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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21NR018349-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Carilion Clinic | OTHER |
| University at Buffalo | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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The goals of this project are to assess the efficacy of remotely delivered episodic future thinking for reducing delay discounting and improving management of type 2 diabetes, including glycemic control, weight loss, medication adherence, dietary intake, physical activity, and blood pressure. This will be accomplished by randomly assigning participants (N = 64) to episodic future thinking or control thinking groups, while tracking outcome measures before, during, and after the 4-month intervention, as well at a 6-month follow-up visit. Participants in both groups will also receive access to an information-based weight loss intervention.
Participants (N = 64) will be randomly assigned to either an episodic future thinking group or control thinking groups. Participants will generate episodic future events or control information, as well as related text-based cues, and will be prompted via smartphone or web application to engage in episodic future or control thinking frequently in their natural environment (e.g., at home or work, before meal times, and in high-risk situations) for a 4-month period. Participants in both groups will be provided with one-on-one, phone-based case management and provided with instructional materials and behavioral tools for weight loss and diabetes management. Instructional materials will include: 1) a modified version of the Traffic Light Diet, which utilizes red, yellow, and green labels for food to guide participants toward the goal of consuming low energy dense, low glycemic, high nutrient dense foods; 2) the Traffic Light Activity Program, which also utilizes red, yellow, and green labels for different levels of caloric expenditure, and 3) tools for self-monitoring of weight, diet, and/or physical activity.
Participants will complete four laboratory-based assessment sessions in which the investigators assess body weight, height, waist and hip circumference, glycemic control (HbA1C), adherence to oral glucose-lowering medication, delay discounting, reinforcing efficacy of food, and blood pressure. These assessments will be completed before the intervention (Week 0), during the intervention (8 weeks), and immediately after the intervention (Week 16), as well after a 2-month post-intervention follow-up (Week 24). The latter three assessments sessions will also include questions to measure participants' perceived effectiveness and ease of use of the intervention. Participants will also complete several remote assessments, including dietary intake and physical activity (during Weeks 0, 8, and 16; via accelerometer), as well as delay discounting and reinforcing efficacy of food (during Weeks 3, 8, and 16).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Episodic future thinking | Experimental | Participants will generate positive future events and related text cues that will be accessed via an electronic app to engage in episodic future thinking. |
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| Control thinking | Sham Comparator | Participants will generate non-future-oriented information and related text cues that will be accessed via an electronic app to engage in control thinking.. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Episodic future thinking | Behavioral | Participants will engage in episodic future thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Hemoglobin | Glycemic control will be assessed by change in glycosylated hemoglobin (hemoglobin A1C, or HbA1c), a standardized diagnostic measure for type 2 diabetes. Negative change scores indicate a reduction in percentage of glycosylated hemoglobin (improved glycemic control); positive scores indicate an increase in percentage of glycosylated hemoglobin (worsened glycemic control) | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Change in kg/m^2 (Body Mass Index) | Change in kg/m^2 (body mass index) will be measures using a digital scale Negative scores indicate reductions in kg/m^2; positive scores indicate increases in BMI. | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Change in Delay Discounting Area Under the Curve (Normalized) | Delay discounting will be assessed using a computerized task that assess participants' indifference points, or the objective amount of a smaller, immediate reward that is subjectively equivalent to a delayed, larger reward ($100), across a range of delays (1 month, 3 months, 6 months, 1 year, 3 years, 5 years, and 12 years). Indifference points will be expressed as a proportion of the larger reward (0 to 1). This delay discounting curve (indifference points as a function of delay) will be summarized using area under the curve (AUC), calculated using subjective value of the delayed reward (0 to 1) as the y-axis unit and delay as the x-axis unit. Individual delays are converted to ordinal units (1-7) prior to analysis. AUC is expressed as a proportion of the maximum possible AUC. This normalized measure of AUC varies from 0 (maximum discounting) to 1 (minimum discounting). Positive scores indicate reductions in delay discounting (i.e., increases in AUC across time); negative sco | Baseline, 8 weeks, 16 weeks, and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Treatment Effectiveness | Perceived treatment effectiveness for the EFT and control conditions will be measured using a 5-point scale, ranging from 1 (not at all) to 5 (extremely). Higher scores reflect greater perceived effectiveness. | 8 weeks, 16 weeks, and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff S Stein, PhD | Virginia Tech Carilion School of Medicine and Research Institute | Principal Investigator |
| John W Epling, MD | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute | Roanoke | Virginia | 24016 | United States |
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Participants were randomized to episodic future thinking and control groups at Week 3 of the study.
