NCT06841796 The YMCA Healthy Lifestyle Program for Prediabetes
| NCT ID | NCT06841796 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Young Men's Christian Association of the Blue Water Area |
| Condition | PreDiabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2025-02-17 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * ● 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% Exclusion Criteria: * 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
Contact & Investigator
Sushma Reddy, MD
PRINCIPAL INVESTIGATOR
Young Men's Christian Association of the Blue Water Area
Frequently Asked Questions
Who can join the NCT06841796 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PreDiabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06841796 currently recruiting?
Yes, NCT06841796 is actively recruiting participants. Contact the research team at svolker@bluewaterymca.com for enrollment information.
Where is the NCT06841796 trial being conducted?
This trial is being conducted at Port Huron, United States.
Who is sponsoring the NCT06841796 clinical trial?
NCT06841796 is sponsored by Young Men's Christian Association of the Blue Water Area. The principal investigator is Sushma Reddy, MD at Young Men's Christian Association of the Blue Water Area. The trial plans to enroll 84 participants.
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