Low-Carbohydrate Diabetes Prevention Program Among Veterans With Prediabetes
Completed · Not applicable
Conditions studied: PreDiabetes
In brief
The investigators will conduct a single-arm mixed methods pilot study to examine the feasibility and acceptability of a low-carbohydrate diabetes prevention program (LC-DPP). The investigators will estimate weight loss as well as the percentage of participants who achieve 5% body weight loss at 6 month and 12 month timepoints. Weight loss from the pilot VA LC-DPP cohort will be compared to weight loss outcomes from previously published DPP studies and the VA MOVE! program. The investigators will also evaluate secondary outcomes including change in physical activity, mental health, psychosocial functioning, and hemoglobin A1c over the 12-month study period. The investigators will also conduct qualitative interviews with participants at 6 and 12 months.
Key facts
- Study ID
- NCT04881890
- Run by
- VA Ann Arbor Healthcare System
- People needed
- 18
- Starts
- 2020-10-05
- Expected to finish
- 2021-12-22
- Last updated by the study team
- 2022-08-08
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 1 year 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.
Where it is running
- Department of Veteran Affairs — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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