=18 Participants
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).
|
Episodic Recent Thinking (ERT) & Neutral Narrative
n=19 Participants
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).
|
|---|---|---|---|---|
|
Reinforcing Value of Food
|
9.9 number of food portions purchased at $0
Standard Deviation 2.4
|
10.7 number of food portions purchased at $0
Standard Deviation 2.5
|
10.6 number of food portions purchased at $0
Standard Deviation 2.5
|
7.4 number of food portions purchased at $0
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Working Memory will be measured at baseline (session 1) and after receiving EFT/ERT Scarcity/Neutral intervention (up to 2 weeks post-baseline)Population: Five participants did not complete both measures of the spatial span task.
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.
Outcome measures
| Measure |
Episodic Future Thinking (EFT) & Scarcity Narrative
n=19 Participants
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).
|
Episodic Future Thinking (EFT) and Neutral Narrative
n=17 Participants
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).
|
Episodic Recent Thinking (ERT) and Scarcity Narrative
n=18 Participants
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).
|
Episodic Recent Thinking (ERT) & Neutral Narrative
n=19 Participants
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).
|
|---|---|---|---|---|
|
Change in Working Memory Span
|
0.05 number of locations
Standard Deviation 0.48
|
0.41 number of locations
Standard Deviation 0.51
|
0.72 number of locations
Standard Deviation 0.49
|
0.16 number of locations
Standard Deviation 0.48
|
Adverse Events
Episodic Future Thinking (EFT) & Scarcity Narrative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Episodic Future Thinking (EFT) & Neutral Narrative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Episodic Recent Thinking (ERT) & Scarcity Narrative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Episodic Recent Thinking (ERT) & Neutral Narrative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place