Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger

NCT03207711 | Completed Results DMC

• 1 other identifier: R61AT009333
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Frequency of Eating in Response to Cravings (Primary Mechanistic Outcome)

  Percent of ecological momentary assessment (EMA) opportunities in which participants reported eating in response to food cravings over a 3 day period. EMA measures were delivered to cell phones 3 times each day. The final EMA measure each day included a second question about whether there were any instances of craving related eating not already reported earlier during the day. Thus there was an opportunity to report eating in response to cravings on 4 different EMA questions each day, a total of 12 potential measures over 3 days. The percent here uses the number of EMA responses received as the denominator.

  change from baseline to 6 months

Secondary Outcomes (10)

• Change in Impulsivity as Measured by Delayed Discounting Score

  change from baseline to 6 months

• Emotion-related Eating (Secondary Mechanistic Outcome)

  change from baseline to 6 months

• Stress-related Eating (Secondary Mechanistic Outcome)

  change from baseline to 6 months

• Glycemic Control, Using HbA1c

  change from baseline to 6 months

• Fasting Glucose

  change from baseline to 6 months

Study Arms (2)

Diet Education

ACTIVE COMPARATOR

All participants will receive instruction in the carbohydrate-restricted diet (CR).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. Foods that are encouraged include green leafy and other non-starchy vegetables, nuts, seeds, oils (especially olive oil), fish, poultry, tofu, and avocados. Other foods consistent with the diet include berries (in modest amounts), meats, eggs, and cheese. Key foods to minimize include any sugar-sweetened foods or beverages, bread, pasta, potatoes, highly processed packaged foods, and other starchy foods.

Behavioral: Carbohydrate-restricted diet

Diet Education + Mindfulness

EXPERIMENTAL

In addition to the carbohydrate-restricted diet described above, the Ed+MBI group will receive mindfulness training consisting of two integrated components: 1) use of a mindful eating app at home to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based meetings to discuss and troubleshoot how the mindfulness practices are working. Key mindfulness content includes helping people improve their relationship with food and control food cravings and using mindful eating approaches including paying attention, noticing habit loops, understanding brain science and food/sugar addiction, disrupting emotional and stress eating, cultivating acceptance and curiosity, lovingkindness, detaching from thoughts, using healthy restraint, and maintaining motivation.

Behavioral: Carbohydrate-restricted diet; Behavioral: Mindfulness

Interventions

Carbohydrate-restricted diet BEHAVIORAL

Education for carbohydrate-restricted diet

Diet Education; Diet Education + Mindfulness

Mindfulness BEHAVIORAL

Mindful eating app-use and instruction

Diet Education + Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of T2DM mellitus. If taking insulin, screening labs will include C-Peptide to rule out T1DM.
• 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. Must be interested in following a carbohydrate- restricted diet, willing to learn about mindful eating and behavioral strategies for following prescribed diets, have sufficient control over their food intake so that they can follow either diet, and otherwise be able and willing to participate in the intervention. Intervention content must be practiced to evaluate whether it is effective.
• 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 or that may need immediate changes in medical management that will affect study outcome measures. Such conditions may include cancer, liver failure, renal failure, untreated hypo or hyperthyroidism, or history of serious bulimia. Some other serious medical conditions that may alter key study outcomes or require other important diet modifications, including untreated hypothyroidism, renal failure, cirrhosis, and conditions requiring oral or parenteral glucocorticoid treatment.
• Pregnant or planning to get pregnant in the next 6 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 weight-loss (bariatric) surgery or bariatric surgery within the past 18 months.
• 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.
• Vegan or vegetarian.
• Unwilling to do home ketone monitoring.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

UCSF Osher Center for Integrative Medicine

San Francisco, California, 94143, United States

Location

Related Publications (2)

• Mason AE, Saslow LR, Moran PJ, Kim S, Abousleiman H, Richler R, Schleicher S, Goldman VM, Hartman A, Leung C, Hartogensis W, Hecht FM. Lipid findings from the Diabetes Education to Lower Insulin, Sugars, and Hunger (DELISH) Study. Nutr Metab (Lond). 2019 Aug 27;16:58. doi: 10.1186/s12986-019-0383-2. eCollection 2019.

  PMID: 31467583 DERIVED

• Mason AE, Saslow L, Moran PJ, Kim S, Wali PK, Abousleiman H, Hartman A, Richler R, Schleicher S, Hartogensis W, Epel ES, Hecht F. 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. JMIR Res Protoc. 2019 Feb 20;8(2):e11002. doi: 10.2196/11002.

  PMID: 30545813 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Carbohydrate-Restricted; Mindfulness

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

We completed planned enrollment and did not have early termination. The trial was the initial part of a potentially two-step grant. This pilot phase was aimed at testing the trial design and assessing if there was evidence of effects on food cravings, a mechanistic goal. It was not powered to assess changes in clinical outcomes.

Results Point of Contact

• Title: Frederick Hecht, MD
• Organization: University of California, San Francisco

rick.hecht@ucsf.edu

(415) 353-9743

Study Officials

• Rick Hecht, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blood tests at LabCorp and 24-hour dietary recall interviews are done by research assistants blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2017
• First Posted: July 5, 2017
• Study Start: February 17, 2017
• Primary Completion: April 30, 2018
• Study Completion: September 1, 2018
• Last Updated: December 8, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)