Metabolic Wellness and CGM

Part of paid clinical trials in Palo Alto, California.

Sponsor
David Kerr
Study ID
NCT06790472
Status
Enrolling By Invitation

Conditions

  • Cardiometabolic Risk Factors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Online Lifestyle Intervention — BEHAVIORAL
    The Metabolic Wellness Program (MWP) is an established 8-week program that provides participants with health education videos and webinars that focus on evidence-based nutrition, fitness, sleep, and stress intervention, including with CGM, allowing participants to monitor their real-time glucose data and to learn which lifestyle choices are best for their glycemic control and personal metabolic health. The program is also intended to help healthy participants maintain their metabolic health and lower their potential risk of developing cardiometabolic disease, as well as at-risk and pre-diabetic participants preventing the progression to T2D and people with established T2D reverse their condition.
  • Continuous Glucose Monitoring — DEVICE
    CGM measurements begin at enrollment with training provided digitally Participants will be asked to "live life as usual" whilst wearing the device with initial 10-14 day readings providing baseline data. Participants will participate in the online lifestyle program, which the investigators refer to as the "intervention stage." Participants will also receive questionnaires on behavior change at the beginning of week 5. During the final two weeks of the program (weeks 7-8), the final 10-14 days of CGM will be used as comparison data with baseline information.

Study Details

The primary objective of this study is to determine the impact of participating in an online lifestyle intervention program on glycemic control as measured by Continuous Glucose Monitoring (CGM), with the primary outcome being the time-in-range (TIR) between 70 and 140 mg/dl comparing before the intervention, at the start of the program (week 1), and after the intervention (week 8).

Key Dates

Start date
Sep 5, 2024
Status verified
Sep 2024
Primary completion
Jun 30, 2025
Completion
Oct 11, 2025

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: SH MWP Participants (Fall 2024)
    Research participants will be Sutter Health employees and their dependents who enroll in the MWP and are invited to participate in a research study about the program. Over 8 weeks, program participants will engage in an online program focusing on evidence-based lifestyle interventions which include education related to food choices, physical activity, sleep, and stress guidance.

Primary Outcome Measure

Glycemic Control (Time-in-Range) [ Time Frame: Baseline and Weeks 2, 7-8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Palo Alto Medical FoundationPalo AltoCalifornia94301-

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