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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Carbohydrate-restricted diet; Behavioral: Mindfulness

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Osher Center for Integrative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. History of T2DM mellitus. If taking insulin, screening labs will include C-Peptide to rule out T1DM.
2. HbA1c >= 6.5% and < 12.0% at screening.
3. Experience food-related cravings most days of the week and eat in response to these cravings regularly.
4. Aged 18 years old and older.
5. Able to engage in light physical activity.
6. 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.
7. Have smartphone and are willing to use it on a regular basis for data collection.
8. Ability to speak English.

Exclusion Criteria:

1. Unable to provide informed consent.
2. 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.
3. Pregnant or planning to get pregnant in the next 6 months, breastfeeding or less than 6 months post-partum.
4. Current use of weight loss medications, such as Alli or amphetamine-based drugs that may affect weight.
5. Planned weight-loss (bariatric) surgery or bariatric surgery within the past 18 months.
6. 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.
7. Vegan or vegetarian.
8. Unwilling to do home ketone monitoring.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Diet Education; 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; Education for carbohydrate-restricted diet
Experimental: Diet Education + Mindfulness; 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; Education for carbohydrate-restricted diet; Behavioral: Mindfulness; Mindful eating app-use and instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of eating in response to cravings (primary mechanistic outcome)	frequency (times/day) of eating in response to cravings using ecological momentary assessment (EMA)	change from baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
decreased impulsivity as measured by delayed discounting (secondary mechanistic outcome)	change in delayed discounting score	change from baseline to 6 months
emotion-related eating (secondary mechanistic outcome)	measured by the coping subscale of the Palatable Eating Motives Scale (PEMS)	change from baseline to 6 months
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	change from baseline to 6 months
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.	6 months
Glycemic control, using HbA1c (secondary clinical outcome)	hemoglobin A1c (HbA1c)	change from baseline to 6 months
Fasting glucose (secondary clinical outcome)	plasma fasting glucose	change from baseline to 6 months
insulin resistance(secondary clinical outcome)	Homeostatic model assessment (HOMA) index of insulin resistance (computed from insulin and fasting glucose measures)	change from baseline to 6 months
Weight change(secondary clinical outcome)	pounds	change from baseline to 6 months
Adherence to diet (secondary clinical outcome)	measured by blood ketones	6 months
Adherence to diet (secondary clinical outcome)	measured by 24-hour diet recall	change from baseline to 6 months
Perceived Stress (secondary mechanistic outcome)	Perceived Stress Scale total score	change from baseline to 6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Rick Hecht, MD, University of California, San Francisco

Publications and helpful links

General 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. Erratum In: Nutr Metab (Lond). 2019 Dec 30;16:91.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: R61AT009333 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No