Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05280925 |
| Other study ID # |
21-440 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 20, 2022 |
| Est. completion date |
October 1, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Virginia Polytechnic Institute and State University |
| Contact |
Jeffrey Stein, PhD |
| Phone |
540-526-2124 |
| Email |
jstein1[@]vtc.vt.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
In a 24-week trial, 120 participants from both urban (n = 60) and rural (n = 60) areas will
be assigned receive either remotely delivered episodic future thinking or a control
condition. Participants will be prompted three times daily to engage in episodic future
thinking or control thinking. All participants will also receive virtual diet and physical
activity support; self-monitoring of diet, activity, and weight; and case management. Outcome
measures will be assessed at baseline, 8 weeks, and 24 weeks.
In the week following informed consent, participants will complete remote assessments of
dietary intake (ASA-24 food recalls) and self-reported physical activity (IPAQ-SF), as well
as self-administered survey (requiring approximately 10 minutes) to obtain sociodemographic
information and delay discounting measures.
The week following baseline, all participants will begin phone-based case management; online
self-monitoring of diet, activity, and weight; and diet and activity support. Beginning in
Week 3, participants will begin episodic future thinking or control thinking conditions.
Here, participants assigned to the EFT group will complete an episodic event generation task
to generate a number of positive, vivid events that may occur at several time frames in the
future (1 month, 3 months, 6 months, 1 year, 3 years, 5 years, and 10 years; a total of 7
events). During this task, participants will also generate corresponding short text
descriptions that will be used as cues to prompt episodic thinking in the natural
environment. Participants will regenerate all cues during weeks 8, 16, and 24, with partial
regenerations (regenerating only the 1 month and 3 month cues) scheduled during weeks 12 and
20. Participants will complete delay discounting tasks while viewing and imagining their EFT
or HIT cues in weeks 3 and 16.
On the day following the event/cue generation, participants will begin thrice-daily
smartphone app prompts to engage in EFT. In each prompt, participants will be presented with
one of their EFT cues, chosen randomly, and asked to read and vividly imagine this event for
a period of 30-60 seconds in a quiet location.
In contrast to the EFT condition, the control condition will be healthy information thinking
(HIT). Specifically, participants assigned to the HIT group will be asked to read
informational health vignettes on various topics related to T2D and health, adapted from
publicly available information (e.g., information on the role of insulin and insulin
resistance in T2D, nutrition labeling, understanding T2D risk factors). Participants will
then be asked to describe, in 1-2 sentences, a specific piece of information they learned
about each topic. This process is designed to mimic the event generation task used for the
EFT group, with the number of topics matched to the number of future EFT events. Beginning in
Week 3, participants will receive smartphone prompts to read and consider their
self-generated topic descriptions with the same frequency and at approximately the same times
of day as the EFT group. Moreover, HIT participants will regenerate these descriptions with
the same frequency as the EFT group.
At Weeks 8 and 24, participants will complete the same primary and secondary outcome measures
they completed during the baseline week, including delay discounting, BMI, and HbA1c.
In addition, during a debriefing stage after Week 24, participants will also rate the
perceived helpfulness and convenience of each intervention component (EFT/control prompting,
diet and activity support, self-monitoring, and case management) and remote outcomes
assessment methods.
