Diabetes Mellitus, Type 2DelishNCT03207711
Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger
A study testing Carbohydrate-restricted diet and Mindfulness in people with Diabetes Mellitus, Type 2, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Carbohydrate-restricted diet and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 1 Sep 2018
- 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. 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.
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 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Osher Center for Integrative Medicine
San Francisco, California, 94143
About this study
Official title: Optimizing Lifestyle Interventions With Mindfulness-based Strategies in Type 2 Diabetes
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.
Read the detailed description
The study will use ecological momentary assessment (EMA) methods to measure eating in response to difficult emotions and/or food cravings. In the R61 phase, the team will ensure this measure is appropriate for further testing and assess the impact of the MBI components on our hypothesized behavioral mechanisms in N=60 persons with T2DM. The study plans 3 waves of 20 persons each with 12 weekly sessions. All participants will attend an in-person group course providing education on basic behavioral strategies for diet and physical activity. Participants will be randomized to receive this education alone (Ed) or this same material with added MBI components (Ed+MBI). The team will also pilot test two levels of intensity of maintenance phase intervention (monthly group meetings alone or supplemented by individualized attention) to prepare them for R33 testing. the investigators plan an R33 phase trial in which 120 persons with T2DM will be randomized (using a 1:2 ratio) to Ed or Ed+MBI conditions and followed for 12 months, including a 9-month maintenance phase. The study will test the robustness of the effect of MBI components on our proposed behavioral mechanisms, and on dietary adherence, as well as preliminary effect sizes on weight and glycemic control. The study will use an innovative adaptive intervention design to optimize maintenance phase intensity, which the investigators believe may be key to augment the MBI effects. The R33 phase will be registered and reported in a separate clinicaltrials.gov record.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Carbohydrate-restricted diet, Mindfulness
- 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
MindfulnessBehavioural
Mindful eating app-use and instruction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Carbohydrate-restricted diet; Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline to 6 months
Secondary outcomes (10)
Change in Impulsivity as Measured by Delayed Discounting Score
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 value of the delayed option, A is its objective amount, D is its delay, and k indexes the discount rate. We calculated values of k for each participant as the inverse of the indifference delay (1/ED50). We log transformed these values prior to analysis. Higher values of K indicate greater discounting, which reflects greater impulsivity.
Measured: change from baseline to 6 months
Emotion-related Eating (Secondary Mechanistic Outcome)
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.
Measured: change from baseline to 6 months
Stress-related Eating (Secondary Mechanistic Outcome)
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.
Measured: change from baseline to 6 months
Glycemic Control, Using HbA1c
Change in hemoglobin A1c (HbA1c) from baseline to 6 months by study arm
Measured: change from baseline to 6 months
Fasting Glucose
Change in plasma fasting glucose from baseline to 6 months by study arm
Measured: change from baseline to 6 months
HOMA-2IR Index of Insulin Resistance (Secondary Clinical Outcome)
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.innovation.ox.ac.uk/software/p/2112/homa2-calculator/1). HOMA index values < 2.0 are generally considered normal and indicate adequate sensitivity of cells to insulin. HOMA index values between 2.0 and 2.5 may indicate borderline changes in insulin sensitivity. HOMA index values > 2.5 clearly indicate insulin resistance.
Measured: change from baseline to 6 months
Weight Change(Secondary Clinical Outcome)
kilograms
Measured: change from baseline to 6 months
Adherence to Diet as Measured by Fingerstick Blood Ketones
Adherence to diet as measured by average proportion of fingerstick blood ketones at or above 0.3 mmol/L at 24 weeks.
Measured: 6 months
Diet Adherence by Mean Grams of Non-fiber Carbohydrate Consumed Per Day
Diet Adherence Between Intervention Arms as Measured by Mean Grams of Non-fiber Carbohydrate Consumed Per Day From 24- Hour Diet Recall
Measured: change from baseline to 6 months
Perceived Stress
Perceived Stress Scale (PPS-10) total score. Scores can range from 0 to 40 with higher scores indicated greater perceived stress.
Measured: change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start17 Feb 2017
- Primary completion30 Apr 2018
- Study completion1 Sep 2018
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 60 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 Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207711
- Sponsor's protocol ID
- R61AT009333
- Other IDs
- R61AT009333
- Acronym
- Delish
- Status last verified
- Dec 2025
- First submitted
- 11 Jun 2017
- Last updated
- 8 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31467583Mason 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.
PubMed 30545813
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. 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
- NCT03207711
- Acronym / sponsor ID
- Delish / R61AT009333
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Posted 8 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will use ecological momentary assessment (EMA) methods to measure eating in response to difficult emotions and/or food cravings. In the R61 phase, the team will ensure this measure is appropriate for further testing and assess the impact of the MBI components on our hypothesized behavioral mechanisms in N=60 persons with T2DM. The study plans 3 waves of 20 persons each with 12 weekly sessions. All participants will attend an in-person group course providing education on basic behavioral strategies for diet and physical activity. Participants will be randomized to receive this education alone (Ed) or this same material with added MBI components (Ed+MBI). The team will also pilot test two levels of intensity of maintenance phase intervention (monthly group meetings alone or supplemented by individualized attention) to prepare them for R33 testing. the investigators plan an R33 phase trial in which 120 persons with T2DM will be randomized (using a 1:2 ratio) to Ed or Ed+MBI conditions and followed for 12 months, including a 9-month maintenance phase. The study will test the robustness of the effect of MBI components on our proposed behavioral mechanisms, and on dietary adherence, as well as preliminary effect sizes on weight and glycemic control. The study will use an innovative adaptive intervention design to optimize maintenance phase intensity, which the investigators believe may be key to augment the MBI effects. The R33 phase will be registered and reported in a separate clinicaltrials.gov record.
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 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. |
| Diet Education + Mindfulness | Experimental | Behavioral: Carbohydrate-restricted diet, Behavioral: MindfulnessIn 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. |
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. 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.
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 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.
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 |
| MindfulnessMindful eating app-use and instruction | Behavioural | Diet Education + Mindfulness |
Primary outcome
Frequency of Eating in Response to Cravings (Primary Mechanistic Outcome)
Time frame: 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 the denominator.
10 secondary outcomes
Change in Impulsivity as Measured by Delayed Discounting Score
Time frame: change from baseline to 6 months
Emotion-related Eating (Secondary Mechanistic Outcome)
Time frame: change from baseline to 6 months
Stress-related Eating (Secondary Mechanistic Outcome)
Time frame: change from baseline to 6 months
Glycemic Control, Using HbA1c
Time frame: change from baseline to 6 months
Fasting Glucose
Time frame: change from baseline to 6 months
HOMA-2IR Index of Insulin Resistance (Secondary Clinical Outcome)
Time frame: change from baseline to 6 months
Weight Change(Secondary Clinical Outcome)
Time frame: change from baseline to 6 months
Adherence to Diet as Measured by Fingerstick Blood Ketones
Time frame: 6 months
Diet Adherence by Mean Grams of Non-fiber Carbohydrate Consumed Per Day
Time frame: change from baseline to 6 months
Perceived Stress
Time frame: change from baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31467583Mason 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.
- Derived from this study: PubMed 30545813Mason 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.
- 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
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 Mindfulness in people with Diabetes Mellitus, Type 2, 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 8 Dec 2025. 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 8 Dec 2025). 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?
Frequency of Eating in Response to Cravings (Primary Mechanistic Outcome) (time frame: change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03207711, which also lists 2 linked publications.
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 8 Dec 2025.