A Low-Carbohydrate Diabetes Prevention Program

Completed · Not applicable

Conditions studied: PreDiabetes

In brief

The investigators will conduct a single-arm mixed methods pilot study to estimate weight loss as well as the percentage of participants who achieve 5% weight loss in a 16-week, Low-Carbohydrate Diabetes Prevention Program (LC-DPP). Weight loss from the pilot LC-DPP cohort will be compared to weight loss outcomes from previously published DPP studies. The investigators will also evaluate secondary outcomes including change in physical activity, mental health, psychosocial functioning, and hemoglobin A1c over the 6-month study period.

Key facts

Study ID

NCT03258918

Run by

University of Michigan

People needed

22

Starts

2017-09-11

Expected to finish

2018-11-07

Last updated by the study team

2018-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Overweight, defined as BMI≥25 kg/m2 [31]
• HbA1c between 5.7-6.4% drawn within 6 months of the study start date
• Willingness to participate in group-based classes
• Able to engage in at least light physical activities such as walking.

You may not qualify if…

• History of type 1 diabetes or type 2 diabetes
• Current participation in another lifestyle or behavior change program or research study
• Vegetarian or vegan lifestyle
• History of bariatric surgery
• Inability to read, write, or speak English
• Inability to provide informed consent
• Women who are pregnant or intend to become pregnant during the intervention period.
• Insured by Premier Care or Grad Care; these individuals have the opportunity to participate in a standard DPP, which is offered as a covered benefit through their health plan.

Where it is running

• Michigan Medicine — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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