Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion
Rick Hecht Elissa Epel

Description

Summary

We 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).

Official Title

Optimizing Lifestyle Interventions With Mindfulness-based Strategies in Type 2 Diabetes

Details

We 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, we 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. We 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). We 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.

Keywords

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Carbohydrate-restricted diet Mindfuless Diet Education Diet Education + Mindfulness

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Location

  • Osher Center for Integrative Medicine accepting new patients
    San Francisco California 94115 United States

Lead Scientists

  • Rick Hecht
    I am trained in Internal Medicine, with additional training in clinical research methods, biostatistics, and behavioral medicine. My research focus for many years was on HIV.
  • Elissa Epel
    Elissa Epel, Ph.D, is a Professor in the Department of Psychiatry, at University of California, San Francisco. Her research aims to elucidate mechanisms of healthy aging, and to apply this basic science to scalable interventions that can reach vulnerable populations.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03837405
Study Type
Interventional
Last Updated