Clinical trial NCT03837405: (R33 Phase) Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger
Official title: Optimizing Lifestyle Interventions With Mindfulness-based Strategies in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-02-12
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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:

1. Test the hypothesis that the Ed+MBI arm will have better dietary adherence than the Ed arm.
2. Test whether our proposed behavioral mechanisms (e.g. decreased eating in response to cravings or difficult emotions) predict dietary adherence.
3. Compare randomized arms in the adaptive maintenance intervention design to optimize maintenance phase dosing in future trials.
4. 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 second phase (R33) will 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 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.

Eligibility criteria: Inclusion Criteria:

1. History of T2DM mellitus.
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 including appropriate participation in the group setting.
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, that may need immediate changes in medical management that will affect study outcome measures, or that may require important adaptations in the study diet.
3. Pregnant or planning to get pregnant in the next 12 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 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.
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; 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.
7. Vegan or vegetarian.
8. Unwilling to do regular blood testing at home for glucose or ketone monitoring.

Primary outcomes:
measure: diet adherence between intervention arms as measured by ketones
timeFrame: measures from ketone measure initiation (week 5) to 12 months
measure: diet adherence between intervention arms as measured by 24- hour diet recall--dichotomous
timeFrame: from 3 to 12 months
Secondary outcomes:
measure: executive functioning /decreased impulsivity-Delayed Discounting
timeFrame: change from baseline to 12 months
measure: emotion-related eating
timeFrame: change from baseline to 12 months
measure: Glycemic control--a1c
timeFrame: change from baseline to 12 months
measure: frequency of eating in response to cravings
timeFrame: change from baseline to 12 months
measure: diet adherence between intervention arms as measured by 24- hour diet recall--total carbs, continuous
timeFrame: from 3 to 12 months
measure: executive functioning /decreased impulsivity--Relative Reinforcing Value of Food (RRVF)
timeFrame: change from baseline to 12 months
measure: Salzburg Stress Eating Scale
timeFrame: change from baseline to 12 months
measure: dietary resilience (resumption of dietary adherence) after dietary non-adherence occurs
timeFrame: 12 months
measure: Weight change
timeFrame: change from baseline to 12 months
Other outcomes:
measure: stress-related eating
timeFrame: change from baseline to 12 months
measure: Perceived Stress
timeFrame: change from baseline to 12 months
measure: Insulin resistance
timeFrame: change from baseline to 12 months
measure: Glycemic control--fasting glucose
timeFrame: change from baseline to 12 months
measure: Mindfulness
timeFrame: change from baseline to 12 months
Locations:
city: San Francisco
country: United States
facility: Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Rick Hecht, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Elissa Epel, PhD
role: PRINCIPAL_INVESTIGATOR
References: