137 Participants Needed

Episodic Future Thinking for Type 2 Diabetes

JS
MS
Overseen ByMegan Stuart
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Virginia Polytechnic Institute and State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, as the trial focuses on lifestyle changes and not medication changes.

What data supports the idea that Episodic Future Thinking for Type 2 Diabetes is an effective treatment?

The available research shows that Episodic Future Thinking (EFT) helps people with type 2 diabetes by reducing delay discounting, which means they are more likely to make healthier choices for their future. In a study with 434 adults with type 2 diabetes and obesity, those who used EFT showed better results in making future-oriented decisions compared to those who used a different method or no method at all. This suggests that EFT can be an effective treatment for encouraging healthier behaviors in people with type 2 diabetes.12345

What safety data exists for Episodic Future Thinking in Type 2 Diabetes?

The provided research does not contain any safety data related to Episodic Future Thinking for Type 2 Diabetes. The studies focus on insulin pump therapy and adverse drug events in diabetes management, but do not mention Episodic Future Thinking or related interventions.678910

Is Episodic Future Thinking a promising treatment for Type 2 Diabetes?

Episodic Future Thinking is a promising treatment for Type 2 Diabetes because it can help people better manage their condition by improving their ability to plan and make healthier choices. This approach encourages individuals to think about their future and how their current actions can impact their long-term health, which can lead to better control of blood sugar levels and overall diabetes management.1112131415

What is the purpose of this trial?

Successful management of type 2 diabetes (T2D) requires adherence to a dietary, physical activity, and medication plan agreed upon between a patient and their healthcare providers. The lifestyle changes involved in these collaborative care plans (CCPs) often provide little to no short-term benefit and may instead be aversive (e.g., caloric restriction and physical activity). However, these changes provide critical health benefits in the future, allowing patients with T2D to halt or reverse disease progression and avoid T2D-related complications (e.g., renal disease or diabetic retinopathy). Thus, successful management of T2D requires one's present behavior to be guided by future outcomes. Unfortunately, accumulating evidence indicates that individuals with T2D and prediabetes show elevated rates of delay discounting (i.e., devaluation of delayed consequences). Moreover, high rates of delay discounting are cross-sectionally and longitudinally associated with poor treatment adherence and clinical outcomes in T2D and prediabetes. These data suggest that high rates of delay discounting prevent successful management of T2D through a mechanism in which the health benefits of lifestyle changes are too delayed to motivate behavioral change. Thus, we believe delay discounting serves as a therapeutic target in T2D, where improving participants' valuation of the future will facilitate healthy lifestyle changes and, in turn, improve T2D management. This study will conduct a randomized 24-week remote clinical trial comparing repeated measures ANOVA, with group (episodic future thinking \[EFT\]/control) and area (urban vs. rural) as between-subjects factors, and time (baseline, week 8, and week 24 assessments) as within-subjects factors in adults with type 2 diabetes.

Research Team

JS

Jeffrey Stein, PhD

Principal Investigator

Fralin Biomedical Research Institute at Virginia Tech Carilion

Eligibility Criteria

This trial is for adults with type 2 diabetes who live in urban or rural areas, have an HbA1c level of at least 7.7%, and a body mass index (BMI) of 30 or higher. It's not suitable for those with intellectual impairments, gestational diabetes, pregnant or lactating women, non-ambulatory individuals, or unmanaged psychiatric conditions.

Inclusion Criteria

You are very overweight.
You live in a city or countryside.
Your HbA1c level is 7.7% or higher.

