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.
Source: View full study details on ClinicalTrials.gov
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