Participants enrolled in person at the Fralin Biomedical Research Institute at Virginia Tech Carilion, from March 2019 to March 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Episodic Future Thinking | Participants will generate positive future events and related text cues that will be accessed via an electronic app to engage in episodic future thinking. Episodic future thinking: Participants will engage in episodic future thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices. |
| FG001 | Control Thinking | Participants will generate non-future-oriented information and related text cues that will be accessed via an electronic app to engage in control thinking.. Control Thinking: Participants will engage in non-future-oriented control thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Episodic Future Thinking | Participants will generate positive future events and related text cues that will be accessed via an electronic app to engage in episodic future thinking. Episodic future thinking: Participants will engage in episodic future thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycosylated Hemoglobin | Glycemic control will be assessed by change in glycosylated hemoglobin (hemoglobin A1C, or HbA1c), a standardized diagnostic measure for type 2 diabetes. Negative change scores indicate a reduction in percentage of glycosylated hemoglobin (improved glycemic control); positive scores indicate an increase in percentage of glycosylated hemoglobin (worsened glycemic control) | Participants randomized to groups at Week 3 of the study | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline, 8 weeks, 16 weeks, and 24 weeks |
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Adverse event data were collected over 24-week participation period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Episodic Future Thinking | Participants will generate positive future events and related text cues that will be accessed via an electronic app to engage in episodic future thinking. Episodic future thinking: Participants will engage in episodic future thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices. |
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The COVID-19 pandemic caused a spike in attrition, with many of the n=59 participants who enrolled in the trial to not reach trial randomization in Week 3 and study completion in Week 24. Likewise, the long-lasting restrictions on in-person assessments and the lack of reliable and feasible methods to collect these measures remotely limited new enrollments. As a result, this trial did not meet its recruitment goals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Stein | Fralin Biomedical Research Institute at VTC | 540-526-2124 | jstein1@vtc.vt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2019 | Nov 18, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants will engage in episodic future or control thinking in the natural environment. All participants will also receive case management regarding the Traffic Light Diet, modified for type 2 diabetes to include glycemic index of foods, as well as the Traffic Light Activity Plan and other techniques to aid in weight loss (e.g., self-monitoring).
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Participants assigned to both groups will be masked to experimental hypotheses. Research personnel who will be conducting assessment sessions, including weight measurements, will not be informed of participants' group assignments.
| Control Thinking | Behavioral | Participants will engage in non-future-oriented control thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices. |
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| BG001 | Control Thinking | Participants will generate non-future-oriented information and related text cues that will be accessed via an electronic app to engage in control thinking.. Control Thinking: Participants will engage in non-future-oriented control thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body mass index | Body mass index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
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| hemoglobin A1c (HbA1c) | Hemoglobin A1c, a measure of glycemic control | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
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| OG001 | Control Thinking | Participants will generate non-future-oriented information and related text cues that will be accessed via an electronic app to engage in control thinking.. Control Thinking: Participants will engage in non-future-oriented control thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices. |
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| Primary | Change in kg/m^2 (Body Mass Index) | Change in kg/m^2 (body mass index) will be measures using a digital scale Negative scores indicate reductions in kg/m^2; positive scores indicate increases in BMI. | Participants randomized to groups at Week 3 of the study | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 8 weeks, 16 weeks, and 24 weeks |
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| Primary | Change in Delay Discounting Area Under the Curve (Normalized) | Delay discounting will be assessed using a computerized task that assess participants' indifference points, or the objective amount of a smaller, immediate reward that is subjectively equivalent to a delayed, larger reward ($100), across a range of delays (1 month, 3 months, 6 months, 1 year, 3 years, 5 years, and 12 years). Indifference points will be expressed as a proportion of the larger reward (0 to 1). This delay discounting curve (indifference points as a function of delay) will be summarized using area under the curve (AUC), calculated using subjective value of the delayed reward (0 to 1) as the y-axis unit and delay as the x-axis unit. Individual delays are converted to ordinal units (1-7) prior to analysis. AUC is expressed as a proportion of the maximum possible AUC. This normalized measure of AUC varies from 0 (maximum discounting) to 1 (minimum discounting). Positive scores indicate reductions in delay discounting (i.e., increases in AUC across time); negative sco | Participants randomized to groups at Week 3 | Posted | Mean | Standard Deviation | Proportion of reward*ordinal delay | Baseline, 8 weeks, 16 weeks, and 24 weeks |
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| Secondary | Perceived Treatment Effectiveness | Perceived treatment effectiveness for the EFT and control conditions will be measured using a 5-point scale, ranging from 1 (not at all) to 5 (extremely). Higher scores reflect greater perceived effectiveness. | Participants randomized to groups at Week 3 of the study. | Posted | Median | Inter-Quartile Range | score on a scale of 1-5 | 8 weeks, 16 weeks, and 24 weeks |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Control Thinking | Participants will generate non-future-oriented information and related text cues that will be accessed via an electronic app to engage in control thinking.. Control Thinking: Participants will engage in non-future-oriented control thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D004700 | Endocrine System Diseases |
| Week 16 |
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| Week 24 |
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| Week 16 |
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| Week 24 |
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| Week 16 |
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| Week 24 |
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