Exclusion Criteria

I cannot walk on my own.
I have an intellectual disability.
Pregnancy or lactating
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
Remote assessments

Baseline Assessment

Participants complete remote assessments of dietary intake, physical activity, and sociodemographic information

1 week
Remote assessments

Treatment

Participants engage in episodic future thinking or control thinking, with diet and physical activity support, self-monitoring, and case management

24 weeks
Thrice-daily smartphone app prompts

Follow-up

Participants are monitored for changes in glycemic control, BMI, dietary intake, physical activity, and medication adherence

4 weeks
Remote assessments at Weeks 8 and 24

Treatment Details

Interventions

  • Episodic Future Thinking
Trial Overview The study tests if 'Episodic Future Thinking'—imagining future events to influence present decisions—can help manage type 2 diabetes better than 'Healthy Information Thinking'. Participants are randomly assigned to one of these two groups and followed over a period of 24 weeks.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Episodic Future ThinkingExperimental Treatment1 Intervention
Participants will generate vivid, episodic events and be prompted via a guided smartphone app to engage in EFT in their daily lives. EFT will be paired with diet and physical activity support.
Group II: Healthy Information ThinkingActive Control1 Intervention
Participants will be prompted via a guided smartphone app to thinking about their written responses to informational health vignettes during their daily lives. The HIT condition will be paired with diet and physical activity support.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials
162
Recruited
26,900+

Carilion Clinic

Collaborator

Trials
85
Recruited
15,400+

University at Buffalo

Collaborator

Trials
139
Recruited
105,000+

Findings from Research

The pilot goal-oriented episodic future thinking (GoEFT) intervention was well-accepted by low-income overweight or obese mothers, with participants appreciating the structured approach to setting and evaluating goals.
The intervention demonstrated significant efficacy in promoting weight loss, increasing fruit and vegetable intake, and improving emotional control, along with reducing fat and sugar intake and alleviating stress, indicating its potential as an effective weight management strategy.
A Pilot Goal-Oriented Episodic Future Thinking Weight Loss Intervention for Low-Income Overweight or Obese Young Mothers.Chang, MW., Tan, A., Wegener, DT., et al.[2023]
Episodic Future Thinking (EFT) significantly reduces delay discounting in adults with type 2 diabetes and obesity, indicating its potential as a clinical tool to promote healthier behaviors.
In a study of 434 participants, those engaging in EFT showed lower levels of delay discounting compared to those in the Health Information Thinking (HIT) and no-cue control conditions, suggesting that EFT is more effective than diabetes-specific health information in influencing decision-making related to health.
Episodic future thinking in type 2 diabetes: Further development and validation of the Health Information Thinking control for clinical trials.Brown, JM., Bickel, WK., Epstein, LH., et al.[2023]
A study involving 204 adults newly diagnosed with Type 2 diabetes found that having a future-oriented time perspective is linked to better weight management behaviors, such as healthier dietary choices and increased physical activity over a 6-month period.
The positive impact of a future-oriented mindset on these behaviors is primarily mediated by stronger intentions to engage in weight management, suggesting that encouraging future thinking could enhance treatment outcomes for individuals with Type 2 diabetes.
Time perspective and weight management behaviors in newly diagnosed Type 2 diabetes: a mediational analysis.Hall, PA., Fong, GT., Cheng, AY.[2022]

References

A Pilot Goal-Oriented Episodic Future Thinking Weight Loss Intervention for Low-Income Overweight or Obese Young Mothers. [2023]
Episodic future thinking in type 2 diabetes: Further development and validation of the Health Information Thinking control for clinical trials. [2023]
Time perspective and weight management behaviors in newly diagnosed Type 2 diabetes: a mediational analysis. [2022]
Translating episodic future thinking manipulations for clinical use: Development of a clinical control. [2023]
An exploratory randomised controlled trial using short messaging service to facilitate insulin administration in young adults with type 1 diabetes. [2021]
Diabetes medication patient safety incident reports to the National Reporting and Learning Service: the care home setting. [2016]
Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. [2018]
Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. [2022]
Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes. [2023]
A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Individual differences and day-to-day fluctuations in goal planning and type 1 diabetes management. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Neurocognitive consequences of diabetes. [2022]
Executive cognitive impairment detected by simple bedside testing is associated with poor glycaemic control in type 2 diabetes. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
Impact of Intensive Lifestyle Intervention on Neural Food Cue Reactivity: Action for Health in Diabetes Brain Ancillary Study. [2020]
The influence of cognition on self-management of type 2 diabetes in older people. [2022]
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