(R33 Phase) Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger

NCT03837405 | Completed DMC

• 1 other identifier: 4R33AT009333
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• diet adherence between intervention arms as measured by ketones

  proportion of ketone measures dichotomized as \> or = 0.3 mmol/L versus \< 0.3

  measures from ketone measure initiation (week 5) to 12 months

• diet adherence between intervention arms as measured by 24- hour diet recall--dichotomous

  proportion of participants consuming \< 50 grams/day of non-fiber carbohydrate (from 24-hour diet recall)

  from 3 to 12 months

Secondary Outcomes (9)

• executive functioning /decreased impulsivity-Delayed Discounting

  change from baseline to 12 months

• emotion-related eating

  change from baseline to 12 months

• Glycemic control--a1c

  change from baseline to 12 months

• frequency of eating in response to cravings

  change from baseline to 12 months

• diet adherence between intervention arms as measured by 24- hour diet recall--total carbs, continuous

  from 3 to 12 months

Other Outcomes (5)

• stress-related eating

  change from baseline to 12 months

• Perceived Stress

  change from baseline to 12 months

• Insulin resistance

  change from baseline to 12 months

Study Arms (2)

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.

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.

Behavioral: Carbohydrate-restricted diet; Behavioral: Mindfuless

Interventions

Carbohydrate-restricted diet BEHAVIORAL

Education for carbohydrate-restricted diet

Diet Education; Diet Education + Mindfulness

Mindfuless BEHAVIORAL

Mindful eating app use plus group sessions to learn mindfulness

Diet Education + Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Osher Center for Integrative Medicine

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Rick Hecht, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Elissa Epel, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blood tests at LabCorp and 24-hour dietary recall interviews are done by research assistants blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 12, 2019
• Study Start: December 12, 2018
• Primary Completion: June 17, 2021
• Study Completion: June 17, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)