NCT03207711: Delish

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

Completed NA Results posted Last updated 8 December 2025

What this trial tests

NA trial testing Carbohydrate-restricted diet in Diabetes Mellitus, Type 2 in 60 participants. Completed in 1 September 2018.

Timeline

17 February 2017

Primary endpoint
30 April 2018

1 September 2018

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	17 February 2017
Primary completion	30 April 2018
Estimated completion	1 September 2018
Sites	1 location across United States

Drugs / interventions tested

• Carbohydrate-restricted diet
• Mindfulness

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of Eating in Response to Cravings (Primary Mechanistic Outcome) Primary · change from baseline to 6 months

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 th

Group	Value	95% CI
Diet Education	-20.39	-28.15 – -12.62
Diet Education + Mindfulness	-25.27	-32.95 – -17.58

Change in Impulsivity as Measured by Delayed Discounting Score Secondary · change from baseline to 6 months

The 5-trial adaptation of the Delayed Discounting (DD; Koffarnus \& Bickel, 2014) is a decision-making exercise where individuals choose between a smaller, immediate reward and a larger, delayed reward. The task measures an individual's "discount rate," or how much they devalue a future reward compared to an immediate one, which is a a key aspect of impulsivity and self-control. Respondents choose between $100 delivered after a delay, or $50 available immediately. To derive estimates of discount rate, we used Mazur's hyperbolic discounting model (V=A/ (1+kD)18, wherein V is the discounted valu

Group	Value	95% CI
Diet Education	87.17	-38.76 – 472.03
Diet Education + Mindfulness	6.42	-63.45 – 209.89

Emotion-related Eating (Secondary Mechanistic Outcome) Secondary · change from baseline to 6 months

Change in emotion-related eating as measured by the Coping subscale of the Palatable Eating Motives Scale (PEMS). The Coping subscale is comprised of 4 items rated on a scale from 1 (almost never/never) to 5 (almost always/always), with possible scores ranging from 4-20. Higher scores reflect worse coping/greater emotional eating. Thus, decreases over time reflect improved coping/decreased emotional eating.

Group	Value	95% CI
Diet Education	-0.62	-1.00 – -0.25
Diet Education + Mindfulness	-0.90	-1.27 – -0.53

Stress-related Eating (Secondary Mechanistic Outcome) Secondary · change from baseline to 6 months

Change in stress-related eating as measured by two questions about stress-related eating from the MIDUS study. Possible scores range from 2-8. Higher scores reflect worse outcomes/greater eating in response to stress. Thus, decreases over time reflect improved outcomes/decreased stress-related eating.

Group	Value	95% CI
Diet Education	-1.62	-2.22 – -1.03
Diet Education + Mindfulness	-1.73	-2.32 – -1.15

Glycemic Control, Using HbA1c Secondary · change from baseline to 6 months

Change in hemoglobin A1c (HbA1c) from baseline to 6 months by study arm

Group	Value	95% CI
Diet Education	-1.32	-1.65 – -0.98
Diet Education + Mindfulness	-0.87	-1.20 – -0.54

Fasting Glucose Secondary · change from baseline to 6 months

Change in plasma fasting glucose from baseline to 6 months by study arm

Group	Value	95% CI
Diet Education	-30.21	-44.48 – -15.94
Diet Education + Mindfulness	-25.92	-39.67 – -12.17

HOMA-2IR Index of Insulin Resistance (Secondary Clinical Outcome) Secondary · change from baseline to 6 months

Insulin resistance estimated from the Homeostatic model assessment (HOMA) model 2 index of insulin resistance. The basic formula is: (glucose × insulin) / 22.5, where glucose is measured in mmol/L and insulin in mU/L. The computer assisted re-calibration in model 2 addresses variations in the glucose resistance of the peripheral tissue and liver, increases in the insulin secretion curve for glucose \> 180 mg/dL, and contribution of circulating pro-insulin. Higher values indicate more insulin resistance (worse outcome). The Oxford University HOMA-2IR calculator was used (https://process.innovat

Group	Value	95% CI
Diet Education	-0.45	-0.93 – 0.02
Diet Education + Mindfulness	-0.85	-1.30 – -0.40

Weight Change(Secondary Clinical Outcome) Secondary · change from baseline to 6 months

kilograms

Group	Value	95% CI
Diet Education	-4.96	-6.44 – -3.49
Diet Education + Mindfulness	-4.43	-5.88 – -2.98

Adherence to Diet as Measured by Fingerstick Blood Ketones Secondary · 6 months

Adherence to diet as measured by average proportion of fingerstick blood ketones at or above 0.3 mmol/L at 24 weeks.

Group	Value	95% CI
Diet Education	0.46	0.26 – 0.66
Diet Education + Mindfulness	0.60	0.41 – 0.79

Diet Adherence by Mean Grams of Non-fiber Carbohydrate Consumed Per Day Secondary · change from baseline to 6 months

Diet Adherence Between Intervention Arms as Measured by Mean Grams of Non-fiber Carbohydrate Consumed Per Day From 24- Hour Diet Recall

Group	Value	95% CI
Diet Education	-91.43	-123.73 – -59.14
Diet Education + Mindfulness	-116.92	-148.53 – -85.31

Perceived Stress Secondary · change from baseline to 6 months

Perceived Stress Scale (PPS-10) total score. Scores can range from 0 to 40 with higher scores indicated greater perceived stress.

Group	Value	95% CI
Diet Education	-1.09	-2.73 – 0.55
Diet Education + Mindfulness	-2.04	-3.65 – -0.44

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Diet Education

Serious: 0/28 (0%)

Deaths: 0/28

Diet Education + Mindfulness

Serious: 0/30 (0%)

Deaths: 0/30

Other adverse events (3 terms — click to expand)

Reaction	System	Diet Education	Diet Education + Mindfulness
other	General disorders	—	—
Hypoglycemia	Metabolism and nutrition disorders	—	—
Hypertriglyceridemia	Cardiac disorders	—	—

Data from ClinicalTrials.gov NCT03207711 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Mason AE, Saslow L, Moran PJ, Kim S, et al · · 2019 · cited 13× · PMID 30545813 · DOI 10.2196/11002
2. Lipid findings from the Diabetes Education to Lower Insulin, Sugars, and Hunger (DELISH) Study.
   Mason AE, Saslow LR, Moran PJ, Kim S, et al · · 2019 · cited 10× · PMID 31467583 · DOI 10.1186/s12986-019-0383-2
3. Meditation for the primary and secondary prevention of cardiovascular disease.
   Rees K, Takeda A, Court R, Kudrna L, et al · · 2024 · cited 5× · PMID 38358047 · DOI 10.1002/14651858.cd013358.pub2