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

Inclusion Criteria4

  • ● 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 Criteria9

  • 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

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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