A Randomized Controlled Trial Evaluating the Safety and Effectiveness of the Intelligently-Driven Signos System for Personalized Weight Management in Overweight and Obese Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Signos Inc
- Enrollment
- 380
- Locations
- 10
- Primary Endpoint
- Average Total Body Weight Loss (TBWL%)
Study Overview
Brief Summary
Metabolic syndrome and resulting downstream health effects remains a growing health concern. In published trials, the use of continuous glucose monitoring (CGM) assists behavioral changes efforts, leading to improved adherence and results from diet and exercise changes in individuals with obesity. Mobile health (mHealth) platforms provide satisfactory, easy-to-use tools that help participants in the pursuit of weight change goals. The investigators hypothesize that the use of CGM data and targeted coaching and nutrition education will assist with weight optimization goals in the general (non-diabetic) population using the Signos mHealth platform, with associated health benefits.
Detailed Description
The scope of this study is to enroll participants into a study that utilizes a continuous glucose monitor (CGM) and mobile health application [Signos] to optimize general wellness and body weight and composition. The Signos users will be compared against a control arm.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •To join our study, participant need to:
- •Be at least 22 years old.
- •Be overweight or obese, which we define as having a Body Mass Index (BMI) between 25 and
- •HbA1c test result should be below 6.5% at the start of the study.
- •Have and know how to use a smartphone that's compatible with the Signos app.
- •Be able to understand, speak, and read English well enough to participate fully in the study.
Exclusion Criteria
- •Participant can't join our study if participant has:
- •Have Type 1 or Type 2 diabetes.
- •Are already using a device to monitor glucose level.
- •Have severe allergies to the sticky part of glucose monitors.
- •Suffer from an eating disorder like anorexia or bulimia.
- •Are currently taking certain medications for diabetes or weight loss.
- •Have had or are planning to have weight loss surgery.
- •Have major health issues like severe kidney disease, untreated thyroid problems, or skin conditions where the glucose monitor would be placed.
- •Have been part of another clinical trial recently.
Outcomes
Primary Outcomes
Average Total Body Weight Loss (TBWL%)
Time Frame: 6 Months
Investigators will measure how much weight, on average, participants have lost after 6 months in the study. This will be calculated as a percentage of their initial weight. This measure helps us understand the effectiveness of the Signos System in helping participants reduce their body weight over a 6-month period.
Responder Rate
Time Frame: 6 Months
Investigators will measure how many participants successfully reached their weight management goals by the end of 6 months. This 'Responder Rate' tells us the percentage of people in our study who effectively managed their weight using the methods we provided, whether it's through the Signos System or standard lifestyle education.
Secondary Outcomes
No secondary outcomes reported
Investigators
Stephanie Kim, M.D., MPH
Clinical Trial Investigator, Signos Inc
Signos Inc