The Lifestyle Education About Prediabetes (Leap) Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

March 20, 2022

Primary Completion Date

November 15, 2025

Study Completion Date

November 15, 2025

Conditions
PreDiabetes
Interventions
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."

Trial Locations (1)

48109

University of Michigan, Ann Arbor

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of Michigan

OTHER