Trial Outcomes & Findings for A Remotely Delivered Episodic Future Thinking Intervention to Improve Management of Type 2 Diabetes (NCT NCT03732209)

Last Updated: 2024-11-01

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

59 participants

Primary outcome timeframe

Baseline, 8 weeks, 16 weeks, and 24 weeks

Results posted on

2024-11-01

Participant Flow

Participants enrolled in person at the Fralin Biomedical Research Institute at Virginia Tech Carilion, from March 2019 to March 2020.

Participants were randomized to episodic future thinking and control groups at Week 3 of the study.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	20	23
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	12	13

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	4	4
Overall Study Withdrawal by Subject	8	9

Baseline Characteristics

A Remotely Delivered Episodic Future Thinking Intervention to Improve Management of Type 2 Diabetes

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeks

Population: Participants randomized to groups at Week 3 of the study

Outcome measures

Outcome measures
Measure	Episodic Future Thinking n=8 Participants 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.	Control Thinking n=10 Participants 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.
Change in Glycosylated Hemoglobin Week 8	-1.2 percentage of glycosylated hemoglobin Standard Deviation 0.77	-0.30 percentage of glycosylated hemoglobin Standard Deviation 0.63
Change in Glycosylated Hemoglobin Week 16	-1.4 percentage of glycosylated hemoglobin Standard Deviation 1.59	-0.5 percentage of glycosylated hemoglobin Standard Deviation 0.4
Change in Glycosylated Hemoglobin Week 24	-3.3 percentage of glycosylated hemoglobin Standard Deviation 1.2	-1 percentage of glycosylated hemoglobin Standard Deviation 1

PRIMARY outcome

Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeks

Population: Participants randomized to groups at Week 3 of the study

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.

Outcome measures

Outcome measures
Measure	Episodic Future Thinking n=8 Participants 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.	Control Thinking n=10 Participants 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.
Change in kg/m^2 (Body Mass Index) Week 8	-1.2 kg/m^2 Standard Deviation 0.81	-0.3 kg/m^2 Standard Deviation 1.04
Change in kg/m^2 (Body Mass Index) Week 16	-1.4 kg/m^2 Standard Deviation 1.11	0.71 kg/m^2 Standard Deviation 0.61
Change in kg/m^2 (Body Mass Index) Week 24	-0.7 kg/m^2 Standard Deviation 0.96	0.1 kg/m^2 Standard Deviation 1.67

PRIMARY outcome

Timeframe: Baseline, 8 weeks, 16 weeks, and 24 weeks

Population: Participants randomized to groups at Week 3

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

Outcome measures

Outcome measures
Measure	Episodic Future Thinking n=8 Participants 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.	Control Thinking n=10 Participants 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.
Change in Delay Discounting Area Under the Curve (Normalized) Week 8	0.07 Proportion of reward*ordinal delay Standard Deviation 0.13	-0.04 Proportion of reward*ordinal delay Standard Deviation 0.12
Change in Delay Discounting Area Under the Curve (Normalized) Week 16	0.07 Proportion of reward*ordinal delay Standard Deviation 0.18	0.02 Proportion of reward*ordinal delay Standard Deviation 0.13
Change in Delay Discounting Area Under the Curve (Normalized) Week 24	0.15 Proportion of reward*ordinal delay Standard Deviation 0.15	-0.07 Proportion of reward*ordinal delay Standard Deviation 0.24

SECONDARY outcome

Timeframe: 8 weeks, 16 weeks, and 24 weeks

Population: Participants randomized to groups at Week 3 of the study.

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.

Outcome measures

Outcome measures
Measure	Episodic Future Thinking n=8 Participants 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.	Control Thinking n=10 Participants 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.
Perceived Treatment Effectiveness Week 8	3.63 score on a scale of 1-5 Interval 3.0 to 4.25	2.4 score on a scale of 1-5 Interval 1.25 to 3.0
Perceived Treatment Effectiveness Week 16	3.5 score on a scale of 1-5 Interval 3.0 to 3.75	3 score on a scale of 1-5 Interval 2.5 to 4.0
Perceived Treatment Effectiveness Week 24	3 score on a scale of 1-5 Interval 3.0 to 3.0	3.75 score on a scale of 1-5 Interval 3.25 to 5.0

Adverse Events

Episodic Future Thinking

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Thinking

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

Jeffrey Stein

Fralin Biomedical Research Institute at VTC

Phone: 540-526-2124

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Episodic Future Thinking n=8 Participants 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.	Control Thinking n=10 Participants 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.	Total n=18 Participants Total of all reporting groups
Age, Continuous	52.38 Years STANDARD_DEVIATION 10.9 • n=5 Participants	56.9 Years STANDARD_DEVIATION 13.1 • n=7 Participants	54.89 Years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Body mass index	38.46 kg/m^2 STANDARD_DEVIATION 8.1 • n=5 Participants	39.60 kg/m^2 STANDARD_DEVIATION 6.5 • n=7 Participants	38.96 kg/m^2 STANDARD_DEVIATION 7.2 • n=5 Participants
hemoglobin A1c (HbA1c)	9.58 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.2 • n=5 Participants	9.37 percentage of glycosylated hemoglobin STANDARD_DEVIATION 2.3 • n=7 Participants	9.48 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.7 • n=5 Participants