Examining the Effects of Mindful Eating Training on Adherence to a Carbohydrate-Restricted Diet in Patients With Type 2 Diabetes (the DELISH Study): Protocol for a Randomized Controlled Trial.

Background: Diet patterns have a profound influence on glycemic control for individuals with type 2 diabetes mellitus (T2DM), and craving-related eating is an important obstacle to dietary adherence. A growing body of research suggests that carbohydrate-restricted (CR) diets can improve glycemic control and reduce medication dependence in T2DM. However, limited data speak to the effects of long-term adherence to CR diets. Mindful eating training has been shown to reduce craving-related eating in overweight populations but has yet to be examined as a behavioral support for dietary adherence in T2DM. This trial examines behavioral mechanisms, particularly craving-related eating, through which mindful eating training might improve adherence to CR dietary recommendations in T2DM. This will clarify the importance of focusing on craving-related eating in the optimization of dietary adherence interventions.

Objective: The aim of this trial is to determine whether providing training in mindful eating increases adherence to a CR dietary recommendation in T2DM.

Methods: We are randomizing 60 participants to receive a CR diet with or without mindful eating training (12-week group intervention) and are following participants for 12 weeks after intervention completion. We hypothesize that participants who receive mindful eating training (relative to those who do not) will demonstrate greater adherence to the CR diet.

Results: Our primary outcome is change in craving-related eating, as assessed using an ecological momentary assessment mobile phone-based platform. Secondary behavioral pathway outcomes include changes in stress-related eating, impulsivity, glycemic control, weight change, dietary adherence, and resumption of dietary adherence after dietary nonadherence.

Conclusions: This theory-driven trial will shed light on the impact of mindfulness training on mechanisms that may impact dietary adherence in T2DM.

Trial Registration: ClinicalTrials.gov NCT03207711; https://clinicaltrials.gov/ct2/show/NCT03207711 (Archived by WebCite at http://www.webcitation.org/73pXscwaU).

International Registered Report Identifier (irrid): DERR1-10.2196/11002.