Trial Summary
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.
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.
12345What 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.
678910Is 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.
1112131415Eligibility 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
+2 more
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Fralin Biomedical Research Institute at VTCRoanoke, VA
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Who Is Running the Clinical Trial?
Virginia Polytechnic Institute and State UniversityLead Sponsor
Carilion ClinicCollaborator
University at BuffaloCollaborator
References
A Pilot Goal-Oriented Episodic Future Thinking Weight Loss Intervention for Low-Income Overweight or Obese Young Mothers. [2023]Episodic future thinking (EFT) has shown efficacy in laboratory settings. We conducted a pilot goal-oriented EFT (GoEFT) intervention in a real-world setting to help low-income overweight or obese mothers lose weight. This paper presents intervention acceptability and efficacy.
Episodic future thinking in type 2 diabetes: Further development and validation of the Health Information Thinking control for clinical trials. [2023]Episodic Future Thinking (EFT) reduces delay discounting and may have the potential as a clinical tool to increase the likelihood of health-promoting behaviors. However, evaluations of EFT in clinical settings require control conditions that match the effort and frequency of cue generation, as well as participants' expectations of improvement. The Health Information Thinking (HIT) control addresses these issues, but how this control affects delay discounting in individuals with diabetes and obesity when utilizing diabetes-management specific health-information vignettes is unknown. Moreover, little research has explored whether EFT reduces delay discounting in individuals with type 2 diabetes. To this end, we examined the impact of EFT, HIT, and a secondary no-cue control condition (NCC; assessments as usual) on delay discounting in 434 adults with self-reported type 2 diabetes and obesity recruited using Amazon Mechanical Turk. After completing an initial screening questionnaire, eligible participants reported demographics, then were randomized to EFT, HIT, or NCC conditions. Following the generation of seven EFT or HIT cues, participants assigned to EFT or HIT conditions completed a delay discounting task while imagining EFT or HIT cues; no-cue participants completed the task without cues. EFT participants demonstrated significantly lower delay discounting levels than HIT or NCC participants; no differences in delay discounting between HIT and NCC participants were observed. These results suggest that engaging in EFT, but not diabetes-specific HIT, results in lower delay discounting in adults with type 2 diabetes and obesity. This provides further evidence for the appropriateness of the HIT control for clinical trials examining the effect of EFT on delay discounting in adults with self-reported type 2 diabetes.
Time perspective and weight management behaviors in newly diagnosed Type 2 diabetes: a mediational analysis. [2022]The primary objective of the current study was to examine the extent to which domain-specific time perspective predicts weight management behaviors (dietary behavior and physical activity) among those newly diagnosed with Type 2 diabetes. A secondary objective was to test potential mediators of the hypothesized effect (behavioral intention, self-efficacy and control beliefs). A total of 204 adults newly diagnosed (≤6 months) with Type 2 diabetes participated in the study, which included a baseline assessment of domain-general and domain-specific time perspective, as well as strength of intention to perform two weight-management behaviors (dietary choice and physical activity); both weight-management behaviors were assessed again at 6 month follow-up. Hierarchical multiple regression analyses revealed a prospective association between domain-specific time perspective and uptake of weight management behaviors. Individuals with newly diagnosed T2DM possessing a future-oriented time perspective reported making less frequent fatty food choices and greater increases in physical activity over the 6-month follow-up interval. These effects were selectively mediated by intention strength, and not competing social cognitive variables. For both behaviors, the total effects and meditational models were robust to adjustments for demographics, body composition and disease variables. A future-oriented time perspective is prospectively associated with superior uptake of weight management behaviors among those with newly diagnosed Type 2 diabetes. The facilitating effect of future-oriented thinking appears to occur via enhanced strength of intentions to perform weight management behaviors.
