(R33 Phase) DELISH Study: Diabetes Education to Lower Insulin, Sugars, and Hunger

Completed · Not applicable

Conditions studied: Type 2 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT03837405

Run by

University of California, San Francisco

People needed

125

Starts

2018-12-12

Expected to finish

2021-06-17

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of T2DM mellitus.
• HbA1c ≥ 6.5% and < 12.0% at screening.
• Experience food-related cravings most days of the week and eat in response to these cravings regularly.
• Aged 18 years old and older.
• Able to engage in light physical activity.
• Willing and able to participate in the interventions including appropriate participation in the group setting.
• Have smartphone and are willing to use it on a regular basis for data collection.
• Ability to speak English.

You may not qualify if…

• Unable to provide informed consent.
• A substance abuse, mental health, or medical condition that, in the opinion of investigators, will make it difficult for the potential participant to participate in the intervention, that may need immediate changes in medical management that will affect study outcome measures, or that may require important adaptations in the study diet.
• Pregnant or planning to get pregnant in the next 12 months, breastfeeding or less than 6 months post-partum.
• Current use of weight loss medications, such as Alli or amphetamine-based drugs that may affect weight.
• Planned or history of weight-loss (bariatric) surgery, or other intestinal surgeries that cause malabsorption. These are likely to change study outcome measures, making it difficult to distinguish the effects of the intervention program, or require extensive tailoring of the diet intervention.
• Currently enrolled in a weight loss program, such as Weight Watchers or a self-help group such as Overeaters Anonymous, or have unalterable plans to enroll in one of these programs in the next year; using a ketogenic low carbohydrate diet in the past 6 months with advice from a health care professional; or use of a mindful eating program with guidance from a professional in the past 6 months or have ever used the study mindful-eating app.
• Vegan or vegetarian.
• Unwilling to do regular blood testing at home for glucose or ketone monitoring.

Where it is running

• Osher Center for Integrative Medicine — San Francisco, California, United States

Full record on ClinicalTrials.gov

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