Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03207711
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2017-06-11
Brief Title:
Delish Study Diabetes Education to Lower Insulin Sugars and Hunger
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
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
Brief Summary:
Type 2 diabetes mellitus T2DM is the most expensive chronic disease in the US
Lifestyle modification is central to T2DM management but long-term adherence to dietary recommendations is difficult A key challenge is the difficulty of coping with cravings for high carbohydrate or sugar-laden foods in an environment where these foods are tempting and widely available One mechanism by which mindfulness may increase long-term dietary adherence is by better equipping individuals with skills to experience food cravings and difficult emotions without eating in response Such approaches seek to strengthen abilities to be non-judgmentally aware of tolerate and respond skillfully to food cravings and difficult emotions without reacting impulsively or maladaptively The investigators hypothesize that improved ability to manage food cravings and emotional eating is a key mechanism through which mindfulness-enhancements can improve dietary adherence The study will test a mindfulness-based intervention MBI for improving dietary adherence Although the particular diet employed is not the focus of this study the study will use a diet with about 10 of calories from carbohydrate as 1 it induces a low level of ketone production which will be used as a biomarker for dietary adherence 2 prior studies suggest it improves metabolic parameters in T2DM including glycemic control
Lifestyle modification is central to T2DM management but long-term adherence to dietary recommendations is difficult A key challenge is the difficulty of coping with cravings for high carbohydrate or sugar-laden foods in an environment where these foods are tempting and widely available One mechanism by which mindfulness may increase long-term dietary adherence is by better equipping individuals with skills to experience food cravings and difficult emotions without eating in response Such approaches seek to strengthen abilities to be non-judgmentally aware of tolerate and respond skillfully to food cravings and difficult emotions without reacting impulsively or maladaptively The investigators hypothesize that improved ability to manage food cravings and emotional eating is a key mechanism through which mindfulness-enhancements can improve dietary adherence The study will test a mindfulness-based intervention MBI for improving dietary adherence Although the particular diet employed is not the focus of this study the study will use a diet with about 10 of calories from carbohydrate as 1 it induces a low level of ketone production which will be used as a biomarker for dietary adherence 2 prior studies suggest it improves metabolic parameters in T2DM including glycemic control
Detailed Description:
The study will use ecological momentary assessment EMA methods to measure eating in response to difficult emotions andor food cravings In the R61 phase the team will ensure this measure is appropriate for further testing and assess the impact of the MBI components on our hypothesized behavioral mechanisms in N60 persons with T2DM The study plans 3 waves of 20 persons each with 12 weekly sessions All participants will attend an in-person group course providing education on basic behavioral strategies for diet and physical activity Participants will be randomized to receive this education alone Ed or this same material with added MBI components EdMBI The team will also pilot test two levels of intensity of maintenance phase intervention monthly group meetings alone or supplemented by individualized attention to prepare them for R33 testing the investigators plan an R33 phase trial in which 120 persons with T2DM will be randomized using a 12 ratio to Ed or EdMBI conditions and followed for 12 months including a 9-month maintenance phase The study will test the robustness of the effect of MBI components on our proposed behavioral mechanisms and on dietary adherence as well as preliminary effect sizes on weight and glycemic control The study will use an innovative adaptive intervention design to optimize maintenance phase intensity which the investigators believe may be key to augment the MBI effects The R33 phase will be registered and reported in a separate clinicaltrialsgov record
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R61AT009333 | NIH | None | httpsreporternihgovquickSearchR61AT009333 |