Translating episodic future thinking manipulations for clinical use: Development of a clinical control. [2023]Many studies support that Episodic Future Thinking (EFT) reduces maladaptive health behaviors and how much individuals devalue the future (steepness of delay discounting). In order to understand the clinical utility of EFT, a control procedure that equates groups in non-specific treatment factors (e.g., expectancy of change, perceived connection of content to health behavior) is needed. The present research evaluated the effects of EFT relative to a novel control (health information thinking; HIT), which was designed to be structurally similar to EFT while incorporating elements from existing clinical controls. In a sample of Amazon Mechanical Turk workers (N = 254), we found that EFT reduced discounting relative to the HIT procedure and a standard EFT control. There were some affective differences across groups and differences in adherence to the intervention content, but these were unrelated to discounting. Delay discounting was not equivalent across the control groups, but this may not be a necessary condition to fulfill for a clinical control. Future research will need to identify whether the HIT procedure serves as a good control for other dependent variables when studying EFT and develop controls analogous to usual care or a "wait-list" in clinical contexts.
An exploratory randomised controlled trial using short messaging service to facilitate insulin administration in young adults with type 1 diabetes. [2021]This exploratory randomised controlled trial examined the effectiveness of a novel short messaging service intervention underpinned by the theory of planned behaviour (TPB) in improving insulin administration in young adults with type 1 diabetes and the role of moderating variables. Those in the intervention condition (N = 8) received one daily text message underpinned by TPB constructs: Attitudes, subjective norms, perceived behavioural control and intention. Those in the control condition (N = 10) received weekly general health messages. Self-reported insulin administration was the main outcome measure; conscientiousness and consideration of future consequences (CFC) were measured as potential moderators. Analyses of covariance revealed no main effects of condition for morning and afternoon injections but a marginally significant effect for evening injections (p = .08). This main effect was qualified by significant interactions of condition with conscientiousness (p = .001), CFC (p = .007) and a three-way interaction among condition, conscientiousness and CFC (p = .009). Exploration of the interactions indicated the intervention significantly improved evening injection rates only in the low conscientiousness and low CFC groups. This effect was particularly strong among those low in both conscientiousness and CFC. Further investigation is warranted, using more objective measures of insulin adherence in a larger sample.
Diabetes medication patient safety incident reports to the National Reporting and Learning Service: the care home setting. [2016]To analyse adverse drug events in older people with diabetes in the care home setting via incident reports obtained from the National Reporting and Learning Service.
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 therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycaemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycaemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilised due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices, EUDAMED) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to 'predicate' products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real-world setting; such data could provide vital information to help healthcare teams to educate and support users, and thereby prevent AEs. As well as requiring more from the manufacturing companies, we call for public funding of more research addressing clinically important questions in relation to pump therapy: both observational studies and clinical trials. At present there are significant differences in the regulatory systems between the USA and European Union at both pre- and post-marketing stages; improvements in the European system are more urgently required. This statement concludes with a series of recommended specific actions for 'meknovigilance' (i.e. a standardised safety approach to technology) which could be implemented to address the shortcomings we highlight.
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 therapy, also known as continuous subcutaneous insulin infusion (CSII), is an important and evolving form of insulin delivery, which is mainly used for people with type 1 diabetes. However, even with modern insulin pumps, errors of insulin infusion can occur due to pump failure, insulin infusion set (IIS) blockage, infusion site problems, insulin stability issues, user error, or a combination of these. Users are therefore exposed to significant and potentially fatal hazards: interruption of insulin infusion can result in hyperglycemia and ketoacidosis; conversely, delivery of excessive insulin can cause severe hypoglycemia. Nevertheless, the available evidence on the safety and efficacy of CSII remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore joined forces to review the systems in place for evaluating the safety of pumps from a clinical perspective. We found that useful information held by the manufacturing companies is not currently shared in a sufficiently transparent manner. Public availability of adverse event (AE) reports on the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database is potentially a rich source of safety information but is insufficiently utilized due to the current configuration of the system; the comparable database in Europe (European Databank on Medical Devices [EUDAMED]) is not publicly accessible. Many AEs appear to be attributable to human factors and/or user error, but the extent to which manufacturing companies are required by regulators to consider the interactions of users with the technical features of their products is limited. The clinical studies required by regulators prior to marketing are small and over-reliant on bench testing in relation to "predicate" products. Once a pump is available on the market, insufficient data are made publicly available on its long-term use in a real-world setting; such data could provide vital information to help health care teams to educate and support users and thereby prevent AEs. As well as requiring more from the manufacturing companies, we call for public funding of more research addressing clinically important questions in relation to pump therapy: both observational studies and clinical trials. At present, there are significant differences in the regulatory systems between the US and European Union at both pre- and postmarketing stages; improvements in the European system are more urgently required. This statement concludes with a series of recommended specific actions for "meknovigilance" (i.e., a standardized safety approach to technology) that could be implemented to address the shortcomings we highlight.
Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes. [2023]Objective: To explore the clinical consequences and potential root causes of insulin pump-associated adverse events (AEs) reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. Research Design and Methods: Qualitative template analysis of narrative data in a 20% stratified random sample (n = 2429) of reported AEs that occurred during the first 6 months of 2020 involving five insulin pump models marketed at that time: (1) MiniMed™ 670G, (2) MiniMed™ 630G, (3) Omnipod®, (4) Omnipod DASH®, and (5) t:slim X2™. Results: Of the 2429 AEs, 92% included a clinical consequence in the narrative description, with critical hyperglycemia (i.e., blood glucose [BG] >400 mg/dL; 47%) and critical hypoglycemia (i.e., BG <54 mg/dL; 24%) being the most common consequence cited. Only 50% of the AE narratives included information to support the identification of a root cause. The most cited root cause informing remarks were issues with the pump or pod reservoir/cartridge (9%), the occurrence of an obstruction of flow alarm (8%), and problems with the infusion set or site (8%). Some clinical consequences and root cause informing remarks were cited more frequently in AE narratives involving specific insulin pump models, but manufacturer variability in the amount and type of information reported may have affected these findings. Conclusions: Our findings show general themes found in insulin pump-associated AE that providers can use to raise patient awareness of potential risks associated with insulin pump use and develop strategies to prevent future AEs. Improvements in AE investigation and reporting processes are still necessary.
A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients. [2022]Clinical drug trials are often conducted in selective patient populations, with relatively small numbers of patients, and a short duration of follow-up. Observational studies are therefore important for collecting additional information on adverse drug events (ADEs). Currently, there is no guidance regarding the methodology for measuring ADEs in such studies. Our aim was to evaluate whether the methodology used to assess non-serious ADEs in observational studies is adequate for detecting these ADEs, and for addressing limitations from clinical trials in patients with type 2 diabetes mellitus. We systematically searched MEDLINE and EMBASE for observational studies reporting non-serious ADEs (1999-2008). Methods to assess ADEs were classified as: 1) medical record review; 2) surveillance by health care professionals (HCP); 3) patient survey; 4) administrative data; 5) laboratory/clinical values; 6) not specified. We compared the range of ADEs identified, number and selection of patients included, and duration of follow-up. Out of 10,125 publications, 68 studies met our inclusion criteria. The most common methods were based on laboratory/clinical values (n = 25) and medical record review (n = 18). Solicited surveillance by HCP (n = 17) revealed the largest diversity of ADEs. Patient surveys (n = 15) focused mostly on hypoglycaemia and gastrointestinal ADEs, laboratory values based studies on hepatic and metabolic ADEs, and administrative database studies (n = 5) on cardiovascular ADEs. Four studies presented ADEs that were identified with the use of more than one method. The patient population was restricted to a lower risk population in 19% of the studies. Less than one third of the studies exceeded pre-approval regulatory requirements for sample size and duration of follow-up. We conclude that the current assessment of ADEs is hampered by the choice of methods. Many observational studies rely on methods that are inadequate for identifying all possible ADEs. Patient-reported outcomes and combinations of methods are underutilized. Furthermore, while observational studies often include unselective patient populations, many do not adequately address other limitations of pre-approval trials. This implies that these studies will not provide sufficient information about ADEs to clinicians and patients. Better protocols are needed on how to assess adverse drug events not only in clinical trials but also in observational studies.
Individual differences and day-to-day fluctuations in goal planning and type 1 diabetes management. [2023]To examine whether individual differences and day-to-day fluctuations in diabetes goal planning are associated with Type 1 diabetes (T1D) management during late adolescence, and whether lapses in daily diabetes goal planning are more disruptive to diabetes management among those with poorer executive functioning (EF).
