N/A
N=78
MINDD 3: Prediabetes and Delay Discounting
PreDiabetes
Bottom Line
View on ClinicalTrials.gov: NCT03664726 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Change in Delay Discounting — -0.002; 0.108; -0.069; 0.035 time*indifference point/delay — p=0.0034
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Episodic Future Thinking (Behavioral); Episodic Recent Thinking (Behavioral); Scarcity Narrative (Behavioral); Neutral Narrative (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Leonard Epstein
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Delay Discounting |
-0.002; 0.108; -0.069; 0.035 | 0.0034 sig |
| PRIMARY Reinforcing Value of Food |
9.9; 10.7; 10.6; 7.4 | 0.76 |
| SECONDARY Change in Working Memory Span |
0.05; 0.41; 0.72; 0.16 | 0.77 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03664726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.