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

University of California, San Francisco125 enrolled

Overview

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).

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. 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 focus of the second phase (R33) is on comparing dietary adherence between the Ed only and ED + MBI arms over a 12-month period. This phase will also 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 maintenance phase intensities will be assessed to provide preliminary data for planning future trials. The primary analysis focus of this phase will be on the comparing the groups formed by the initial randomization to Ed versus Ed + MBI. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

125

Conditions

Type 2 Diabetes Mellitus

Interventions

Carbohydrate-restricted dietBEHAVIORAL

Education for carbohydrate-restricted diet

MindfulessBEHAVIORAL

Mindful eating app use plus group sessions to learn mindfulness

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Osher Center for Integrative Medicine

San Francisco, California, United States

Outcomes

Primary Outcomes

Diet Adherence Between Intervention Arms as Measured by % of Ketones >= 0.5 mmol/L

Percent of participant ketone measures \> or = 0.5 mmol/L during trial, by study arm

Time frame: Measures from ketone measure initiation (week 5) to 12 months. Ketones were measured daily over 7 days at 5 study timepoints: 5 weeks, 3, 6, 9, and 12 months.

Diet Adherence Between Intervention Arms as Measured by % of Participants in Each Arm With < 50 Grams/Day of Non-fiber Carbohydrate on 24- Hour Diet Recall

Average percent of participant measures with consumption of \< 50 grams/day of non-fiber carbohydrate (from 24-hour diet recall) by arm. Each participant was assigned a % of up to three measures reporting \< 50 grams/day of non-fiber carbohydrate consumption, and this percent was averaged across each arm.

Time frame: Average of three measures, done at 3, 6 and 12 months

Secondary Outcomes

Emotion-related Eating

change in emotion-related eating as measured by the Coping subscale of the Palatable Eating Motives Scale (PEMS). The coping subscale ranges from 1 to 5 (based on a mean of 4 items), with higher values indicating more emotion-related eating (the intervention aimed to lower this score--lower scores represent improvement).

Time frame: change from baseline to 12 months

Glycemic Control--HbA1c

Change in Hemoglobin A1c from baseline to 12 months with study arm

Time frame: change from baseline to 12 months

Frequency of Eating in Response to Cravings

Frequency of eating in response to cravings (indulgence) using ecological momentary assessment (EMA), operationalized as the percent of solicited occasions when a participant reported eating in response to cravings (rather than in response merely to hunger). Participants received 18 queries about eating in response to cravings over 3 days. Participants had to respond to at least 9 queries to have adequate data completeness for analysis. Frequency of eating in response to cravings is the proportion (scaled as a percent) of queries that participants responded to with responses that reported eating in response to cravings.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.