Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06841796

The YMCA Healthy Lifestyle Program for Prediabetes

Led by Young Men's Christian Association of the Blue Water Area · Updated on 2025-02-24

84

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

Sponsors

Y

Young Men's Christian Association of the Blue Water Area

Lead Sponsor

D

DexCom, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

The YMCA Healthy Lifestyle Program for Prediabetes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • Diagnosis of prediabetes defined by fasting glucose 100-125 mg/dl or A1c 5.7-6.4%
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Previous use of continuous glucose monitor (CGM)
  • Lack of smartphone or smart device
  • Use of steroids
  • Active cancer treatment
  • Active chronic infection requiring long-term antibiotics
  • Terminal illness
  • Dementia or mental impairment
  • Non-English speaking

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

YMCA of the Blue Water Area

Port Huron, Michigan, United States, 48060

Actively Recruiting

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Research Team

S

Sheila Volker

CONTACT

J

Josh Chapman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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