The YMCA Healthy Lifestyle Program for Prediabetes

Part of paid clinical trials in Port Huron, Michigan.

Sponsor
Young Men's Christian Association of the Blue Water Area
Study ID
NCT06841796
Status
Recruiting
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Conditions

  • PreDiabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Real time continuous glucose monitor (Stelo) — DEVICE
    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

Study Details

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 Dates

Start date
Feb 17, 2025
Status verified
Feb 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Group 1 : Intervention with Stelo
    Stelo CGM
  • No Intervention: Group 2 : control
    Group 2 will only wear a blinded CGM for 10 days at 6,12 and 24 weeks

Primary Outcome Measure

Time in tight range (TITR) [ Time Frame: Assessed at baseline, 6,12 and 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
YMCA of the Blue Water AreaPort HuronMichigan48060
Sheila Volker
[email protected]
810-987-6400
Josh Chapman
[email protected]
810-987-6400
Sushma Reddy, MD (PRINCIPAL_INVESTIGATOR)
Annette Gilmer, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
YMCA of the Blue Water Area· Port Huron, MI

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