Using Signos mHealth Platform in Adults for Weight Management
- Conditions
- Metabolic SyndromeWeight LossOverweight and Obesity
- Interventions
- Device: Signos SystemOther: Standard Lifestyle Education
- Registration Number
- NCT06214221
- Lead Sponsor
- Signos Inc
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 380
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Signos System Signos System For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness. Standard Lifestyle Education Standard Lifestyle Education The "Active Comparator: Standard Lifestyle Education" arm in the clinical trial refers to a control group that receives conventional lifestyle modification advice instead of the experimental Signos System.
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Helios Clinical Research
🇺🇸Houston, Texas, United States
Seattle Clinical Research
🇺🇸Seattle, Washington, United States
Helios Clinical Research (Phoenix)
🇺🇸Phoenix, Arizona, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Segal Trials
🇺🇸North Miami, Florida, United States