Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
100 participants
OBSERVATIONAL
2024-09-05
2025-10-11
Brief Summary
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Detailed Description
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To evaluate the success (or otherwise) of the MWP, the aim of this pilot study is to assess the impact of participating in the MWP on glycemic control, with the primary outcome being the time-in-range between 70 and 140 mg/dl measured by CGM. Data from this pilot study will provide evidence for a larger future randomized controlled trial (RCTs).
The secondary objectives are to:
* Examine additional changes in CGM variables comparing before (at baseline)and after the intervention (at week 8 and at 3 months post-intervention) Examine changes in self-reported behavior changes related to food choices, physical activity, sleep quality, and stress levels.
* Examine changes in lab values (if available as part of routine clinical care from the previous 12 months and up to 6 months after the program): and
* Examine engagement with the program, engagement with CGM, and satisfaction with the program
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Online Lifestyle Intervention
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
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.
Interventions
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Online Lifestyle Intervention
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
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.
Eligibility Criteria
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Inclusion Criteria
* Adults ≥ 18 years of age at enrollment.
* Willing to wear a CGM device.
* Sutter Health employee or employee's dependent enrolled in SutterSelect Employee Medical Benefits
Exclusion Criteria
* Taking insulin
* Chronic kidney disease and on dialysis
* Any active clinically significant disease or disorder which, in the investigator's opinion, could interfere with participation in the study
18 Years
ALL
Yes
Sponsors
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William Marsh Rice University
OTHER
Abbott Diabetes Care
INDUSTRY
David Kerr
OTHER
Responsible Party
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David Kerr
Senior Investigator, Diabetes and Digital Health Equity
Locations
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Palo Alto Medical Foundation
Palo Alto, California, United States
Countries
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Related Links
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Sutter Health Metabolic Wellness Program
Other Identifiers
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2024.055-1
Identifier Type: -
Identifier Source: org_study_id
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