Type 2 Diabetes MellitusDELISH R33NCT03837405
(R33 Phase) DELISH Study: Diabetes Education to Lower Insulin, Sugars, and Hunger
A study testing Carbohydrate-restricted diet and Mindfuless in people with Type 2 Diabetes Mellitus, run by University of California, San Francisco at 1 site in United States.
Trial 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 for T2DM, or this same education content with added mindful eating/Mindfulness-Based Intervention components (Ed+MBI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Carbohydrate-restricted diet and Mindfuless
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2018to 17 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Osher Center for Integrative Medicine
San Francisco, California, 94115
About this study
Official title: Optimizing Lifestyle Interventions With Mindfulness-based Strategies in Type 2 Diabetes
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).
Read the 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) arm and follow them for 12 months. The interventions will be provided in a weekly group setting, with about 10 to 12 persons per group. Some educational intervention components will be delivered using a smartphone app. After the 12-week initial intervention, the investigators will re-randomize participants using an adaptive intervention design to receive low, medium, or high intensity maintenance training, depending on level of adherence achieved during the initial intervention period. Follow-up assessments will be performed at 3, 6, 9, and 12 months. The investigators will address the following specific aims:
- Test the hypothesis that the Ed+MBI arm will have better dietary adherence than the Ed arm.
- Test whether our proposed behavioral mechanisms (e.g. decreased eating in response to cravings or difficult emotions) predict dietary adherence.
- Obtain preliminary assessment of intervention effects on clinical outcomes
This is the second phase of a two-phase study. Pilot testing has been completed in the first phase (R61). The focus of the second phase (R33) is on comparing dietary adherence between the Ed only and ED + MBI arms over a 12-month period. This phase will also include employing an adaptive intervention design in the post-treatment phase to test optimization of the maintenance intervention (i.e. assigning maintenance intensity/dose based on how a participant is doing). The maintenance phase intensities will be assessed to provide preliminary data for planning future trials. The primary analysis focus of this phase will be on the comparing the groups formed by the initial randomization to Ed versus Ed + MBI. The investigators will use fingerstick blood ketone measures, which provide an objective measure of whether the target levels of carbohydrate restriction have been attained, as our primary adherence outcome measure. This will be supplemented by 24-hour diet recall measures of carbohydrate consumption. Important secondary outcome measures will include clinical measures such as glycosylated hemoglobin and behavioral measures such as frequency of eating in response to food cravings.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Carbohydrate-restricted diet, Mindfuless
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate-restricted dietBehavioural
Education for carbohydrate-restricted diet
MindfulessBehavioural
Mindful eating app use plus group sessions to learn mindfulness
| Study group | Role | What they receive |
|---|---|---|
| Diet Education | Active comparator | All participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. 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. Receives: Behavioral: Carbohydrate-restricted diet |
| Diet Education + Mindfulness | Experimental | In addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. Receives: Behavioral: Carbohydrate-restricted diet; Behavioral: Mindfuless |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Adherence Between Intervention Arms as Measured by % of Ketones >= 0.5 mmol/L
Percent of participant ketone measures > or = 0.5 mmol/L during trial, by study arm
Measured: Measures from ketone measure initiation (week 5) to 12 months. Ketones were measured daily over 7 days at 5 study timepoints: 5 weeks, 3, 6, 9, and 12 months.
Diet Adherence Between Intervention Arms as Measured by % of Participants in Each Arm With < 50 Grams/Day of Non-fiber Carbohydrate on 24- Hour Diet Recall
Average percent of participant measures with consumption of < 50 grams/day of non-fiber carbohydrate (from 24-hour diet recall) by arm. Each participant was assigned a % of up to three measures reporting < 50 grams/day of non-fiber carbohydrate consumption, and this percent was averaged across each arm.
Measured: Average of three measures, done at 3, 6 and 12 months
Secondary outcomes (6)
Emotion-related Eating
change in emotion-related eating as measured by the Coping subscale of the Palatable Eating Motives Scale (PEMS). The coping subscale ranges from 1 to 5 (based on a mean of 4 items), with higher values indicating more emotion-related eating (the intervention aimed to lower this score--lower scores represent improvement).
Measured: change from baseline to 12 months
Glycemic Control--HbA1c
Change in Hemoglobin A1c from baseline to 12 months with study arm
Measured: change from baseline to 12 months
Frequency of Eating in Response to Cravings
Frequency of eating in response to cravings (indulgence) using ecological momentary assessment (EMA), operationalized as the percent of solicited occasions when a participant reported eating in response to cravings (rather than in response merely to hunger). Participants received 18 queries about eating in response to cravings over 3 days. Participants had to respond to at least 9 queries to have adequate data completeness for analysis. Frequency of eating in response to cravings is the proportion (scaled as a percent) of queries that participants responded to with responses that reported eating in response to cravings.
Measured: Change from baseline to 12 months
Diet Adherence Between Intervention Arms as Measured by Mean Grams of Non-fiber Carbohydrate Consumed Per Day From 24- Hour Diet Recall
Mean grams of non-fiber carbohydrate consumed per day (from 24-hour diet recall) during trial. We calculated average grams of non-fiber consumed per day across up to three measures during the trial for each participant, and this was averaged across arms.
Measured: From 3 to 12 months, using measures done at 3, 6, and 12 months
Salzburg Stress Eating Scale
Change in stress-related eating as measured by Salzburg Stress Eating Scale. Range is from 1 to 5. Higher scores indicate greater stress-related eating.
