Back to resultsDelish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger (Delish)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carbohydrate-restricted diet
Mindfulness
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- UCSF Osher Center for Integrative Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Diet Education
Diet Education + Mindfulness
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
frequency of eating in response to cravings (primary mechanistic outcome)
frequency (times/day) of eating in response to cravings using ecological momentary assessment (EMA)
Secondary Outcome Measures
decreased impulsivity as measured by delayed discounting (secondary mechanistic outcome)
change in delayed discounting score
emotion-related eating (secondary mechanistic outcome)
measured by the coping subscale of the Palatable Eating Motives Scale (PEMS)
stress-related eating (secondary mechanistic outcome)
measured by two questions about stress-related eating from the MIDUS study and one additional stress-related eating question
resumption of dietary adherence after dietary non-adherence occurs (secondary mechanistic outcome)
time from a ketone measure of < 0.3 mmol/L to higher levels of >= 0.3 mmol/L, indicating a return to nutritional ketosis after a period of consuming foods that depress ketosis.
Glycemic control, using HbA1c (secondary clinical outcome)
hemoglobin A1c (HbA1c)
Fasting glucose (secondary clinical outcome)
plasma fasting glucose
insulin resistance(secondary clinical outcome)
Homeostatic model assessment (HOMA) index of insulin resistance (computed from insulin and fasting glucose measures)
Weight change(secondary clinical outcome)
pounds
Adherence to diet (secondary clinical outcome)
measured by blood ketones
Adherence to diet (secondary clinical outcome)
measured by 24-hour diet recall
Perceived Stress (secondary mechanistic outcome)
Perceived Stress Scale total score
Full Information
NCT ID
NCT03207711
First Posted
June 11, 2017
Last Updated
June 24, 2021
Sponsor
University of California, San Francisco
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT03207711
Brief Title
Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger
Acronym
Delish
Official Title
Optimizing Lifestyle Interventions With Mindfulness-based Strategies in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Blood tests at LabCorp and 24-hour dietary recall interviews are done by research assistants blinded to treatment assignment.
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet Education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Diet Education + Mindfulness
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Carbohydrate-restricted diet
Intervention Description
Education for carbohydrate-restricted diet
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
Mindful eating app-use and instruction
Primary Outcome Measure Information:
Title
frequency of eating in response to cravings (primary mechanistic outcome)
Description
frequency (times/day) of eating in response to cravings using ecological momentary assessment (EMA)
Time Frame
change from baseline to 6 months
Secondary Outcome Measure Information:
Title
decreased impulsivity as measured by delayed discounting (secondary mechanistic outcome)
Description
change in delayed discounting score
Time Frame
change from baseline to 6 months
Title
emotion-related eating (secondary mechanistic outcome)
Description
measured by the coping subscale of the Palatable Eating Motives Scale (PEMS)
Time Frame
change from baseline to 6 months
Title
stress-related eating (secondary mechanistic outcome)
Description
measured by two questions about stress-related eating from the MIDUS study and one additional stress-related eating question
Time Frame
change from baseline to 6 months
Title
resumption of dietary adherence after dietary non-adherence occurs (secondary mechanistic outcome)
Description
time from a ketone measure of < 0.3 mmol/L to higher levels of >= 0.3 mmol/L, indicating a return to nutritional ketosis after a period of consuming foods that depress ketosis.
Time Frame
6 months
Title
Glycemic control, using HbA1c (secondary clinical outcome)
Description
hemoglobin A1c (HbA1c)
Time Frame
change from baseline to 6 months
Title
Fasting glucose (secondary clinical outcome)
Description
plasma fasting glucose
Time Frame
change from baseline to 6 months
Title
insulin resistance(secondary clinical outcome)
Description
Homeostatic model assessment (HOMA) index of insulin resistance (computed from insulin and fasting glucose measures)
Time Frame
change from baseline to 6 months
Title
Weight change(secondary clinical outcome)
Description
pounds
Time Frame
change from baseline to 6 months
Title
Adherence to diet (secondary clinical outcome)
Description
measured by blood ketones
Time Frame
6 months
Title
Adherence to diet (secondary clinical outcome)
Description
measured by 24-hour diet recall
Time Frame
change from baseline to 6 months
Title
Perceived Stress (secondary mechanistic outcome)
Description
Perceived Stress Scale total score
Time Frame
change from baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick Hecht, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Osher Center for Integrative Medicine
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31467583
Citation
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. Erratum In: Nutr Metab (Lond). 2019 Dec 30;16:91.
Results Reference
derived
PubMed Identifier
30545813
Citation
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. Erratum In: JMIR Res Protoc. 2020 Jan 13;9(1):e17226.
Results Reference
derived
Learn more about this trial
Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger
We'll reach out to this number within 24 hrs