Metabolic Syndrome, Overweight and Obesity, Weight Loss
Conditions
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.
Interventions
DEVICESignos System
The intervention involves the use of the Signos System, a combination of a proprietary software application with a continuous glucose monitor (CGM), to manage weight in overweight and obese adults.
In the Standard Lifestyle Education arm, participants receive conventional advice on diet and exercise, focusing on general healthy lifestyle habits to manage weight.
Sponsors
Lindus Health, Inc.
Signos Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In an open-label randomization model, participants and researchers both know the treatment each participant is receiving. This model involves randomly assigning participants to different treatment groups, ensuring unbiased distribution across interventions, but without concealing the nature of the treatment from either the participants or the study team.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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 40. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate | 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. |
| Average Total Body Weight Loss (TBWL%) | 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. |
Countries
United States
Outcome results
None listed