TrialGlobe

Clinical trial

Using Signos mHealth Platform in Adults for Weight Management

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06214221

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age22 Years to Not listed
SexAll
Healthy volunteersAccepted
ConditionOverweight and Obesity, Metabolic Syndrome, Weight Loss

Full registry criteria

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.

Treatments and study arms

Signos System

Device

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.

Standard Lifestyle Education

Other

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

Primary outcomes

Responder Rate6 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.

Study locations

5 locations were listed when this page was built. The first 40 are shown.

Helios Clinical Research🇺🇸 Houston, Texas, United States
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Segal Trials🇺🇸 North Miami, Florida, United States
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Helios Clinical Research (Phoenix)🇺🇸 Phoenix, Arizona, United States
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Seattle Clinical Research🇺🇸 Seattle, Washington, United States
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Diablo Clinical Research🇺🇸 Walnut Creek, California, United States
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