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OpenTrials
Active, Not Recruiting

NCT Number: NCT06214221

Using Signos mHealth Platform in Adults for Weight Management

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Overweight and Obesity Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helios Clinical Research (Phoenix), Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Signos Inc

Industry

Collaborators

  • Lindus Health, Inc.

Registry information

Official study title

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

Acronym: SWEET

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Jan 19, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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