NCT06214221

Using Signos mHealth Platform in Adults for Weight Management

A Randomized Controlled Trial Evaluating the Safety and Effectiveness of the Intelligently-Driven Signos System for Personalized Weight Management in Overweight and Obese Adults

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Signos Inc · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Conditions

• Overweight and Obesity
• Metabolic Syndrome
• Weight Loss

Interventions

Type	Name	Description
DEVICE	Signos 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.
OTHER	Standard Lifestyle Education	In the "Standard Lifestyle Education" arm, participants receive conventional advice on diet and exercise, focusing on general healthy lifestyle habits to manage weight.

Timeline

• Start date: 2024-01-02
• Primary completion: 2024-12-31
• Completion: 2026-04-30
• First posted: 2024-01-19
• Last updated: 2024-10-08

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study