Neurocognitive consequences of diabetes. [2022]Mild cognitive dysfunction is a well-established complication of diabetes and its management, although large numbers of psychologists and health professionals may be unaware of its existence, clinical implications, and etiology. Drawing on results from key studies, systematic reviews, and meta-analyses, this article delineates the neurocognitive phenotypes characteristic of Type 1 diabetes (T1D) and Type 2 diabetes (T2D), and identifies the most plausible risk factors, both those that may be modifiable, like degree of metabolic control, and those that cannot be changed, like the age when a child or adult is diagnosed. Most children and adults with T1D typically manifest lower scores on measures of intelligence and academic achievement, attention, psychomotor speed, and executive functions. These effects are especially pronounced in those who develop diabetes early in life, before the age of 6 or 7 years. Chronically elevated blood glucose values increase the risk of both cognitive dysfunction and microstructural changes in white matter tracts. Adults with T2D manifest cognitive dysfunction characterized by poorer performance on tasks requiring attention, psychomotor speed, planning and executive functions, and learning and memory. They are also at increased risk of developing dementia. Poorer metabolic control accelerates the rate of cognitive decline over time, and research suggests that improving metabolic control may slow the rate of decline. Psychologists and behavioral scientists can play a key role in preventing the onset of cognitive complications or in ameliorating their severity by implementing behavioral strategies known to increase adherence to medical regimens and improve metabolic control. (PsycINFO Database Record
Executive cognitive impairment detected by simple bedside testing is associated with poor glycaemic control in type 2 diabetes. [2022]Cognitive impairment in people with type 2 diabetes is a barrier to successful disease management. We sought to determine whether impaired executive function as detected by a battery of simple bedside cognitive tests of executive function was associated with inadequate glycaemic control.
Impact of Intensive Lifestyle Intervention on Neural Food Cue Reactivity: Action for Health in Diabetes Brain Ancillary Study. [2020]The Action for Health in Diabetes (Look AHEAD) research study was a randomized trial comparing the effects of an intensive lifestyle intervention (ILI) versus a diabetes support and education (DSE) control group in adults with type 2 diabetes and overweight or obesity. Functional magnetic resonance imaging was used to determine whether neural food cue reactivity differed for these groups 10 years after randomization.
The influence of cognition on self-management of type 2 diabetes in older people. [2022]Diabetes is a growing public health issue, increasing in prevalence, eroding quality of life, and burdening health care systems. The complications of diabetes can be avoided or delayed by maintaining good glycemic control, which is achievable through self-management and, where necessary, medication. Older people with diabetes are at increased risk for cognitive impairment. This review aims to bring together current research that has investigated both cognition and diabetes self-management together. The Cumulative Index to Nursing and Allied Health (Cinahl), Excerpta Medica Database (Embase), Medical Literature Analysis and Retrieval System (Medline), and Psychological Information (PsychInfo) databases were searched. Studies were included if they featured older people with type 2 diabetes and had looked for associations between at least one distinct measure of cognition and at least one distinct measure of diabetes self-management. English language publications from the year 2000 were included. Cognitive measures of executive function, memory, and low scores on tests of global cognitive functioning showed significant correlations with multiple areas of diabetes self-management, including diabetes-specific numeracy ability, diabetes knowledge, insulin adjustment skills, ability to learn to perform insulin injections, worse adherence to medications, decreased frequency of self-care activities, missed appointments, decreased frequency of diabetes monitoring, and increased inaccuracies in reporting blood glucose monitoring. The nature of the subjects studied was quite variable in terms of their disease duration, previous medical histories, associated medical comorbidities, and educational level attained prior to being diagnosed with diabetes. The majority of studies were of an associational nature and not findings confirmed by repeat testing or by the effects of an intervention, neither were the majority of studies designed to give a view or conclusion on the clinical value or implications of the research. This only allows speculation of their importance. Most studies do not separate out the influence of aging itself in altering diabetes self-care behavior. We conclude that older people with type 2 diabetes are at increased risk for cognitive dysfunction. Changes in cognition may negatively affect diabetes self-management behaviors, influencing self-care outcomes. Age and depression may exacerbate any cognitive impairment.