The purpose of this study is to establish the reasonableness of using food-based photo diaries and continuous glucose monitors (CGM) to engage in counterfactual thinking strategies. These strategies may improve food choices among participants diagnosed with prediabetes (intervention group).
The long-term objective of this project is to create a counterfactual-based lifestyle intervention that curtails the progression of prediabetes to T2DM through management and knowledge of food choices. This is a significant objective since 70% of prediabetes patients go on to develop T2DM. The project addresses a major objective of PATHS-UP in general and Thrust 4 in particular, by developing an innovative behavior-change intervention that will eventually make use of information from the Lab-on-your-Wrist device. To our knowledge, this is the first project to (1) propose an intervention based on counterfactual thinking for diabetes prevention and (2) combine continuous glucose monitors (CGMs) and food photography to promote a better understanding of how food choices affect blood glucose.The specific aim of this project is to establish the validity of leveraging photo-based food diaries and CGMs to engage counterfactual thinking strategies that improve food choices amongst prediabetes participants. This will be measured by changes in (1) eating attitudes and behaviors, (2) behavioral intentions to improve healthy eating behavior, (3) motivation to improve eating behavior, (4) increased self- efficacy for healthy eating, and (5) number of glucose excursions and time-in-range.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
50
The intervention occurs during the third study visit. This is a counterfactual intervention, which will involve asking the subjects to think of an alternative reality that "might have been" based on the concurrency of their glucose readings and the meals they ate.
Center for Translational Research in Age and Longevity
College Station, Texas, United States
Change in average daily glucose level
Collected via the Freestyle Libre Pro continuous glucose monitor placed on the participants' upper arm.
Time frame: Data will be collected in between study visits 1-4 (at baseline, 3 weeks, 4 weeks, and 6 weeks)
Change in number of glucose excursions and time in range
Collected via the Freestyle Libre Pro continuous glucose monitor placed on the participants' upper arm.
Time frame: Data will be collected in between study visits 1-4 (at baseline, 3 weeks, 4 weeks, and 6 weeks)
Change in HbA1C
Blood will be sampled through venipuncture technique on the upper arm. A blood sample of 4 mL will be collected for each measurement of the subject's A1c.
Time frame: A blood sample will be collected at the screening visit, and at 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Change in the Self Regulation of Eating Behaviors Questionnaire (SREBQ) scores
Participants will report their ability to regulate and/or change their eating habits. Items correspond to a Likert style format ranging from 1 (never) to 5 (always), where higher scores indicate worse regulation (aside from one item that must be reverse-scored).
Time frame: Collected via survey measures at baseline (Study Visit #1), 4 weeks (Study Visit #3), at 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Change in General Health Intentions (GHI) scores
Participants will self-report their intentions to engage in healthier food habits over the next six months. Participants respond using a Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree), where higher scores indicate greater intentions to eat healthy.
Time frame: Self-report general health intentions data will be collected at baseline (Study Visit #1), 4 weeks (Study Visit #3), 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
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Change in Regulation of Eating Behaviors Scale (REBS) scores
Participants will self-report their motivations for eating via the Regulation of Eating Behaviors Scale, including whether they eat to cope with negative affect, to be social, to comply with others' expectations, and to enhance pleasure. Scores are measured on a Likert scale from 1 (does not correspond at all) to 7 (corresponds exactly), where higher scores indicate greater regulation of eating behaviors (with the exception of a few items that must be reverse-scored).
Time frame: Collected via survey measures at baseline (Study Visit #1), 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Change in the Eating Self-Efficacy Scale (ESES) scores
Participants respond to a survey (ESES) intended to measure self-efficacy and self-regulation of healthy eating. Items are answered using a Likert scale ranging from 1 (not difficult at all) to 7 (extremely difficult), where higher scores indicate greater use of excessive food intake in social and emotional situations.
Time frame: Data will be collected at baseline (Study Visit #1), 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Change in the Behavioral Strategies - Engagement and Intentions score
Collected via questions developed through this study (Behavioral Strategies - Engagement and Intentions) by lead investigators asking about participant's (experimental group only) use of counterfactual strategies developed during Study Visit #3 (3 weeks) (e.g., "Reduce rice intake"). Responses are answered using a Likert scale ranging from 1 (none of the time) to 7 (most of the time), where higher scores indicate greater engagement and intentions to use behavioral strategies.
Time frame: Collected once per week over the first 6 weeks.