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The YMCA Healthy Lifestyle Program for Prediabetes

NCT06841796 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-02-24

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Real 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

Sponsors & Collaborators

  • DexCom, Inc.

    collaborator INDUSTRY

  • Young Men's Christian Association of the Blue Water Area

    lead OTHER

Principal Investigators

  • Sushma Reddy, MD · Young Men's Christian Association of the Blue Water Area

  • Annette Gilmer, MD, MPH · Young Men's Christian Association of the Blue Water Area

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06841796 on ClinicalTrials.gov