RecruitingNot ApplicableNCT06841796

The YMCA Healthy Lifestyle Program for Prediabetes

The Young Men's Christian Association (YMCA) Healthy Lifestyle Program for Prediabetes


Sponsor

Young Men's Christian Association of the Blue Water Area

Enrollment

84 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the YMCA's Diabetes Prevention Program alongside the use of a continuous glucose monitor (CGM) — a small sensor worn on the skin that tracks blood sugar levels throughout the day — for adults with prediabetes. The goal is to see if real-time blood sugar feedback helps people make better lifestyle changes. **You may be eligible if...** - You are 18 years old or older - You have prediabetes (fasting blood sugar of 100–125 mg/dL or A1c of 5.7–6.4%) - You have a smartphone or smart device - You speak English **You may NOT be eligible if...** - You are pregnant - You have previously used a continuous glucose monitor (CGM) - You are on steroid medications - You are currently undergoing cancer treatment - You have a serious infection requiring long-term antibiotics - You have dementia or significant mental impairment - You have a terminal illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEReal time continuous glucose monitor (Stelo)

Real time CGM will be worn continuously for 24 weeks. Participants will be able to see the glucose data from the CGM facilitating changes in nutritional habits and physical activity


Locations(1)

YMCA of the Blue Water Area

Port Huron, Michigan, United States

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NCT06841796


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