At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Personalized Dietary Management in Type 2 Diabetes
In Brief
A clinical study evaluating Standardized, Usual Care Control (UCC), and 1 other intervention for Type 2 Diabetes. Completed, enrolled 294 participants across 1 site.
Signals
Detailed Summary
In a randomized trial of 255 participants with early-stage T2D, participants will be randomized to 1 of 3 groups: Standardized, Personalized, or a Usual Care Control (UCC). In the first phase, participants will be randomized with equal allocation to these 3 groups. In the second phase (current phase), the remaining participants will be randomized with equal allocation to the Standardized and UCC groups.
Study Details
Timeline
Arms & Interventions
Baseline advice about the Mediterranean-style diet and attention control.
One-size-fits-all dietary counseling to follow a Mediterranean-style diet
Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response
Interventions
Participants are instructed to follow a Mediterranean-style diet. Dietary counseling is paired with SCT-based behavioral counseling, which focuses on the role played by self-referent thought in the maintenance of behavior change. Self-efficacy (e.g., the participant's confidence in their ability to engage in healthier behavior) is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states. Participants self-monitor their diet using a mobile app and receive real-time feedback from the app on macronutrient distribution.
Participants are instructed to follow a Mediterranean-style diet,
Participants are instructed to follow a Mediterranean-style diet. Dietary counseling is paired with SCT-based behavioral counseling, which focuses on the role played by self-referent thought in the maintenance of behavior change. Self-efficacy (e.g., the participant's confidence in their ability to engage in healthier behavior) is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states. Participants self-monitor their diet using a mobile app and receive real-time feedback from the app on their predicted PPGR to meals and snacks at the time they enter them into their smart phone. PPGR predictions will be generated from a gut microbiome-based machine learning algorithm.