Measured: change from baseline to 12 months
Weight Change
Body mass in kilograms (kg) from baseline to 12 months
Measured: change from baseline to 12 month weight data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start12 Dec 2018
- Primary completion17 Jun 2021
- Study completion17 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Rick Hecht, MD, Principal investigator, University of California, San FranciscoElissa Epel, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837405
- Sponsor's protocol ID
- 4R33AT009333
- Other IDs
- 4R33AT009333
- Acronym
- DELISH R33
- Status last verified
- May 2026
- First submitted
- 8 Feb 2019
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Lifestyle Interventions With Mindfulness-based Strategies in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03837405
- Acronym / sponsor ID
- DELISH R33 / 4R33AT009333
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 17 Jun 2021 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Posted 17 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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) arm and follow them for 12 months. The interventions will be provided in a weekly group setting, with about 10 to 12 persons per group. Some educational intervention components will be delivered using a smartphone app. After the 12-week initial intervention, the investigators will re-randomize participants using an adaptive intervention design to receive low, medium, or high intensity maintenance training, depending on level of adherence achieved during the initial intervention period. Follow-up assessments will be performed at 3, 6, 9, and 12 months. The investigators will address the following specific aims:
- Test the hypothesis that the Ed+MBI arm will have better dietary adherence than the Ed arm.
- Test whether our proposed behavioral mechanisms (e.g. decreased eating in response to cravings or difficult emotions) predict dietary adherence.
- Obtain preliminary assessment of intervention effects on clinical outcomes
This is the second phase of a two-phase study. Pilot testing has been completed in the first phase (R61). The focus of the second phase (R33) is on comparing dietary adherence between the Ed only and ED + MBI arms over a 12-month period. This phase will also include employing an adaptive intervention design in the post-treatment phase to test optimization of the maintenance intervention (i.e. assigning maintenance intensity/dose based on how a participant is doing). The maintenance phase intensities will be assessed to provide preliminary data for planning future trials. The primary analysis focus of this phase will be on the comparing the groups formed by the initial randomization to Ed versus Ed + MBI. The investigators will use fingerstick blood ketone measures, which provide an objective measure of whether the target levels of carbohydrate restriction have been attained, as our primary adherence outcome measure. This will be supplemented by 24-hour diet recall measures of carbohydrate consumption. Important secondary outcome measures will include clinical measures such as glycosylated hemoglobin and behavioral measures such as frequency of eating in response to food cravings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet Education | Active comparator | Behavioral: Carbohydrate-restricted dietAll participants will receive instruction in the Carbohydrate-Restricted (CR) diet and basic behavioral strategies in weekly, in-person, group sessions for 3 months. 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. |
| Diet Education + Mindfulness | Experimental | Behavioral: Carbohydrate-restricted diet, Behavioral: MindfulessIn addition to the diet components described above, participants randomized to the Education + Mindfulness (Ed+MBI) group will receive MBI components using the Eat Right Now (ERN) platform. This will consist of two integrated components: 1) use of the ERN app at home, during the week, to learn and practice mindfulness skills for food-cravings and eating, and 2) in-person group-based discussions of how the mindful eating practices are going, trouble-shooting obstacles/pain points, and doing group exercises and reflecting on them. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate-restricted dietEducation for carbohydrate-restricted diet | Behavioural | Diet Education, Diet Education + Mindfulness |
| MindfulessMindful eating app use plus group sessions to learn mindfulness | Behavioural | Diet Education + Mindfulness |
Primary outcome
Diet Adherence Between Intervention Arms as Measured by % of Ketones >= 0.5 mmol/L
Time frame: Measures from ketone measure initiation (week 5) to 12 months. Ketones were measured daily over 7 days at 5 study timepoints: 5 weeks, 3, 6, 9, and 12 months.
Percent of participant ketone measures > or = 0.5 mmol/L during trial, by study arm
Diet Adherence Between Intervention Arms as Measured by % of Participants in Each Arm With < 50 Grams/Day of Non-fiber Carbohydrate on 24- Hour Diet Recall
Time frame: Average of three measures, done at 3, 6 and 12 months
Average percent of participant measures with consumption of < 50 grams/day of non-fiber carbohydrate (from 24-hour diet recall) by arm. Each participant was assigned a % of up to three measures reporting < 50 grams/day of non-fiber carbohydrate consumption, and this percent was averaged across each arm.
6 secondary outcomes
Emotion-related Eating
Time frame: change from baseline to 12 months
Glycemic Control--HbA1c
Time frame: change from baseline to 12 months
Frequency of Eating in Response to Cravings
Time frame: Change from baseline to 12 months
Diet Adherence Between Intervention Arms as Measured by Mean Grams of Non-fiber Carbohydrate Consumed Per Day From 24- Hour Diet Recall
Time frame: From 3 to 12 months, using measures done at 3, 6, and 12 months
Salzburg Stress Eating Scale
Time frame: change from baseline to 12 months
Weight Change
Time frame: change from baseline to 12 month weight data
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick Hecht, MD principal investigator
University of California, San Francisco
Elissa Epel, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate-restricted diet and Mindfuless in people with Type 2 Diabetes Mellitus, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Adherence Between Intervention Arms as Measured by % of Ketones >= 0.5 mmol/L (time frame: Measures from ketone measure initiation (week 5) to 12 months. Ketones were measured daily over 7 days at 5 study timepoints: 5 weeks, 3, 6, 9, and 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.