Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-09 @ 4:10 AM
Study NCT ID:
NCT03837405
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2019-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
(R33 Phase) Delish Study: Diabetes Education to Lower Insulin, Sugars, and Hunger
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Optimizing Lifestyle Interventions With Mindfulness-based Strategies in Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Delish R33
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 4R33AT009333 | NIH | None | https://reporter.nih.gov/quic… | View |