CompletedNot Applicable

The Lifestyle Education About Prediabetes (Leap) Study

United States304 participantsStarted 2022-03-20

Plain-language 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.

Who can participate

Age range21 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * overweight, defined as BMI \>= 25 kg/m2 \>= 23 kg/m2 if of Asian descent * HbA1c between 5.7% - 6.4% verified at baseline * willingness to participate in group-based sessions * able to engage in at least light physical activities such as walking * willingness to follow a prescribed diet, be randomized, self-weight, track diet, and report physical activity minutes * physician approval to participate Exclusion Criteria: * history of type 1 diabetes or type 2 diabetes * use of anti-obesity medications or participation in another weight loss program or intervention * use of glucose lowering medications other than metformin * pregnant or planning to become pregnant during the intervention period * breastfeeding * use of oral corticosteroids * previous bariatric surgery or planning to have bariatric surgery during the study period * blood disorders that influence HbA1c, including frequent blood transfusions, phlebotomy, anemia, hemoglobinopathy, polycythemia * any condition for which the study team deems participation to be unsafe or inappropriate * inability to read, write, or speak English * inability to provide informed consent * adherence to a vegan or vegetarian diet * adherence to a very low-carbohydrate (keto) diet * difficulty chewing or swallowing * no influence over what foods are purchased, prepared, and/or served * above weight limit for DEXA (500 pounds) * untreated eating disorder or mental health conditions, such as depression with suicidal i…

What they're measuring

Change in HbA1c

Timeframe: 0 to 12 months

Trial details

NCT IDNCT05235425

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-14