CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Carbohydrate-restricted diet +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03207711
NCT03207711N/ACompleted

Optimizing Lifestyle Interventions With Mindfulness-based Strategies in Type 2 Diabetes

University of California, San Francisco·interventional·Posted Jul 5, 2017·Updated Dec 8, 2025

In Brief

A clinical study evaluating Carbohydrate-restricted diet and Mindfulness for Diabetes Mellitus, Type 2. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Type 2 diabetes mellitus (T2DM) is the most expensive chronic disease in the U.S. Lifestyle modification is central to T2DM management, but long-term adherence to dietary recommendations is difficult. A key challenge is the difficulty of coping with cravings for high carbohydrate or sugar-laden foods in an environment where these foods are tempting and widely available. One mechanism by which mindfulness may increase long-term dietary adherence is by better equipping individuals with skills to experience food cravings and difficult emotions without eating in response. Such approaches seek to strengthen abilities to be non-judgmentally aware of, tolerate, and respond skillfully to food cravings and difficult emotions without reacting impulsively or maladaptively. The investigators hypothesize that improved ability to manage food cravings and emotional eating is a key mechanism through which mindfulness-enhancements can improve dietary adherence. The study will test a mindfulness-based intervention (MBI) for improving dietary adherence. Although the particular diet employed is not the focus of this study, the study will use a diet with about 10% of calories from carbohydrate as: (1) it induces a low level of ketone production, which will be used as a biomarker for dietary adherence; (2) prior studies suggest it improves metabolic parameters in T2DM, including glycemic control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 5, 2017
Enrollment StartFeb 17, 2017
Primary CompletionApr 30, 2018
Study CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.0 years ago

Interventions

Carbohydrate-restricted dietbehavioral

Education for carbohydrate-restricted diet

Mindfulnessbehavioral

Mindful eating app-use and instruction