Status:
COMPLETED
(R33 Phase) Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 fo...
Detailed Description
The investigators will randomize 120 persons with T2DM in a 1:1 ratio to a nutrition education alone arm (Ed n=60) vs. a nutrition education with mindfulness-based intervention components (Ed+MBI n=60...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2021
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03837405
Start Date
December 12 2018
End Date
June 17 2021
Last Update
June 29 2021
Active Locations (1)
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1
Osher Center for Integrative Medicine
San Francisco, California, United States, 94115