At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Optimizing Lifestyle Interventions With Mindfulness-based Strategies in Type 2 Diabetes
In Brief
A clinical study evaluating Carbohydrate-restricted diet and Mindfuless for Type 2 Diabetes Mellitus. Completed, enrolled 125 participants across 1 site.
Detailed Summary
The investigators plan an R33 phase trial in which 120 persons with type 2 diabetes (T2DM) will be randomized (using a 1:1 ratio) to education alone (Ed) on following a carbohydrate restricted diet for T2DM, or this same education content with added mindful eating/Mindfulness-Based Intervention components (Ed+MBI).
Study Details
Timeline
Arms & Interventions
All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. The study diet has approximately 10% of kcal coming from carbohydrate, typically 50 grams/day or fewer, not including fiber. Participants will be encouraged to eat a normal amount of protein, typically about 80-100 grams/day (about 20-25% of calories), and the rest of their calories from fat.
In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them.
Interventions
Education for carbohydrate-restricted diet
Mindful eating app use plus group sessions to learn mindfulness