The YMCA Healthy Lifestyle Program for Prediabetes
Recruiting now · Not applicable
Conditions studied: PreDiabetes
In brief
The goal of this 26 week randomized controlled clinical trial is to learn if using a real time continuous glucose monitor (CGM) in a healthy lifestyle program for adults with prediabetes at the YMCA can improve glucose levels, dietary habits and physical activity The main questions it aims to answer is * Does use of a CGM improve the percent of time spent with glucose values between 70-140 mg/dl * Does use of a CGM improve nutritional habits as measured by Picture Your Plate (PYP) score * Does use of a CGM improve physical activity as measured by International Physical Activity Questionnaire (IPAQ) score Researchers will compare individuals using real time CGM to those not using CGM Participants will be asked to: * attend weekly health coach sessions for 12 weeks followed by 3 monthly sessions. * attend a YMCA class of their choice * fill out questionnaires at baseline, 12 and 24 weeks * have an A1c blood test at baseline, 12 and 24 weeks. * wear a CGM. All participants will wear a blinded CGM at baseline. The intervention group will wear a real time CGM for 24 weeks. The control group will wear a blinded CGM for 10 days at 6, 12 and 24 weeks
Key facts
- Study ID
- NCT06841796
- Run by
- Young Men's Christian Association of the Blue Water Area
- People needed
- 84
- Starts
- 2025-02-17
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ● Adults 18 years or older AND
- A diagnosis of prediabetes as defined by:
- Fasting glucose 100-125 mg/dl OR
- A1c 5.7-6.4%
You may not qualify if…
- Pregnancy
- Previous CGM use
- Lack of smart phone/smart device
- Use of steroids
- Active cancer treatment
- Active chronic infection requiring long term use of antibiotics
- Terminal illness
- Dementia, mental impairment
- Non English speaking
Where it is running
- YMCA of the Blue Water Area — Port Huron, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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