Type 2 Diabetes
Conditions
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALEpisodic future thinking
Participants will engage in episodic future thinking, prompted via text-based cues, when making decisions about dietary, exercise, and medication adherence choices.
BEHAVIORALControl 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.
Sponsors
Carilion Clinic
University at Buffalo
National Institute of Nursing Research (NINR)
Virginia Polytechnic Institute and State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Overweight or obese (BMI of 25 or greater) * Poorly controlled type 2 diabetes (HbA1C of 8% or greater) * Prescribed or recommended oral glucose-lowering medication
Exclusion criteria
* Current insulin therapy for type 2 diabetes * History of gestational diabetes * Pregnant or lactating * Not ambulatory * Intellectual impairment * Unmanaged medical or psychiatric disorder * Abnormal glucose related to medications (e.g, glucocorticoids)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in kg/m^2 (Body Mass Index) | Baseline, 8 weeks, 16 weeks, and 24 weeks | 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. |
| Change in Glycosylated Hemoglobin | Baseline, 8 weeks, 16 weeks, and 24 weeks | 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) |
| Change in Delay Discounting Area Under the Curve (Normalized) | Baseline, 8 weeks, 16 weeks, and 24 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Treatment Effectiveness | 8 weeks, 16 weeks, and 24 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Participants enrolled in person at the Fralin Biomedical Research Institute at Virginia Tech Carilion, from March 2019 to March 2020.
Pre-assignment details
Participants were randomized to episodic future thinking and control groups at Week 3 of the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 10 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Withdrawal by Subject | 8 | 9 |
Baseline characteristics
| Characteristic | Total | Control Thinking | Episodic Future Thinking |
|---|---|---|---|
| Age, Continuous | 54.89 Years STANDARD_DEVIATION 11.3 | 56.9 Years STANDARD_DEVIATION 13.1 | 52.38 Years STANDARD_DEVIATION 10.9 |
| Body mass index | 38.96 kg/m^2 STANDARD_DEVIATION 7.2 | 39.60 kg/m^2 STANDARD_DEVIATION 6.5 | 38.46 kg/m^2 STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 10 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| hemoglobin A1c (HbA1c) | 9.48 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.7 | 9.37 percentage of glycosylated hemoglobin STANDARD_DEVIATION 2.3 | 9.58 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 13 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 10 |
| other Total, other adverse events | 0 / 8 | 0 / 10 |
| serious Total, serious adverse events | 0 / 8 | 0 / 10 |
Outcome results
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
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks
Population: Participants randomized to groups at Week 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Episodic Future Thinking | Change in Delay Discounting Area Under the Curve (Normalized) | Week 8 | 0.07 Proportion of reward*ordinal delay | Standard Deviation 0.13 |
| Episodic Future Thinking | Change in Delay Discounting Area Under the Curve (Normalized) | Week 16 | 0.07 Proportion of reward*ordinal delay | Standard Deviation 0.18 |
| Episodic Future Thinking | Change in Delay Discounting Area Under the Curve (Normalized) | Week 24 | 0.15 Proportion of reward*ordinal delay | Standard Deviation 0.15 |
| Control Thinking | Change in Delay Discounting Area Under the Curve (Normalized) | Week 8 | -0.04 Proportion of reward*ordinal delay | Standard Deviation 0.12 |
| Control Thinking | Change in Delay Discounting Area Under the Curve (Normalized) | Week 16 | 0.02 Proportion of reward*ordinal delay | Standard Deviation 0.13 |
| Control Thinking | Change in Delay Discounting Area Under the Curve (Normalized) | Week 24 | -0.07 Proportion of reward*ordinal delay | Standard Deviation 0.24 |
Comparison: Due to minimal data available at Week 16 and 24 due to COVID-19-related attrition, only ratings from Week 8 were included in the analysis.p-value: 0.146ANOVA
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)
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks
Population: Participants randomized to groups at Week 3 of the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Episodic Future Thinking | Change in Glycosylated Hemoglobin | Week 8 | -1.2 percentage of glycosylated hemoglobin | Standard Deviation 0.77 |
| Episodic Future Thinking | Change in Glycosylated Hemoglobin | Week 16 | -1.4 percentage of glycosylated hemoglobin | Standard Deviation 1.59 |
| Episodic Future Thinking | Change in Glycosylated Hemoglobin | Week 24 | -3.3 percentage of glycosylated hemoglobin | Standard Deviation 1.2 |
| Control Thinking | Change in Glycosylated Hemoglobin | Week 8 | -0.30 percentage of glycosylated hemoglobin | Standard Deviation 0.63 |
| Control Thinking | Change in Glycosylated Hemoglobin | Week 16 | -0.5 percentage of glycosylated hemoglobin | Standard Deviation 0.4 |
| Control Thinking | Change in Glycosylated Hemoglobin | Week 24 | -1 percentage of glycosylated hemoglobin | Standard Deviation 1 |
Comparison: Due to minimal data being available at Weeks 16 and 24 due to COVID-19-related attrition, only baseline (Week 0) and Week 8 data were included in the analysis.p-value: 0.017ANOVA
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.
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks
Population: Participants randomized to groups at Week 3 of the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Episodic Future Thinking | Change in kg/m^2 (Body Mass Index) | Week 8 | -1.2 kg/m^2 | Standard Deviation 0.81 |
| Episodic Future Thinking | Change in kg/m^2 (Body Mass Index) | Week 16 | -1.4 kg/m^2 | Standard Deviation 1.11 |
| Episodic Future Thinking | Change in kg/m^2 (Body Mass Index) | Week 24 | -0.7 kg/m^2 | Standard Deviation 0.96 |
| Control Thinking | Change in kg/m^2 (Body Mass Index) | Week 8 | -0.3 kg/m^2 | Standard Deviation 1.04 |
| Control Thinking | Change in kg/m^2 (Body Mass Index) | Week 16 | 0.71 kg/m^2 | Standard Deviation 0.61 |
| Control Thinking | Change in kg/m^2 (Body Mass Index) | Week 24 | 0.1 kg/m^2 | Standard Deviation 1.67 |
Comparison: Due to minimal data being available at Weeks 16 and 24 due to COVID-19-related attrition, only baseline (Week 0) and Week 8 data were included in the analysis.p-value: 0.042ANOVA
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.
Time frame: 8 weeks, 16 weeks, and 24 weeks
Population: Participants randomized to groups at Week 3 of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Episodic Future Thinking | Perceived Treatment Effectiveness | Week 8 | 3.63 score on a scale of 1-5 |
| Episodic Future Thinking | Perceived Treatment Effectiveness | Week 16 | 3.5 score on a scale of 1-5 |
| Episodic Future Thinking | Perceived Treatment Effectiveness | Week 24 | 3 score on a scale of 1-5 |
| Control Thinking | Perceived Treatment Effectiveness | Week 8 | 2.4 score on a scale of 1-5 |
| Control Thinking | Perceived Treatment Effectiveness | Week 16 | 3 score on a scale of 1-5 |
| Control Thinking | Perceived Treatment Effectiveness | Week 24 | 3.75 score on a scale of 1-5 |
Comparison: Due to minimal data available at Week 16 and 24 due to COVID-19-related attrition, only ratings from Week 8 were included in the analysis.p-value: 0.042Wilcoxon (Mann-Whitney)