NCT05235425

The Lifestyle Education About Prediabetes (Leap) Study

Testing a Very Low-carbohydrate Diet Version of the Diabetes Prevention Program to Reduce Risk Factors for Type 2 Diabetes: The LEAP (Lifestyle Education About Prediabetes) Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This research will test whether a standard version or very low-carbohydrate version of the Diabetes Prevention Program better improves outcomes like blood glucose control and body weight for patients with prediabetes. Participants will have screening (includes blood draw) and baseline testing with a continuous glucose monitor. Once these enrollment steps are completed and the participants will be randomized to one of two groups: standard National Diabetes Prevention Program (NDPP) or a very low-carbohydrate version. In addition to the diet (12 months) participants will be asked to participate in hour-long weekly group classes over zoom. After four months in the program, classes will occur about every month to help participants maintain the new diet. There will also be check-ins and follow-up visits through out the study.

Conditions

• PreDiabetes

Interventions

Type	Name	Description
BEHAVIORAL	Standard NDPP	Participants in this arm will be taught to manage their prediabetes with the Centers for Disease Control's standard National Diabetes Prevention Program. It teaches a lower calorie, lower fat diet. There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month.
BEHAVIORAL	Very low-carbohydrate diet	Participants in this arm will be taught to manage their prediabetes with the Centers for Disease Control's National Diabetes Prevention Program, adapted to teach a very low-carbohydrate diet, also called a ketogenic or "keto" diet. This diet involves eating non-starchy vegetables, leafy greens, cheese, meats, berries, nuts, and seeds and avoiding starchy foods like pasta, bread, rice, beans, many fruits, etc. There will be a core phase and a maintenance phase of this study; the core phase will last for about 4 months and will involve weekly or every other week classes, home assignments, and brief check-in surveys. The maintenance phase will last for the remaining time, with classes and check-in surveys approximately once a month.

Timeline

• Start date: 2022-03-20
• Primary completion: 2025-11-14
• Completion: 2025-11-14
• First posted: 2022-02-11
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States